ANTIMICROBIAL TRANSCUTANEOUS ACCESS SHIELD AND KIT

Technical Background

The present invention is directed to an apparatus for preventing infection associated with transcutaneous access during medical and surgical procedures.

Background Art

The present invention is directed to an apparatus, kit and method for preventing infection associated with transcutaneous access during medical and surgical procedures. Typical antimicrobial medical and surgical preparation procedures, such as preparation for accessing blood vessels with catheters and other invasive instruments, attempt to reduce the incidence of infection by seeking to eliminate microbes at the skin's surface. However, studies have confirmed that over 20% of microbes reside under the skin's surface, such as in the pores and skin appendages (e.g. hair follicles, sweat glands, sebaceous glands, and the like), where topical preparations cannot adequately penetrate. Elegant research has shown that microbes are present on and in the skin and skin structures after even the most thorough preparation. Research has also shown that it is these microbes that are responsible for most of the catheter related bloodstream infections. The microbes are introduced during insertion of the catheters and while the catheters are left in place as a result of direct contact of the instruments and catheter with the skin. The present invention thus seeks to reduce the incidence of bloodstream infections arising from such access and thereby reduce morbidity, mortality, and healthcare costs.

In 2002, the Centers for Disease Control and Prevention published guidelines in its Morbidity and Mortality Weekly Report in which they outline steps to minimize blood stream infections. The guidelines indicate that in American intensive care units, the average infection

rate for central venous catheters is 5.3 per 1000 catheter days. At 15 million catheter days per year, there are an estimated 80,000 preventable infections per year. The mortality rate with these infections ranges from 0% to 35%. Additional costs range from $34,508 to $56,000 per infection for an annual total of $296 million to $2.3 billion. When entire hospitals are considered, there are an estimated 250,000 catheter related bloodstream infections per year with mortality rates of 12% to 25% and a cost of $25,000 per infection.

U.S. Pat. No. 6,074,380 to Byrne et al, incorporated herein by reference, discloses one attempt to reduce the risks of such infections in transcutaneous surgery though the use of a shallow dish-shaped shield device with an instrument access port. However, the Byrne et al. shield device is a bulky, funnel-type apparatus that is not practical or easy to position and use.

Further, the Byrne et al. device is relatively complex to manufacture.

Accordingly there is a need for an inexpensive, easy-to-manufacture and easy-to-position shield apparatus that resists infection during surgical access into the body of humans and animals, including vascular procedures, orthopedic procedures, organ access, neurosurgery, catheter/tubing insertion, arthroscopic procedures, cosmetic surgeries (e.g. liposuction) and the like.

Disclosure of the Invention

To answer these needs, the present invention provides in one embodiment a shield device that isolates and shields microbes left on and in the skin and skin structures (after typical antiseptic preparation) from instruments accessing the body, including surgical tools, tubes, intravascular catheters and the like, during the insertion and/or leaving in place of the instruments. In other embodiments the shield device may include other shapes with an instrument opening, dependent on the necessary application and access point to the body. It will

be appreciated that embodiments of the present invention may be employed in both human and veterinary medical and surgical procedures.

In embodiments of the invention including a shield for indwelling vascular access catheters, a shield may be used either only during the procedure of insertion or it may be left in place for an extended period of time. A shield left in place protects from bloodstream infections by preventing "pistoning" action at skin's surface of a catheter placed through the skin by the shield anchoring itself to the catheter and to the skin. In various embodiments, anchoring between the catheter and shield is facilitated by adhesives, surface friction, mechanical securing means and the like. Antimicrobial materials comprising, impregnating and/or coating the shield will also be appreciated to further protect from infection when the shield is used in conjunction with a catheter.

It is therefore an objective of the invention to reduce the incidence of bloodstream infections to reduce morbidity, mortality, and healthcare costs.

It is a further objective to eliminate all contact of the instruments with microbes that cause the infections.

In embodiments of the invention a shield of the present invention includes an aperture with top and bottom frustum portions with a narrow midsection, such as an hourglass-type shape. Such frustum portions with larger diameters than a narrow midsection provide enhanced access angles for needles and instruments through the aperture. In an embodiment, an apparatus of the invention is used in conjunction with standard central vascular access technique (Seldinger technique). It will be appreciate that the invention can also be used with all vascular access catheters and may be scaled to accommodate catheters of different sizes, as well as in adult, pediatric and veterinary applications.

In some embodiments an apparatus of the invention is made from a semi-rigid plastic for ease of manufacture and disposability. In embodiments of the invention an antimicrobial is impregnated, sprayed or coated in or on the device. It will be appreciated that an other embodiments, an apparatus of the invention may be manufactured from various polymers and metals, including antimicrobial materials.

In one embodiment of the invention, a handle with a shield positioner and hook are provided to ease placement of the shield device. The positioner, hook and shield device may be packaged as a sterile unit or as part of kit, such as catheter kit. In other embodiments a positioner, hook and shield device may be individually provided in separate sterile packages and usable with each of the other components as necessary.

In further embodiments, a shield device of the present invention may be semi-transparent to allow for visualization of the skin edge to monitor the wound, particularly for infections.

A further objective of the invention, in one embodiment, is to permit the shield device to be left in place for the entire period of short-term or long-term catheter use. In a further embodiment of the invention, a shield device reduces the incidence of infection associated with orthopedic external fixation procedures. In such embodiments, the invention protects the skin from trauma related to the insertion of the pins or screws, thereby making the skin less susceptible to microbial overgrowth.

In still further embodiments, a shield device of the present invention includes perforations, creases or similar deconstruction means, permitting the shield to be removed from the access site, including removable from around a catheter or similar instrument that might remain in place at an access site.

Brief Description of Drawings

FIG. 1 is a cross-section perspective view of a shield device inserted for transcutaneous access in an embodiment of the present invention.

FIGS. 2A-2C are perspective views of a shield device and shield positioner depicting insertion of the shield device into the skin in an embodiment of the present invention.

FIG. 3 is a front partial cross-sectional view of a shield positioner and shield device in an embodiment of the present invention.

FIG. 4 is front view of a hook device in an embodiment of the present invention. FIG. 5 is a front perspective view of a shield positioner and shield device in an embodiment of the present invention.

FIG. 6 is a front perspective partial cutaway view of a shield positioner and shield device in an embodiment of the present invention.

FIG. 7 is a front partial cutaway view of a shield positioner and shield device in an embodiment of the present invention. FIG. 8 is a front perspective view of a shield positioner and shield device with handle in an embodiment of the present invention.

FIG. 9 is a front perspective partial cutaway view of a shield positioner and shield device with handle in an embodiment of the present invention.

FIG. 10 is a front partial cutaway view of a shield positioner and shield device with handle in an embodiment of the present invention.

Best Mode for Carrying Out the Invention

In embodiments, the present invention provides an apparatus and related methods for providing a shield that resists infection-causing microbes that may enter the body during human and veterinary surgical and other medical procedures requiring transcutaneous access and introduction of instruments that might otherwise contact such microbes in the skin or skin structures.

Although depicted embodiments of the invention are particularly well-suited for use in providing catheter access to blood vessels, such as a central venous catheter, the invention is not intended to be limited solely thereto and may be utilized with various instruments and medical procedures, including orthopedic external fixation hardware, neurosurgery and shunt access, arthroscopic procedures, cosmetic surgery (including liposuction), long and short-term catheters, implants, and other access points into the body with a high risk of infection.

Accordingly, it will be appreciated that a shield device and related depicted optional components, such as a shield positioner and hook device, of the present invention may include different sizes (including adult, pediatric or veterinary), different shapes that include an aperture for body access, and may be manufactured from different medical grade materials. In embodiments of the invention, medical grade plastics (such as PVC, polyutherane and the like) provide cost-efficient manufacturing materials for an apparatus of the present invention. In certain embodiments, the shield device may be constructed of flexible materials to facilitate placement. In other embodiments, medical grade metals may be utilized. Different colors may be used to improve visualization of the access point for a procedure and/or for signifying information associated with a procedure such as the individual who inserted the shield 10, when a shield 10 (and e.g. catheter) was inserted, and the like. Further, a transparent or semi-

transparent shield 10 may be used to permit monitoring of the underlying wound. Antimicrobial agents may also be utilized in the manufacture such as impregnation and/or coating of a shield device and related components, including the use of antimicrobial polymers, metals, and the like. Further, in embodiments of the invention, antimicrobial gels, ointments and other wound/opening preparation agents may be applied in conjunction with a shield device of the present invention.

In various embodiments of the invention, a shield apparatus and optional related components such as a shield positioner, hook device and/or catheter, may all be disposable and provided in sterile packaging as a kit, may be packaged with other instruments (such as a catheter kit), or may be individually packaged and used together as necessary for a particular medical application.

In other embodiments of the invention a shield device 10 and positioner 20 may include adjustable components. For example, a shield device 10 may be provided with retractable periphery and/or adjustable aperture wall 11 by conventional means. A positioner 20 may include an adjustable handle length.

Referring to FIG. 1, in one embodiment of the invention, shield device 10 includes an aperture for providing a transcutaneous access point during a surgical or medical procedure in which an instrument is introduced into the body. In the depicted embodiment, shield device 10 comprises a wall 11 surrounding an aperture. In embodiments of the invention providing improved access angles for needles and other instruments over a cylindrical shape, the aperture wall defines top and bottom conical frustum portions with a narrow midsection of the aperture, like an hourglass-type shape. In embodiments, an upper protruding brim 12 and lower protruding brim 14 facilitate holding and shielding the surrounding skin and infection-causing microbes

therein from the access point. In embodiments of the invention, the shield device 10 is particularly well-suited for insertion of a central venous catheter that may require long or short- term insertion.

In an embodiment of the invention shown in FIG. 1, the upper protruding brim of shield 10 covers the surface of the epidermis around the periphery of the aperture and access point.

Accordingly, the upper protruding brim 12 shields instruments from contamination by unwanted touching of the surrounding skin at the access point into the body, such as insertion of a catheter into a vein. Further, the upper 12 and lower 14 protruding brims of shield 10 better stabilize the outer surrounding skin for keeping the shield 10 in place over other prior art shields (such as disclosed in U.S. Pat. Nos. 6,074,380).

It will be appreciated that a surgical incision may be made at the desired access point and the shield device 10 inserted and situated manually by hand and/or with known tools such as forceps and the like.

With specific reference to FIGS. 2A through 2C, and further reference to FIGS. 3-10, in other embodiments, shield device 10 may be inserted and situated with a shield positioner 20. In further embodiments a hook 30 may also be provided, although not required, to retract the skin at the access point and facilitate insertion and positioning of the shield device 10. It will be appreciated that in some embodiments the shield device 10 may be positioned with only one or both of the shield positioner 20 and hook 30. In further embodiments the shield 10 may be provided with an integral or detachable handle 15.

In one embodiment of the invention, a procedure utilizing a shield device 10 is as follows:

1 : The access site is chosen (subclavian, internal jugular, femoral)

2: Skin is prepared using antimicrobial skin prep of choice and drape is placed.

3 : Anatomic landmarks are carefully identified.

4: Skin incision is made.

5: Hook 30 is used to elevate an edge of skin. (FIG. 2A) 6: Bottom protruding brim (or flange) 14 of shield device 10 is placed under skin with positioner device 20. (FIG. 2B)

7: Hook 30 is used to elevate opposite edge of skin. (FIG. 2B)

8: Bottom protruding brim (or flange) 14 of shield 10 is placed under second edge of skin thereby securing the device with upper protruding brim (or flange) 12 secured over the skin surface. (FIG. 2C)

9: Seldinger technique is then used through the aperture defined by aperture wall 11 to access vessel and place catheter.

It will be appreciated that these steps in conjunction with shield 10 eliminate any contact of the tools or catheter with microbes left after the skin prep. In embodiments of the invention a shield may be left in place with a catheter for an extended period of time to protect from bloodstream infections by preventing "pistoning" action at skin's surface of a catheter placed through the skin by the shield anchoring itself to the catheter and to the skin. In various embodiments, anchoring between the catheter and shield is facilitated by adhesives, surface friction, mechanical securing means and the like. Antimicrobial materials comprising, impregnating and/or coating the shield will also be appreciated to further protect from infection when the shield is used in conjunction with a catheter.

With further reference to FIG. 3, in one embodiment of the invention a shield device may include the following non-limiting illustrative dimensions by letter reference: (A) about 2.5 to

3.5 mm; (B) about 2.5 to 3.5 mm; (C) about 17 to 19 mm; (D) about 8.5 to 9.5 mm; (E) about 3.25 to 4.0 mm; (F) about 3.5 to 4.5 mm.

In certain embodiments of the invention, shield 10 may also include one or more creases, perforations or similar deconstruction means that permit the shield to be broken down and removed from an access site,, including from around a catheter or other instrument to be left in place at a site

With further reference to FIGS. 3 and 5-10, in embodiments of the invention positioner

20 is provided with a head 22 contoured to engage aperture wall 11 of shield device. In one depicted embodiment positioner head 22 includes a protruding brim portion and tapered portion contoured for releasably engaging the aperture wall 11 of shield 10. In one non- limiting embodiment positioner 20 includes a handle length from end tip to brim of head 22 of about 50 to 50 mm and a protruding brim diameter length of head 22 of about 10 to about 11 mm. In one non-limiting embodiment positioner head 22 is a frustum portion tapering from a protruding brim along a length of about 4 to 5 mm to the head tip. In a non-limiting embodiment the head tip of positioner head 22 includes a diameter of about 3 to 4 mm.

It will be appreciated that in other non-limiting embodiments positioner 20 may be provided other conventional releasable engagement means in conjunction with shield 10, such as a retractable head portion, releasable grips and the like.

Accordingly, the present invention is not confined to the structures and process described in the foregoing description, but is intended to include those embodiments within the full scope of the following claims.