Tube Holder and Method of Securing Catheters to a Patient

A tube holder includes a base mounted on a support surface, and male and female gripping members extending substantially transversely from the base with the base and gripping members unitarily, integrally formed of a one-piece, soft, low durometer elastomer and one of the gripping members having a plurality of apertures therein for receiving the other of the gripping members to positively grip a tube therebetween. A method of securing a catheter to a patient utilizing the tube holder.

DETAILED DESCRIPTION OF THE INVENTION

As used herein, the term “tube” means an elongate member (i.e. a member having a length greater than its diameter/width) regardless of the cross-sectional configuration thereof (e.g. round, circular, oval, curved, three or more sided, polygonal or the like). The “tube” can be hollow or partially hollow or can be constituted by a tubular coating on an object such as a metal wire or can be formed of a slotted sleeve, such as a catheter support sleeve. As used herein, the term “body” means a corpus, such as of an animal or a human, or a part thereof such as skin or an appendage.

A tube holder20according to the present invention, as shown inFIGS. 1-5, includes an elongated base22having opposing lateral sides or edges24and26and and26defines a width for the base and the spacing between ends28and30defines a length for the base with the length being greater than the width. Extending substantially transversely from the base are gripping members in the form of female straps32and34and gripping members in the form of male straps36and38in lateral alignment with female straps32and34, respectively. The female straps are longitudinally spaced along the base, and the male straps are similarly longitudinally spaced along the base such that the male straps36and38are in opposed alignment with the female straps32and34, respectively, forming pairs of gripping members32,36and34,38.

The base22has a central domed platform40raised above a substantially flat bottom surface42to form a shock absorbing and isolating structure upon which the male and female straps are mounted. The flat bottom surface42of the base22extends widthwise entirely across the width of the base, and the raised platform40has a domed upper surface spaced from the bottom surface42with the width of the platform being less than the width of the base. The male and female straps extend arcuately from the lateral sides of the platform to curve laterally and upwardly away from the base. The longitudinal ends28and30of the base have surfaces44and46, respectively, sloping from the upper surface of the platform40to the bottom surface42of the base at an angle on the order of 21° to accommodate the preferred angle of entry for catheters into a patient's body thereby reducing upward forces or leverage that would occur if the base had transversely extending (square) longitudinal ends. The sloping surfaces44and46support catheter tubes as the tubes extend toward the body of a patient from the platform40.

The male straps36and38have tapered free ends48and50, respectively; and, a series of flared, arrow-shaped, flexible locking members or detents52are carried along the lengths of the male straps of a size to pass through the apertures in the female straps in a flexed condition. More particularly, the arrow-like shapes of the flexible locking members52allow the flanges thereof to flex while passing through an aperture and then return to an unflexed position to lock the male straps within the female straps. The male straps36and38have fixed ends54and56, respectively, coupled with the base22along a lateral side of the domed platform40, and the flexible locking members52of each strap are carried along a flexible body of the strap extending between the fixed end and the free end with the flexible bodies of the male straps being arcuate in configuration to define engagement portions adjacent the fixed ends as illustrated inFIGS. 8,9and10.

The female straps each have a plurality of apertures therein spaced along the length thereof. As shown inFIG. 2, female straps32and34each have at least two apertures58,60in female strap32and62,64in female strap34. The lower apertures60and64looking atFIG. 2are closer to the base22than the upper apertures58and62, and the apertures are sized such that the heights of apertures80and84are less than the heights of apertures58and62, respectively. The lower heights of the apertures closer to the base provide secure gripping of smaller diameter tubes and also minimize the opportunity for a small diameter tube to be caught therein or pass therethrough.

The male and female straps join each other at their fixed ends providing a trough with a bottom for receiving and gripping tubes. The base, the gripping members/male and female straps are preferably unitarily, integrally formed of a one-piece soft, low durometer elastomer having a hardness less than or equal to 30 Shore A.

As shown inFIG. 6, the tube holder20includes a support surface or member66in the form of an adhesive foundation pad for securement to a patient's body with the base22mounted on the support member. As shown inFIG. 6A, the support member66is formed of an adhesive layer68, such as hydrocolloid, bonded to an elastomeric film carrier70, such as polyurethane, to provide ergonomic and skin-compatible features including moisture balance and elasticity similar to skin, preferably at least 250% elongation, most preferably 300% elongation. The ergonomics result in gradual and uniform transfer of stresses originated from a catheter, and the hydrocolloid on the elastomeric film also provides for extended wear, is hypoallergenic and creates a firm hold even in the presence of perspiration. The adhesive and film combination is preferably transparent or semi-transparent to allow additional infection control by permitting visual detection of any potential underlying skin irritation or infection. The film70can be made of polyurethane or any other suitable elastomeric material and as shown, the film70is disposed between the bottom surface42of base22and the layer of hydrocolloid68. The adhesive layer/pad66optimally has an elliptical shape, preferably with a major axis length of twice the length of the base22and a major to minor axis ratio of 1.5 to assist in assuring natural movement with the skin. An elliptical shape provides a geometry to assure optimal confirmation to contours of a patient's body which may change shape in multiple planes. The bottom of the adhesive layer68is covered with a siliconized release paper71which can be plow-folded to facilitate removal thereof prior to placement of the adhesive layer on a patient's skin.

When the tube holder20is utilized adjacent a catheter insertion site, the adhesive pad can have a slit or slot72therein such that a catheter can extend through the slot as shown inFIG. 6. The adhesive pad adjacent the slot can be used to cover entry of the catheter into the insertion site. When the slot is used, the catheter is inserted at the base of the slot, and the free ends of the ellipse of the adhesive pad which are created by the slot form flaps shown at74which overlap. The flaps provide a fully occlusive seal around the catheter which minimizes infection and adds to the positive grip of the catheter thus preventing in-and-out micromotion or pistoning of the catheter at the insertion site which otherwise could lead to distribution of bacterial films and various pathogens. Additionally, the overlapping arrangement of the flaps74provides a robust, yet flexible, occlusive seal and protects the skin surface from exposure to fluids or caustic material (e.g. gastric fluids) and further assures a controlled and stable angle of entry of the catheter at the skin/catheter interface to prevent tissue damage through either ischemia (tearing) and/or crushing. The slotted configuration of the adhesive foundation pad66coupled with the flexible, soft nature of the base and gripping members enhances the robustness of the occlusive seal with the catheter thereby resisting disruption of the seal. In use, the free ends or flaps of the foundation pad adjacent the slot are wrapped alternately around the catheter such that the hydrocolloid adhesive seals to both the skin of the patient and the foundation pad surfaces to provide the highly occlusive seal against pathogens and guard against in-and-out micromotions that are common with catheter holding devices of the prior art. Since the flaps are integral with the flexible foundation pad and encircle the catheter, the catheter is maintained in proper position at all points from the securement of the tube holder to the skin to the point of catheter insertion into the patient's body.

A small diameter tube76is shown inFIG. 6being gripped by the female straps32and34and the male straps36and38, the small diameter tube being, for example a 1.9 Fr catheter. The small diameter tube76is gripped by passing the free ends48and50of the male straps36and38, respectively, through the lower, smaller size apertures60and64in the female straps32and34, respectively, thereby securely gripping the tube68and limiting the opportunity for the tube to be drawn through the aperture along with the male strap. As shown inFIG. 8, the small diameter tube76is gripped in a trough or space77between a female strap34and a male strap38defined by engagement portions78and80, respectively of female strap34and male strap38. The space between the engagement portions does not conform completely to the configuration of the tube76such that the male and female gripping members/straps provide a channel jaw, pliers type arrangement due to the configurations and thicknesses of the lower segments of the male and female gripping members. That is, as best shown inFIGS. 4 and 5, the thickness of the lower portion of each male member cooperates with the shape of each female gripping member to create a channel-like gripping arrangement therebetween.

FIG. 9illustrates the securement of an intermediate size tube82in space77with the male gripping member38passing through the lower aperture64such that channel lock pliers-type gripping is created by the jaws formed by the engagement portions78and80of female and male gripping members34and38, respectively.

FIG. 10illustrates the securement of a large size tube86with the male gripping member38passing through the upper aperture62of the female gripping member to grip the tube with a channel lock plier-gripping arrangement but with the jaws or engagement portions of the gripping members having a configuration more closely approximating the outer configuration of the tube86such that engagement portion78of female gripping member34is arcuate as is the engagement portion84of male gripping member38.

FIG. 7illustrates a tube holder having a base and gripping members as shown inFIGS. 1-5but where the support surface or foundation pad is formed by a strap88surrounding a limb of a patient. With the base22being secured, such as by adhesive, to the strap, the use of a strap permits the tube holder to be positioned at various locations on a patient's body as well as on environmental surfaces adjacent a patient. The ends of the strap can be fastened via hook and loop type fasteners (Velcro) or other suitable fasteners such as snaps, buckles and the like or the strap can be elastic with no requirement for fastening of the ends together. Accordingly, the tube holder shown inFIG. 7is reusable in nature and can be attached to various structures as desired.

The narrowed tips of the male gripping members eases insertion of the male members into a chosen aperture in the female gripping member even while the caregiver is wearing gloves. The thickness of the base and the configuration of the raised platform of the base reduces warping when the tube holder is subjected to stress as a gripping member/strap is pulled tight after insertion through an aperture in an opposing gripping member and further prevents transmission of the stress on the male strap to the patient's skin. The use of an adhesive layer such as hydrocolloid allows the support surface to act as a wound dressing as well as providing securement for the tube holder and further permits incorporation therein of antimicrobial agents to provide an antimicrobial Catheter insertion site dressing. As previously noted, the thickening of the male straps near the base and the curvature of the male straps allow the male straps to come over a tube to be gripped to the female strap like channel lock jaws thus holding small (tiny) catheters. By forming the base and gripping members of the tube holder of a low durometer (less than 30 Shore A and as low as 3 Shore A elastomer), high friction elastomers can be used that grip tubes without kinking and transfer compound twisting and bending forces are transferred uniformly to a patient's skin in that the components of the tube holder act together to transfer significant compound forces to the compound body shapes where the tube holder is applied. With the forces isolated as noted above, the tube holder provides improved and uniform gripping force on tubes while reducing the potential for dislodgement and inadvertent tear-out of the tubes. The sloping surfaces at the longitudinal ends of the base provide a controlled and stable angle of entry of the catheter at a skin-catheter interface thus resisting transmission of leverage forces of the catheter which otherwise might potentially cause tissue damage through ischemia (tearing) and crushing and prevent the catheter from twisting or rotating about the longitudinal axis of the catheter. The use of an adhesive foundation pad, particularly including a hydrocolloid, provides a support surface capable of flexing to accommodate body contours, stretching to match the physiological properties of a patient's skin including swelling from edema and anasarca, facilitates natural movement of a patient's subcutaneous structures with body movement, and assures the skin/adhesive interface remains intact. The gripping arrangement of the tube holder allows a catheter to be easily changed without removing the adhesive support surface from the skin by folding the arrow-shaped flanges of the male gripping members to allow the male gripping members to be pulled backwards through the apertures in the female gripping members while simultaneously providing a positive lock on a catheter such that the catheter cannot be pulled out of the tube holder inadvertently or by a patient using a single hand.

A method of securing a catheter to a patient's body in accordance with the present invention utilizing a tube holder as described above includes the steps of securing the support surface to the patient's body, positioning the catheter between at least one pair of the male and female gripping members in the trough defined therebetween by the engagement portions thereof, selecting one of the apertures in the female gripping member based on the size of the catheter, inserting the tapered free end of the male gripping member in the selected aperture and pulling the male gripping member through the selected aperture to grip the catheter therebetween, it being noted that when multiple pairs of male/female gripping members are utilized, the gripping members are tightened sequentially.

Inasmuch as the present invention is subject to many variations, modifications and changes in detail, it is intended that all subject matter discussed above or shown in the accompanying drawings be interpreted as illustrative only and not be taken in a limiting sense.