Organizing, anchoring, safety device for peripheral intravenous catheters

An organizing, safety and securement device for use with a peripheral intravenous catheter includes: (a) a catheter base with an opening, that is covered by a transparent membrane, and an upper securement element with a luer fitting indentation, (b) a lower securement element having a top surface with a luer fitting indentation (c) an organizer base with upper and lower clamping members that are hinged together and have free surfaces with tubing indentations that include color coded, mainline and apinch tubing portions, and (d) a tether which connects the catheter and organizer bases.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention generally relates to surgery and means for securing conduits to a body. Specifically, the invention is directed to an organizing, safety and securement means or device and its related methods for dealing with peripheral intravenous catheters.

2. Description of the Related Art

Medical treatment of patients frequently involves the use of peripheral intravenous catheters to direct fluids into the bloodstream. The fluid (e.g., parenteral liquid, blood, medication or anesthesia) typically drains from a container positioned above the patient. The fluid flows through tubing and into the catheter. The catheter and fluid tubing are commonly removably attached by a luer-type or luer connector, adapter or fitting.

In common practice, a health care provider uses adhesive or surgical tape to maintain the catheter in place on the skin of the patient. The connection between the tubing and the catheter is likewise maintained by use of tape. A safety loop may also be formed in the tubing so that any tension applied to the tubing is absorbed by the slack of the safety loop and does not directly pass to the catheter, and typically this loop is also taped to the skin of the patient.

Furthermore, this catheterization process can often requires frequent disconnections between the catheter and the fluid supply tube (e.g., to replace the tubing on a frequent basis, to inspect the insertion point for inflammation or infection, to change a patient's dressing gown) which can necessitate a repeat of the above-described taping procedures. This frequent application and removal of surgical tape can result in the excoriation of the skin of the patient in the area of the insertion.

Also, it can happen that the integrity of the catheter's fluid flow is interrupted when there are problems with the adhesive tape's ability to secure the catheter to the patient's skin due to, for example, accidental tugging or pulling on the tubing that is attached to the catheter. This situation often happens during times when the patient is anxious, combative or has suffered a considerable amount of blood loss due to their medical status. These can be high acuity instances when the patient needs to have a stabilized intravenous access for the administration of life saving medications, intravenous fluids or a blood transfusion. Avoiding such interruptions and keeping the time required to reestablish the intravenous feed to a minimum can be critical.

Additional safety concerns can arise when the patient needs to be simultaneously, intravenously receiving multiple types of fluids, some of which can be mixed (plain intravenous fluids or medications that can be mixed without adverse effects) and other that cannot (e.g., anti-infectives, patient controlled analgesia, potassium/electrolytes, insulin drips, narcotics, chemotherapy, heparin/anti-coagulants). Avoiding fluid-mixing mistakes in these situations can be a life or death matter.

A number of catheterization systems have been developed to address many of the above listed concerns (i.e., securement, minimize stress on the patient's skin, safety concerns related to fluid mixing mistakes). See, for example, U.S. Pat. Nos. 10,350,388; 9,017,290; 8,979,805; 8,834,427; 8,556,859; 8,500,698 and 7,967,792.

In spite of these advancements, there still continue to be widespread reports of problems and dissatisfaction with current peripheral, intravenous catherization systems or devices. Thus, there continues to exist a need to improve the methods and devices that are used in current peripheral, intravenous catherization procedures.

DESCRIPTION OF THE PREFERRED EMBODIMENT

The present invention generally relates to improved methods and means for peripheral, intravenous catherization systems or devices, including those that provide for the enhanced securement of the device, minimizing the adverse consequences of the use of the device on a patient's skin, and providing the means for better organizing multiple intravenous lines so as to avoid fluid mixing mistakes.

FIG.1shows the typical, prior art practice of using considerable amounts of surgical tape to maintain or secure a peripheral, intravenous catheter2in place on the skin of the arm8of a patient. In this instance, the catheter has the typical luer fitting3upstream of the catheter's cannula4. This catherization assembly also has a short length of tubing5with the appropriate luer connectors at both ends and a clamping means6attached to the tubing to help regulate the flow rate of the fluid through the tubing. It can also be considered to have something of a safety loop7in the tubing so that any tension applied to the tubing is absorbed by the slack of the safety loop and does not directly pass to the catheter.

It should also be noted that the catherization assembly shown is a relatively simple one compared to other, more complex assemblies that may have additional features (e.g., a Y-connector immediately upstream of the catheter's luer fitting so as to allow for two tubing lines that lead to their own fluid containers/reservoir, each of which has a different fluid; thereby allowing these differing fluids to pass through the same opening in the patient's arm, an injection port connector for the insertion of a syringe that can be used to, on a-one-time basis, insert medication through the catheter and into the patient's vein). These additional features can also require additional surgical tape6aor taping on other parts of the patient's arm.

Shown inFIG.2is a perspective view of a preferred embodiment of the present invention. It is an organizing, anchoring (securement) and safety device or sysytem1, or PIVOASS, for use with a wide variety of peripheral intravenous (PIV) catheter assemblies. Its major components are a peripheral intravenous catheter base or catheter base10, a tubing organizer base or organizer base50and a tether90that has a downstream end92to which the catheter base is attached and an upstream end94to which the organizer base is attached. The tether shown inFIG.2has been rotated 180 degrees in passing from its upstream to its downstream; this allow the top surface52of the organizer base and the bottom surface14of the catheter base to be shown in this single perspective view.

The top surface52of the organizer base50is shown because it has an attached organizer60that has two color-coded passageways. One 70 of which is used by mainline tubing5athrough which can flow only fluids that can be mixed, while the other passageway72is used by apinch tubing through which can flow only fluids that cannot be mixed (e.g., high risk medicines such as anti-infective agents, anti-psychotics, potassium, insulin, narcotics and sedative agents, chemotherapy and heparin and other anticoagulants—these are represented in the medical community by the acronym ‘A PINCH’ or apinch).

The bottom surface14of the catheter base10is shown because it has attached to it a securement element or means20that is configured to interact with top, outer surface of the catheter's luer fitting3so as to help prevent the catheter's movement once the tip of its cannula4has been inserted into the vein of a patient. Interacting, for this same purpose, with the with bottom, outer surface of the catheter's luer fitting3is a cradle assembly or means40which is itself attached to the top surface of a cradle base42whose bottom surface has an adhesive that is used to releasably attach the cradle base to a patient's skin.

FIGS.3A and3Bshow, respectively, the top 12 and bottom14surfaces of the catheter base10. It has an elongated shape and extends between its downstream10aand upstream10bends. This base has a boundary edge16and is made from a thin foam material. Proximate its downstream edge is a first portion that includes an opening18, which has a perimeter18athat extends between its top and bottom surfaces. A transparent membrane19covers this opening by having its edges adhered to this base's bottom surface.

When the PIVOASS is in use, this opening18will be placed over the insertion point where the catheter's cannula4enters a patient's skin so as to allow a caregiver to visually monitor this insertion point to help ensure that the patient's skin in this area is not adversely impacted by the use of the catheter. A medical grade adhesive30is used on this base's bottom surface14and around the edges of the transparent membrane to attach the catheter base to a patient's skin and seal the area around the catheter's insertion point from infection-causing micro-organisms, etc. entering the area.

The securement element or means20which is attached to a second portion of the catheter's base's bottom surface14is seen to be configured so that it can interact with top of the catheter's luer fitting3to help prevent the catheter's movement once the tip of its cannula4has been inserted into the vein of a patient and the catheter base's adhesive is being used to secure the base to the patient's skin. SeeFIG.3Cwhich shows an illustration of the peripheral intravenous catheter's base and its upper securement element or securement means20hovering over the top surface of a catheter's luer fitting and when its bottom surface is about to be placed in the lower securement element or cradle means40which is attached to the top surface of the cradle base42that has been attached to a patient's skin. Both the securement20and cradle40means will typically be plastic elements with outer or free surfaces22(upper-securement-element free surface),44(lower-securement-element free surface), that contain indentations24,46or unique shapes that have been designed to interact with the configuration of the luer fitting's outer surface so as to securely lock it in place once these elements are properly aligned and adhered to the luer fitting and the catheter10and cradle42bases have been secured to a patient's skin.

Note also inFIG.3Cthat two tubing lines appear to be connected to the catheter shown. This suggests that a Y-connector is being used just upstream of the luer fitting so as enable these two pieces of tubing to connect through the Y-connector to the catheter. This is often a preferred mode of operation as it allows a second fluid or medicine to flow into the patient's vein through the single injection point.

A significant advantage of the present invention over the prior art, where only tape is being used to anchor a catheter and its intravenous tubing, is that the catheter and cradle bases provide significant, additionally anchoring ability for the catheter beyond that which is provided by the adhesive which is used to adhere the portion of the catheter base surrounding its opening to a patient's skin. Additionally, the present invention1provides still more securement features, while also enhancing the safety in using a peripheral, intravenous catheter2, by utilizing upstream of the catheter base a second base or an organizer base50. SeeFIGS.4A and4B.

FIG.4Ashows an upstream, perspective view of an organizer base50and its attached organizer60that is being used in this illustration with mainline tubing5awhich is passing though the organizer's color-coded (e.g., green), mainline tubing passageway70. Meanwhile, the organizer's color-coded (e.g., red), apinch tubing passageway72is not in use. It should be noted that the color-coding of these passageways provides an additional, much-needed safety step in the process of initiating a new IV line as it forces the caregiver who is installing the line to take a moment and give some consideration to the type of fluid that will be used in the line and whether or not it is a high risk, apinch fluid that cannot be mixed with other fluids. To further avoid the possibility of improperly mixing medications or fluids, it is recommended that color-coded labels be applied to the tubing itself at a position on the tubing that is just upstream of where the tubing will pass through the present invention's organizer. The same type of color-coded labels are also recommended for any medication ports in the tubing.

FIG.4Bshows an elevated, perspective view of a preferred embodiment of an organizer60its “open” position and thus reveals that it has upper62and lower64clamping members which are hinged together on the side by a hinge68so as to allow the organizer's upper member to be moved upwards to temporarily gain access to either of the organizer's passageways. Indentations66(i.e., bottom-portion-tubing indentations that include mainline and apinch portions) in the lower member top surface and similar indentations (i.e., top-portion-tubing indentations that include mainline and apinch portions) in the upper member's bottom surface provide for the simultaneous use of both mainline and apinch tubing. These mainline and apinch portions are color coded to prevent connecting the wrong fluids to the tubing that runs through these color coded passageways. In addition to the embodiment shown, an alternative embodiment involves providing each color-coded passageway with its own individual hinged, upper and lower members that can be open and closed to accept or receive the appropriate tubing.

The organizer base's bottom surface54is typically coated with a medical grade adhesive to attach the organizer base to a patient's skin. The organizer base has multiple functions: (1) to secure the tubing and prevent it from dangling or tugging at the catheter's insertion site, (2) to organize medication ports for easy accessibility, (3) to signal a healthcare provider as to whether or not medications should be mixed, and (4) to prevent repetitive removal of adhesive tape from a patient's arm when changing hospital gowns or replacing tubing.

This last function is achieved by simply opening its clamping members62,64, while the organizer base remains attached to the patient, to remove and replace the tubing, and then reclosing the clamping members. Without this organizer base, adhesive tape would typically be used for this function and thereby result in multiple cycles of removing and replacing adhesive tape which can result in impaired skin integrity and possibly put the patient at the risk of hospital acquired infections.

FIG.5shows the general layout of the present invention as it is being positioned on a patient's arm when it is to be used with a peripheral, intravenous catheter2whose cannula end is to be inserted into a vein that is approached from the fingers and toward the wrist and through the skin on the top portion of a patient's hand. Alternatively, the peripheral, intravenous catheter's cannula end can be inserted into a patient's forearm. Unseen are the cradle means and its base that are positioned on the top portion of a patient's hand and beneath the catheter base.

Once the catheter's cannula end has been inserted, the cradle base is positioned below the catheter's luer fitting so that the cradle means can be placed against the luer fitting bottom surface so as assist in preventing any upstream or downstream motion of it. The catheter base's securement means20is then placed against the luer fitting's top surface above the cradle means40and a check is made to ensure that the catheter base's opening18is situated so the cannula's insertion point can be clearly seen through this opening. Once these conditions are met, the adhesive30on the catheter's bottom surface is used to secure the catheter base to, in this instance, the top portion of a patient's hand.

After the catheter base has been adhered to the patient's hand, the tether is rotated 180 degrees so as to locate the organizer base50above the catheter base and, in this instance, on the patient's forearm. Next, the tubing coming from the catheter is placed in the organizer's appropriate passageway, either mainline or apinch.

Utilizing the procedure described above, the present invention or PIVOASS secures the intravenous catheter and its tubing in two locations, assists in organizing this tubing and serves to enhance the safe use of the catheter by helping to prevent the dangerous mixing of apinch medications with mainline fluids.

Finally, it should be noted that the foregoing is considered as illustrative only of the principles of the present invention.

For example, another version of this preferred embodiment consists of a dressing base9which is very similar to the previously described catheter base except that it has a longer length with three portions9a-9cthat accommodate an organizer base9dbeing mounted in the third portion9cof its top surface9e. The bottom surface9fof its first portion9acontains an upper securement element9gand its second portion9bcontains an opening9hwith its transparent membrane9i. Note also the still required lower securement element9j. SeeFIGS.6A-6B.

Since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described herein. Accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention set forth in the claims in the following section.