US20070173768A2 - Catheter anchoring system - Google Patents

Abstract

A catheter anchoring system is provided to securely anchor to a patient's skin a catheter and fluid supply tube interconnection. The anchoring system comprises a retainer configured to receive a catheter adaptor in a variety of positions. The adaptor interconnects the catheter and the fluid supply tube. In one embodiment the adaptor has a radial recess that circumscribes the adaptor. The anchoring system additionally includes a flexible, adhesive anchor pad which can supports a tube clip, as well as the retainer. The retainer includes a channel that is configured to receive the adaptor in a snap-fit manner. The retainer also includes a plurality of laterally arranged projections that extend from a channel wall and into a channel. Each radial recess is sized to receive and to capture at least a portion of the projection of the retainer so as to inhibit the adaptor from moving within the channel.

Description

RELATED CASES
• This is a divisional application of copending application Ser. No. 10/096,088 filed 11 Mar. 2002, which is a continuation-in-part of application Ser. No. 09/809,460 filed 15 Mar. 2001, now U.S. Pat. No. 6,786,892 issued on 7 Sep. 2004, which is a continuation of application Ser. No. 09/069,029 filed 27 Apr. 1998, now U.S. Pat. No. 6,290,676 issued on 18 Sep. 2001, which is a continuation-in-part of application Ser. No. 08/753,277 filed 25 Nov. 1996, now U.S. Pat. No. 5,827,230 issued on 27 Oct. 1998, which is a continuation of application Ser. No. 08/223,948 filed 6 Apr. 1994, now U.S. Pat. No. 5,578,013 issued 26 Nov. 1996, which is a continuation-in-part of application Ser. No. 08/121,942, filed 15 Sep. 1993, now U.S. Pat. No. 5,456,671 issued 10 Oct. 1995, which is a continuation-in-part of application Ser. No. 08/034,340 filed 19 Mar. 1993, now U.S. Pat. No. 5,354,282 issued 11 Oct. 1994, all of which are hereby incorporated by reference in their entireties. This application is a divisional application of copending application Ser. No. 10/096,088 filed 11 Mar. 2002, which is also a continuation of copending application Ser. No. 09/165,367 filed 2 Oct. 1998, which is a continuation-in-part of application Ser. No. 09/069,029 filed 27 Apr. 1998, now U.S. Pat. No. 6,290,676 issued on 18 Sep. 2001 and whose predecessor cases are listed above, all of which are hereby incorporated by reference in their entireties.
BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• The present invention relates in general to a percutaneous catheterization system, and, in particular, to a catheter anchoring system which securely interconnects an indwelling catheter with a tubing and securely anchors such interconnection to a patient's skin.
• 2. Description of Related Art
• Medical treatment of patients commonly involves the use of percutaneously inserted catheters to direct fluids directly into the bloodstream, a specific organ or an internal location of the patient, or to monitor vital functions of the patient. For instance, intra-arteriosus catheters are commonly used to direct fluids and/or medication directly into the bloodstream of the patient. Epidural catheters are commonly used to direct anesthesia into an epidural space to anesthetize a specific location of the patient. Intervascular catheters are commonly used to monitor arterial blood pressure.
• The fluid (e.g., parenteral liquid, medication or anesthesia) typically drains from a container positioned above the patient. The fluid flows through tubing and into an indwelling catheter. The catheter and fluid tubing are commonly removably attached by a conventional lure-type connector, such as the type described in U.S. Pat. No. 4,224,937.
• In common practice, a health care provider, such as, for example, a nurse or doctor (for ease of description, as used herein the term “nurse” will refer to health care providers generally and will not be restrictive in meaning), 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.
• The nurse may also form a safety loop in the tubing so that any tension applied to the tubing does not directly pass to the catheter cannula, but rather is absorbed by the slack of the safety loop. The nurse typically loosely tapes the loop to the skin of the patient.
• This entire taping procedure takes several minutes of the valuable time of the health care provider. Furthermore, nurses commonly remove their gloves when taping because most nurse find such taping procedures difficult and cumbersome when wearing gloves.
• The catheterization process often requires frequent disconnection between the catheter and the fluid supply tube. For instance, intravenous catheterization is frequently maintained for several days, depending upon the condition of the patient. The catheter tubing is generally replaced every 24 to 48 hours in order to maintain the sterility of the fluid and the free-flow of the fluid through the tubing. A nurse must thus frequently change the tubing and retape the connection. Moreover, the tape, which secures the catheter to the skin of the patient, often covers the cannula insertion point. The nurse must remove the tape to inspect the insertion point for inflammation or infection, and must then repeat the above-described taping procedure.
• A great deal of valuable time is thus used in applying significant amounts of surgical tape to indwelling catheters. The frequent application and removal of surgical tape also commonly results in the excoriation of the skin of the patient in the area of the insertion.
• A number of catheterization systems have recently been developed which improve the stabilization of the catheter system and obviate the need for frequent application and removal of surgical tape. One such system is disclosed by U.S. Pat. No. 5,192,273 issued to the present Applicant, which is hereby incorporated by reference.
• The '273 patent discloses an adaptor which interconnects the catheter with a fluid supply tubing. The adaptor snaps into a base attached to the patient's skin by an adhesive pad. Specifically, a nurse presses the adaptor between upstanding legs of the base. Detents on the adaptor legs slide into corresponding annular grooves in the adaptor body to hold the adaptor to the base.
• Although the base holds the adaptor securely in place, a nurse may have difficulty positioning and aligning the annular grooves of the adaptor with the detents on the base. Exigent circumstances may further exacerbate the difficulties associated with properly positioning the adaptor onto the base. Some nurses and other health care providers may also have trouble determining how to engage the catheter adaptor with the base.
SUMMARY OF THE INVENTION
• The catheter anchoring system of the present invention provides an adaptor retainer which is not position or technique sensitive. That is, the nurse simply locates the catheter adaptor generally above the retainer, and presses the adaptor into the retainer. Engagement requires only coarse alignment of the adaptor with the retainer.
• In accordance with one aspect of the present invention, an anchoring system is provided for use with a catheter having an adaptor with at least one recess. A retainer is provided to receive the adaptor. The retainer includes a channel that extends through the retainer about a longitudinal axis. The channel is configured to receive at least a portion of the adaptor in a snap-fit manner. At least one projection on the retainer extends into the channel in a direction generally normal to the longitudinal axis. The projection has a longitudinal length so dimensioned to substantially equal the longitudinal length of the recess of the adaptor. The cooperation between the projection of the retainer and the recess of the adaptor inhibit longitudinal movement of the adaptor relative to the retainer.
• In accordance with another aspect of the present invention, an anchoring system is provided for use with a catheter having an adaptor with a recess. The retainer includes a channel that extends through the retainer about a longitudinal axis. The channel is configured to receive at least a portion of the adaptor in a snap-fit manner. At least one projection on the retainer extends into the channel in a direction generally normal to the longitudinal axis. The projection has a longitudinal length so dimensioned to substantially equal the longitudinal length of the recess of the adaptor. The cooperation between the projection of the retainer and the recess of the adaptor inhibit longitudinal movement of the adaptor relative to the retainer.
• In accordance with yet another aspect of the present invention, an anchoring system is provided for use with a catheter having an adaptor with a radially extending member that projects from the fitting. The anchoring system comprises a retainer that includes first and second channel portions. The channel portions extend about a longitudinal axis, and each is configured to receive a corresponding portion of the catheter fitting. A plurality of lateral slots are positioned between the channel portions. Each lateral slot is dimensioned so as to receive the radially extending member of the catheter fitting to prevent the catheter from moving in a longitudinal direction. The lateral slots are also arranged next to each other along the longitudinal axis so as to provide multiple positions in the longitudinal direction in which to insert the radially extending member of the catheter fitting when positioning the catheter fitting within the retainer.
• Another aspect of the present invention involves a catheterization system includes a catheter and a retainer to secure the catheter to a patient. The catheter includes a fitting with a radially extending member that projects from the fitting. The retainer includes first and second channel portions that extend about a longitudinal axis. Each channel portion generally has a truncated cross-sectional shape with an opening along the longitudinal axis. Each channel is also sized to surround at least a portion of the fitting through an arc of greater than 180° about the longitudinal axis. At least one lateral slot of the retainer extends generally perpendicular to the longitudinal axis and lies between the first and second channel portions. The slot has a longitudinal length so dimensioned to substantially equal the thickness of the radially extending member of catheter fitting and to be generally less than the combined longitudinal lengths of the first and second channel portions. This dimensional relationship between the channel portions and the slot provides lateral stability of the catheter fitting when the radially extending member is positioned within the lateral slot of the retainer.
• In accordance with a further aspect of the present invention, a catheter anchoring system comprises a catheter adaptor, a retainer and a base pad which adheres to the skin of a patient and supports the retainer. The catheter adaptor comprises a tubular body connected to a radially extending support arm. The support arm in turn connects to a clip which pivots relative to the tubular body.
• The retainer comprises a pair of opposing longitudinal walls. Each wall defines a series of slots. Each slot is sized such that a portion of the support arm of the catheter adaptor extends through the slot. The slot prevents the support arm from moving in a direction generally parallel to a longitudinal direction of the retainer.
• The retainer further comprises a central channel which extends through the retainer about an axis which is generally parallel to the longitudinal axis. The channel is interposed between the opposing longitudinal walls and has a truncated circular cross-sectional shape. The central channel, in cross-section, is sized to encompass the tubular body through an angle greater than about 180°.
• The anchoring system may additionally comprise a tube clip configured to receive a portion of the tube. The anchoring system may also comprise an S-clip having a plurality of retainers to secure a microbore tubing connected to the tube by the adaptor.
• An additional aspect of the present invention provides a catheter anchoring system for securing an indwelling catheter within a body lumen of a patient and for securely interconnecting the indwelling catheter with a tube. The catheter anchoring system comprises a catheter adapter having a generally tubular body defined between distal and proximal ends. The distal end is configured to engage the catheter proximal end and the proximal end is configured to couple to a distal end of the supply tube. The catheter adapter additionally comprises a radially extending member which projects from an exterior surface of the tubular body in a radial direction.
• A retainer of the catheter anchoring system comprises a longitudinal channel configured to receive the tubular body of the adapter in a snap fit manner. The retainer additionally comprises a plurality of lateral slots or projections which are sized to receive and to capture the radially extending member of the adapter with the adapter positioned within the channel. The slots can be formed in a variety of ways, such as by laterally arranging a plurality of gaps next to each other and through the opposing longitudinal walls of the retainer. The projections can similarly be formed in a variety of ways, such as by laterally arranging a plurality of projections next to each other from the opposing longitudinal walls of the retainer and projecting the projections into the channel. The retainer prevents the adapter from sliding in a longitudinal direction when one of the slots.
• In a preferred embodiment, the radially extending member comprises a support arm which connects a clip to the tubular body. In an alternative preferred embodiment, the radially extending member comprises an annular collar which circumscribes the tubular body.
• In accordance with a preferred method of anchoring an indwelling catheter/tube interconnection to a patient, an adapter is provided having a generally tubular body with a recess. An anchor pad is also provided with an adhesive back. The anchor pad supports a retainer configured to receive the adapter and has a series of lateral projections. The anchor pad is attached to the patient's skin proximate to an indwelling catheter. The recess of the adapter is positioned above the series of projections. The retainer is deflected so as to open the channel to a size sufficient to receive the adapter, and the adapter is inserted into the channel. The recess is inserted around at least a portion of one of the projections. The retainer is then permitted to spring back to an undeflected position such that the tubular body is captured within the retainer.
BRIEF DESCRIPTION OF THE DRAWINGS
• These and other features of the invention will now be described with reference to the drawings of preferred embodiments which are intended to illustrate and not to limit the invention, and in which:
• FIG. 1 is a perspective view of a catheter anchoring system in accordance with a preferred embodiment of the present invention, mounted on the back of a patient's hand;
• FIG. 2 is a top plan view of the catheter anchoring system ofFIG. 1;
• FIG. 3 is a top plan view of a retainer of the catheter anchoring system ofFIG. 2;
• FIG. 4ais a front elevational view of the retainer ofFIG. 3;
• FIG. 4bis a rear elevational view of the retainer ofFIG. 3;
• FIG. 5 is a side elevational view of the retainer ofFIG. 3;
• FIG. 6 is a top plan view of a catheter anchoring system in accordance with another preferred embodiment of the present invention;
• FIG. 7ais a front elevational view of a retainer and rail assembly of the catheter anchoring system ofFIG. 6;
• FIG. 7bis a side elevational view of the retainer and rail assembly ofFIG. 6;
• FIG. 8 is a cross-sectional view of the retainer and rail assembly taken along line8-8 ofFIG. 7a;
• FIG. 9 is a top plan view of a catheter anchoring system in accordance with an additional preferred embodiment of the present invention;
• FIG. 10 is a side elevational view of an S-clip of the catheter anchoring system ofFIG. 9 taken along line10-10;
• FIG. 11 is a top perspective view of a catheter anchoring system in accordance with an additional preferred embodiment of the present invention;
• FIG. 12 is a top plan view of the catheter anchoring system ofFIG. 11 illustrating an adaptor held by a retainer;
• FIG. 13ais a side elevational view of the retainer ofFIG. 12;
• FIG. 13bis a top plan view of the retainer ofFIG. 12;
• FIG. 14 is a partially sectioned perspective view of an alternative embodiment of a catheter adaptor which may be used with the anchoring system ofFIG. 11;
• FIG. 15ais side elevational view of a catheterization system in accordance with another preferred embodiment of the present invention with a retainer of the catheterization system shown in cross-section;
• FIG. 15bis a top plan view of the retainer ofFIG. 15aas viewed in the direction ofarrows15b-15b;
• FIG. 15cis a front end elevational view of the retainer ofFIG. 15aas viewed in the direction ofarrows15c-15c; and
• FIG. 16 is a perspective view of a catheterization system configured in accordance with another embodiment of the present invention, and illustrates a catheter in a position separate from a retainer of the catheterization system;
• FIG. 17 is a perspective view of a catheterization system configured in accordance with another embodiment of the present invention, and illustrates the a catheter adaptor having a plurality of radial recesses and a retainer having a plurality of projections that cooperate with the recesses when the retainer receives the catheter adaptor; and
• FIG. 18 is a perspective view of the catheterization system configured in accordance with an additional embodiment of the present invention, and illustrates the catheter adaptor having a plurality of radial recesses and a retainer having a plurality of projections that extend into a channel having a tapered diameter.
DETAIL DESCRIPTION OF PREFERRED EMBODIMENTS
• FIG. 1 illustrates in perspective view acatheter anchoring system10 in accordance with the present invention. The anchoringsystem10 securely connects a tube12 (e.g., a fluid supply tube) to anindwelling catheter14 and maintains thecatheter14 in the desired indwelling position. The anchoringsystem10 is designed for rapid attachment to thecatheter14 and to the patient, without requiring precise alignment or positioning of the components of theanchoring system10.
• Moreover, sturdy anchoring of the catheterization system is achieved without the use of surgical tape. For most catheterization, the anchoring system is attached to the patient only once. Although thefluid supply tubing12 may be replaced every 24 to 48 hours for intravenous catheterization, the components of theanchoring system10 attached to the patient remains in place. Thus, surgical tape need not be applied and removed from the patient's skin on multiple occasions.
• Thecatheter anchoring system10 principally comprises aflexible pad16 having an adhesivebottom side18 which attaches to the skin of a patient when used. Thepad16 supports aretainer20. Theretainer20 is configured to receive and secure in place acatheter adaptor22 which interconnects thehub30 of anindwelling catheter14 and thefluid supply tube12 connected to a fluid supply container (not shown). The container maintains the fluid to be dispensed to the patient which is fed either by gravity or by pressure. A clamp (not shown) may be used to regulate the fluid flow through thetubing12. Thepad16 may also support atubing clip24 which is used to retain a portion oftubing12.
• AlthoughFIG. 1 illustrates the catheter anchoring system located on the back of a patient's hand (illustrated in phantom lines), it is contemplated that the present invention may be used for catheterization in other locations on the patient's body. For instance, the anchoring system may be used on the medial side of the wrist in connection with a radial artery. The anchoringsystem10 may also be used for epidural catheterization, as discussed in detail below, and thus located on the anterior or posterior of the patient's torso.
• FIG. 1 illustrates a longitudinal axis, a transverse axis and a lateral axis in relation to thecatheter anchoring system10 to facilitate the following description. Additionally, as used herein, “the longitudinal direction” refers to a direction substantially parallel to the longitudinal axis. “The lateral direction” and “the transverse direction” are in reference to the lateral axis and transverse axis, respectively. Also, “proximal” and “distal” are in reference to the proximity of the fluid supply container attached to the tube12 (seeFIG. 1). The individual components of thecatheter anchoring system10 will now be described in detail.
• Catheter Adaptor
• FIG. 1 illustrates thecatheter adaptor22 interconnected with acatheter14.FIG. 2 illustrates thecatheter adaptor22 disconnected fromcatheter14. Although these figures illustrate theadaptor22 as the type disclosed in U.S. Pat. No. 5,193,273, it is contemplated that other types of adaptors can be used as well with the presentcatheter anchoring system10. For instance, thecatheter adaptor22 could be a lure-type adaptor, such as the type illustrated byFIG. 11 and described below, or a lure-locktype catheter adaptor22, such as the type illustrated byFIG. 14 and described below. It is contemplated that those skilled in the art could readily select the type ofcatheter adaptor22 to be used with the presentcatheter anchoring system10 depending on the particular application (e.g., venous, arterial, epidural, peripheral, etc.) of theanchoring system10.
• As best seen inFIG. 2, theadaptor22 comprises atubular body25 defined between a distal end26 and aproximal end28. Theproximal end28 is adapted to receive a distal end of thetube12. In an exemplary embodiment, at least a portion the fluid supply tube is permanently attached to the bodyproximal end28. As shown inFIG. 2, the proximal end of the tubing may then include a standard lure-type connector29 to connect into afluid supply line12.
• The distal end26 is configured to engage theproximal hub30 of the catheter14 (seeFIG. 1) or any lure-type connector. AlthoughFIG. 2 illustrates the distal end of theadaptor22 as having a frusto-conical shape configured to engage a standard lure-type catheter hub30, it is contemplated that the distal end26 could be configured as well to engage other types of catheter connectors, such as, for example, a Toughy-Bourst adaptor.
• Asupport arm32 extends outwardly from thetubular body25 in cantilever fashion. Thesupport arm32 supports, on a radially outer end of thearm32, a clip support element (not shown) that extends generally parallel to and is spaced from a longitudinal axis of thetubular body25.
• FIG. 2 further illustrates aclip34 of the catheter adaptor. Theclip34 attaches to and slides over the clip support element in the longitudinal direction. Theclip34 includes adistal latch36 which has a generally forked shape to engage a outer surface of thecatheter hub30 distal of a hub collar38 (seeFIG. 1) to securely attach theadaptor22 to thecatheter hub30.
• Interengaging structure (not shown) between the clip support element and theclip34 permits theclip34 to slide in the proximal direction, but prevents theclip34 from sliding in the distal direction. The interengaging element desirably comprises a series of ratchet teeth (not shown) disposed up on upper surface of the clip support element and a pawl (not shown) connected to theclip34. The pawl extends from theclip34 in a cantilever fashion and engages the ratchet teeth to prevent distal movement of the clip, as discussed in detail in U.S. Pat. No. 5,193,273, which has been incorporated by reference.
• Thetubular body25, thesupport arm32 and the clip support element are preferably integrally formed of molded plastic, such as, for example, a clear polycarbonate, so as to be generally stiff, but somewhat flexible. Thesupport arm32 desirably has enough elasticity to bend. Depressing the proximal end of theclip34 towards thetubular body25 moves thelatch36 of theclip34 away from thetubular body25. In this manner, theclip34 pivots about thetubular body25.
• With reference again toFIG. 2, the clip support element desirably comprises aprotuberance40 positioned on aninner surface42 of the clip support element, proximate to the proximal end of theclip34. The protuberance is spaced from the support arm by a distance L. Theprotuberance40 prevents theclip34 from pivoting when secured by theretainer20, as discussed below in detail. Theprotuberance40 also limits the degree of deflection of thesupport arm32 to reduce fatigue, as fully explained in U.S. Pat. No. 5,193,273, which has been incorporated by reference.
• Retainer for Catheter Adaptor
• FIGS. 3 through 5 illustrate theretainer20. Theretainer20 has a generally parallelepiped shape defining acentral channel44 interposed between a pair of opposinglongitudinal walls46. Thecentral channel44 extends through theretainer20 along an axis which is generally parallel to the longitudinal axis of the retainer.
• As best seen inFIG. 4, thecentral channel44 has a generally circular cross-sectional shape which is truncated at a upper end to form a generally U-shaped channel having anupper opening47. Thecentral channel44 has a diameter sized to receive thetubular body25 of thecatheter adaptor22. In a preferred embodiment, the diameter of thecentral channel44 generally matches that of thetubular body25 or is slightly larger.
• In cross-section, thecentral channel44 extends through an arc greater than 180° about the channel axis such that the transverse length of theopening47 is less than the diameter of thecentral channel44. In an exemplary embodiment, thecentral channel44 extends through an arc of about 200° about the channel axis.
• FIG. 5 illustrates the channel axis which is desirably skewed relative to abase surface48 of theretainer20. An incident angle θ formed between thebase surface48 and the channel axis is less than 45°. The incident angle θ desirably ranges between 0° and 30°. In an exemplary embodiment for intravenous use, the angle θ preferably equals approximately 7°. In another exemplary embodiment for arterial use, the incident angle θ preferably equals about 22°. In a further exemplary embodiment, for peripherally inserted central catheters (PICC), the incident angle θ preferably equals 0°.
• Thelongitudinal walls46 are substantially identical. Eachwall46 has a thickness measured in the lateral direction less than the length of thesupport arm32. Thewall46 is thus interposed between thetubular body25 and theclip34 when thetubular body25 is inserted into thecentral channel44. The length of eachwall46, measured in the longitudinal direction, is preferably coextensive with the length of theretainer20.
• Eachwall46 comprises a uniform series ofslots50. The series comprises at least two (2)slots50, and not more than twenty (20)slots50. More preferably, the series comprises less than seven (7)slots50. In an exemplary embodiment, as illustrated in the figures of the application, the series comprises four (4)slots50.
• Eachslot50 is sized to receive thesupport arm32 of thecatheter adaptor22 to prevent longitudinal displacement of theadaptor22, as discussed in detail below. Eachslot50 desirably has a rectangular shape. As seen inFIG. 3, theslots50 extend from anexterior surface52 through thewall44, and open into thecentral channel44. The width of each slot50 (measured longitudinally) is desirably slightly greater than the width of thesupport arm32, measured in the longitudinal direction to receive thesupport arm32, as discussed below.
• As illustrated byFIG. 5, eachslot50 has a height as measured in the transverse direction between anupper edge54 of thelongitudinal wall46 and the bottom56 of thecentral channel44. The height of theslot50 desirably equals approximately the width of thesupport arm32 such that thesupport arm32 does not protrude from theretainer20 in the transverse direction.
• The spacing S between theslots50, on center, desirably equals about half the distance L (seeFIG. 2) between thesupport arm32 and theprotuberance40 of thecatheter adaptor22.
• AsFIG. 3 illustrates, a distance X between the mostdistal slot50 and the distal end of theretainer20 is less than the longitudinal distance Y (seeFIG. 2) between thesupport arm32 and thelatch36 positioned in its most proximal position. This spacing enables thesupport arm32 to rest in the mostdistal slot50 with thelatch36 retaining acatheter hub30 distal of the retainer distal end.
• FIG. 5 illustrates theupper edge50 of thelongitudinal wall46 which comprises a series of chamfers58, each of which slopes into aslot50. That is, the portion ofupper edge50 of thelongitudinal wall46 which surrounds aslot50 includes a pair of chamfers58, with one chamfer58 located on either side of theslot50. The chamfers58 slope downward toward theslot50 to facilitate the insertion of thesupport arm32 of thecatheter adaptor22 into theslot50, as discussed below.
• As shown byFIGS. 3 and 5, eachlongitudinal wall46 further comprises arelief60 disposed on the proximal end of theretainer20. Therelief60 is sized to receive theprotuberance40 of theadaptor22. The depth of therelief60 measured in the lateral direction desirably is slightly greater than the height of the protuberance40 (i.e., the distance by which the protuberance protrudes from the inner surface42).
• Therelief60 is spaced in the longitudinal direction from the mostproximal slot50 by a distance approximately equal to the spacing S between theslots50. Thus, theprotuberance40 rests in therelief60 with thesupport arm32 positioned in either of the two mostproximal slots50, as discussed in detail below.
• FIGS. 3 and 4 illustrate a key-way groove62 of theretainer20. The key-way groove62 facilitates the removal of thecatheter adaptor22 from theretainer20, as discussed below in detail. The key-way groove62 lies at the proximal end of theretainer20. The key-way groove62 extends into theretainer20, and toward theretainer base surface48 from thebottom surface56 of thecentral channel44. The key-way groove62 has a transverse width less than the diameter of thecentral channel44, and more preferably has a width approximately equal to two-thirds the diameter of thecentral channel44. The longitudinal length of the key-way groove62 desirably equals approximately the longitudinal length of therecesses60 in thelongitudinal walls46.
• Theretainer20 is made of relatively stiff plastic material (e.g., polycarbonate), but is somewhat flexible such that theadaptor22 forces theupper edges54 of thelongitudinal walls46 outwardly when a nurse presses theadaptor24 into thecentral channel44 of theretainer20. When theadaptor22 sits in thecentral channel44, theupper edges54 of thewalls46 snap inwardly to their original position to securely hold theadaptor22 within theretainer20.
• An adhesive attaches theretainer20 tobase pad16. Alternatively, theretainer20 may be attached to thebase pad16 by like means (e.g., embedding or otherwise weaving theretainer20 into the base pad16) as well.
• Base Pad
• As illustrated byFIG. 1, theflexible base pad16 comprises a laminate structure comprising an upper paper or other woven ornon-woven cloth layer64, an innercellulose foam layer66, and thebottom adhesive layer18. Alternative, theflexible base pad16 may comprise an adhesive bottom layer and an upper cellulose foam layer. An upper surface of the foam layer is roughened by corona treating the foam with a low electric charge, as known in the art. The roughened or porous upper surface of thebase pad16 improves cyano-acrylate (or other types of adhesive) adhesion when attaching theretainer20 to thepad16.
• A removable paper or plastic backing (not shown) desirably covers thebottom adhesive layer18 before use. The backing preferably resists tearing and is divided into a plurality of pieces to ease attachment of thepad16 to the patient's skin, as explained below. Desirably, the backing is split along the center line of theflexible base pad16 in order to expose only half of theadhesive bottom surface18 at one time. The backing also advantageously extends beyond at least one edge of thebase pad16 to ease removal of the backing from theadhesive layer18.
• As seen inFIG. 2, one ormore tabs67 may be attached to a portion of the backing which extends beyond theflexible base pad16. In an exemplary embodiment, thetabs67 have the same laminate structure as theflexible base pad16. Thetabs67 also can be formed by the paper backing extending beyond the edge of thebase pad16. Thetab67 may also includeindicia69 in the form of dots, words, figures or the like to indicate the placement of fingers when removing the backing from thebase pad16.
• A nurse grips thetab67, preferably at the location of theindicia69, and peels the backing off one half of thebottom adhesive layer18. The nurse then places thebottom layer18 against the patient's skin to adhere thebase pad16 to the patient. Light pressure over theupper layer64 assures good adhesion between thebase pad16 and the patient's skin. Thebase pad16, due to its flexibility, conforms to the contours of the topical surface to which thebase pad16 adheres. The nurse then repeats this procedure for the other half of thepad16. Alternatively, the nurse may completely remove the backing from thepad16 before attaching thepad16 to the patient's skin.
• Thebase pad16 desirably comprises anotch68 positioned distal of the location of theretainer20 on thepad16 and adjacent to the point of insertion of the catheter cannula. Thenotch68 is sized to permit visual inspection of the catheterized site.
• As seen inFIG. 2, thebase pad16 desirably may compriseindicia70 in the form of an arrow which indicates the proper orientation of thebase pad16 in reference to catheterized site. Although the figures illustrate the indicia in the form of an arrow, it is contemplated that other forms of indicia, such as, for example, words or other graphics, could be used as well. In proper use, as illustrated inFIG. 1, theindicia70 should point in the proximal direction, towards the indwellingcatheter14, or otherwise indicate the proper locate of thepad16 in reference to theindwelling catheter14.
• In an exemplary embodiment, the laminate structure of the base pad is preferably formed by rolling a paper tape, such as a micro-porous rayon tape, available commercially as MICRO-PORE tape from 3M (Item No. 1530), over a medical grade polyvinyl chloride foam tape, such as that available commercially from 3M (Item No. 9777L). The foam tape preferably includes the bottom liner or backing. Thebase pad16 and thetabs67 are then stamped out of the laminated sheet of foam and paper. The backing between the tabs and the base pad, however, is desirably not severed such that thetabs67 remain attached to the backing covering theadhesive section18 of thebase pad16. The backing is then cut into two pieces along the center line of thepad16 and between thetabs67.
• Tube Clip
• FIGS. 1 and 2 illustrate thetube clip24. Theclip24 secures thefluid supply tube12 to form a safety loop, as known in the art.
• The tube clip has a plate-like base72 adhered to or embedded in thebase pad16. Thetube clip24 may be located on thebase pad16 on either side of theretainer20 to accommodate left hand or right hand mounting. As illustrated inFIG. 6, the anchoringsystem10 may further include asecond tube clip24 located on the other side of theretainer20 from thefirst tube clip24.
• Theclip24 defines achannel74 having a generally circular cross-sectional configuration truncated to form anupper orifice76. The diameter of thechannel74 is desirably slightly less than that of thefluid supply tube12 so as to ensure a secure interconnection. Thechannel74 receives a portion of thefluid supply tube12 through theorifice76 upon application of gentle pressure or by pulling thetubing12 across and through theorifice76 of thetube clip24, as explained below. Theclip24 surrounds a substantial portion of thetubing12 with thetubing12 positioned within thechannel74.
• As seen inFIG. 2, the upper edge of the channel includes tapered ends77 at the proximal and distal ends of theclip24. Eachtapered end77 forms a smooth transition between the side edge of thechannel74 and the upper edge, and tapers in lateral width from the side edge toward the center of thetube clip24. The tapered ends77 help guide thefluid supply tube12 into thechannel74 when a nurse pulls the tube across theclip24. Thus, the nurse does not have to pinch thetube12 to insert it into theclip24. Also, the nurse's gloves do not get stuck in theclip24 when inserting thetube12, as is typically the case where the nurse is required to pinch thetube12 to insert it into theclip24.
• Slide Clamp
• As illustrated inFIGS. 1 and 2, thecatheter anchoring system10 desirably additionally includes aslide clamp78 to regulating fluid flow through the tubing, as known in the art. Theclamp78, at one end, includes anaperture80 which receives thefluid supply tube12, and, at the opposite end, includes atab82. Theclamp78 has a generally forked shape formed by a pair ofprongs84 which defines theaperture80. Thetube12 snaps between theprongs84 and into theaperture80, which has a diameter slightly larger that thefluid supply tube12.
• Theprongs84 converge together in the direction towards thetab82 to form atapering slot86 which opens into theaperture80. Theprongs84 pinch thetube12 closed with thetube12 positioned in theslot86 so as to block fluid flow therethrough. Theclamp78, however, slides over thetube12 with thetube12 positioned through theaperture80.
• Thetab82 desirably has a rectangular shape which generally corresponds the to shape of the key-way groove62 of theretainer20. Thetab82 preferably has a thickness greater than that of the distal end of key-way groove62, measured in the transverse direction, so as to pry theadaptor22 from theretainer20. As explained in detail below, thetab82 may be used to remove thecatheter adaptor22 from theretainer20.
• Retainer Location Adjustment Mechanism
• FIG. 6 through8 illustrate a catheter anchoring system10ain accordance with another preferred embodiment of the present invention. Where appropriate, like numbers with an “a” suffix have been used to indicate like parts of the two embodiments for ease of understanding.
• The catheter anchoring system10ais substantially identical to the above-describedanchoring system10, with the addition of a retainerlocation adjustment mechanism90.
• As best seen inFIG. 8, thelocation adjustment mechanism90 comprises abase92 and interlocking mechanism94 which interconnects thebase92 and theretainer20a. Theretainer20aslides over thebase92 and the interlocking mechanism94 secures theretainer20ato the base92 at various longitudinal positions. The adjustment mechanism thus allows for precise positioning of theretainer20 relative to thecatheter14 after thepad16 is attached to the patient's skin.
• Thebase92 has a generally parallelepiped shape and comprises arail96.FIG. 7abest illustrates that therail96 desirably has a “dove-tail” configuration in cross section. That is, therail96 has a cross-sectional shape with a flatupper edge98 and a pair of opposing side edges100, eachedge100 being angled inward from theupper edge98 toward the middle of therail96. Therail96 extends along the longitudinal length of the base92 from thedistal end102 of the base92 to a point just short of the baseproximal end104. Thebase92 includes a pair ofstops106 at theproximal end104 which close off the proximal end of therail96.
• An adhesive attaches the base92 to base pad16a. Alternatively, thebase92 may be attached to the base pad16aby like means (e.g., embedding or otherwise weaving the base92 into the base pad16a) as well.
• Theretainer20a, configured in accordance with the above-description, additionally comprises agroove108 having a cross-sectional shape corresponding to that of therail96. Theretainer groove108 receives thebase rail96 in a manner permitting theretainer20ato slide over thebase92, but preventing theretainer20afrom moving in the transverse direction away from thebase92. The base stops106 also limit the retainer's longitudinal travel in a proximal direction.
• The interlocking mechanism94 comprises a plurality ofteeth110 disposed on anupper surface112 of thebase92, and apawl114 connected to theretainer20a. Theteeth110 desirably have generally rectangular cross-sectional shapes, and lie in seriatim along the longitudinal axis of thebase92. The upper edge of eachtooth110 includes achamfer112 to facilitate the engagement of thepawl114 with a hollow116 formed betweenadjacent teeth110, as discussed below. The longitudinal length of eachtooth110 desirably extends generally normal to the longitudinal axis of thebase92.
• Thepawl114 has a shape configured to insert into and engage with the hollow116 defined between theteeth110. Thepawl114 preferably has a width, measured in the longitudinal direction, slightly less than that of the hollow116.
• Theretainer20acomprises an aperture118 extending between the retainer base surface48aand the channel bottom surface56a. Aflexible finger120 extends from theretainer20ain a cantilever fashion and into the retainer aperture118. Theflexible finger120 supports thepawl114 at its distal end. AlthoughFIG. 8 illustrates thefinger120 as extending in the distal direction, it is contemplated that thefinger120 can alternatively extend in the proximal direction as well.
• Theflexible finger120 preferably comprises aprotuberance122 which extends upwardly beyond the channel bottom surface56aand into the central channel44awith thefinger120 in an undeflected state. The cantilever nature of thefinger120 enables thefinger120 to deflect downward so that theprotuberance122 lies below theretainer bottom surface56a. With thefinger120 so deflected, thepawl114 engages the series ofteeth110. That is, thepawl114 inserts into a hollow116 defined between theteeth110. The interengagement betweenpawl114 and theteeth110 prevents theretainer20afrom sliding over thebase92.
• S-Clip
• FIGS. 9 and 10 illustrate a catheter anchoring system10bin accordance with a further embodiment of the present invention. Where appropriate, like numbers with an “b” suffix have been used to indicate like parts of the embodiments for ease of understanding.
• The catheter anchoring system10bis substantially identical to theanchoring system10 first described above, with the addition of an S-clip124 to retain a microbore orsmall bore tubing126. The microbore tubing is commonly used, for example, with epidural catheterization procedures, as discussed in detail below.
• The S-clip124 comprises a generallyU-shaped channel128 defined by a pair of arcuate,upstanding walls130 extending from abase plate132. As best seen inFIG. 10, the S-clip124 further comprises a plurality of retainers134, each retainer134 having aspherical head136 support by acylindrical stem138. The stems138 extend from thebase plate132. The retainer stems138 are positioned from one another and from theupstanding walls130 by a distance slightly greater than the diameter of themicrobore tubing126. The retainers134 are also positioned such that thespherical heads136 of the retainers134 are positioned from one another and from theupstanding walls130 by a distance slightly less than themicrobore tubing126. As best seen inFIG. 10, the retainer heads136 prevent themicrobore tubing126 from disengaging from the S-clip124 in the transverse direction once themicrobore tubing126 is snaked between the retainers134 and theupstanding walls130.
• An adhesive attaches thebase plate132 of the S-clip124 to base pad16b. Alternatively, thebase plate132 may be attached to the base pad16bby like means (e.g., embedding or otherwise weaving thebase plate132 into the base pad16b) as well.
• The components of theanchoring system10, save the base pad16 (i.e., theretainer20,tube clip24,adaptor22,slide clamp78,base92 and S-clip124), may be constructed in any of a variety of ways which will be well known to one of skill in the art. For instance, each individual component may be integrally molded such as by injection molding or by thermoplasty. The components preferably comprise a durably, flexible material, and more preferably comprise a generally inert, non-toxic material. In a preferred embodiment, the components are molded of plastic, such as, for example, polycarbonate, polyvinylchloride, polypropylene, polyurethane, tetrafluoroethylene (e.g., TEFLON®), polytetrafluoroethylene (a.k.a., PTEF), acetal resin (e.g., DELRIN®), chlorotrifluoroethylene (e.g., KEL-F®), nylon or like polymers.
• Method of Use
• The following discussion of the method of use will be with reference toFIGS. 1 and 2, and initially will be in the context of intravenous catheterization. As the following discussion will illustrate, however, it is understood that theanchoring system10 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 invention, and, thus, should be read together.
• A nurse typically begins the catheterization process by positioning thecatheter14 at a desired location above a vein. The nurse introduces a needle or other stylus through a cannula portion of thecatheter14 and into the skin of the patient at a desired angle of incident. For intravenous use, thecatheter14 commonly has an incident angle of approximately 7°. The nurse then inserts the cannula of thecatheter14 into the patient and withdraws the needle or stylus. Thecatheter hub30 remains exposed above the skin.
• The nurse inserts the distal end of the adaptor26 into thecatheter hub30. Theclip34 has been slidably mounted in a most distal position so that it does not interfere with the insertion of the adaptor distal end26 into thecatheter hub30.
• The nurse then slides theclip34 in a proximal direction to engage thecatheter hub30. In this manually selected position, theclip34 securely attaches theadaptor22 to thecatheter14. The ratchet teeth of theadaptor22 cooperate with the pawl to resist distal movement of theclip34 and to hold theclip34 in the manually selected position.
• The nurse removes the paper backing which initially covers theadhesive bottom surface18 of thebase pad16, and attaches thepad16 to the patient's skin proximate to theindwelling catheter14. Specifically, the nurse grips thebacking tab67 proximate to theretainer20. Theindicia69 on thetab67 indicates the locate at which the nurse should grip thetab67. The nurse then pulls on thetab67 and peels the backing off one half of thebottom adhesive layer18. The nurse positions theslot68 of thepad16 around thecatheter cannula14 with the instructing indicia70 (e.g., indicating arrow) pointing in the direction of thecatheter14. The nurse then places thebottom layer18 against the patient's skin to adhere thebase pad16 to the patient. Light pressure over theupper layer64 assures good adhesion between thebase pad16 and the patient's skin. Thebase pad16, due to its flexibility, conforms to the contours of the topical surface to which thebase pad16 adheres.
• The nurse then repeats this procedure for the other half of thepad16. Alternatively, the nurse may completely remove the backing from thepad16 before attaching thepad16 to the patient's skin.
• The nurse orients theadaptor22 with theclip34 positioned to the side of the tubular body25 (i.e., with thesupport arm32 extending in the lateral direction) and locates theadaptor support arm32 above the series ofretainer slots50 with thelatch36 positioned distal of the retainer distal end.
• The nurse then snaps theadaptor22 into theretainer20 located proximal of thepad notch68. In doing so, theadaptor22 is pressed between thelongitudinal walls46 of theretainer20 with thesupport arm32 extending in a lateral direction. As the nurse presses theadaptor22 into theretainer20, the chamfered edges58 around theslots50 of thelongitudinal wall46 guide thesupport arm32 into one of theslots50.
• As mentioned above, theopening47 of thechannel46 has a smaller width measured in the lateral direction than the diameter of thetubular body25. Thelateral walls46 thus deflect outwardly in a lateral direction. Once thetubular body25 of theadaptor22 rests within thecentral channel44 of theretainer20, thelateral walls46 spring back to snap theadaptor22 in place. Thewalls46 of theretainer20 thus prevent unintentional transverse and lateral movement of theadaptor22.
• In this position, theprotuberance40 of theadaptor22 either rests either in aslot50 or in therelief60, proximal of theslot50 through which thesupport arm32 passes. Theprotuberance40 engages a portion of thelongitudinal wall46, which forms either therelief60 or theslot50, to prevent theclip34 from pivoting relative to thetubular body25. Theprotuberance40 thus ensures that thelatch36 maintains engagement with thecatheter hub30.
• Theslot50 through which thesupport arm32 passes prevents theadaptor22 from sliding in the longitudinal direction. That is, theslot50 prevents longitudinal displacement of theadaptor22 when secured within thecentral channel44.
• The ergonomic design of theretainer20 provides for a variety of positions of theadaptor22 in theretainer20 so that theretainer22 is not technique or position sensitive. That is, a nurse can simply press theadaptor22 into theretainer20, irrespective of the side on which thesupport arm32 is located, and irrespective of the position of thesupport arm32 relative to aparticular slot50. So long as thesupport arm32 is positioned above the series ofslots50, the chamfered edges58 of thewall46 will guide thesupport arm32 into aslot50. Theprotuberance40 of theadaptor22 also fits within anadjacent slot50 or therelief60.
• With thesupport arm32 extending through aslot50 of theretainer20, theadaptor22 lies in a “low profile” position. That is, thesupport arm32 of theadaptor22 extends in the lateral direction to reduce the overall height of theanchoring system10, as measured in the transverse direction. This position of theadaptor22 reduces the risk of thesystem10 interfering with surrounding action. Theretainer20, however, allows theadaptor22 to rotate either to a position in which thesupport arm32 extends in the transverse direction, or to a position1800 for the original position to locate theadaptor clip34 on the opposite side of theretainer20.
• Once in the low profile position, theadaptor22 will normally remain in this position until theadaptor22 and its associatedtubing12 are removed and replaced by another.
• AsFIG. 1 illustrates, the nurse may also form a safety loop in thefluid supply tubing12, as known in the art, and secure the safety loop to the patient by inserting a portion of thetubing12 into thetube clip24. The safety loop absorbs any tension applied to the fluid supply tube to prevent theadaptor22 and/orcatheter14 from being pulled.
• A nurse may use theslide clamp78 to remove theadaptor body25 from theretainer20. The nurse inserts thetab82 of theslide clamp78 into the key-way groove62 on the proximal end of theretainer20. Because thetab82 has a larger width than the depth of the key-way groove62, measured in the transverse direction, thetab62 pries thetubular body25 from thecentral channel44 as the nurse inserts thetab82 into the key-way groove62 in the distal direction. The nurse may further use theslide clamp78 to leverage the proximal end of thetubular body25 out theupper opening47 of theretainer20. Having displaced the proximal end of theadaptor22 from theretainer20, the nurse may easily remove the adaptor distal end from of theretainer20. Alternatively, the nurse may also remove thetubular body25 by lifting up on thetubing12 while holding down thepad16 or theretainer20 with the other hand.
• FIGS. 6 through 8 illustrate the catheter anchoring system10aparticularly suited for arterial catheterization. Because of the criticality of the incident angle (i.e., the angle at which the catheter14aprojects into the patient) at which the catheter14amust be maintained, it is advantageous to precisely position theretainer20aso that theretainer20aholds the catheter14aat the desired incident angle. The desired range of incident angle commonly is about 5°-30° for arterial catheterization. The incident angle preferably ranges between about 15° and about 25°, and more preferably equals about 22°.
• A nurse inserts the catheter cannula14ainto an artery in a similar manner to that described above in connection with intravenous catheterization. The nurse subsequently connects the adaptor22ato the indwelling catheter14aas previously described. The nurse also attaches the flexible pad16ato the patient in a like manner to that described above. If desired, the nurse can remove one of thewings140 of the pad16abefore attaching the pad16ato the patient, by tearing the pad16aalong theperforation line142.
• The nurse orients the adaptor22awith the clip34apositioned to the side of the tubular body25a(i.e., with the support arm32aextending in the lateral direction) and locates the adaptor support arm32aabove the series ofretainer slots50awith the latch36apositioned distal of the retainer distal end. If the nurse positions pad16atoo close to or too far from the indwelling catheter14a, the nurse can slide theretainer20ain the desired direction to locate theretainer slots50abeneath the adaptor support arm32a.
• The nurse then snaps the adaptor22ainto theretainer20alocated proximal of the pad notch68a. In doing so, the chamfered edges58aaround theslots50aof thelongitudinal wall46aguide the support arm32ainto one of theslots50a. Theretainer20aautomatically slides longitudinally to precisely position acorresponding slot50abeneath the support arm32a. The adaptor22athus snaps into theretainer20awithout causing the catheter14ato move substantially.
• The tubular body25acontacts theprotuberance122 of thefinger120 and causes thefinger120 to deflect downward as the adaptor tubular body25asnaps into the central channel44a. In turn, thepawl114 engages the series ofteeth110 which prevents longitudinal movement of theretainer20awhile holding theadaptor20a. If the nurse removes the adaptor22a—preferably by using the slide clamp tab82a—thefinger120 springs back to its undeflected state and theretainer20afreely slides over therail96. Thepawl114 normally does not engage the series ofteeth110.
• The ability to precisely position theretainer20abeneath the catheter adaptor22aconnected to the catheter14a, enables the nurse to hold the catheter14ain a stable position and ensures that theretainer20awill hold the adaptor22a, and thus the catheter14a, at the precise incident angle. Without the ability to adjust the longitudinal position of theretainer20a, the nurse may perform a series of position iterations before properly locating base pad16a, and thus theretainer20a, relative to the indwelling catheter14a.
• For epidural catheterization, an anesthesiologist, for example, inserts the distal end ofmicrobore tubing126 into the epidural space. The proximal end of themicrobore tubing126 conventionally includes a Toughy-Bourst adaptor144 or other adaptor device to couple with thefluid supply tube12btransporting the anesthesia. It is imperative that the connection between themicrobore tubing126 and thefluid supply tubing144 remain intact, and that the distal end of themicrobore tubing126 remains in place. For if the epidural space is exposed to air-borne microbes, meningitis may develop. Thus, a secure interconnection between themicrobore tubing126 and thefluid supply12bshould exist and themicrobore tubing126 should be isolated from any tension placed on either thefluid supply tube12b, as well as theadaptor22b.
• FIGS. 9 and 10 illustrate the catheter anchoring system10bparticularly suited for epidural catheterization. A doctor uses the present anchoring system10bin a manner similar to that described above in connection with intravenous catheterization, with the exceptions that doctor connects theadaptor22btomicrobore tubing126 and adheres the base pad16bto the patient's torso.
• The doctor subsequently snakes themicrobore tubing126 through the S-clip124 by first pressing thetubing126 between a retainer134 and thewall130, and then wrapping thetubing126 between the first and second retainers134. Light pressure forces thetube126 between the retainers134. The doctor then wraps thetube126 back between the second retainer134 and thesecond wall130, and presses thetube126 therebetween. The S-clip124 secures themicrobore tube126 in place and isolates themicrobore tube126 from tension placed on theadaptor22band/or thefluid supply tube12bwith themicrobore tube126 inserted accordingly.
Additional Embodiments
• As mentioned above, it is contemplated that other types of adaptors in addition to the one disclosed above can be used as well with the present catheter anchoring system.FIGS. 11 and 12 illustrate a catheter anchoring system10cin accordance with a further embodiment of the present invention which includes a different catheter adaptor style. Where appropriate, like numbers with a “c” suffix have been used to indicate like parts of the embodiments for ease of understanding.
• Like the catheter anchoring systems described above, the present catheter anchoring system10cprincipally comprises aflexible anchor pad16chaving an adhesivebottom side18c, which attaches to the skin of the patient. Thepad16csupports aretainer20c. Theretainer20cis configured to receive and secure in place acatheter adaptor22cwhich connects to an indwelling catheter14c. The pad16amay also support atube clip24cwhich is used to retain a portion of thetubing12c.
• FIG. 11 illustrates theadaptor22cas comprising a generallytubular body25cdefined between adistal end26cand aproximal end28c. Theproximal end28cis adapted to receive a distal end of thetube12c. In an exemplary embodiment, at least a portion of thefluid supply tube12cis permanently attached to the bodyproximal end28c.
• Thedistal end26cis configured to engage a proximal end of the indwelling catheter14c(not shown). AlthoughFIGS. 11 and 12 illustrate thedistal end26cof theadaptor22cas having a frusto-conical shape configured to engage a standard lure-type catheter hub30c(not shown), it is contemplated that thedistal end26ccould be configured as well to engage other types of connectors.
• FIG. 14 illustrates an alternative configuration of thedistal end26dof thecatheter adaptor22d. Again, for consistency, like numbers with a “d” suffix have been used to indicate like parts of the catheter adaptor ofFIG. 11 and the catheter adaptor ofFIG. 14.
• Thecatheter adaptor22dincludes a standard lure-lock type fitting220 attached to the body25dof thecatheter adaptor22dso as to circumscribe thedistal end26dof thecatheter adaptor22d. The lure-lock fitting220 preferably is attached in a manner which permits the fitting220 to be rotated about the catheter adaptor body25d. It is contemplated, however, that the distal end of the adaptor could comprise a female lure-lock type connector (i.e., a hub including nubs or threads on its external surface) as well if required by a particular application.
• In the illustrated embodiment, the fitting220 has a generally tubular shape with a closedproximal end222. Theclosed end222 includes anaperture224 of a sufficient size to receive a portion of the adaptor body25d, as described below. The fitting220 includes conventionalinternal threads226 in order to engage corresponding threads of a conventional female lure-lock fitting (not shown).
• The adaptor body25ddesirably includes anannular groove228 which receives a portion of theclosed end222 of the fitting220 to interconnect the fitting220 and the adaptor body25d. This interconnection also permits the fitting220 to be rotated about the adaptor body25d.
• To assemble thecatheter adaptor22d, the conical shapeddistal end26dof the body25dis inserted into theaperture224 of fittingclosed end222. The body25dis then forced into the fitting220 to slightly deflect theclosed end222 until theclosed end222 snaps into theannular groove228 of the body25d. In this position, the body25dcaptures a portion of the fitting220 to couple these elements together.
• With reference toFIG. 11, theadaptor22cincludes at least oneannular collar200 interposed between the proximal anddistal ends28c,26cof thetubular body25c. Theadaptor22dofFIG. 14 also includes a likeannular collar200d. It is contemplated that thecollar200 of theadaptor22cofFIG. 11 and thecollar200dof theadaptor22dofFIG. 14 will be substantially identical, and, thus, the description herein will be understood as applying equally to both embodiments.
• Theannular collar200 flares radially outwardly and circumscribes thetubular body25c. Theannular collar200 has a thickness measured in a longitudinal direction which is slightly less than a width of aslot50cin aretainer wall46cso that thecollar200 fits within theslot50cof aretainer wall46c, as discussed in detail below.
• Theadaptor22cis preferably formed of a durable, biocompatible plastic material. Theadaptor22cmore preferably is formed of clear plastic so a nurse can see bubbles or backflow through theadaptor22c. In an exemplary embodiment, the adaptor is formed of polycarbonate by injection molded; however, those skilled in the art will readily appreciate that the adaptor can be formed by other construction methods known in the art.
• FIGS. 11 and 12 also illustrate theretainer20cwhich is substantially identical to theretainer20 described above. Theretainer20ccomprises acentral channel44cinterposed between a pair of opposinglongitudinal walls46c. Thecentral channel44cextends through theretainer20calong an axis which is generally parallel to a longitudinal axis of theretainer20c.
• Thecentral channel axis44chas a generally circular cross-sectional shape which is truncated at an upper end to form anopening47c. Thecentral body44chas a diameter sized to receive thetubular body25cof thecatheter adaptor22c. In a preferred embodiment, the diameter of thecentral channel44cgenerally matches that of thetubular body25c.
• In cross section, thecentral channel44cextends through an arc greater than 180° about the channel axis such that the lateral length of theopening47cis less than the diameter of thecentral channel44c. In an exemplary embodiment, the cross-sectional shape of thecentral channel44cextends through an arc of about 200° about the channel axis.
• As best seen inFIG. 13a, the channel axis is desirably skewed relative to abase surface48cof theretainer20c. An incident angle θ formed between thebase surface48cand the channel axis is less than 45°. The incident angle θ desirably ranges between 5° and 30°. In an exemplary embodiment for intravenous use, the angle θ preferably approximately equals 7°.
• Thelongitudinal walls46care substantially identical. Eachwall46chas a thickness measured in the lateral direction less than the length of thesupport arm32 of theadaptor22, as it is desirable for thepresent retainer20cto accept both the above-describedadaptor22 which comprises asupport arm32 connected to aclip34, as well as thepresent adaptor22cwhich comprises anannular collar200. Preferably, the thickness of thewall46cmeasured in the lateral direction is greater than the distance measured radially by which thecollar200 extends beyond the exterior surface of thetubular body25c(i.e., a radial height). The length of eachwall46c, as measured in the longitudinal direction, is preferably coextensive with the length of theretainer20c.
• Eachwall46ccomprises a uniform series ofslot50c. The series comprises at least two (2)slots50cand not more than twenty (20)slots50c. More preferably, the series comprises less than seven (7)slots50c. In an exemplary embodiment, as illustrated in the figures, the series comprises four (4)slots50c.
• As discussed above, eachslot50cis sized to receive thecollar200 of theadaptor22c, as well as thesupport arm32 of thecatheter adaptor22, to prevent longitudinal displacement of therespective adaptor22,22c. Eachslot50cdesirably has a rectangular shape. As seen inFIG. 12, theslots50cextend from anexterior surface52c, through thewall46c, and open into thecentral channel44c. The width of theslot50c, as measured in the longitudinal direction, is desirably slightly greater than the width of thesupport arm32 and the width of thecollar200.
• As illustrated byFIG. 13a, eachslot50cextends in the transverse direction from anupper edge54cof thelongitudinal wall46cto a point below the bottom56cof thecentral channel44c. The height of theslot50c, as measured in the transverse direction, is thus greater than the distance between theupper edge54cand the channel bottom56cof theretainer20c. As seen inFIG. 13b, theretainer20cfurther includes a series oflateral grooves202 which extend between opposingslots50cand extend into theretainer20cfrom thechannel bottom surface56c. The opposingslots50cand groove202 thus form a lateral channel which extends through theretainer20cin the lateral direction and cuts into theretainer20cfrom theupper edge54cto a point below thechannel bottom surface56c. Thegroove202 desirably is sized to receive a portion of thecollar200 such that with thetubular body25cpositioned within thecentral channel44c, thecollar200 extends between opposingslots50cand into thegroove202. Thus, thegroove202 has a depth, measured between thelower surface56cof thecentral channel44cand the bottom of the groove in transverse direction, which is greater than the radial height of theannular collar200.
• FIG. 13billustrates that the spacing S between theslots50c, on center, desirably equals about half the distal L (seeFIG. 2) between thesupport arm32 and theprotuberance40 of thecatheter adaptor22. The position of the slots in relation to the proximal anddistal ends26c,28cof theretainer20cis desirably configured in accordance with the spacing and positioning discussed above in connection with the above-describedretainer22, such that thepresent retainer22ccan be used with the above-describedadaptor22, including aclip34.
• FIGS. 11 and 13aillustrate the upper edge of eachlongitudinal wall46cwhich comprises a series ofchamfers58cformed and positioned as disclosed above in connection with theretainer20. As discussed above, thechamfers58cslope downwardly towards theslot50cto facilitate the insertion of either thesupport arm32 of the above-describedcatheter adaptor22 or theannular collar200 of thepresent catheter adaptor22cinto theslot50c.
• AsFIGS. 11-13billustrate, eachlongitudinal wall46cmay further comprise arelief60cdisposed on the proximal end of theretainer20c. The configuration and position of therelief60cdesirably is in accordance with the above description of theretainer20.FIG. 11 further illustrates that theretainer20cmay additionally comprise a key-way groove62cto facilitate removal of thecatheter adaptor22cfrom theretainer20c, as discussed above. The key-way groove62cdesirably is also positioned and configured in accordance with the above disclosure in connection with theretainer20.
• Theretainer20cis made of relatively stiff plastic material, but is somewhat flexible such that theadaptor22cforces theupper edges54cof thelongitudinal walls46coutwardly when a nurse presses theadaptor22cinto thecentral channel44cof theretainer20c. Theretainer20cis desirably formed of polycarbonate by injection molding. When theadaptor22csits within thecentral channel44c, theupper edges54cof thewalls46csnap inwardly to their original position to securely hold theadaptor22cwithin theretainer20c.
• An adhesive preferably attaches theretainer20cto theanchor pad16c. Alternatively, theretainer20cmay be attached to theanchor pad16cby like means as well, e.g., embedding or otherwise weaving the retainer into theanchor pad16c.
• FIG. 11 illustrates theanchor pad16cas comprising a flexible, laminate structure comprising an upper paper or other woven ornon-woven cloth layer64cand abottom adhesive layer18c, with an innercellulose foam layer66cinterposed therebetween. Alternatively, theflexible base pad16 may comprise an adhesivebottom layer18 and an upper cellulose foam layer. An upper surface of the foam layer is roughened by corona treating with a low electric charge, as known in the art. Thefoam layer66cforms a cushion between the patient's skin and the rigid,plastic retainer20candtube clamp24c. Theadhesive layer18cmay comprise a coating of diaphoretic or nondiaphoretic material, depending upon the patient's skin condition. A medical grade foam tape with a diaphoretic or a nondiaphoretic adhesive is available commercially from NDM Manufacturers.
• The removable paper or plastic backing (not shown) desirably covers thebottom adhesive layer18 before use. As discussed above and illustrated inFIG. 12, the backing is preferably divided into a plurality of piece and includestabs67cto ease removal of the backing from thepad16. Thetabs67cmay includeindicia69c(e.g., dots, text, arrows, etc.) to indicate the location at which to grip the correspondingtab67cwhen peeling the removable backing off thepad16c.
• As best seen inFIG. 12, theanchor pad16 desirably has a generally trapezoidal shape with rounded corners. Adistal edge206 of theanchor pad16cdesirably has a width, as measured in the lateral direction, wider than that of aproximal edge204. The longerdistal edge206 provides a longer adhesive surface over a rough contact surface, such as, for example, over knuckles, vertebrae, or the like. The generally trapezoidal shape, however, minimizes the overall size of theanchor pad16cattached to the patient. The trapezoidal shape also provides the same surface area as a square pad with a appearance of a smaller pad. Thelongitudinal sides208 of theanchor pad16cpreferably taper from theproximal edge206 to thedistal edge204, and more desirably have concave shapes.
• The anchor pad includes anotch68cpositioned along theproximal edge204 of theanchor pad16cand adjacent to the point of insertion of the catheter cannula. Preferably, thenotch68cis symmetrically positioned about thechannel axis44cof theretainer20cattached to theanchor pad16c. Thenotch68cis sized to permit visual inspection of the catheterized site and is large enough to allow for variable placement of thepad16cwith respect to the insertion site. That is, thenotch68cis large enough that a nurse is not required to precisely position the pad on the patient's skin with respect to the indwelling catheter14c(not shown).
• As seen inFIGS. 11 and 12, theanchor pad16cdesirably may compriseindicia70csometimes in the form of an arrow which indicates the proper orientation of theanchor pad16 in reference to the catheterized site. When properly used, theindicia70cpoints toward the indwelling catheter14c(not shown).
• Theanchor pad16cpreferably supports aclip24cwhich secures thefluid supply tube12cto theanchor pad16c. As seen inFIG. 12, thefluid supply tube12cis preferably looped back around in a proximal direction and inserted into theclip24cto form a safety loop, as known in the art. Thetube clip24cis desirably configured in accordance with the above description. Theclip24cmay be made in a variety of sizes to accommodate various calibers offluid flow tubing12c.
• In use, a nurse typically uses the catheter anchoring system10cin connection with an indwelling catheter14c(not shown). The catheter14cis inserted into a body lumen, such as a vein, in accordance with the above description. The nurse then inserts thedistal end26cof theadaptor22cinto a catheter hub30c(not shown) to connect theadaptor22cto the catheter14c. The nurse may then secure theadapter22cto the catheter14cby means of the ratchet clip, or the lure-lock fitting.
• The nurse removes the paper backing which initially covers theadhesive bottom surface18cof theanchor pad16c, as described above, and attaches theanchor pad16cto the patient's skin proximate to the indwelling catheter14c. The nurse specifically positions thenotch68cof thepad16caround the catheter cannula14cwith the indicatingarrow70cpointing in the direction of the catheter14c. The nurse generally aligns theproximal edge204 of theanchor pad16cwith the insertion site.
• The nurse positions theadaptor22cabove the series ofretainer slots50c, and snaps theadaptor22cinto theretainer20c. In doing so, theadaptor22cis pressed between thelongitudinal walls46cof theretainer20cwith theannular collar200 extending into opposingslots50cand into thecorresponding groove202 of theretainer20c. As the nurse presses the adaptor into theretainer20c, the chamfered edges58caround theslots50cof thelongitudinal walls46cguide theannular collar200 into theslots50c. Theretainer20csecures theadaptor20cas described above.
• With theannular collar200 positioned in the opposingslots50ctheadaptor22cis prevented from sliding in a longitudinal direction.
• Like the above-described embodiments of the retainer, the ergonomic design of theretainer20cprovides for various positions of theadaptor22cin theretainer20cso that theretainer22cis not technique- or position-sensitive. That is, a nurse can simply press theadaptor22cinto theretainer20c, irrespective of the position of theannular collar20 relative to aparticular slot50cof theretainer20c. So long as theannular collar200 is positioned above the series ofslots50c, the chamfered edges58cof thewall46cwill guide theannular collar200 into theslot50c.
• The present embodiment of theretainer20c, as mentioned above, may also be used with the above-describedadaptor22 having theclip34. A nurse uses the present retainer with the above-describedadaptor22 in the same manner as described above in connection with the above-describedretainer20.
• If the catheter hub30 (seeFIG. 1) is a standard female lure-lock fitting, the lure-lock fitting220 (FIG. 14) of theadaptor body22dis rotated with thedistal end26dinserted into thecatheter hub30 to interlock the correspondingfittings222,30 in the known manner. Thecatheter adaptor22dis then used with the anchoring system in a like manner to that described above.
• The above embodiments illustrate the adaptor with the radially extending member being affixed to an end of a tube set or other fluid line. The radially extending member can also be arranged on the adaptor or fitting that is affixed to the proximal end of the catheter body.FIGS. 15athrough15cillustrate this arrangement.
• FIGS. 15athrough15cillustrate a catheterization system configured in accordance with another embodiment of the present invention. The catheterization system includes a catheter and an anchoring system that includes a retainer and an anchoring pad. Although the anchoring pad has been omitted fromFIGS. 15athrough15cto simplify the drawings, the anchor pad desirably is constructed in accordance with the above description and is shaped in the form shown inFIG. 16. Again, for consistency, like numbers with an “e” suffix have been used to indicate like parts of the anchoring system of FIGS.11 and of15a-15c. The above description of like components thus should be understood as applying equally to the present embodiment, unless stated otherwise.
• The catheter desirably includes an elongated tubular body with a tubular adaptor or fitting attached to the body. At least one lumen of the adaptor communicates with a corresponding lumen of the catheter. In the illustrated embodiment, theadaptor22eis permanently attached to a proximal end of the fitting and is configured to cooperate with a corresponding adaptor formed on a distal end of a fluid line. Theadaptor22e, however, can be releasably attached to the catheter body.
• In the illustrated embodiment, thetubular adaptor22eis configured as a female-component of the coupling between the catheter body and the fluid line. Theadaptor22eof course can be configured as the male component of the coupling. In either case, both the male and female adaptors of the coupling have corresponding generally frusto-conical shapes which mate together in a generally fluid tight engagement. The coupling adaptors also include interengaging elements that lock together the adaptors. Thetubular adaptor22eof the illustrated embodiment includes a threadedcoupler306 formed by an external thread that runs about aproximal end300 of a tubular body of theadaptor22e. The external thread of the threaded coupler is configured to corresponding to an internal thread of a spin nut disposed on the end of the corresponding adaptor (such as the type illustrated inFIG. 14).
• In the illustrated embodiment, the tubular body of theadaptor22eincludes a frusto-conicalshaped section304 on thedistal side302 of the threadedcoupler306. The corresponding form of theadaptor22egenerally corresponds to a conventional catheter hub, such as the type illustrated inFIG. 1.
• Unlike a conventional catheter hub, however, theadaptor22eincludes a radially extending member that projects from the tubular body. In the illustrated embodiment, the radially extending member comprises anannular collar200ethat circumscribes a portion of the frusto-conicalshaped section304 of the tubular body. Thecollar200eis generally positioned about midway between the proximal anddistal ends300,302 of the tubular body; however, it need not be as illustrated in embodiment ofFIG. 16.
• As understood fromFIGS. 15athrough15c, theretainer20edefines a central channel44ethat has a generally conical shape corresponding to the shape of the adaptor tubular body. The channel44eis interposed between a pair of opposing converginglongitudinal walls46e.
• Thewalls46eare spaced apart such that there is a variable lateral distance therebetween. Thewalls46ehave aproximal end300 and adistal end302, with the proximal end width being desirably wider than the distal end width.
• The central channel44eextends through theretainer20ealong the longitudinal axis and between the convergingwalls46e. The channel44eis similarly of variable lateral dimension as taken at points along the longitudinal axis direction.
• The central channel44ehas a truncated upper section which gives the channel a generally U-shape having anupper opening47e. The bottom and side surfaces of the channel44eare arcuate and substantially match the shape of thecatheter adaptor22e, which can be received therein. The variable diameter of the channel44eis sized to receive the longitudinal length of thecatheter adaptor22e. Each section of the channel44ehas arcuate shape of a radius of curvature that generally matches a corresponding section of thecatheter adaptor22e. In the illustrated embodiment, the radii of curvature vary along the longitudinal length of the channel44e; however, the channel44ecan have generally uniform radii of curvature, as illustrated by the above embodiments.
• In cross section, as best understood fromFIG. 15c, the channel44eextends through an arc of greater than 180° about the longitudinal axis such that the lateral length of theupper opening47eis less than the diameter of the channel44eat a given point in the longitudinal direction. In the illustrated embodiment, the channel44edesirably extends through an arc of about 200° about the channel axis.
• The retainer also includes at least oneslot50ethat lies generally perpendicular to the longitudinal axis and extends across the channel44eto section the channel44einto a proximal channel portion and a distal channel portion. In the illustrated embodiment, the proximal and distal channel portions have generally equal longitudinal lengths; however, they need not have the same length. The length of the channel portions though desirably provides stability to thecatheter adaptor22ewhen inserted into theretainer20eto prevent thecatheter adaptor22efrom yawing (i.e. pivoting relative to the retainer within a plane parallel to the anchor pad). Each channel section of theretainer20eis also sized to receive a corresponding section of thecatheter adaptor22e. Eachslot50eis sized to receive thecollar200eof thecatheter adaptor22e.
• Theslot50ehas a thickness that substantially matches the thickness of theadaptor collar200e. The thickness ofslot50e, however, is less than the combined longitudinal lengths of the proximal and distal channel portions. This dimensional relationship provides further stability to the retainedcatheter adaptor22ewhen inserted into theretainer20e.
• In the illustrated embodiment, theretainer20eincludes at least twolateral slots50earranged in series (i.e., next to each other) between the proximal and distal channel portions. The series of slots desirably includes between two (2) and twenty (20) slots. More preferably, the series comprises less than seven (7) slots. The illustrated embodiment shows two (2) slots.
• As described above, eachslot50eis sized to receive a portion of the adaptor annular collar200cto prevent longitudinal displacement of the catheter, as discussed in detail above. Eachslot50edesirably has a rectangular shape and extends from an exterior surfaces52ethrough thewalls46e, and across thecentral channel46e. The width of eachslot50e(measured longitudinally) is desirably slightly greater than the width of the fitting304, measured in the longitudinal direction to receive the fitting304, as discussed above.
• Theretainer20ealso desirably includes a relief308 formed on the bottom of the channel44e. The relief308 is sized to receive a portion of thecollar200ewhen placed within one of theslots50e.
• Finger platforms310 extend from theside walls46eof theretainer20e. The finger platforms310 are sized and configured to enable allow a health care provider to press theretainer20eagainst the skin of the patient while pulling up on thecatheter adaptor22eor on the adaptor to which it is connected, when disengaging thecatheter adaptor22efrom theretainer20e.
• So configured, in addition to the interengagement between theslots50eandannular collar200e, longitudinal movement of the catheter in the proximal-to-distal direction is further inhibited by cooperation between the conical-shaped channel44eand frusto-conicalshaped fitting304. That is, when an applied force directs the fitting304 in the distal direction, the fitting304 advances until contact with a section of thewalls46e(which are of uniformly narrower diameter as measured toward the proximal end of thewalls46e). When contact is made, the fitting304, and catheter which is attached thereto, is restricted from further distal movement.
• FIG. 16 illustrates another embodiment of the catheterization system similar to that described above in connection withFIGS. 15a-15c. Accordingly, like reference numerals with a “f” suffix have been used to indicate similar components between these embodiments. The above description of like components thus applies equally to the present embodiment, unless stated otherwise.
• In the illustrated embodiment, the conical shaped section of thecatheter hub304 has an irregular step in diameter between the side proximal300fof thecollar200fand the side distal302fof thecollar200f. That is a minimum diameter of the conical section on the side proximal300fthecollar200fis larger than a maximum diameter of the conical section on the side distal302fof thecollar200f.
• Theretainer20fhas a shape corresponding to that of the conical section of thecatheter adaptor22f. The proximal300fchannel portion has a radius of curvature generally matching that of the proximal300fside of the adaptor conical section. And the distal302fchannel portion has a radius of curvature generally matching that of the distal302fside of the adaptor conical section. As such, a minimum diameter of the proximal300fchannel section is larger than a maximum diameter of the distal302fchannel section.
• Theretainer20fis mounted atop an anchor pad16fwith its upper opening47fbeing exposed and facing away from the anchor pad16f. The construction of the anchor pad16fand theretainer20f, as well as the attachment of theretainer20fto the anchor pad16f, are in accordance with the above description. The anchor pad16falso supports atube clip24f, as illustrated inFIG. 16.
• As similar to the above embodiment, the present catheterization system is used by first connecting the catheter to a fluid line (be it supply or drainage). The catheter is inserted into a body lumen, such as a vein, in accordance with the above description. The nurse then inserts a distal end of one of thecoupling adaptor22cinto a catheter adaptor to connect together the adaptors. The nurse may then interconnect the adapters by means of the above-described ratchet clip, or the lure-lock fitting formed between the threaded coupler on the proximal end of the catheter adaptor and the spin nut on the end of the adaptor attached to the fluid tube.
• The nurse removes the paper backing which initially covers an adhesive bottom surface of the anchor pad16f, as described above, and attaches the anchor pad16fto the patient's skin proximate to the indwelling catheter. The nurse specifically positions a notch of the pad16faround the catheter body or cannula. The nurse generally aligns the proximal edge of the anchor pad16fwith the insertion site.
• The nurse positions theadaptor22fabove the series of retainer slots50f, and snaps theadaptor22finto theretainer20f. In doing so, theadaptor20fis pressed between thelongitudinal walls46fof theretainer20fwith theannular collar200fextending into one of the slots50fof theretainer20f. As the nurse presses theadaptor22finto theretainer20f, chamferededges312 around the slots50f(seeFIG. 15a) of thelongitudinal walls46fguide theannular collar200finto the slots50f. With theannular collar200fpositioned in one of the slots50f; theadaptor22fis prevented from sliding in a longitudinal direction.
• Like the above-described embodiments of theretainer20f, the ergonomic design of theretainer20fprovides for various positions of theadaptor22fin theretainer20fso that theretainer20fis not technique- or position-sensitive. That is, a nurse can simply press theadaptor22finto theretainer20f, irrespective of the position of theannular collar200frelative to a particular slot50fof theretainer20f. So long as theannular collar200fis positioned above the series of slots50f, the chamferededges312 of the wall will guide theannular collar200finto the slot50f.
• FIGS. 17 and 18 illustrate a catheterization system configured in accordance with another embodiment of the present invention. Like the other embodiments of the catheterization system, this embodiment includes a catheter and an anchoring system that includes a retainer and an anchoring pad. Again, for consistency, like numbers with an “g” suffix have been used to indicate like parts of the anchoring system of FIGS.11 and of16. The above description of like components thus should be understood as applying equally to this embodiment, unless stated otherwise.
• The present embodiment, like the previous embodiments, utilizes the concept of providing an adaptor and retainer which cooperate with each other to secure the catheter to the body of a patient and inhibit movement of the catheter in the longitudinal, transverse and lateral directions. Also, like the previous embodiments, the anchoring system can include the concept of not being position or technique sensitive. That is, the medical attendant can simply locate the catheter adaptor generally above the retainer and press the adaptor into the retainer. Engagement thus requires only coarse alignment of the adaptor with the retainer.
• FIG. 17 shows theretainer20gcomprising a longitudinal channel44gformed between a pair of substantially parallel walls46gand configured to receive the tubular body of theadaptor22gin a snap fit manner. The construction of the channel thus is similar to that described above and about a longitudinal axis L.
• Theretainer20gadditionally comprises at least one projection orprotuberance400 that extends from one of the walls46gtoward the longitudinal axis in the lateral direction. Theprojection400 is sized and configured to cooperate with a recess on thecatheter adaptor22g, as explained below. Theprojection400, however, can extend into the channel44gtoward the longitudinal axis in the transverse direction.
• In the illustrated embodiment, theretainer20gincludes a plurality ofprojections400. In one mode, two projections are positioned across from each other on opposite walls46g. The set ofprojections400 thus oppose each other. Theretainer20galso desirably includes a plurality of projection sets400 which are spaced along a length of the channel44g. The multiple projection sets400 thus provide multiple positions in which theadaptor22gcan occupy within theretainer20g, so as to require only coarse alignment between theretainer20gand theadaptor22gbefore engagement. Both laterally and transversely extendingprojections400 can be used with the retainer.
• Theprojections400 desirably are positioned between a first portion of the channel44gand a second portion of the channel44g. In the illustrated embodiment, one channel portion is formed at a proximal end of the channel44gand the other end is formed at a distal end of the channel44g. Each of the channel portions desirably are sufficiently long and support a sufficient length of theadaptor22gso as to prevent theadaptor22gfrom rocking.
• Eachprojection400 desirably has sufficient thickness or bulk so as to resist nominal applied forces, i.e. not break when the medical attendant presses on it. Also, the portion of theprojection400 that projects into the channel44gis of sufficient lateral or transverse dimension to inhibit movement of thecatheter adaptor22gin the longitudinal direction, without inhibiting placement of thecatheter adaptor22ginto or out of the channel44g. That is, theprojections400 extend into the channel by a sufficient amount to engage with corresponding structure on thecatheter adaptor22g, as described below.
• In the illustrated embodiment, eachprojection400 has generally a rectangular shape in a plane generally parallel to the retainer base48g. Thus, theprojections400 generally form a series of square teeth along a section of each wall46gat an upper rim of the channel44g. Theprojection400, however, can be configured in a wide variety of other shapes, including, but not limited to, semi-circular, square, curvilinear, triangular or the like. Thus, theprojection400 may be linear, as illustrated, or curved or curvilinear to suit a particular application, so as to inhibit migration of thecatheter adaptor22gin the longitudinal direction.
• Below the upper rim of the channel44g, each projection tapers back toward the corresponding side wall46g. In the illustrated embodiment, thistaper406 generally follows an arcuate path that desirably corresponds to a surface to theadaptor22g, as described below. Theprojections400, however, can extend about the entire arc of the channel44g(i.e., down one side wall, across the bottom of the channel and up the other side wall) or theprojections400 can extend downward to the channel bottom (FIG. 18).
• As noted above, theprojections400 are advantageously sized and configured to cooperate with a corresponding recess(es) on thecatheter adaptor22g. Without limitation, thecatheter adaptor22gcan be a fitting on the end of either the fluid tube, as shown inFIG. 17, or the catheter as shown inFIG. 18 (e.g., a catheter hub).
• In one mode, theprojections400 fit into the recess(es) and engage the sides of the recess(es) so as to inhibit longitudinal movement of theadaptor22grelative to theretainer20g. In the illustrated embodiment, theadaptor22gincludes a plurality of annular grooves or depressions408 (e.g., three grooves); however, any number ofannular grooves408 can be used with theadaptor22g. In order to accommodate theadaptor22gin multiple positions within theretainer20g, however, the number of projection sets400 should be less than the number ofgrooves408.
• Eachannular groove408 is interposed between the proximal and distal ends28g,26gof theadaptor22gand extends radially inward while circumscribing theadaptor22g. Eachannular groove408 also has a thickness measured in the longitudinal direction which is slightly less than the longitudinal length of theprojection400 so that at least a portion of theannular depression408 fits around theprojection408 of the retainer wall46g, as described above.
• Eachannular groove408 thus defines an arcuate surface on the exterior of theadaptor22g. In the illustrated embodiment, the radius of this arcuate surface desirably is not greater than the radius of curvature followed by the corresponding projection(s)400 as it tapers toward the respective wall46g, as noted above.
• FIG. 18 is generally similar toFIG. 17 except that theretainer20gis configured to receive a frusto-conical shaped section304gof theadaptor22g, rather than an adaptor22ghaving a uniform diameter, as shown inFIG. 17. To form the snap fit engagement between theretainer20gand taperedadaptor22g, the channel44gextends through theretainer20galong the longitudinal axis and between converging walls46g, thus forming a tapered or stepped region. The illustrated embodiment also shows fourprojections400 formed on theretainer20g, however, it is understood that any suitable number of projections (2-20) can be used with theretainer20g.
• The present embodiment of the catheterization system is used by first catheter is inserted into a body lumen, such as a vein, in accordance with the above description. The medical attendant then connects the catheter adaptors together so as to attach the catheter to the fluid line. The medical attendant may then interconnect the adapters by means of the above-described ratchet clip, or the lure-lock fitting formed between the threaded coupler on the proximal end of the catheter adaptor and the spin nut on the end of the adaptor attached to the fluid tube.
• The medical attendant positions theadaptor22gabove the series ofretainer projections400, and snaps theadaptor22ginto theretainer20g. In doing so, theadaptor22gis pressed between the longitudinal walls46gof theretainer20gwith at least a portion of theannular depression408 receiving acorresponding projection400. With at least a portion of theannular depression408 positioned around one of theprojections400, theadaptor22gis inhibited from moving in a longitudinal direction. The medical attendant then removes the paper backing which initially covers an adhesive bottom surface of theanchor pad16gand attaches theanchor pad16gto the patient's skin proximate to the indwelling catheter, as described above.
• As previously explained, the ergonomic design of theretainer20gprovides for various positions of theadaptor22gin theretainer20gso that theretainer20gis not technique or position sensitive. That is, a medical attendant can simply press theadaptor22ginto theretainer20g, irrespective of the position of theannular depression408 relative to aparticular projection400 of theretainer20g. Further, so long as theannular depression408 is positioned above the series ofprojections400, the chamfered edges312gof the wall46gwill guide the annular depression around at least a portion of theprojection400.
• Although this invention has been described in terms of certain preferred embodiments, other embodiments apparent to those of ordinary skill in the art are also within the scope of this invention. It is also understood that various aspects of one embodiments can between with another embodiment. Accordingly, the scope of the invention is intended to be defined only by the claims which follow.

Claims (36)

1-29. (canceled)

30. A securement device for attaching a medical article to a patient, the medical article having a generally elongated body and a side member that projects away from the body, the securement device comprising:

a retainer having a first channel portion and a second channel portion, the channel portions being disposed about a longitudinal axis of the retainer and having a length measured in a direction parallel to the longitudinal axis of the retainer, each channel portion extending about the longitudinal axis of the retainer by greater than 180°, the first channel portion being spaced from the second channel portion, at least part of the first channel portion being wider, as measured perpendicularly to the longitudinal axis of the retainer, than the second channel portion, the combined longitudinal lengths of the first and second channel portions being larger than a distance separating the first and second channel portions along the longitudinal axis of the retainer, said distance substantially equaling a dimension of the side member of the medical article as measured along the longitudinal axis of the retainer.

31. A securement device according toclaim 30, wherein at least one of the channel portions is exposed though a longitudinally extending opening.

32. A securement device according toclaim 30, wherein each channel portion defines a longitudinally extending opening.

33. A securement device according toclaim 32, wherein each opening has a width less than a width of the corresponding channel portion.

34. A securement device according toclaim 30 further comprising a flexible anchor having an adhesive bottom surface and a top surface above which the retainer is disposed.

35. A securement device according toclaim 34, wherein the retainer is disposed in a position above the top surface so as to expose the openings to the channel portions.

36. A securement device according toclaim 34, wherein the longitudinal axis of the retainer is disposed at an acute angle relative to the anchor.

37. A securement device according toclaim 30, wherein at least one of the first and second channel portions has a truncated generally circular cross-sectional shape.

38. A securement device according toclaim 30, wherein the cross-section of at least one of the first and second channel portions tapers in size along its length.

39. A securement device according toclaim 30, wherein at least one of the first and second channel portions has a generally frusto-conical shape.

40. A securement device according toclaim 30, wherein the distance separating the first and second channel portions forms a continuous gap which extends around the longitudinal axis of the retainer for at least 180 degrees.

41. A securement device according toclaim 30, wherein the retainer further comprises a pair of opposing surfaces from which the first and second channel portions extend in opposite directions along the longitudinal axis.

42. A securement device according toclaim 41, wherein the opposing surfaces are generally perpendicular to the longitudinal axis.

43. A securement device for attaching a medical article to a patient, the medical article having a generally elongated body and a side member that projects away from the body, the securement device comprising:

an anchor pad;

a base affixed to the anchor pad; and

a retainer movably coupled to the base, the retainer comprising at least first and second channel portions arranged side-by-side along a longitudinal axis of the retainer with at least one gap occurring between the channel portions, the gap having a dimension in a direction parallel to the longitudinal axis of the retainer that generally matches a dimension of the side member of the medical article as measured along the longitudinal axis of the retainer.

44. A securement device according toclaim 43, wherein at least one of the channel portions is exposed though a longitudinally extending opening.

45. A securement device according toclaim 43, wherein each channel portion defines a longitudinally extending opening.

46. A securement device according toclaim 45, wherein each opening has a width less than a width of the corresponding channel portion, where said widths are measured perpendicularly to the longitudinal axis of the retainer.

47. A securement device according toclaim 46, wherein the retainer is disposed above the base and in a position that exposes the openings to the channel portions.

48. A securement device according toclaim 43, wherein the anchor pad comprises an adhesive bottom surface and a top surface above which the base is disposed.

49. A securement device according toclaim 48, wherein the longitudinal axis of the retainer is disposed at an acute angle relative to the bottom surface of the anchor pad.

50. A securement device according toclaim 43, wherein the cross-section of at least one of the first and second channel portions tapers in size along its length.

51. A securement device according toclaim 43, wherein at least one of the first and second channel portions has a generally frusto-conical shape.

52. A securement device according toclaim 43, wherein said gap is defined by a pair of opposing surfaces.

53. A securement device according toclaim 52, wherein the opposing surfaces lie generally perpendicularly to the longitudinal axis of the retainer

54. A securement device according toclaim 43, wherein the distance separating the first and second channel portions forms a continuous gap which extends around the longitudinal axis of the retainer for at least 180 degrees.

55. A securement device according toclaim 43, wherein at least one of the first and second channel portions extends about the longitudinal axis of the retainer by greater than about 180°.

56. A securement device according toclaim 43, wherein the first channel portion of the retainer has a truncated circular cross-sectional shape and surrounds at least a portion of the medical article through an arc of greater than 180 degrees about the longitudinal axis of the first channel portion when the medical article is received by the first channel portion.

57. A securement device according toclaim 43, wherein at least part of the first channel portion is wider, as measured perpendicularly to the longitudinal axis of the retainer, than the second channel portion.

58. A securement device according toclaim 43, wherein the retainer is coupled to the base in a manner permitting the base to move in a linear direction relative to the anchor pad.

59. A securement device for attaching a medical article to a patient, the medical article having a generally elongated body and a side member that projects away from the body, the securement device comprising:

a retainer including first and second channel portions that each extend about a longitudinal axis of the retainer by more than 180°, each channel portion having an opening that extends along the longitudinal axis of the retainer, the first and second channel portions being disposed apart with at least one gap therebetween, a distance across the gap as measured in a direction parallel to the longitudinal axis of the retainer being substantially the same as a dimension of the side member of the medical article, which is measured along the longitudinal axis of the retainer, and being less than the combined lengths of the first and second channel portions as measured along the longitudinal axis of the retainer; and

a flexible anchor having a bottom surface with an adhesive for attaching the anchor to the patient, the retainer being coupled to the anchor and being disposed relative thereto such that when the anchor is adhered to the patient said openings of the retainer remain exposed.

60. A securement device according toclaim 59, wherein at least one of the first and second channel portions has a truncated circular cross-sectional shape.

61. A securement device according toclaim 59, wherein the cross-section of at least one of the first and second channel portions tapers in size along its length.

62. A securement device according toclaim 59, wherein at least one of the first and second channel portions has a generally frusto-conical shape.

63. A securement device according toclaim 59, wherein said gap is defined by a pair of opposing surfaces.

64. A securement device according toclaim 63, wherein the opposing surfaces generally lie perpendicular to the longitudinal axis of the retainer.

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