SECUREMENT DEVICE

A securement device is provided for engaging a catheter in an engaged position on a patient's skin. The device is formed of a flexible base having two half portions foldable to adhere to a sandwiched engagement of the catheter along a pathway. A tearaway portion in one half portion when removed forms an exit for the catheter to allow for changing of the securement device. Pads are provided in positions to communicate anti-pathogenic agents to the skin at the insertion site.

In this description, the directional prepositions of up, upwardly, down, downwardly, front, back, top, upper, bottom, lower, left, right and other such terms refer to the device as it is oriented and appears in the drawings and are used for convenience only; they are not intended to be limiting or to imply that the device has to be used or positioned in any particular orientation.

Now referring to drawings inFIGS. 1-29, wherein similar components are identified by like reference numerals, there is seen inFIG. 1,FIG. 2, andFIG. 3views of a particularly preferred mode of the catheter securement device10. The device10is preferably formed from a first half portion12and second half portion28, which are held in operative engagement in a central area therebetween forming hinge portion30providing a means for folding one half over the other and into an as-used position, adhered to the skin of the patient, and in a sandwiched engagement with the catheter components such as inFIGS. 11 and 27.

Shown in the figures, the hinge30engages the lateral side edges of the respective half portions12,28such that the folding procedure may be performed horizontally, (i.e right to left, or vis versa) to thereby achieves a registered engagement of the first half portion12with the second half portion28to position a sandwiched engagement of the catheter64underneath and aligned with a frangible portion38. In accordance with a first preferred mode, the half portions12,28may be formed from conventional adhesive medical securement material, such as polymeric or plastic material such as TAGADERM or any other suitable material.

The first half portion12, defines a lower or skin-adjacent portion of the device10when in the folded mode (FIGS. 11 and 20and27). The first half portion12includes a top surface14, bottom surface15, distal end19, and a proximal end16wherein a first pad member24is engaged. The first half portion12preferably includes a formed cut or notch17which is in a communication through the first pad member24to define an engagement and support area support area surrounding the insertion and catheter. In use the support area provides a protective covering that shields the insertion site2000and contacts the PICC line or other type of intravenous catheter64exiting the insertion site2000.

The first pad member18is preferably configured to be impregnated with and/or communicate a reservoir of anti-pathogenic agents over time, at and around the insertion site2000. Preferably it may also be layered to provide a contact section to provide a means for absorbing wound drainage at the insertion site2000. To that end, the first pad member24can be one or a combination of pad forming materials from a group including foam, hydro-colloid, polyurethane foam, polymeric pads, hydrofibers, gauze, biosynthetics, hydropolymers, alginates, or any other material suited for the intended purpose set forth in this disclosure. It may be formed in layers or a laminate configuration to allow for the multiple actions noted.

The reservoir of anti-pathogenic agent can be impregnated into the material, or a layer thereof such as a gel, or otherwise formed within or in the pad member18, or it may be also communicated to the first pad member18from a secondary reservoir engaged with one side surface of the device10. The reservoir of communicated agent for all types of pathogens and bacteria and germs and the like anticipated in a hospital setting and/or at such insertions sites, can be one or a combination of anti-pathogenic agents from a group including, manuka honey, silver nitrate, silver ions, aluminum ions, chlorhexidine gluconate (CHG), para chloro meta xylenol (PCMX), octenidine Di-hydrochloride (ODH), and other suitable materials to the discerned pathogen causing the patient infection.

The contact or bottom surface15of the first half portion12includes an adhesive layer which provides means to removably engage the user skin when in the used mode. In use (FIGS. 8-13and27, and others) the first pad member18is positioned over and surrounding the insertion site2000and concurrently engages around the catheter64exiting the insertion site2000on a patient's skin such as on the arm1000, or other location. As shown, the catheter64and first pad28engagement is enhanced via a formed slot either declining in cross-section or a shaped curvilinear slot20extending from a proximal terminating edge16of the pad18a distance toward the distal end19. There may also be included a notch22or17at the terminating edge16of the slot20to aid the user in guiding the catheter64into the slot20.

Slot20is preferably formed in one mode in a curvilinear manner resembling a hook as can be clearly seen in the figures. As such, the support area of the pad member18can achieve a hooked splayed engagement with and around the circumference or most thereof, of the catheter64(FIG. 10) exiting the insertion site2000. This mode of the slot allows the first pad member18to completely surround and envelop the catheter64and insertion site, in an engagement that aids in securely engaging the catheter thereon and completely covering the insertion site2000to prevent communication of bacteria to the site2000for reducing infection.

The device10is configured to provide a means for a triangulated engagement of the device10, with the skin1000and with the engaged catheter64by providing a multi angle resistive support to any dismount, from multiple opposing angles. This configuration provides means for aiding the user to position device10in the used position (FIGS. 9 and 11and27) in an aligned registered engagement with the catheter64, and covering the insertion site2000.

The legs and body of the device forming the triangulated engagement means provides multiple support adhered surfaces at converging vectors by employing at least two extending arm portions26which are configured traverse to the axis of the engaged catheter64, in a substantially “Y”-shape. The “Y” shape as shown in the figures, with the catheter64aligned with the axis of the “Y”, additionally provides a means to maintain a secured mounted engagement of the device10to the skin of the patient. Further, the “Y”-shaped portion encourages the natural movement of patients skin between the distal tips of the “Y” and therefor improved comfort to the patient.

The second half portion28is formed of a mating or top surface32, a bottom surface33, and proximal34and distal36ends or edges. The mating or top surface32preferably includes an adhesive layer such that when folded over, will achieve an adhered engagement with the top surface14of the first half portion12and the catheter64.

The second half portion28additionally can preferably include a second pad member44which is configured to roll or rotate to a registered engagement with, and communicate over, the first pad24and support area of the first half portion12when folded thereover. The second pad member44is shown substantially circular as to provide a substantial matching covering of the notch17and first pad24and support area. However, it is noted that the pad44can be any shape suitable for the intended purpose and may change to match a changed shape of the first pad24.

The second pad member44may also preferably be impregnated with or otherwise formed to hold a time-dispensed reservoir of an anti-pathogenic agent to the insertion site and to the first pad member24, to provide an additional means to recharge the first member and to communicate anti-pathogenic agents to the insertion site2000due to the proximity to the support area in the used mode, covering and contacting the first pad member24.

FIG. 4shows a particularly preferred mode wherein the device10employs one or a plurality of removable backing layers50,52, for removably covering the adhesive on the two half portions which is especially well configured for packaging and storing the device10. The backing layers50,52will cover the adhesive surfaces of the device10, and the user will remove the prior to operative employment of the device10.

The second or bottom surface33of the second half portion28is preferably non adhesive, as it will be the exposed surface when folded over in the used mode shown inFIGS. 11 and 27. To aid in the removal of the catheter64from the device10, and patient comfort, there is included at least one perforation-defined, frangible, or tear-away portion38, which with the two half portions in registered engagement, aligns with the axis of the length of catheter64, extending from the insertion site2000.

Shown inFIG. 12andFIGS. 13 and 25for instance, a tab42of the tear-a-way or frangible portion38defined by perforations extends past the edge of the central portion30of the body of the device10, and may be easily gripped with gloved fingers and pulled away from the device10, and remove the frangible portion38as shown inFIGS. 28-29. As such, the frangible portion38provides a means to expose a passage39and thereby provide a disengagement of the underlying catheter64, through the wall forming the second half portion, so that the securement device10or the catheter64may be changed or removed without imparting force to the catheter64or the patients skin or insertion site, all of which can be painful to the patient.

This removable or frangible portion28being torn away easily, is a particular advantage over prior art since the catheter64can be removed without the need to completely remove the device10(i.e the first portion12and the remaining parts of the second portion28) from the adhered engagement with the users skin, which will commonly tug on the users skin and potentially irritate the catheter64inserted in the vein. This affords an easy replacement of the device10, or removal of the catheter64without first removing the first half portion from the skin of the patient.

In additional preferred modes, the exposed or top surface32of the second half portion28, exposed when in the used position, may include a mount46engaged at the proximal end34. The mount46is shown but can be moved to be preferably configured to removably engage one or a plurality of mounting auxiliary components48, in operative engagement with the device10shown inFIG. 6. The mounting auxiliary components48may be one or a combination of such components from a group including time release, or time delayed, or other reservoirs or supplies of anti-pathogenic fluids or agents, or, a light projection means for providing phototherapy to the insertion site when in the folded over as used mode. Communication of such agents or light therapy would be through the wall surface of the second half portion or an aperture formed therein.

In the modes employing light projection means, a power source (such as a battery) and LED or other powered light emitter will be included as part of the light mounting component48or provided in a communication therewith from a battery or power source or engaged switch allowing for timed or pulsed communication of light to the insertion site and down the catheter if formed of polymeric material configured therefor, such as a catheter having a noticed exterior configured to capture transmitted light, and communicate such light along the path of the catheter wall through the insertion site and into the patient.

If a switched power supply is engaged, a microprocessor may be employed to pulse the communicated light and/or provide light therapy at timed intervals to the insertion site and surrounding area to aid in the killing of pathogens and tissue regeneration. Different wavelengths of light may be communicated to the insertion site by the employment of LED's or other light generation means, in operative engagement with a mounting component48. For instance, light in the red wavelengths encourages cell regeneration while light in the blue wavelengths kills pathogens. In that fashion, using the employed switch or software running on a microprocessor, different wavelengths of light therapy can be communicated in a single session or multiple sessions as needed.

In the folded, as-used mode, in registered engagement of the two half portions, the mount46and an operatively engaged mounting component48is operatively positioned over or adjacent the support area of the first half portion12and through the close proximity can communicate the anti-pathogenic agent or light through a contact or communication with the underlying pad member44and/or through a communication through the bandage portion to the insertion site2000.

In the case of light therapy, a bandage forming the second half portion, and parts of the first half portion, of light transmitting material will allow the insertion site to stay covered even with the addition of light therapy.

Further, a mounting component48with an additional supply of an alternative or the same antipathogenic agent also allows for supplemental treatment without uncovering the insertion site and risking contamination. The mount46engages the bandage using attachment means such as adhesives, and as shown inFIG. 12athe mount46is formed as a collar type, bayonet, or other frictional or mechanical mount for the mounting component48. The mounting component48thus operatively engages thereto in a removable engagement to allow for replacement or substitution or additional antipathogenic therapies without uncovering the insertion site and inviting the perils which occur conventionally after a securement disruption.

FIG. 5andFIG. 9, show a particularly preferred phototherapy mounting component54, which is employable in combination with the device10in the as-used mode. The phototherapy mounting component54includes a catheter engagement portion56having a notch or recess58configured to engage around the exterior surface of the catheter64. A light projection portion62is also provided and includes a plurality of phototherapy light-emitting components, such as LED's as noted above which may transmit light on one or a plurality of differing wavelengths.

As shown inFIG. 9, a means for light emitting phototherapy mounting component54can be optionally employed with the device10in the used mode by engaging a recess58around the exterior of the catheter64, extending from the insertion site2000, then folding the light projection portion62about a common hinge60such that the light emitters project over the support area and insertion site2000to provide light therapy thereto and/or down the wall of the catheter, which may be configured to receive light transmissions exterior to the insertion site, and to broadcast them at the insertion site and below the skin such as with notches in the exterior of the catheter64forming projecting or fresnel lens configuration portions of the wall of the catheter.

FIG. 7shows a view of a particularly preferred catheter64employing means for phototherapy and one or a plurality of wavelengths as well. The catheter64as earlier noted, can be formed with fiber optic65portions to communicate light provided by the phototherapy component54, into the insertion site2000. In addition, the catheter fitting66, conventionally called a luer lock or STATLOCK, can include planar wing portions68having light-receptive coatings, or configurations such as a prism, which capture and communicate the transmitted phototherapy light from the phototherapy component54, to the fiber optics65of the catheter64. The catheter64under the skin of the patient would have notches or prisms or fresnel lenses or the like formed in the wall thereof, to cause a communication of the light traveling through the wall axially, and light emissions below the skin surface as a means to kill pathogens. The light in all modes may be provided in one or a plurality of wavelengths, and may be pulsed, continuous, or at timed intervals. Light therapy in the 620-660 nm range may be employed for pain management, accelerated wound healing and cell growth, improvement in blood properties and blood circulation.

As noted, transmitted light in the blue range of (400-600 nm) may be employed to kill bacteria that are frequently found in infected wounds with 400-480 nm being particularly favored for this purpose. These ranges and others are anticipated for employment herein singularly or in combination, in continuous, timed, or pulsed modes, and combinations thereof.

FIG. 12ashows a collar style mount46adapted for a sliding of a mounting component48therein to provide light therapy or to communicate more or different anti pathogenic agents to the pad member44to enhance performance if resistance is noted to the pathogenic agent being used. A frictional engagement or a mechanical engagement can be provided by the collar style mount46with the mounting component48having light therapy or communicable pathogenic agents thereon. This allows for the addition of supplemental antipathogenic agents such as silver ions or aluminum ions to the pad member44, or light therapy to the insertion site and surrounding areas with a phototherapy component54, after engagement of the device without uncovering the insertion site. Keeping the securement bandage in place covering the insertion site, while allowing for supplemental medications and therapies such as light therapy to enhance healing or kill pathogens, avoids the pitfalls of securement disruption which currently are a major source of infection.

FIG. 14shows cross sectional view of a preferred mode of the pad members18,44of the device10. In this mode the pads18,44can be formed from a plurality of planar layers, for example a first layer of foam or padding70, an intermediate layer of anti-pathogenic impregnated material72, and a second layer of foam or padding74or fluid absorbing material to aid drainage. Various other combinations and pluralities of layers may also be employed and are anticipated. The layering of the pads18,44can provide a means to regulate the rate of communication of the anti-pathogenic agent out of the pad18,44and onto the insertion site2000and surrounding skin, and the rate can be of the designers choice. Any or all of the pads described herein may be employed on any mode or configuration of the device herein, and may be employed without, or in combination with the light therapy emitting components herein.

FIG. 15andFIG. 16show unfolded and folded positions of yet another mode of the securement device10. In this mode the first and second portions12,28are engaged about a hinge31disposed on the distal edges19,36such that the folding procedure is done vertically (i.e top to bottom, or vis versa). There is additionally included a notched portion76which will allow the catheter64to communicate from the support area, through a sandwiched engagement between the first portion12and second portion28, and out and away from the device10.

FIG. 17shows yet another preferred mode wherein the device10is providable to the user in a kit78. The kit78may include a plurality of the bandage device10, phototherapy mounting component54, mounting component48, and catheter64. The kit78may also include an introducer and catheter fittings (such as a STATLOCK or luer lock) employing means for communicating photo therapeutic light to the insertion site2000. The kit78may be providable in a sterilized package80.

FIG. 18depicts another enlarged overhead view of the securement device10showing the two halve portions12and28engaged at a central portion30defining a hinge and having paper or film covering adhesive on the second half portion which extends to a tab42for dismount.

FIG. 19depicts an overhead view of the device ofFIG. 18, with film or paper removed by pulling on the tab42, and showing adhesive43on the second half portion28and frangible portion38and also surrounding the second pad member.

FIG. 20depicts an overhead view of the opposite side of that shown inFIG. 18, and showing the pull tab42portion of the paper or film covering the adhesive on the first half portion12.

FIG. 21depicts the device ofFIG. 20with the film or paper removed and adhesive43covered area surrounding the first pad member24.FIG. 22depicts the insertion site2000on the skin of the arm1000of a patient with catheter64extending therefrom and ready for engagement with the device10.

FIG. 23depicts a first step of removing the covering from the adhesive43on the contacting surface of the first half portion12of the device10.

FIG. 24depicts the sliding engagement of the device10as configured inFIG. 23, to place the slot formed in the first pad24to a position abutting and surrounding a portion of the circumference of the catheter64extending from the insertion site.

FIG. 25shows a next step in removing the covering for the adhesive43on the second half portion28by pulling on the extending pull tab42to expose the underlying adhesive43.

FIG. 26depicts the device10adhered to the patient's skin of the arm1000with the second adhesive covering removed from the adhesive43which is shown, and ready for the step of folding the device10in the middle area30, and onto itself.

FIG. 27shows the device ofFIG. 26secured in a registered engagement of the first pad24adjacent the second pad44, and the elongated frangible portion38aligned with and contacting the catheter64. Also shown is an enlargement of the registered overlapping engagement of the first and second pads.

FIG. 28depicts the step of removing the frangible portion38from the second half portion28to expose the exit passage39for the catheter64by pulling on the tab42to remove the tear away section defined by the frangible portion38.

FIG. 29shows the result of removal of the frangible portion38and formation of an exit passage39in the area formerly occupied by the frangible portion38. As noted this allows the device10and/or the catheter64to be disengaged so that removal of either does not tug on the other and injure or cause pain to the patient.

The invention of the disclosed device herein has other applications, potentially, and one skilled in the art upon reading this disclosure and being educated with regard to this device and method could discover such. The disclosure and explanation of the features of the disclosed device does not limit the claims of this application, and other applications developed by those skilled in the art are considered to be included in this invention.

It is additionally noted and anticipated that although the device is shown in its most simple form, various components and aspects of the device may be differently shaped or slightly modified when forming the securement device herein. As such those skilled in the art will appreciate the descriptions and depictions set forth in this disclosure or merely meant to portray examples of preferred modes within the overall scope and intent of the invention, and are not to be considered limiting in any manner.