Conventional commercial procedures for inserting and maintaining catheters or cannulae in patients are often cumbersome, time consuming, inefficient, and less than optimally hygienic. For example, in a typical conventional procedure for inserting and maintaining an angiocatheter in a human patient to connect the patient to an IV (as generally described in U.S. Pat. Nos. 4,772,264 and 7,491,189), a needle of an insertion device within the angiocatheter is inserted into the patient's vein at a low angle. Once this cannulized needle has been inserted, one advances the angiocatheter approximately two cm to allow the catheter to enter into the vessel lumen. Then one places pressure at the tip of the catheter, and while securing the catheter with one's fingers removes the needle from the vein and catheter, leaving the catheter in place. Then one quickly connects the IV tubing to the catheter and attempts to secure the catheter with tape. This requires obtaining a piece of tape from a separate source (often placed by the practitioner on nearby non-sterile surfaces), trying to properly position the tape using one hand while stabilizing the catheter with the other (or requiring the assistance of another health care practitioner), and then positioning one or more other pieces of tape over the catheter at other, possibly random, locations. Not only is this procedure cumbersome and inefficient, there is a distinct possibility of contamination of the insertion site during the taping procedure.
A number of prior art proposals have sought to minimize the disadvantages of conventional procedures, such as the one described above, using more sophisticated devices. For example, such as shown in U.S. Pat. No. 6,231,548 an anchor pad having wings may be utilized to facilitate the taping procedure. U.S. Pat. No. 3,973,565 proposes using a butterfly catheter with a trailing scored sheet having pressure sensitive adhesive whereby after insertion a release sheet can be removed from the adhesive and the trailing sheet folded over about the score lines to bring the adhesive into contact with the patient's skin adjacent the insertion site (in fact typically covering it); compare FIGS. 3 & 4 thereof. U.S. Pat. No. 6,827,706 in FIGS. 19-21, and U.S. Pat. No. 3,589,361 in FIGS. 8-11 thereof, show a butterfly catheter having adhesive covered by a release sheet on what will become the inferior surface of the wings to provide primarily lateral stability to the catheter when inserted. U.S. Pat. Nos. 7,083,598, 6,582,403, 6,955,659, and 4,698,057, and U.S. Patent Application Publication 2002/0143295, show other devices using some form of adhesive element operatively connected to a catheter or cannula to facilitate stabilization. However all of these either have adhesive elements that are almost as difficult to use (or perhaps even more difficult) as conventional pieces of tape, obscure the insertion area and/or the stabilization junctures, could interfere with optimal catheter insertion or repositioning, require catheter elements per se to have adhesive, lack versatility, and/or don't afford optimal stabilization in all the dimensions necessary.
According to the present invention, a stabilizing device for insertion and maintenance of a catheter or cannula, and a method of utilization thereof, are provided which overcome all or most of the drawbacks of the prior art. In general, the invention is simple, relatively inexpensive, versatile, and provides optimal stabilization.
While the invention will be described primarily with respect to angiocatheters and butterfly catheters, it is to be understood that these are representative only, and the invention is applicable to a wide variety of catheters and cannulae.
According to one aspect of the present invention there is provided a stabilizing device for insertion and maintenance of a catheter or cannula, comprising: A first stabilizing element including a pair of bilateral wings and a catheter or cannula receiving element generally between the bilateral wings. A proximal stabilizing element operatively connected to at least one of the bilateral wings and including a sterile adhesive for affixing at least one of the bilateral wings to a patient to provide stability for the catheter or cannula during the removal of the needle and for the duration that the catheter or cannula is inserted into the patient. And, a lateral stabilizing element distinct and spaced from the proximal stabilizing element, the lateral stabilizing element including a sterile adhesive for affixing at least one (and preferably both) of the bilateral wings to a patient to provide primarily lateral and medial stability to a catheter or cannula in a patient. The separation of the proximal and lateral stabilizing elements allows the proximal elements to be applied first. Then, lateral and superior adjustments can be made to the needle and catheter or cannula (i.e. to better establish blood flow therethrough), as well as cleaning of blood or IV fluid below the device hub or base, before the lateral stabilizing elements are secured. By providing spaced and distinct lateral and proximal stabilizing elements, the invention allows clear visibility of the insertion site (to facilitate insertion, withdrawal, cleaning of spillage, and adjustment), yet readily provides essentially optimum stability.
While the proximal and lateral stabilizing elements may comprise integral portions of the bilateral wings (and/or the receiving element), or have other configurations, preferably they are provided by conventional pieces of tape pre-applied to the wings (that is applied during manufacture, or before insertion by the health care practitioner). The tape strips may have non-adhesive portions thereof facilitating removal of the tape strips from a patient's skin when desired.
In a preferred embodiment the proximal stabilizing element comprises at least first and second distinct and spaced tape strips with pressure sensitive sterile adhesive on portions thereof proximally overlapping the bilateral wings, one connected to each of the bilateral wings. The proximal tape strips—as the name indicates—extend toward the insertion site, that is are “proximate” to it. Also in this preferred embodiment, the lateral stabilizing element comprises at least third and fourth distinct and spaced tape strips with pressure sensitive sterile adhesive on portions thereof laterally overlapping the bilateral wings, one connected to each of the wings. Where the tape strips are generally quadrate the overlapping portions of the lateral strips may extend substantially transverse to the first and second tape strips. The lateral tape strips—again as the name indicates—extend laterally of the insertion site. Most desirably the proximal stabilizing element consists essentially of the first and second strips (i.e. there are only two), and the lateral stabilizing element consists essentially of the third and fourth strips (i.e. only two). The first and second proximal strips provide primarily proximal and distal stability, while the third and fourth lateral strips provide primarily medial and lateral stability.
The configuration of the tape strips may vary considerably, for example to increase stability by providing an increases adhesive surface area, to enhance visibility, or to improve other functions. They may be rectangular, partially rectangular and partially trapezoidal, or have a variety of other configurations. Also, especially the proximal tape strips need not necessarily extend parallel to the catheter (although that may be desirable to serve as a guide for needle insertion); for example they may extend at an angle of about 10-45 degrees. Also, fold lines may be provided on the tape strips to allow them to be easily and precisely folded out of the way during the insertion procedure.
The device may further comprise a separate release sheet covering adhesive on each of the tape strips to maintain sterility and enhance functionality. Along one or both side edges of the tape strips continuous or spaced non-adhesive areas may be provided. This makes grasping of a release sheet easier, and also allows ready removal of the tape from the patient's skin after the catheter has been removed.
Alternatively instead of a release sheet at least one (and maybe all) of the tape strips may have a bottom (inferior) surface with a pattern of pressure sensitive adhesive and release sections. The tape strip with this pattern is folded over on itself so that the adhesive and release sections operatively engage each other to maintain sterility until unfolded to be affixed to a patient's pre-sterilized skin.
Again, while a wide variety of constructions may be used, the device of the invention is desirably used in combination with an angiocatheter or a butterfly catheter. [Butterfly catheters derive their name from the highly flexible plastic wings extending laterally outwardly from the sides of a hollow needle (the hollow needle forming at least part of the catheter). Exemplary prior art butterfly catheters are shown in U.S. Pat. Nos. 3,589,361, 3,973,565, 4,177,809, 4,698,057, 6,743,209, and 6,827,706.]
The device of the invention may further comprise at least fifth and sixth distinct and spaced distal tape strips, one operatively connected to each of the bilateral wings and having a portion thereof with pressure sensitive adhesive distally overlapping a wing. As the name indicates, the distal strips are remote from the insertion site and extend away from it (i.e. distally). Also, the device may further comprise at least seventh or eighth transverse tape strips, one each operatively connected to each of the bilateral wings and having a portion thereof with pressure sensitive adhesive overlapping a wing. These strips are remote to the insertion sight and extend diagonally across the cannula hub and attach on the opposite side of the hub.
The receiving element of the device preferably comprises a substantially tubular hub or base, and a catheter extending proximally from the base. When the insertion device is an angiocatheter or the like, typically at some point the device is in combination with a conventional catheter insertion device having a needle extending through the base and catheter. The needle is withdrawn from the combination (and a piece of IV tubing operatively connected to the catheter hub or base) once the patient's skin has been penetrated, and the catheter properly advanced into place.
According to another aspect of the invention there is provided a method of stabilizing a catheter or cannula in a patient (human or animal) using a first stabilizing element having bilateral wings extending from a catheter or cannula supporting element, and at least one each of distinct and spaced proximal and lateral stabilizing elements having sterile pressure sensitive adhesive associated therewith, comprising: a) Inserting a catheter or cannula associated with the supporting element into the patient's body adjacent the at least one proximal stabilizing element. Then, b) applying the sterile adhesive from the at least one proximal stabilizing element to a patient's skin adjacent an area of insertion of a catheter or cannula to stabilize against catheter or cannula inadvertent withdrawal or adverse repositioning. And then c) applying the sterile adhesive from the at least one lateral stabilizing element to the patient's skin to provide primarily lateral and medial stability to the catheter or cannula.
In one embodiment, especially when placing an angiocatheter, b) is practiced using a removable insertion device with a needle, and the method further comprises d) removing the removable insertion device after b) and before c), or after c). The method typically further comprising e) lifting the receiving element and removing any blood flash or IV fluid from the patient's skin between b) and c), and the distinct and spaced proximal and lateral stabilizing elements allow this procedure to be accomplished quickly and easily without disturbing the insertion site, and with optimum probability of maintaining sterility.
In this method, most desirably, the supporting element supports an angiocatheter and the at least one proximal stabilizing element comprises first and second distinct and spaced proximal tape strips each having a portion with sterile pressure sensitive adhesive overlapping a bilateral wing, and the at least one lateral stabilizing element comprises third and fourth distinct and spaced lateral tape strips each having a portion with sterile pressure sensitive adhesive overlapping a bilateral wing. In this case, in the method, b) is practiced to separately bring the sterile adhesive of each of the first and second tape strips into contact with a patient's skin; c) is practiced to separately bring the sterile adhesive of each of the third and fourth tape strips into contact with a patient's skin; and a)-c) are practiced to insert into, and maintain within a patient, an angiocatheter.
According to a further aspect of the invention there is provided a stabilizing device for insertion and maintenance of a catheter or cannula, comprising: A stabilizing element including a pair of bilateral wings and a catheter or cannula supporting element generally between the bilateral wings. And at least first and second spaced and distinct tape strips, operatively connected to at least one bilateral wing preferably both for bilateral support) for stabilizing the receiving element, the tape strips each having a bottom surface with a pattern of pressure sensitive adhesive and release sections, and being folded over on itself so that the adhesive and release sections operatively engage each other to maintain sterility, and after unfolding affix the tape strips to a patient's skin with the pressure sensitive adhesive sections. This pattern of adhesive and non-adhesive portions eliminates the need for a release sheet while still providing sterility and ready utilization of the device. As described above, preferably the at least first and second tape strips comprise a pair of spaced and distinct proximal tape strips, and a pair of spaced and distinct lateral tape strips.
According to yet another aspect of the invention, there is provided a butterfly catheter having a base and highly flexible wings with superior and inferior surfaces. This butterfly catheter comprises: At least two spaced, distinct, pieces of adhesive tape, with sterile adhesive. And at least one piece of adhesive tape operatively connected to the superior surface of each of the flexible wings and each including a portion with sterile pressure sensitive adhesive overlapping a flexible wing so that the sterile adhesive on the overlapping portion may be affixed to a patient's skin. In a preferred form of the butterfly catheter according to the invention the at least two spaced, distinct, pieces of adhesive tape comprise only two proximal pieces (one on the left and one on the right of the hub), proximal pieces being most desirably for providing stability of a butterfly catheter in the case of distal and even proximal movement of the apparatus. However this device may also include two lateral pieces for stabilizing against medial and lateral movement, and perhaps even two distal pieces. As with other embodiments, the overlapping adhesive of the tape strips is covered with a release sheet, or the tape strips are folded over and have the pattern of adhesive and non-adhesive sections described above.
The following specific advantages (over one or more prior art devices or procedures) may be expected according to the invention:
Maintains a sterile field. The practitioner's sterile-gloved hands use only sterile, pre-applied tape according to the invention, insuring that the practitioner's sterile hands do not leave the sterile field, minimizing entry of MRSA or other infectious agents.
Minimizes the use of tape in general, and in particular minimizes the use of sterile tape, and minimizes the time for applying the tape while maximizing the chances of success of the associated medical procedure;
Provides for substantially immediate and effective stabilization of the catheter after insertion (and after withdrawal of the needle when inserting an angiocatheter). In particular the proximal tape strips are positioned so that they are readily accessible, and provide optimal bilateral stability against inadvertent displacement of the catheter, while still continuously allowing a clear view of the insertion area. Because the tape strips are attached to the first stabilizing element wings, and not directly to the receiving element, the receiving element is easy for the practitioner to grasp with her/his fingers during insertion, and also to hold the catheter in place during proximal and lateral tape attachment.
As a result of the advantages of the invention, the field is completely sterile and the catheter completely stable, so that an occlusive sterile dressing (e.g. a sterile transparent bandage) can ultimately be placed over the field with no pathogens near the insertion area.
It is the primary object of the present invention to provide a simple, versatile, and effective stabilizing device for a catheter or cannula, and/or a catheter or cannula in combination therewith, as well as a method of utilization thereof. This and other objects of the invention will become clear from an inspection of the detailed description of the drawings, and from the appended claims.
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USPTO Backgrounds