Patent Description:
Further state of the art relevant for the present invention is described in <CIT>, <CIT> and <CIT>.

The present disclosure relates generally to devices, systems, and associated methods (not claimed) to secure and stabilize a vascular access device inserted into a blood vessel of a patient. In some embodiments, an anchor system to secure the vascular access device to the patient may include an anchor pad, which includes a lower surface, an upper surface, and a window extending through the anchor pad. The lower surface includes an adhesive layer to adhere the anchor pad to skin of the patient. The window provides access to the skin of the patient for application of a topical skin adhesive at an insertion site of the vascular access device, the insertion site being disposed within the window.

The skin adhesive is disposed within the window, preferably to secure the vascular access device in place at the insertion site. The window encloses the insertion site, which facilitates controlled and contained application of the skin adhesive at the insertion site. In further detail, the skin adhesive contacts the skin of the patient within the window, but may be prevented or discouraged from contacting skin of the patient outside of the window, reducing a likelihood of a messy application of the skin adhesive. In some embodiments, the skin adhesive may provide localized stabilization of the vascular access device at the insertion site and/or may provide a seal around the vascular access device at the insertion site, which may prevent infection. The skin adhesive may also increase an indwell time for the vascular access device.

In some embodiments, a securement mechanism may be disposed on the upper surface of the anchor pad and may secure the vascular access device to the anchor pad. In some embodiments, the securement mechanism may include an adhesive well. In some embodiments, the securement mechanism may include a retainer capable of receiving a portion of the vascular access device. In some embodiments, the retainer may be coupled to the upper surface.

In some embodiments, the anchor pad may include a release liner that may cover the adhesive layer and may be removed prior to adhering the anchor pad to the skin of the patient. In some embodiments, the anchor pad may include a slot that may extend from the window to an exterior of the anchor pad. The slot may allow the vascular access device to be inserted into the patient prior to positioning and securing the anchor pad to the skin of the patient.

Not forming part of the claimed invention is a method of securing the vascular access device may include providing the anchor pad and/or the securement mechanism. In some embodiments, the method may include inserting the vascular access device into the patient at the insertion site. In some embodiments, the method may include adhering the anchor pad to the skin of the patient via the adhesive layer. In some embodiments, the method may include securing a portion of the vascular access device within the securement mechanism. In some embodiments, the method may include applying the skin adhesive at the insertion site and/or proximate the insertion site within the window after the vascular access device is inserted at the insertion site and after the anchor pad is adhered to the skin of the patient.

In some embodiments in which the anchor pad includes the slot, adhering the anchor pad to the skin of the patient via the adhesive layer may include placing the window around a vascular access device via the slot, the vascular access device having been previously inserted at the insertion site. In some embodiments, adhering the anchor pad to the skin of the patient via the adhesive layer may include removing the release liner covering the adhesive layer.

In order that the manner in which the above-recited and other features and advantages of the invention will be readily understood, a more particular description of the devices, systems, to secure and stabilize a vascular access device briefly described above will be rendered by reference to specific embodiments thereof, which are illustrated in <FIG>. Understanding that these Figures depict only typical embodiments and are not, therefore, to be considered to be limiting of its scope, the invention will be described and explained with additional specificity and detail through the use of the accompanying Figures in which:.

The presently preferred embodiments of the described invention will be best understood by reference to the Figures, wherein like parts are designated by like numerals throughout. It will be readily understood that the components of the present invention, as generally described and illustrated in the Figures in the present disclosure, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of the embodiments, represented in <FIG>, is not intended to limit the scope of the invention, as claimed, but is merely representative of some embodiments of the invention.

Referring to <FIG>, an example anchor system <NUM> for securing a catheter <NUM> to a patient is illustrated. It is understood, however, that the anchor system <NUM> may be utilized in connection with other vascular access devices, including, but not limited to, fluid supply and drainage lines, feeding tubes, chest tubes, scopes, connectors, adaptors, electrical wires and cables, and the like, any of which may be secured to the patient by the anchor system <NUM>.

The anchor system <NUM> includes an anchor pad <NUM>, which may include various shapes and sizes. The anchor pad <NUM> clean includes a lower surface <NUM>, an upper surface <NUM>, and a window <NUM> extending through the anchor pad <NUM>. The lower surface <NUM> includes an adhesive layer <NUM> to adhere the anchor pad <NUM> to skin <NUM> of the patient.

The upper surface <NUM> includes a catheter securement mechanism, such as, for example, a retainer or another suitable mechanism. The retainer <NUM> is attached to the upper surface <NUM> and may be capable of receiving a portion of the catheter <NUM>. The window <NUM> provides access to the skin <NUM> of the patient for application of a topical skin adhesive <NUM> at an insertion site of the catheter <NUM>, the insertion site being disposed within the window <NUM>. In some embodiments, a catheter tubing of the catheter <NUM> may extend beneath the anchor pad <NUM>, as illustrated in <FIG>, for example, into a blood vessel of the patient. In some embodiments, the retainer <NUM> may include a clip, clasp, clamp, snap, button, strap, Velcro® or any other suitable mechanism for securing the portion of the catheter <NUM> to the anchor pad <NUM>. In some embodiments, the retainer <NUM> may allow selective coupling of the portion of the catheter <NUM> to the anchor pad <NUM>.

The skin adhesive <NUM> is disposed within the window <NUM> to secure the catheter <NUM> in place at the insertion site. The window <NUM> encloses the insertion site, which facilitates controlled and contained application of the skin adhesive <NUM> at the insertion site. In further detail, the skin adhesive <NUM> may contact the skin <NUM> of the patient within the window <NUM> and/or a portion of the anchor pad <NUM> proximate the window <NUM>, but may be prevented or discouraged from contacting skin <NUM> of the patient outside of the window <NUM>, reducing a likelihood of a messy application of the skin adhesive <NUM>. In some embodiments, the skin adhesive <NUM> may provide localized stabilization of the catheter <NUM> at the insertion site and/or may provide a seal around the catheter <NUM> at the insertion site, which may prevent infection. The skin adhesive <NUM> may also increase an indwell time for the catheter <NUM>.

In some embodiments, the catheter <NUM> may be inserted into the patient prior to application of the skin adhesive <NUM> to the insertion site. Given the difficultly and usability challenges of holding the catheter <NUM> in position while applying the skin adhesive <NUM> to the insertion site, it may be advantageous to provide a means of securement of the catheter <NUM>, such as the anchor pad <NUM> and the catheter securement mechanism, prior to application of the skin adhesive <NUM>. Thus, in some embodiments, insertion of the catheter <NUM> and placement of the anchor pad <NUM> on the skin of the patient may occur prior to application of the skin adhesive <NUM>. The anchor pad <NUM> and the catheter securement mechanism may facilitate greater control and accuracy in placement of the skin adhesive <NUM> at the insertion site, reduce an amount of skin adhesive <NUM> required, reduce a likelihood of a messy application of the skin adhesive <NUM>, and reduce a risk of the catheter <NUM> becoming dislodged due to unintentional movement during application of the skin adhesive <NUM>. Further, the anchor pad <NUM> and the catheter securement mechanism may eliminate a need for the clinician to hold the catheter <NUM> while the skin adhesive <NUM> dries, which may reduce a likelihood of the skin adhesive <NUM> bonding to a hand or glove of the clinician.

In some embodiments, an outer edge of the window <NUM> may be spaced apart from an outer edge of the anchor pad <NUM>. In further detail, in some embodiments, the window <NUM> may be inset from the outer edge of the anchor pad <NUM>. In some embodiments, the securement mechanism may be aligned with the window <NUM> such that the catheter <NUM> may extend outwardly from the securement mechanism to the window <NUM>. In some embodiments, the catheter <NUM> may extend through a middle portion of the window <NUM>.

In some embodiments, the skin adhesive <NUM> may include cyanoacrylate or another suitable glue or bonding material. In some embodiments, cyanoacrylate may include liquid monomers and may polymerize on contact with the skin, creating a flexible and/or semi-rigid layer. In these and other embodiments, liquid skin adhesive, e.g. cyanoacrylate, is applied at the insertion site within the window <NUM> and may cure to a solid form within a period of seconds.

In some embodiments, the adhesive layer <NUM> may include any type or form of adhesive that is suitable for use with the methods and embodiments discussed in the present disclosure. In some embodiments, the adhesive layer <NUM> may be a spray-on adhesive, adhesive film, or any other type of adhesive application. In some embodiments the adhesive layer <NUM> may be formed of or include a polymer-based pressure sensitive adhesive. For example, when a polymer-based pressure sensitive adhesive is used in the adhesive layer <NUM>, a bond may formed between the adhesive layer <NUM> and the skin <NUM> of the patient by applying light pressure between anchor pad <NUM> and the skin <NUM>. In some embodiments, the adhesive layer <NUM> may include a slight liquid carrier that facilitates bonding with the skin <NUM>. In some embodiments, the adhesive layer <NUM> may include a single-use glue, such that the adhesive layer <NUM> loses its adhesive properties once removed from the skin <NUM>. In some embodiments, the adhesive layer <NUM> may include an antimicrobial agent to aid in maintaining sterility of the insertion site. In some embodiments, the adhesive layer <NUM> may include a multiple-use glue, which may allow the anchor pad <NUM> to be applied repeatedly.

In some embodiments, the window <NUM> may provide access to skin <NUM> of the patient for application of the skin adhesive <NUM> and/or a cleaning or disinfection agent at the insertion site of the catheter <NUM>. In some embodiments, the cleaning agent may be disposed within the window <NUM> and may contact the skin <NUM> of the patient within the window <NUM>. In some embodiments, the skin adhesive <NUM> and/or the cleaning agent may be prevented or discouraged from contacting the skin <NUM> of the patient outside of the window <NUM> and/or beyond an outer edge of the anchor pad <NUM>. In some embodiments, the skin adhesive <NUM> and/or the cleaning agent may be wicked or pulled into the anchor pad <NUM> from the window <NUM> but may not contact the skin <NUM> beyond the outer edge of the anchor pad <NUM>.

In some embodiments, a material of the anchor pad <NUM> may absorb a portion of the skin adhesive <NUM> and/or the cleaning agent and prevent spreading of the skin adhesive <NUM> and/or cleaning agent beyond the outer edge of the anchor pad <NUM>. In some embodiments, the skin adhesive <NUM> and/or the cleaning agent may be contained within the window <NUM>. In some embodiments, the anchor pad <NUM> may include any suitable medical grade material. In some embodiments, in addition to the adhesive layer <NUM>, the anchor pad <NUM> may include a cloth layer and/or a foam layer. In some embodiments, the cloth layer may include the upper surface <NUM>. In some embodiments, the foam layer may include the upper surface <NUM>. In some embodiments, the cloth layer may be non-woven or woven. In some embodiments, the anchor pad <NUM> may include one or more antimicrobial agents, which may be applied in a film or otherwise.

In some embodiments, the retainer <NUM> may be coupled to the upper surface <NUM> through any number of means, such as, for example, mounting, attaching, etc. In some embodiments, the retainer <NUM> may be coupled to the upper surface <NUM> by means of cyanoacrylate or another bonding material. The retainer <NUM> may increase a force necessary to dislodge the catheter <NUM> at the insertion site. In some embodiments, the retainer <NUM> may include any mechanism configured to engage and secure the catheter <NUM> within the retainer <NUM>. In some embodiments, the retainer <NUM> may prevent movement of the catheter <NUM> in a distal and/or proximal direction. For example, the retainer <NUM> may have at least one abutment. In some embodiments, the retainer <NUM> may include a channel shaped to receive a catheter hub or another portion of the catheter <NUM>. In some embodiments, the retainer <NUM> may be similar to or include any suitable retainer of a StatLock® external stabilization device (Bard Medical) or another external stabilization device.

In some embodiments, the retainer <NUM> may be constructed as a single piece or from multiple different pieces. For example, the entire retainer <NUM> may be formed by injection molding or components of the retainer <NUM> may be formed separately and thereafter joined together. In some embodiments, the retainer <NUM> or portions thereof may be rigid or flexible. The retainer <NUM> may be constructed of one or more materials, which may include, for example, plastics, polymers or composites such as polypropylene, polyethylene, polycarbonate, polyvinylchloride, acrylonitrile butadiene styrene, nylon, olefin, acrylic, polyester, as well as moldable silicon, thermoplastic urethane, thermoplastic elastomers, thermoset plastics, or another suitable material.

In some embodiments, the anchor pad <NUM> may include a slit or slot <NUM> that may extend from the window <NUM> to an exterior of the anchor pad <NUM>. In some embodiments, the slot <NUM> may allow the catheter <NUM> to be inserted into the patient prior to positioning and securing the anchor pad <NUM> to the skin <NUM> of the patient. In some embodiments, the anchor system <NUM> may be placed over the catheter <NUM>, which may be secured to the retainer <NUM> via a snap mechanism or similar mechanism. In these embodiments, the catheter <NUM> may be inserted at the insertion site prior to positioning and securing the anchor pad <NUM> to the patient without presence of the slot <NUM>.

Referring now to <FIG>, in some embodiments, the anchor pad <NUM> may include a release liner <NUM> that may cover the adhesive layer <NUM> and may be removed prior to adhering the anchor pad <NUM> to the skin <NUM> of the patient. In some embodiments, the release liner <NUM> may include any material or combination of materials that permit temporary bonding between the release liner <NUM> and the adhesive layer <NUM>. In some embodiments, the release liner <NUM> may be divided into multiple pieces to ease attachment of the anchor pad <NUM> to the skin <NUM> of the patient. In some embodiments, the release liner <NUM> may include an aperture corresponding to the window <NUM>, as illustrated in <FIG>, or the release liner <NUM> may cover the window <NUM>. In some embodiments, the release liner <NUM> may include paper, plastic, or another suitable material. In some embodiments, the release liner <NUM> may include one or more antimicrobial agents.

In some embodiments, the release liner <NUM> may include one or more pull-tabs <NUM> to facilitate removal of the release liner <NUM> from the adhesive layer <NUM>. In some embodiments, the release liner may be removed by pulling or peeling the release liner <NUM> in a distal direction, in a proximal direction, or toward one or more sides of the anchor pad <NUM>. In some embodiments, the pull-tabs <NUM> may be designed in a variety of configurations and need not be disposed along a centerline of the anchor pad <NUM>.

Referring now to <FIG>, in some embodiments, the window <NUM> may partially enclose the insertion site, which may facilitate controlled and contained application of the skin adhesive <NUM> at the insertion site and allow easy attachment of the catheter <NUM> to the retainer <NUM>. In some embodiments, a distal portion of the window <NUM> may be closed and/or a proximal portion of the window <NUM> may be open. In some embodiments, the window <NUM> may extend beneath the retainer <NUM>. In some embodiments, an edge of the window <NUM> may extend to the outer edge of the anchor pad <NUM>.

Referring now to <FIG>, in some embodiments, the release liner may be removed by pulling or peeling the release liner <NUM> toward one or more sides of the anchor pad <NUM>. The release liner <NUM> of <FIG> is divided into two pieces, according to some embodiments. In some embodiments, the release liner <NUM> may be divided into any number of pieces.

As discussed previously in the present disclosure, the retainer <NUM> may include any mechanism configured to engage and secure the catheter <NUM> within the retainer <NUM>. In some embodiments, the retainer <NUM> may be similar to or include any suitable retainer of a StatLock® external stabilization device (Bard Medical) or another external stabilization device. <FIG> illustrates a peripheral IV catheter coupled to a particular retainer <NUM> similar to the retainer of the StatLock® IV Select Stabilization Device (Bard Medical). However, it is understood that the anchor system <NUM> may be utilized in connection with various types of catheters and/or retainers, a few of which are illustrated in <FIG>. The anchor system <NUM> may be utilized in connection with, for example, peripheral IV catheters, central venous catheters (CVCs), peripherally inserted central catheters (PICCs), hemodialysis catheters, arterial catheters, pediatric IV catheters, neonate IV catheters, integrated IV catheters, non-integrated IV catheters, etc..

<FIG> illustrates the anchor pad <NUM> coupled to a particular retainer <NUM> configured to secure a neonate catheter and similar to the retainer of the StatLock® IV Ultra Neonate Stabilization Device (Bard Medical), according to some embodiments.

<FIG> illustrates the anchor pad <NUM> coupled to a particular retainer <NUM> configured to secure a pediatric catheter and similar to the retainer of the StatLock® IV Ultra Pediatric Stabilization Device (Bard Medical), according to some embodiments.

<FIG> illustrates the anchor pad <NUM> coupled to a particular retainer <NUM> configured to secure a hemodialysis catheter and similar to the retainer of the StatLock® IV Dialysis Stabilization Device (Bard Medical), according to some embodiments.

<FIG> illustrates the anchor pad <NUM> coupled to a particular retainer <NUM> configured to secure a PICC and similar to the retainer of the StatLock® PICC Plus Stabilization Device (Bard Medical), according to some embodiments.

<FIG> illustrates the anchor pad <NUM> coupled to a particular retainer <NUM> similar to the retainer of the StatLock® Arterial Select Stabilization Device (Bard Medical), according to some embodiments. In some embodiments, the window <NUM> illustrated in any of <FIG> may enclose the insertion site, as illustrated, for example, in <FIG>. In some embodiments, the window <NUM> illustrated in any of <FIG> may partially enclose the insertion site, as illustrated, for example, in <FIG>.

Referring now to <FIG>, in some embodiments, the anchor pad <NUM> of the anchor system <NUM> may include a recess or well <NUM>. In these and other embodiments, including embodiments illustrated in <FIG>, the anchor pad may include the slit or slot <NUM> and/or the adhesive layer <NUM>. In some embodiments, the well <NUM> may be an indentation in the anchor pad <NUM>. In other embodiments, the well <NUM> may extend entirely through the pad, similar to the window <NUM>. In some embodiments, the well <NUM> may have a similar shape and/or size as a portion of the catheter <NUM>, which may include one or more stabilization platforms or wings <NUM>. In some embodiments, the well <NUM> may match a foot print of the portion of the catheter <NUM> in shape and size.

In some embodiments, another adhesive layer <NUM> may be disposed within the well. For example, the adhesive layer <NUM> may be disposed at a bottom of the well <NUM>. In embodiments in which the well <NUM> extends through the anchor pad <NUM>, a substrate (not illustrated) may support the adhesive layer <NUM>. In some embodiments, the portion of the catheter <NUM> disposed within the well <NUM> may be pressed into contact with the adhesive layer <NUM> to secure the portion of the catheter <NUM> to the anchor pad <NUM>. In some embodiments, the well <NUM> may be proximate the window <NUM>. In some embodiments, the well <NUM> may be spaced apart from the window <NUM>.

In some embodiments, the catheter <NUM> may be integrated, as illustrated in <FIG>. For example, the catheter <NUM> may include the BD NEXIVA™ Closed IV Catheter (Becton, Dickinson and Company), the BD SAF-T-INTIMA™ Closed IV Catheter (Becton, Dickinson and Company), or another integrated catheter <NUM>.

Referring now to <FIG>, in some embodiments, a method <NUM> of securing a catheter may begin at block <NUM>. At block <NUM>, an anchor pad may be provided. The anchor pad may include or correspond to the anchor pad <NUM> discussed with respect to any of the previous <FIG>. Block <NUM> may be followed by block <NUM>.

At block <NUM>, a catheter securement mechanism may be provided. In some embodiments, the catheter securement mechanism may include a retainer and/or an adhesive well. The retainer and the adhesive well may include or correspond to the retainer <NUM> and the well <NUM>, respectively, discussed with respect to any of the previous <FIG>. In some embodiments, the retainer may be coupled to the anchor pad. Block <NUM> may be followed by block <NUM>.

At block <NUM>, a catheter may be inserted into a patient at an insertion site. The catheter may include or correspond to the catheter <NUM> discussed with respect to any of the previous <FIG>. In some embodiments, once a distal tip of the catheter is properly placed into a blood vessel of the patient and an introducer needle is withdrawn from the blood vessel and the distal tip, the catheter may be left in place to provide intravenous access to the patient. Block <NUM> may be followed by block <NUM>.

At block <NUM>, the anchor pad may be adhered or attached to the skin of the patient via an adhesive layer disposed on a lower surface of the anchor pad. The adhesive layer may correspond to the adhesive layer <NUM> discussed with respect to any of the previous <FIG>. In some embodiments in which the anchor pad includes a slot, which may correspond to the slot <NUM> discussed with respect to <FIG>, adhering the anchor pad to the skin of the patient via the adhesive layer may include placing an window of the anchor pad around the catheter via the slot, the catheter having been previously inserted at the insertion site. In some embodiments, adhering the anchor pad to the skin of the patient via the adhesive layer may include removing a release liner covering the adhesive layer. Block <NUM> may be followed by block <NUM>.

At block <NUM>, a portion of the catheter may be secured within the catheter securement mechanism. Block <NUM> may be followed by block <NUM>.

At block <NUM>, a skin adhesive may be applied at the insertion site and/or proximate the insertion site within the window. The skin adhesive may correspond to the skin adhesive <NUM> discussed with respect to any of the previous <FIG>. In some embodiments, the skin adhesive may be applied after the catheter is inserted at the insertion site and after the anchor pad is adhered to the skin of the patient. Block <NUM> may be followed by block <NUM>.

At block <NUM>, a securement dressing may be applied over top of the anchor pad, the catheter securement mechanism, and the catheter. In some embodiments, the securement dressing may include an antimicrobial agent, such as, for example, TEGADERM™ or CHLORASHIELD™.

Claim 1:
An anchor system (<NUM>) for securing a catheter (<NUM>) to a patient, comprising:
a retainer (<NUM>) capable of receiving a portion of the catheter;
an anchor pad (<NUM>) comprising a lower surface (<NUM>), an upper surface (<NUM>), and a window (<NUM>) extending through the anchor pad the lower surface comprising an adhesive layer to adhere the anchor pad to skin of the patient, the retainer attached to the upper surface, and an insertion site disposed within the window; and
a liquid topical skin adhesive (<NUM>) disposed within the window and applied to the insertion site, wherein the window facilitates controlled and contained application of the liquid topical skin adhesive at the insertion site.