Abstract:
An anchoring system includes a simply-structured device which permits a portion of a catheter or similar medical article to be easily anchored to a patient, desirably without the use of tape or needles and suture. The anchoring system comprises an anchor pad and a retainer mounted upon the anchor pad. The retainer includes a plurality of intersecting channels into which the medical article to be retained is placed. The medical article is secured within the intersecting channels by retaining at least one axially extending member on the medical article.

Description:
RELATED APPLICATIONS  
       [0001]     This application claims the benefit of U.S. Provisional Patent No. 60/683,926, filed May 23, 2005, which is hereby incorporated by reference in its entirety. 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]     1. Field of the Invention  
         [0003]     The present invention relates in general to a medical article anchoring system. In one mode, the present invention involves a catheterization system that interconnects an indwelling catheter with medical tubing and securely anchors the interconnection to a patient&#39;s skin.  
         [0004]     2. Description of the Related Art  
         [0005]     Medical treatment of patients commonly involves the use of percutaneously inserted catheters to deliver fluids directly into the bloodstream, a specific organ or an internal location within the patient, or to monitor vital functions of the patient. For instance, short, peripherally-inserted, intra-arteriovenous catheters are commonly used to direct fluids and/or medications directly into the bloodstream of the patient.  
         [0006]     The fluid (e.g., parenteral liquid, medication, etc.) typically drains from a container positioned above the patient to feed under gravity or is delivered via an infusion pump. The fluid flows through tubing and thence into the indwelling catheter. The catheter and the fluid tubing are commonly removably attached to each other by a conventional t-connection.  
         [0007]     A t-connection generally includes a male connector with a tapered conical portion that is adapted to fit into a correspondingly shaped receptacle of a female connector (i.e., a hub). A spin nut is commonly disposed on the male connector and is rotatable relative to the tapered conical portion. The spin nut includes internal threads that are adapted to engage external threads on the female connector to lock together the connectors. When properly engaged, theconical portion fits tightly within the receptacle to produce a sealed interconnection.  
         [0008]     A healthcare provider can experience difficulty at times breaking the seal between the engaged conical portion and the hub of the t-connectors when disconnecting the male connector from the female connector. In order to aid such disconnection, some t-connectors include spin nuts that can slide axially between a distal position, in which the spin nut can freely rotate relative to the coupled connectors, and a proximal position, in which the spin nut and male connector are rotationally locked. The rotational lock is provided to assist in breaking the sealed coupling between the corresponding surfaces of the conical portion and the hub of the interengaged connectors.  
         [0009]     The catheterization process often requires relatively frequent disconnection between the catheter and the fluid supply tube, as well as dressing changes. For instance, intravenous catheterization is frequently maintained for several days, depending upon the condition of the patient. The tubing is generally replaced every 48 to 72 hours in order to maintain the sterility of the fluid and the free-flow of the fluid through the tubing. A healthcare provider thus must frequently change the tubing and re-tape the connection. The healthcare provider also must frequently clean the insertion site about the indwelling catheter and change the dressings. Moreover, the tape, which secures the catheter to the skin of the patient, often covers the cannula insertion point. The healthcare provider must remove the tape to inspect the insertion point for inflammation or infection.  
         [0010]     The traditional method of intravenous catheter securement—surgical tape and transparent dressings alone—have not always prevented catheter migration and/or dislodgment. Taped intravenous catheters are also easily pulled out during a “routine” dressing change, especially by inexperienced healthcare providers. And if the catheter migrates too far or dislodgment occurs, the healthcare provider must replace the catheter, thus exacerbating the time and expense required to maintain the intravenous feed. Such catheter re-starts also pose the risk of needle stick to the healthcare provider.  
         [0011]     Prior securement methods have not served the patient as well. Surgical tape or foam strips are uncomfortable. Many patients also do not rest comfortably and worry about catheter dislodgment when they move, when only tape and a dressing secure the catheter in place.  
         [0012]     Several additional drawbacks result from the use of tape to stabilize the catheter. One is contamination. Healthcare providers often tear off small strips of tape and place them on the hand rail on the patient&#39;s bed. Clostridium and other bacteria commonly exist on these surfaces and can be transferred to the patient&#39;s skin in the proximity of the insertion site.  
         [0013]     In addition, tape securement requires the healthcare provider to handle the tape while wearing protective latex gloves. Tearing adhesive tape tends to produce microscopic and/or visible holes in the gloves and thus destroys glove barrier protection.  
       SUMMARY OF THE INVENTION  
       [0014]     The systems and methods of the present invention have several features, no single one of which is solely responsible for its desirable attributes. Without limiting the scope of this invention as expressed by the claims which follow, its more prominent features will now be discussed briefly. After considering this discussion, and particularly after reading the section entitled “Detailed Description of the Preferred Embodiments” one will understand how the features of this invention provide several advantages over traditional catheter securement systems.  
         [0015]     An aspect of the invention is a securement device for anchoring a medical article having a first tubular body and a second tubular body connected to and extending from the first tubular body. The second tubular body is in fluidic communication with the first tubular body. The securement device comprises a retainer having a body member that has a first channel section formed through the body member. The first channel is configured to retain at least a portion of the first tubular body of the medical article and has a longitudinal access opening disposed along a longitudinal axis of the body member to allow at least ingress of the retained portion of the first tubular body into the first channel section. The body member further comprises a second channel section formed through at least a portion of the body member and intersects with the first channel section. The second channel section is configured to retain at least a portion of the second tubular body of the medical device and has an access opening disposed generally normal to the longitudinal axis to allow at least ingress of the retained portion of the second tubular body into the second channel portion. The body member further comprises a first abutment surface formed along the first channel and lying generally normal to the longitudinal axis of the body member and a second abutment surface formed along the second channel and lying generally normal to the longitudinal axis of the body member. The second abutment surface is spaced longitudinally apart from the first abutment surface by at least a distance that generally corresponds to a longitudinal width of the second tubular body.  
         [0016]     Another aspect of the invention is a catheterization system that comprises a catheter connector that includes a first tubular body and a second tubular body attached to the first tubular body. The first tubular body is in fluidic communication with the second tubular body. The catheterization system further comprises a retainer having a proximal body portion and a distal body portion. The retainer further comprises a first channel extending through the proximal body portion and the distal body portion along a longitudinal axis. The first channel is configured to retain at least a portion of the first tubular body and has a longitudinal access opening to allow at least ingress of the first tubular body into the first channel. The retainer further comprises a second channel intersecting with the first channel and lying between the proximal and distal body portions. The second channel is configured to retain at least a portion of the second tubular body and has an access opening to allow at least ingress of the second tubular body into the second channel. The retainer further comprises a first abutment surface disposed on the proximal body portion of the retainer and a second abutment surface disposed on the distal body portion, each of the first and second abutment surfaces lying generally normal to the longitudinal axis. The catheterization system further comprises an anchor pad including upper and lower sides. The retainer is disposed on the upper side of the anchor pad, and the lower side of the anchor pad includes an adhesive surface to secure the retainer to the skin of a patient.  
         [0017]     Still another aspect of the invention is an anchoring system for securely anchoring to a patient a medical article of the type having an elongated body including first and second elongated tubular bodies. The second elongated tubular body intersects with the first elongated tubular body. The anchoring system comprises a retainer including a body and first and second channels extending through at least a portion of the body. The channels are configured to accept at least a portion of the first and second elongated tubular bodies of the madical article. The anchoring system further comprises means for capturing both the first and second tubular bodies within the retainer body so as to arrest movement of the medical article relative to the retainer and an anchor pad having two sides, the retainer being mounted on one side and the other side including a layer of adhesive.  
         [0018]     Yet another aspect of the invention is a retainer for securing a t-connector including at least first and second tubular members in flow communication with one another. The retainer comprises a first channel for receiving the t-connector without regard to the orientation of the second tubular member so that the second tubular member may be in any of a plurality of radial positions with respect to an axis through the first channel. The second tubular member being in a first position of the plurality of positions, being in a second position of the plurality of positions when rotated from the first position by approximately 180 degrees, and being in a third position of the plurality of positions when rotated from the first position by approximately 90 degrees. The retainer further comprises a first pair of abutment surfaces longitudinally restraining the first tubular member in both longitudinal directions when the second tubular member is in the first position and a second pair of abutment surfaces longitudinally restraining the first tubular member in both longitudinal directions when the second tubular member is in the second position. The second pair of abutment surfaces is different than the first pair of abutment surfaces. The retainer further comprises an abutment surface longitudinally restraining the first tubular member in a longitudinal direction when the second tubular member is in the third position. The abutment surface is different than the first and second pairs of abutment surfaces. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0019]     The preferred embodiments will now be described with reference to the drawings. The drawings contain the following figures:  
         [0020]      FIG. 1  is a perspective view of a catheterization system in accordance with a preferred embodiment of the present invention;  
         [0021]      FIG. 2  is a perspective view of an anchor pad of the catheterization system illustrated in  FIG. 1 ;  
         [0022]      FIG. 3  is a perspective view of a retainer of the catheterization system of  FIG. 1 ;  
         [0023]      FIG. 4  is a top plan view of the retainer of  FIG. 3 ;  
         [0024]      FIG. 5  is a bottom plan view of the retainer of  FIG. 3 ;  
         [0025]      FIG. 6  is an elevational proximal end view of the retainer of  FIG. 3 ;  
         [0026]      FIG. 7  is an elevational distal end view of the retainer of  FIG. 3 ;  
         [0027]      FIG. 8  is an elevational side view of the retainer of  FIG. 3 ;  
         [0028]      FIG. 9  is a cross-sectional view of the retainer of  FIG. 4 , taken along line  9 - 9 ;  
         [0029]      FIG. 10  is a cross-sectional view of the retainer of  FIG. 4 , taken along line  10 - 10 ;  
         [0030]      FIG. 11  is a perspective view of a catheter t-connector for use with the catheterization system illustrated in  FIG. 1 ;  
         [0031]      FIG. 12  is an exploded, perspective view of the t-connector fitting aligned with the anchor pad and the retainer of  FIG. 1 .  
         [0032]      FIG. 13  is an exploded, perspective view of the t-connector fitting being inserted into the retainer of  FIG. 1 .  
         [0033]      FIG. 14  is a perspective view of the t-connector fitting secured to the securement device of  FIG. 1 . 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0034]     The present embodiment of the medical article anchoring system is disclosed in the context of a catheterization system, and in particular in the context of a catheterization system utilizing a t-connector. The catheterization system also can include a catheter, a tube extension set and/or dressing materials.  
         [0035]     The principles of the present invention, however, are not limited to catheters or to the specific type of t-connector disclosed. Instead, it will be understood by one of skill in this art, in view of the present disclosure, that the anchoring system disclosed herein also can be successfully utilized in connection with other types of t-connectors. In addition, it will be understood by one of skill in this art that the anchoring system disclosed herein also can be successfully utilized in connection with other types of medical articles, including other types of catheters, fluid drainage and delivery tubes. For example, but without limitation, the retainer disclosed herein can be configured to secure peripheral catheters, peripherally inserted central catheters, hemodialysis catheters, surgical drainage tubes, feeding tubes, chest tubes, nasogastric tubes, scopes, as well as electrical wires or cables connected to external or implanted electronic devices or sensors. One skilled in the art may also find additional applications for the devices and systems disclosed herein.  
         [0036]     With reference now to the preferred embodiment,  FIG. 1  illustrates in perspective view a catheter anchoring system  20 . The anchoring system  20  cooperates with a t-connector (see  FIG. 11 ) that securely connects a tube (e.g., a fluid supply line) to an indwelling catheter. The cooperation between the anchoring system  20  and the t-connector  22  maintains the catheter in the desired indwelling position.  
         [0037]     The anchoring system  20  principally comprises a flexible anchor pad  28  having an adhesive bottom side that attaches to the skin of a patient. The pad  28  can be attached at any number of locations on a patient&#39;s body. For example, the anchoring system  20  could be located on the back of a patient&#39;s hand. The anchoring system can be used for catheterization at other locations on the patient&#39;s body, e.g., on the medial side of the wrist in connection with catheterization of a radial artery or on the anterior or posterior of the patient&#39;s torso in connection with epidural catheterization. The pad  28  supports a retainer  30 . The retainer  30  in turn is configured to receive and secure in place the t-connector  22 .  
         [0038]     To assist in the description of the components of the anchoring system  20 , the following coordinate terms are used (see  FIG. 1 ). A “longitudinal axis” is generally parallel to the channel of the anchoring system  20 . A “lateral axis” is normal to the longitudinal axis and is generally parallel to the plane of the anchor pad  28 . A “transverse axis” extends normal to both the longitudinal and lateral axes. In addition, as used herein, “the longitudinal direction” refers to a direction substantially parallel to the longitudinal axis; “the lateral direction” refers to a direction substantially parallel to the lateral axis; and “the transverse direction” refers to a direction substantially parallel to the transverse axis. The terms “proximal” and “distal”, which are used to describe the present anchoring system, are used consistently with the description of the exemplifying application. Thus, proximal and distal are used in reference to the catheter&#39;s insertion site on the patient (not shown). The term channel is not intended to connote a particular length and may connote a segment or small portion of a channel. Also, the terms “top,” “bottom,” “upper,” and “lower” are used in the context of the orientation of the anchoring system illustrated in  FIG. 1 , and are not intended to imply a limitation to the orientation that the anchoring system  20  can assume on the patient. A detailed description of the catheterization system (including the present anchoring system), and its associated method of use now follows.  
         [0000]     T-Connector  
         [0039]     As best seen in  FIG. 11 , the t-connector  22  comprises a first tubular body  34  defined between a proximal end  38  and a distal end  36 . A second tubular body or t-fitting  26  connects to the tubular body  34  between the proximal and distal ends of the tubular body  34 . The t-fitting  26  and tubular body  34  form a right angle in the illustrated embodiment. However, the t-fitting  26  and tubular body  34  may intersect to form obtuse or acute angles therebetween. For example, an obtuse angle may be selected to closely align the flow paths through the t-fitting  26  and the tubular body  34 . In the preferred embodiment, the t-fitting  26  has a cylindrical shape with an outer diameter L 2 . However, the t-fitting  26  may have other shapes to match a non-cylindrical receiving channel of the retainer  30 .  
         [0040]     The proximal end  38  is configured to engage the distal end of a hub of a catheter or of any female connector. The proximal end  38  of the t-connector  22  forms a fluid tight seal for fluids to pass from the t-connector  22  and into the catheter. In the illustrated embodiment, the proximal end  38  of the t-connector  22  is configured as a male portion to be inserted into a standard receptacle of a catheter hub. The proximal end  38 , however, can be configured to engage other types of catheter connectors. Those skilled in the art can readily select the type of catheter connector to be used with the present anchoring system  20  and can modify the anchoring system according to the teachings of the present invention to suit the particular application (e.g., venous, arterial, epidural, peripheral, etc.).  
         [0041]     As seen in  FIG. 11 , at least a portion of the proximal end  38  has a frusto-conical shape and extends proximally from the tubular body  34 . Tapered shoulders  42 ( a ),  42 ( b ) are disposed on the tubular body  34  and between the t-fitting  26  and the proximal end  38 . Tapered shoulder  42 ( b ) is spaced a distance L 1  from the distal side of the t-fitting  26 . A central lumen extends through the tubular body  34  and terminates at an opening at the proximal end  38 .  
         [0042]     The distal end  36  of the t-connector  22  comprises a needle stick membrane  24  or septum. The needle stick membrane  24  or septum is configured to allow a syringe needle to penetrate through the membrane and into the central lumen. For example, fluids injected into the t-connector  22  via the membrane  24  flow through the fluid tight seal formed between the t-connector  22  and catheter and then into the patient. A distal end of the central lumen terminates at the membrane  24 .  
         [0043]     The t-fitting  26  is adapted to receive an end of a medical supply tube. In an exemplifying embodiment, at least a portion of the fluid tube is permanently attached to (e.g., embedded within) the end of the t-fitting  26 . A second lumen through the t-fitting  26  communicates with the central lumen to allow fluid flowing through the t-fitting  26  to enter the central lumen of the t-connector  22 .  
         [0044]     Fluids enter the t-connector  22  via the needle stick membrane  24  and the t-fitting  26 . The connection between the medical supply tube and the t-fitting  26  forms a first passageway for fluids to enter the t-connector  22 . A second passageway into the t-connector  22  if formed through the membrane  24 . For example, a healthcare worker using a syringe needle punctures the distally located membrane  24 . Once the syringe needle penetrates the membrane  24 , the healthcare worker injects the contents of the syringe directly into the first passageway through the connector  22 .  
         [0045]     With reference to  FIGS. 1 and 11 , the distal end  36  of the t-connector  22  includes a radially extending member  44  projecting outward from the tubular body  34 . In particular, the t-connector  22  can include one or more radially extending members  44  disposed between the distal end  36  and the t-fitting  26 . The radially extending member  44  provides a ridge for the healthcare worker to steady a syringe during insertion of the needle through the membrane  24 .  
         [0000]     Anchor Pad  
         [0046]      FIG. 2  illustrates the anchor pad  28  apart from the rest of the securement device  20  shown in  FIG. 1 . The lower side of the pad  28  faces toward the skin of the patient, and is preferably covered with an adhesive surface suitable for attaching the anchor pad  28  to the skin of the patient. The entire surface, however, need not be covered. An upper surface  170  of the anchor pad  28  faces away from the skin of the patient and supports the retainer  30 . The anchor pad  28  comprises a generally trapezoidal shape. Although only a single shape of the anchor pad is illustrated in  FIG. 2 , those of skill in the art will recognize that a variety of shapes can be used.  
         [0047]     The anchor pad  28  desirably comprises a laminate structure with an upper plastic, paper or foam layer (e.g., closed-cell polyethylene foam) and a lower adhesive layer. The lower adhesive layer constitutes a lower surface  160  of the anchor pad. The lower surface  160  desirably is a medical-grade adhesive and can be either diaphoretic or nondiaphoretic, depending upon the particular application. Such foam with an adhesive layer is available commercially from Avery Dennison of Painsville, Ohio. While not illustrated, the anchor pad  28  can include suture holes in addition to the adhesive layer to further secure the anchor pad to the patient&#39;s skin.  
         [0048]     In other variations, a hydrocolloid adhesive or zinc oxide-based adhesive can advantageously be used upon the anchor pad  28  for attaching the anchor pad to the skin of the patient. The hydrocolloid or zinc oxide-based adhesive can be used either alone or in combination with another medical grade adhesive (e.g., in combination with the adhesive available from Avery Dennison). Hydrocolloid and zinc oxide-based adhesives have less of a tendency to excoriate the skin of a patient when removed. This can be particularly important for patients whose skin is more sensitive or fragile, such as neonates and those with a collagen deficiency or other skin related condition.  
         [0049]     A surface of the upper foam layer constitutes an upper surface  170  of the anchor pad  28 . The upper surface  170  can be roughened by corona-treating the foam with a low electric charge. The roughened or porous upper surface can improve the quality of the adhesive joint (which is described below) with the bottom surface of the retainer  30 .  
         [0050]     A removable paper or plastic release liner  180  desirably covers the adhesive lower surface  160  before use. The liner  180  preferably resists tearing and desirably is divided into a plurality of pieces to ease attachment of the pad to a patient&#39;s skin.  
         [0051]     The liner  180  comprises a folded over portion to define a pull tab  190 . The pull tab  190  can be utilized to remove the paper or plastic release liner  180  from the adhesive lower surface  160  before use. A healthcare provider uses the pull tab  190  by grasping and pulling on it so that the liner  180  is separated from the lower surface  160 . The pull tab  190  overcomes any requirement that the healthcare provider pick at a corner edge or other segment of the liner  180  in order to separate the liner  180  from the adhesive layer.  
         [0052]     The pull tab  190  of course can be designed in a variety of configurations. For example, the pull tab  190  can be located along a center line of the anchor pad  28 ; or alternatively, the pull tab can be located along any line of the anchor pad  28  in order to ease the application of the anchor pad  28  onto the patient&#39;s skin at a specific site. For example, an area of a patient&#39;s skin with an abrupt bend, such as at a joint, can require that the pull tab  190  be aligned toward one of the lateral ends of the anchor pad  28  rather than along the center line. In the embodiment illustrated in  FIG. 2 , the fold forming the pull tab  190  is located along a centerline  195 .  
         [0053]     In another variation, the anchor pad  28  comprises a laminate structure with an upper woven layer and a lower adhesive layer. The upper layer can be polyester or other suitable polymer or textile materials. One particular suitable material is woven polyester available commercially under the name “Tricot” from Tyco. The lower adhesive layer constitutes the lower surface  160  of the anchor pad.  
         [0000]     Retainer  
         [0054]      FIGS. 3 through 10  illustrate the retainer  30 , which is configured in accordance with a preferred embodiment of the present invention. The retainer  30  has a body  50  that defines a central or first channel  52  disposed above a base surface  54 . The channel  52  extends about a central, longitudinally extending axis C and has an opening  56  that faces away from the base surface  54 . The proximal and distal ends of the channel  52  also open through the ends of the retainer body  50 . A radius of curvature for the channel  52  preferably matches or at least approximates the radius of the portion of the connector tubular body  34  to be retained. In a preferred embodiment, at least a portion of the first channel  52  has a lateral width that is smaller than a maximum diameter of the connector tubular body  34 , as described below in greater detail.  
         [0055]     The retainer further includes a second channel  29  which intersects with the first channel  52 . The second channel  29  extends about a laterally extending axis D and has an opening  88  that faces away from the base surface  54 . The first channel  52  includes a first channel segment and a second channel segment disposed on opposite sides of the axis D. The second channel  29  has a first channel segment and a second channel segment disposed on opposite sides of the axis C. The lateral ends of the second channel  29  open through the sides of the retainer body  50 . A radius of curvature for the second channel  29  preferably matches or at least approximates the radius of the portion of the t-fitting  26  to be retained. In a preferred embodiment, at least a portion of the second channel  29  has a longitudinal width that is smaller than a maximum diameter of the t-fitting  26 .  
         [0056]      FIG. 8  illustrates the channel axis C skewed relative to a base surface  54  of the retainer  30 . An incident angle θ defined between the base surface  54  and the channel axis C preferably is less than 45°. More preferably, the incident angle θ ranges between 5° and 30°. In an exemplifying embodiment for intravenous use, the angle θ preferably equals approximately 7°. In another exemplifying embodiment for arterial use, the incident angle θ preferably equals about 22°.  
         [0057]     As best seen in  FIGS. 3, 4 ,  8  and  9 , the retainer  30  also includes a plurality of abutment surfaces that extend laterally from the channel  52 . Each abutment surface lies generally normal to the central axis C of the channel  52 . These abutment surfaces include a proximal-most abutment surface  60 , a distal-most abutment surface  62  and an intermediate surface  64 . The abutment surfaces capture both the first tubular body  34  and the second tubular body  26  within the retainer  30  so as to arrest movement of the medical article relative to the retainer. The proximal-most abutment surface  60  is defined by a protruding wall from the inside circumference of the first channel  52  at the proximal end of the retainer  30 . The distal-most abutment surface  62  and the intermediate surface  64  lie between the proximal-most abutment surface  60  and the distal end of the retainer  30 .  
         [0058]     As shown most clearly in  FIG. 8 , the distal-most abutment surface  62  and the intermediate surface  64  are defined by an inside surface of the second channel  29 . The proximal- and distal-most abutment surfaces  60 ,  62  preferably are separated by a distance that is generally equal to the longitudinal length between the shoulder  42 ( b ) of the connector tubular body  34  and a distal surface of the t-fitting  26 . This distance is illustrated as L 1  in  FIG. 11 . The proximal-most abutment surface  60  contacts with the shoulder  42 ( b ) of the connector fitting  22  to inhibit proximal, longitudinal motion of the connector fitting relative to the retainer  30 . The distal-most abutment surface  62  contacts with the distal surface of the t-fitting  26  to inhibit distal, longitudinal motion of the connector fitting  22  relative to the retainer  30 . Together, the proximal and distal-most abutment surfaces  60 ,  62  inhibit movement of the retainer in both longitudinal directions. However, a single abutment surface may be used independently to arrest movement in the proximal or distal direction. Alternatively, the first channel  52  can have a tapering shape which, together with a single abutment surface, arrests longitudinal movement in the proximal and distal directions. In a variation of the retainer  30 , the proximal-most abutment surface  60  can be omitted when the distal-most abutment surface  62  and the intermediate surface  64  are defined by a distance that is generally equal to the outer diameter of the second channel  29 . This distance is illustrated as L 2  in  FIG. 11 . In such an embodiment, the proximal and distal portions of the t-fitting  26  cooperate with the proximal and distal sides of the lateral channel  29  to arrest all longitudinal movement of the t-connector  22  relative to the retainer  30 .  
         [0059]     As seen in  FIG. 3 , the retainer body  50  includes proximal and distal body portions  72 ,  74 , respectively. The first channel  52  extends through these body portions  72 ,  74  and is open at each of its ends through end walls of the proximal and distal body portions  72 ,  74 .  
         [0060]     As seen in  FIG. 3 , the retainer body  50  includes lateral side portions  76 ,  78 . The lateral channel  29  extends through these portions  76 ,  78  and is open at each of its ends through side walls of the lateral side portions  76 ,  78 .  
         [0061]     The retainer  30  has a plurality of protuberances defined by the intersection of the second channel  29  and the first channel  52 . Protuberance pairs  90 ( a ),  90 ( d ) and  90 ( b ),  90 ( c ) are arranged on opposing sides of the distal and proximal portions  76 ,  78 , respectively. The protuberances  90  extend generally toward the central axis C of the first channel  52 . Thus, the protuberances  90  reduce the lateral width of the channel opening  52  as defined between the opposing walls of channel  52 . In this manner, each pair of opposing protuberances  90  either grip onto or at least extend over an upper section of the connector tubular body  34  to inhibit unintentional transverse movement of the t-connector  22  once situated within the retainer  30 .  
         [0062]     The walls of the second channel  29  further inhibit unintentional transverse movement of t-connector  22 . For this purpose, the second channel  29  has a plurality of protuberances which are defined by the intersection of the second channel  29  and the first channel  52 . As seen in  FIGS. 4, 8  and  9 , protuberance pairs  92 ( a ),  92 ( b ) and  92 ( c ),  92 ( d ) are arranged on opposite sides of the second channel  29 . The protuberances  92  extend generally toward the central axis D of the second channel  29 . The protuberances  92  reduce the lateral width of the channel opening  88  as defined between the opposing walls of the second channel  29 . Each pair of opposing protuberances  92  is configured to either grip onto or at least extend over an upper section of the t-fitting  29  to inhibit unintentional transverse movement of the t-fitting  26  once situated within the retainer  30 . The retainer  30  can have one or both protuberances pairs  92 ( a ),  92 ( b ) and  92 ( c ),  92 ( d ). To inhibit transverse movement, the t-fitting  29  is placed between one of the protuberance pairs  92 ( a ),  92 ( b ) and  92 ( c ),  92 ( d ) depending on the orientation of the medical supply tube attached to the t-fitting  26 . Each pair of opposing protuberances  92  can further arrest rotation of the t-connector  22  about the longitudinal C axis.  
         [0063]     The channels  29 ,  52  have a generally U-shaped cross-sectional shape. However, the protuberances  90 ,  92  extend generally toward the central axis of their respective channels. Thus the protuberances  90 ,  92  reduce the lateral widths of their respective channel openings  56 ,  88  as defined between the opposing walls of each channel. In this manner, each pair of opposing protuberances  90 ,  92  either grip onto or at least extend over an upper section of the connector  22  to inhibit unintentional transverse movement once the t-connector  22  is situated within the retainer  30 .  
         [0064]     Alternatively, one or both of the channels  29 ,  52  can have a truncated, circular cross-sectional shape that extends through an arc of greater than 180°. In an exemplifying embodiment, the first channel  52  extends through an arc of about 200° about the channel axis C. The first channel  52 , in cross-section, thus may extend through an arc of a little more than 180° about the channel axis C such that the lateral width of the opening  56  is slightly smaller than the overall diameter of the first channel  52 . This allows for the t-connector  22  to be snapped into the first channel  52 . With such an arrangement, transverse movement can be inhibited when using a retainer  30  that does not include protuberances  90 .  
         [0065]     As best seen in  FIGS. 9 and 10 , the upper side surfaces of the protuberances  90 ,  92  preferably are rounded or chamfered and slop toward the channel opening  56 ,  88  to guide the connector tubular body  34  and the t-fitting  26  into their respective channels  29 ,  52 . As a result, the t-connector  22  slides more smoothly over the protuberances  90 ,  92  and into the channels as the opposing walls of the channels  29 ,  52  are deflected outwardly by the interference with the t-connector  22  during the insertion process. A two step insertion process can also be used. For example, the t-connector  22  is rotated about the longitudinal axis C so that the passageway through the t-fitting  26  is parallel to the transverse axis while the tubular body  34  is aligned with the first channel opening  56 . The aligned tubular body  34  is inserted through the channel opening  56  and into the first channel  52 . Once inserted the protuberances  90  grip onto or at least extend over an upper section of the tubular body  34 . The t-connector  22  is then rotated about the longitudinal axis C so that the passageway through the t-fitting  26  is parallel to the laterally extending axis D. As the connector  22  is rotated about the longitudinal C-axis, the t-fitting  26  passes between the protuberances  92  and enters through the channel opening  88  and into the second channel  29 . Once rotated, the protuberances  92  grip onto or at lest extend over an upper section of the t-fitting  26  to thereby inhibit rotational and transverse movement of the t-connector  22 .  
         [0066]     In a preferred mode, the proximal and/or distal body portions  72 ,  74  have sufficient lengths to prevent the connector  22  from yawing (i.e., movement side to side in a longitudinal-lateral plane). That is, the length of the proximal or distal body portion  72 ,  74 , which interacts with the t-connector  22  is sufficient so that the portion does not act as a fulcrum. However, while such wall length is preferred, the wall length can be significantly shorter (e.g., interact with the connector at a single longitudinal point) where the connector body  34  is also held near the opposite end (i.e. proximal or distal end).  
         [0067]     As seen in  FIG. 10 , the retainer  30  also includes a groove  100  that extends longitudinally along the base surface  54  and beneath at least a portion of the first channel  52 . In the illustrated embodiment, the groove  100  runs along the entire longitudinal length of the retainer  30 . The lateral width of the groove  100  is less than the diameter of the first channel  52 .  
         [0068]     As seen in  FIGS. 6, 7  and  10 , a pair of ridges  102  flank the groove  100 . Each ridge  102  extends slightly below the base surface  54  to inhibit an influx of adhesive into the groove  100  when the retainer is attached to the anchor pad  28 .  
         [0069]     As seen in  FIGS. 4 and 5 , recesses  104 ( a ),  104 ( b ),  104 ( c ), and  104 ( d ) are defined in the retainer body  50  at the four intersection points of the first channel  52  with the second channel  29 , and extend toward the base surface  54  from the bottom surfaces of the channels  29 ,  52 . In the illustrated embodiment, the recesses  104  extend between the first channel  52  and the base surface  54  in order to reduce the material weight of the retainer  30 .  
         [0070]     The proximal body portion  72  defines a proximal channel segment  106  of the first channel  52 . The proximal channel segment  106  is disposed between the proximal sides of the protuberances  90 ( b ),  90 ( c ) and the proximal-most abutment surface  60 . The proximal channel segment  106  generally has a U-shaped cross-section with a radius of curvature at least as large as the minimum radius of the connector tubular body  34 .  
         [0071]     The proximal body portion  72  also includes a proximal upstanding wall  108  that extends laterally across the proximal end of the retainer  30 . The upstanding wall  108  includes a U-shaped opening  110  that defines the proximal end of the first channel  52 . In the illustrated embodiment, the opening  110  has a lateral width that is smaller than the diameter of the distal end  36  of the t-connector  22 , but is larger than the diameter of the proximal end  38  of the t-connector  22 . The proximal upstanding wall  108  defines the proximal-most abutment surface  60  on its distal side. The proximal-most abutment surface  60  thus, in the illustrated embodiment, lies at the proximal end of the proximal channel segment  106  and at the distal end of the upstanding wall  108 .  
         [0072]     Both the proximal opening  110  and the proximal channel segment  106  of the channel  52  have generally U-shapes; however, one or both of these channel segments can have, for example, a truncated, generally circular shape. In this variation, the opening  110  or the proximal channel segment  106  can receive the proximal end  38  of the connector tubular body  34 , in a snap fit manner to inhibit further transverse movement of the t-connector  22  relative to the retainer  30 . It is preferred, however, that these channel segments do not so engage the connector body in order to ease the insertion process, as described below.  
         [0073]     As illustrated in  FIG. 3 , the retainer  30  includes finger platforms  112  on both sides of the first channel  52 . Each finger platform  112  extends laterally from one side of the retainer  30  at a location slightly above the base surface  54 . Each finger platform  112  also has a ribbed upper surface  114  to improve frictional contact between a healthcare provider&#39;s fingers and the platform  112 . The finger platforms  112  are sized and configured to allow a healthcare provider to press the anchoring system  20  against the skin of the patient while pulling up on the t-connector  22  when disengaging the t-connector  22  from the retainer  30 .  
         [0074]     The combination of the finger platforms  112  and the groove  100  along the base surface  54  beneath the first channel  52  makes it easier for the healthcare provider to open the first channel  52  to a sufficient degree so as to insert the connector tubular body  34  into the first channel  52 .  
         [0075]     The retainer  30  is made of relatively stiff plastic material (e.g., polycarbonate), but is somewhat flexible such that the t-connector  22  will force the protuberances  90  of the distal and proximal body portions  72 ,  74  outwardly when a healthcare provider presses the t-connector  22  into the first channel  52  of the retainer  30 . When the t-connector  22  sits in the first channel  52 , the protuberances  90  of the first channel  52  snap inwardly to their original position to securely hold the t-connector  22  within the retainer  30 . The connector is rotated about the longitudinal axis C until the t-fitting  26  contacts protuberances  92 . The flexibility of the retainer  30  allows the healthcare provider to press the t-connector  22  into the second channel  29 . When the t-connector  22  sits in the second channel  29 , the protuberances  92  of the second channel  29  snap inwardly to their original position to further securely hold the t-connector  22  within the retainer  30 .  
         [0076]     The retainer  30  may be constructed in any of a variety of ways which will be well known to one of skill in the art. For instance, the retainer  30  may be integrally molded such as by injection molding or by thermoplasty. The retainer  30  preferably comprises a durably, flexible material, and more preferably comprise a generally inert, non-toxic material. Suitable materials include plastics, polymers, or composites such as polypropylene, polyethylene, polycarbonate, polyvinylchloride, polyurethane, tetrafluoroethylene (e.g., TEFLON®), polytetrafluoroethylene (a.k.a., PTEF), acetal resin (e.g., DELRIN®), chlorotrifluoroethylene (e.g., KEL-F®), acrylonitrile butadiene styrene, styrene butadiene, nylon, olefin, acrylic, polyester, moldable silicon, thermoplastic urethane, thermoplastic elastomers, thermoset plastics and the like. The retainer  30  is preferably formed by injection molding using a polycarbonate, available commercially from GE Plastics (See www.geplastics.com). However, other materials can be used.  
         [0000]     Method of Use  
         [0077]     The following discussion of the method of use will be with reference to  FIGS. 1 and 11 - 14 , and will be in the context of intravenous catheterization. As the following discussion will illustrate, however, it is understood that the anchoring system  20  can be used in other catheterization procedures as well. The discussion of the method of use is intended to augment the above description of the preferred embodiments, and, thus, should be read together. In order to illustrate more clearly the interaction between the retainer  30  and the t-connector  22  in this embodiment, the anchor pad  28  of the anchoring system  20  is illustrated as detached from the retainer. In accordance with the preferred embodiment, however, the entire anchoring system  20  is assembled in accordance with the above-description (e.g., the anchor pad is attached to the retainer) and is sterilized before use.  
         [0078]     A healthcare provider typically begins the catheterization process by positioning the catheter at a desired location above a vein. The healthcare provider introduces a needle or other stylus through a cannula portion of the catheter and into the skin of the patient at a desired angle of incident. For intravenous use, the catheter commonly has an incident angle of approximately 7°. The healthcare provider then inserts the cannula of the catheter into the patient and withdraws the needle or stylus. Part of the catheter remains exposed above the skin. The healthcare provider inserts the proximal end  38  of the t-connector  22  into the catheter hub (not shown). The healthcare provider then securely attaches the t-connector  22  to the catheter by engaging, for example, a spin nut with the catheter hub in a known manner.  
         [0079]     The healthcare provider positions the retainer  30  below the t-connector  22  and inserts a portion of the proximal end  38  through the proximal opening  110 . At this point, the axis of the t-connector  22  is skewed relative to the axis C of the first channel  52 . The healthcare provider pulls the t-connector  22  proximally (or conversely slides the retainer distally) until the tapered shoulder  42 ( b ) of the connector tubular body  34  contacts the proximal-most abutment surface  60 . This act registers the longitudinal position of the t-connector  22  with the retainer  30  to align the t-connector  22  above the retainer  30 . So positioned, the longitudinal midpoint of the t-fitting  26  of the t-connector  22  is aligned with the longitudinal midpoint of the second channel  29  of the retainer  30  and with the longitudinal midpoint between the intermediate surface  64  and the distal-most abutment surface  62 . The healthcare provider then presses the t-connector  22  into the first channel  52  of the retainer  30 . In doing so, the t-connector  22  is pressed between the protuberances  90  of the distal and proximal body portions  72 ,  74  of the retainer  30 . As the healthcare provider presses the t-connector  22  into the retainer  30 , the t-fitting  29  is rotated and generally guided into the space between the intermediate surface  64  and the distal-most abutment surface  62 . Alternatively, the t-fitting  29  is rotated after the t-connector  22  is secured in the first channel  52 .  
         [0080]     As mentioned above, the opening  56  of the first channel  52  at the longitudinal locations of the protuberances  90  has a smaller width measured in the lateral direction than the diameter of the connector tubular body  34  at those locations. The distal and proximal body portions  74 ,  72  thus deflect outwardly in a lateral direction. Once the tubular body  34  of the t-connector  22  rests within the first channel  52  of the retainer  30 , the protuberances  90  spring back to snap the t-connector  22  in place. The first channel  52  and protuberances  90  of the retainer  30  thus prevent unintentional transverse and lateral movement of the t-connector  22 . The protuberances  92  further prevent unintentional rotational and transverse movement of the t-connector  22 .  
         [0081]     Once the t-connector  22  is secured in the retainer  30 , the healthcare provider removes the liner  180  which initially covers the adhesive lower surface  160  of the anchor pad  28 . The healthcare provider attaches the pad  28  to the patient&#39;s skin proximate to the indwelling catheter. Specifically, the healthcare provider grips one of the two pull tabs  190 . The healthcare provider then pulls on the tab  190  and peels the backing off one side of the bottom adhesive layer. The healthcare provider positions the anchor pad  28  over the placement site and places the exposed bottom layer against the patient&#39;s skin to adhere the anchor pad  28  to the patient. Light pressure over the upper surface  170  assures good adhesion between the anchor pad  28  and the patient&#39;s skin. The anchor pad  28 , due to its flexibility, contours to the contours of the topical surface to which the anchor pad  28  adheres.  
         [0082]     The healthcare provider repeats this procedure for the other side of the lower surface of the anchor pad  28 . Alternatively, the healthcare provider may completely remove the liner  180  from the pad  28  before attaching the pad  28  to the patient&#39;s skin. Additionally, the anchor pad  28  can be attached to the patient before the t-connector  22  is inserted into the retainer  30 .  
         [0083]     The present anchoring system thus provide a sterile, tight-gripping, needle- and tape-free way to anchor a medical article to a patient. The retainer eliminates use of tape, and if prior protocol required suturing, it also eliminates accidental needle sticks, suture-wound-site infections and scarring. In addition, the retainer can be configured to be used with any of a wide variety of catheters, fittings, tubes, wires, and other medical articles. Patient comfort is also enhanced and application time is decreased with the use of the present anchoring system.  
         [0084]     Of course, it is to be understood that not necessarily all such objects or advantages may be achieved in accordance with any particular embodiment of the invention. Thus, for example, those skilled in the art will recognize that the invention may be embodied or carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other objects or advantages as may be taught or suggested herein. In addition to the variations described herein, other known equivalents for each feature can be incorporated by one of ordinary skill in this art to construct anchoring systems in accordance with principles of the present invention.  
         [0085]     Although this invention has been disclosed in the context of certain preferred embodiments and examples, it will be understood by those skilled in the art that the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. In particular, while the present retainer has been described in the context of particularly preferred embodiments, the skilled artisan will appreciate, in view of the present disclosure, that certain advantages, features and aspects of the retainer may be realized in a variety of other applications, many of which have been noted above. For example, while particularly useful for small-scale applications, such as the illustrated medical application, the skilled artisan can readily adopt the principles and advantages described herein to a variety of other applications, including larger scale devices. Additionally, it is contemplated that various aspects and features of the invention described can be practiced separately, combined together, or substituted for one another, and that a variety of combination and subcombinations of the features and aspects can be made and still fall within the scope of the invention. Thus, it is intended that the scope of the present invention herein disclosed should not be limited by the particular disclosed embodiments described above, but should be determined only by a fair reading of the claims that follow.