US20120197205A1 - Universal stabilization device - Google Patents

Universal stabilization device Download PDF

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Publication number
US20120197205A1
US20120197205A1 US13/320,381 US201013320381A US2012197205A1 US 20120197205 A1 US20120197205 A1 US 20120197205A1 US 201013320381 A US201013320381 A US 201013320381A US 2012197205 A1 US2012197205 A1 US 2012197205A1
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Prior art keywords
connector
stabilization device
catheter
adapter
anchor pad
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Abandoned
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US13/320,381
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Gary Peters
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CR Bard Inc
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CR Bard Inc
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Priority to US17892809P priority Critical
Priority to US61178928 priority
Application filed by CR Bard Inc filed Critical CR Bard Inc
Priority to US13/320,381 priority patent/US20120197205A1/en
Priority to PCT/US2010/035004 priority patent/WO2010132837A1/en
Assigned to C. R. BARD, INC. reassignment C. R. BARD, INC. EMPLOYMENT AGREEMENT Assignors: PETERS, GARY
Publication of US20120197205A1 publication Critical patent/US20120197205A1/en
Application status is Abandoned legal-status Critical

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02Holding devices, e.g. on the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02Holding devices, e.g. on the body
    • A61M2025/028Holding devices, e.g. on the body having a mainly rigid support structure

Abstract

A universal catheter stabilization system includes a medical article integrated with a securement device. The medical article can comprise one or more of a male luer adapter, a female luer adapter, an integrated extension set, and an integrated mechanical valve.

Description

    RELATED APPLICATION
  • This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Application No. 61/178,928, filed May 15, 2009, entitled “Universal Stabilization Device,” which is hereby incorporated by reference in its entirety.
  • BACKGROUND OF THE INVENTION
  • 1. Field of the Invention
  • This application is directed to a universal stabilization device for stabilizing a medical article, such as a catheter, near an insertion site. More particularly, this application is directed to a stabilization device having an integrated adapter, such as an integrated female luer adapter, an integrated extension set, or an integrated mechanical valve.
  • 2. Description of the Related Art
  • It is common in the treatment of patients to utilize catheters to introduce fluids and medications directly into the patient or to withdraw fluids from the patient. Often, it becomes desirable to maintain such catheterization over an extended period of time during the treatment of a patient. In order to keep the catheter or other medical article properly positioned for the duration of treatment, the catheter or medical article can be secured to the patient in a variety of ways. Most commonly, this involves taping or suturing the catheter or medical article to the patient.
  • Securing a catheter with tape upon the patient traditionally has certain drawbacks. The use of tape at the insertion site can retain dirt or other contaminant particles, potentially leading to infection of the patient. Tape also fails to limit catheter motion and, therefore, contributes to motion related complications like phlebitis, infiltration and catheter migration. Additionally, removal of taped dressings can itself cause undesired motion of the catheter upon the patient.
  • Taped dressings also require periodic changes. The frequent, often daily, removal and reapplication of adhesive tape to the skin of the patient can excoriate the skin. Such repeated applications of tape over the catheter or medical article can additionally lead to the build up of adhesive residue on the outer surface of the catheter or medical article. This residue can result in contaminants adhering to the medical article itself, increasing the likelihood of infection of the insertion site. This residue can also make the catheter or medical article stickier and more difficult to handle for healthcare providers.
  • Suturing also carries risk, both to healthcare workers and patients. Healthcare workers can suffer accidental needlestick injury, which may expose them to hepatitis, HIV, and other pathogens. Patients can suffer local or even systemic infection from suture, as well as scarring and pain.
  • SUMMARY OF THE INVENTION
  • An aspect of the invention is directed to a catheter stabilization device comprising at least one anchor pad having a lower surface at least partially covered by an adhesive for contacting a patient's skin, at least one mounting wing disposed on the at least one anchor pad, an adapter member having a longitudinal axis, a proximal portion, and a distal portion, the adapter member comprising a first connector forming at least part of the proximal portion, a second connector forming at least part of the distal portion, and a lumen extending from the first connector to the second connector, the first connector being configured to connect to a hub of a catheter near an insertion site, and at least one support member supporting the adapter member away from the at least one mounting wing.
  • Another aspect is directed to a method of stabilizing a catheter near an insertion site on a patient, the method comprising providing a stabilization device having an anchor pad, a base member disposed on the anchor pad, an adapter member, and a support member supporting the adapter member over the base member, the adapter member comprising a first connector at its proximal end, a second connector at its distal end, and a lumen extending from the first connector to the second connector, connecting the first connector to a hub of a catheter, and adhering the stabilization device to the patient's skin near the insertion site.
  • Another aspect is directed to a retainer comprising an adapter having proximal and distal ends and a lumen extending therebetween, a first connector formed on the proximal end of the adapter, the first connector being configured to secure to a catheter, a second connector formed near the distal end of the adapter, the second connector being selected from the group consisting of a mechanical valve, an extension set, and a split septum, at least one mounting wing disposed below the adapter, and at least one support member supporting the adapter away from the at least one mounting wing.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • The above-mentioned and other features of the invention will now be described with reference to the drawings of various embodiments which are intended to illustrate but not to limit the invention. The drawings contain the following figures:
  • FIG. 1 is an isometric view of a stabilization device having an integrated female luer fitting, configured in accordance with a preferred embodiment of the present invention.
  • FIG. 2 is a top plan view of the stabilization device of FIG. 1.
  • FIG. 3 is a side view of the stabilization device of FIG. 1.
  • FIG. 4 is an isometric view of the stabilization device of FIG. 1, shown connected to an extension set.
  • FIG. 5 is an isometric view of a stabilization device having an integrated extension set, configured in accordance with a preferred embodiment of the present invention.
  • FIG. 6 is a top plan view of the stabilization device of FIG. 5.
  • FIG. 7 is a side view of the stabilization device of FIG. 5.
  • FIG. 8 is an isometric view of a stabilization device having an integrated mechanical valve, configured in accordance with a preferred embodiment of the present invention.
  • FIG. 9 is a top plan view of the stabilization device of FIG. 8.
  • FIG. 10 is a side view of the stabilization device of FIG. 8.
  • FIG. 11 is an isometric view of the stabilization device of FIG. 8, shown connected to an extension set.
  • FIG. 12 is an isometric view of a stabilization device having an integrated split septum, configured in accordance with a preferred embodiment of the present invention.
  • FIG. 13 is a top plan view of the stabilization device of FIG. 12.
  • FIG. 14 is a side view of the stabilization device of FIG. 12.
  • DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
  • The following description and the accompanying figures, which describe and show the preferred embodiments, are made to demonstrate several possible configurations that a stabilization system can take to include various aspects and features of the invention. The illustrated embodiments are shown in use with an illustrative example of an extension set for connection to the stabilization system and/or an illustrative example of a connector fitting with a spin nut for connection to a catheter hub. The illustration of the stabilization device in this context is not intended to limit the disclosed aspects and features of the invention to the specified embodiments or to usage only with the illustrated extension set or connector. Those of skill in the art will recognize that the disclosed aspects and features of the invention are not limited to any particular embodiment of a stabilization system, and stabilization systems, which include one or more of the inventive aspects and features herein described, can be designed for use with a variety of medical articles including, for example, catheter hubs.
  • To assist in the description of these components of the stabilization system, the following coordinate terms are used (see FIG. 1). A “longitudinal axis” is generally parallel to a portion of the catheter hub or other medical article connected to the stabilization system, as well as parallel to the axis of a channel of the stabilization device. A “lateral axis” is normal to the longitudinal axis. A “transverse axis” extends normal to both the longitudinal and lateral axes. In addition, as used herein, “the longitudinal direction” refers to a direction substantially parallel to the longitudinal axis; “the lateral direction” refers to a direction substantially parallel to the lateral axis; and “the transverse direction” refers to a direction substantially parallel to the transverse axis. The term “axial” as used herein refers to the axis of the channel or connector fitting, and therefore is substantially synonymous with the term “longitudinal” as used herein. Also, the terms “proximal” and “distal”, which are used to describe the present stabilization system, are used consistently with the description of the exemplary applications (i.e., the illustrative examples of the use applications). Thus, proximal and distal are used in reference to the center of the patient's body. The terms “upper,” “lower,” “top,” “bottom,” “underside,” “upperside” and the like, which also are used to describe the present stabilization system, are used in reference to the illustrated orientation of the embodiment. For example, the term “upperside” is used to describe the portion of the stabilization device that is located above a lateral axis that passes through the axis of the channel. The term “underside” is used to describe the portion of the stabilization device that is located below a lateral axis that passes through the axis of the channel. Brief introductions to some of the features, which are common to the described embodiments of the stabilization systems, are now described. In the illustrated embodiment, the arrows on the stabilization device point in the direction toward the insertion site (i.e., in the proximal direction).
  • The preferred embodiments of the present invention advantageously provide a stabilization system for stabilizing a medical article, such as a catheter, to the skin of a patient near an insertion site. By incorporating an adapter as part of the stabilization device, embodiments of the invention allow for use in universal catheter, valve, and extension set applications, independently of the catheter, valve, or extension set being used. In addition, embodiments provide modular, mechanical stabilization of the catheter, while allowing for the connection and disconnection of valves, extension sets, primary fluid administration tubing sets and the like, directly to the stabilization device.
  • Stabilization Device with Integrated Connector Fitting
  • Embodiments of the invention provide a stabilization device with an integrated medical article, such as, for example, a female luer fitting, so that the stabilization device can be used in universal catheter, valve, and extension set applications, independent of the catheter, valve, or extension set being used.
  • In some embodiments, a universal modular stabilization device is provided that is configured to attach to the hub of a catheter, for example with a male luer adaptor that is incorporated into the stabilization device. In some embodiments, the stabilization device also incorporates a female luer fitting, such as a tapered conical female luer fitting. By such a configuration, embodiments provide modular, mechanical stabilization of a catheter, while allowing for the connection and disconnection of valves, extension sets, primary fluid administration tubing sets and the like, as well as for the connection of a syringe having a male luer fitting, directly to the stabilization device.
  • In some embodiments, the female luer fitting can be incorporated as part of the stabilization device, at a distal portion of the device, for example in the general region where extension tubing would normally be connected to an adapter in a conventional retainer/adapter system.
  • In some embodiments, the male luer adapter can be configured such that the male luer portion protrudes from the body of the stabilization device by a smaller amount than in systems that utilize separate retainers and adapters. Thus, in some embodiments, the stabilization device can be positioned closer to the catheter hub (and thus, closer to the insertion site) than in conventional systems. Further, in some embodiments, the male luer adapter portion can be provided with protruding annular rings configured to mechanically interface with the body of the stabilization device.
  • Also, in some embodiments, the stabilization device can have a more compact design than systems that utilize separate retainers and adapters, as an integrated design can obviate the need for separate retaining structure overlying the adapter portion.
  • As will be understood by one of skill in the art, embodiments of the invention can be specifically configured to include different types of tubing attached to the male luer adapter (including but not limited to bifurcated tubing, or tubing of various lengths), as well as various types of tubing attachments (including but not limited to dust caps, valves, and the like).
  • In one embodiment, the stabilization device can include a split-septum cover (or surface) over, or as part of, the female luer fitting. Incorporating a split-septum cover allows for needleless luer access, while providing a closed system with an easy to clean and disinfect surface. In some embodiments, alternative structure can be included to provide other forms of needleless luer access.
  • The body of the stabilization device and/or of the adaptor member can have different angles, shapes, sizes, and lengths, depending on the needs of the particular application. In addition, embodiments can be adapted for a variety of application methods, including application via one or more adhesive-backed anchor pads (for example as illustrated herein).
  • The stabilization devices described herein include at least one support that is preferably disposed on the underside of the device, at a position lower than the lowest extent of the adapter portion. With this construction, the device holds the adapter portion of the stabilization device away from the patient's skin (at least within the region of the support(s)), to avoid chafing or excoriating the skin. The support in each of the illustrated embodiments includes left and right mounting wings that are integral with the body member and are attached to left and right anchor pads. The lower surfaces of the left and right anchor pads attach to the patient's skin.
  • The stabilization device and anchor pad(s) also can have other constructions in order to inhibit contact between the skin and the adapter. For example, the anchor pads can be thicker, in which case the mounting wings can be located higher on the retainer body.
  • With reference to FIG. 1, a stabilization device 100 according to an embodiment is illustrated. The stabilization device 100 has a generally rigid structure (at least in comparison to foam or tape), and includes a body member 102 and a pair of mounting wings or base members 104 a, 104 b. Each of the mounting wings or base members 104 a, 104 b is disposed on one of a pair of anchor pads 106 a, 106 b. The mounting wings 104 a, 104 b support the body member 102. For example, supports 108, 110 connect the body member 102 to the mounting wings 104 a, 104 b. In the illustrated embodiment, the supports 108, 110 also extend laterally across the device 100 to connect the mounting wings 104 a, 104 b together, and to provide additional rigidity to the device 100. The supports 108, 110 extend across the device generally along the underside of the adapter member 112, but above the upper surfaces of the mounting wings 104 a, 104 b. Although illustrated with two supports 108, 110, some embodiments can include more than two supports, or only a single support.
  • The body member 102 also includes an adapter member 112. The adapter 112 includes a male luer connector 111 and surrounding spin nut 114 extending from the proximal end of the device 100, and are configured for connection to a catheter hub (not shown) near an insertion site. At the distal end of the device 100, a female luer fitting 116 is provided. The adapter member 112 has a lumen extending longitudinally from the male luer connector 111 at the proximal end to the female luer fitting 116 at the distal end. The connectors 111, 116 and the lumen cooperate to allow a fluid connection from the catheter, through the body member 102, and to an extension set or other device which may be attached or connected to the proximal end of the stabilization device 100.
  • The body member 102, mounting wings 104 a, 104 b, and adapter member 112 are integrally formed to comprise a unitary stabilization device. This can be accomplished in any of a variety of ways well known to those skilled in the art. For instance, the entire stabilization device can be injection molded in order to reduce fabrication costs. The illustrated stabilization device can be formed by injection molding using polyethylene or polypropylene material. Alternatively, the various portions of the stabilization device, such as the body member 102, mounting wings 104 a, 104 b, and the adapter member 112 can be separately formed and then coupled together. Additionally, the body member, mounting wings, and adapter member can have other forms and can have other orientations relative to one another. The body member 102, the mounting wings 104 a, 104 b, and/or the adapter member 112 also can be clear or transparent if desired.
  • FIG. 2 shows a top plan view of the device 100, and illustrates that the supports 108, 110 extend across the device from mounting wing 104 a to mounting wing 104 b. FIG. 3 shows a side view of the device 100, and illustrates that the body member 102 and the adapter member 112 can be arranged at an incident angle, such as a 7 degree angle, with respect to the mounting wings 104 a, 104 b (and thus with respect to the skin of a patient, as well as the insertion site). FIG. 4 shows the device 100 connected to an exemplary extension set 120.
  • Each mounting wing preferably comprises a glue dam around a portion of its periphery on its underside. The glue dam restricts adhesive flow beyond an inner edge of the respective mounting wing. The outer edge of each mounting wing does not include the glue dam to allow any excess glue or adhesive to seep out from under the mounting wing during the manufacturing process in the lateral direction away from the stabilization device.
  • The body member 102 of the stabilization device is attached to the upper surface of the anchor pad via the mounting wings, as is shown in FIG. 1. The body member is desirably secured to the upper surface of the pad by a solvent bond adhesive, such as cyanoacrylate or other bonding material. One such adhesive is available commercially as Part No. 4693 from 3M.
  • Suitably rigid materials for use in forming all or part of the stabilization devices disclosed herein include, for example, but without limitation: plastics, polymers or composites such as polypropylene, polyethylene, polycarbonate, polyvinylchloride, acrylonitrile butadiene styrene, nylon, olefin, acrylic, polyester, as well as moldable silicon, thermoplastic urethane, thermoplastic elastomers, thermoset plastics and the like. However, other materials can be utilized.
  • Stabilization Device with Integrated Extension Set
  • Embodiments of the invention provide a stabilization device with an integrated extension set. The embodiment illustrated in FIGS. 5 through 7 is similar to the embodiment illustrated in FIGS. 1 through 6 except that the distal end of the device includes an integral extension set instead of the female luer fitting 116 illustrated in FIGS. 1 through 6 as described below. Accordingly, the description of the other features from the embodiment illustrated in FIGS. 1 through 5 applies to the corresponding feature in the embodiment illustrated in FIGS. 5 through 7. For simplicity, the reference numerals for corresponding features between the embodiments are identical except for the third digit which is increased by one, for example from 104 a to 204 a, for the embodiment illustrated in FIGS. 5 through 7.
  • Adapter member 212 includes an extension set 220, comprising extension tubing 222 which is connected to the body member 202 at a distal region of the body member 202. In some embodiments, the extension tubing 222 can be bonded into an aperture in the distal region of the body member 202. The adapter member 212 has a lumen extending longitudinally from the male luer connector 211 at the proximal end to the extension set 220 at the distal end. The male luer connector 211 and the lumen of the adapter member 212 cooperate to allow a fluid connection from the catheter, through the body member 202, and to the extension set 220.
  • Stabilization Device with Integrated Mechanical Valve
  • Embodiments of the invention provide a stabilization device with an integrated mechanical valve as part of the device. The embodiment illustrated in FIGS. 8 through 11 is similar to the embodiment illustrated in FIGS. 1 through 6 except that the distal end of the device includes an integral mechanical valve instead of the female luer fitting 116 illustrated in FIGS. 1-6 as described below. Accordingly, the description of the other features from the embodiment illustrated in FIGS. 1 through 5 applies to the corresponding feature in the embodiment illustrated in FIGS. 8 through 11. For simplicity, the reference numerals for corresponding features between the embodiments are identical except for the third digit which is increased by two, for example from 104 a to 304 a, for the embodiment illustrated in FIGS. 8 through 11.
  • Toward the distal end of the device 300, the adapter 312 includes a mechanical valve 320. The adapter member 312 has a lumen extending longitudinally from the male luer connector 311 at the proximal end to the mechanical valve 320 at the distal end. The male luer connector 311 and the lumen of the adapter member 312 cooperate to allow a fluid connection from the catheter, through the body member 302, and to the mechanical valve 320. FIG. 11 shows the device 300 connected to an exemplary extension set 330.
  • Stabilization Device with Integrated Split Septum
  • Embodiments of the invention provide a stabilization device with an integrated split septum unit as part of the device. The embodiment illustrated in FIGS. 12 through 14 is similar to the embodiment illustrated in FIGS. 1 through 6 except that the distal end of the device includes an integral split septum instead of the female luer fitting 116 illustrated in FIGS. 1-6 as described below. Accordingly, the description of the other features from the embodiment illustrated in FIGS. 1 through 5 applies to the corresponding feature in the embodiment illustrated in FIGS. 12 through 14. For simplicity, the reference numerals for corresponding features between the embodiments are identical except for the third digit which is increased by three, for example from 104 a to 404 a, for the embodiment illustrated in FIGS. 12 through 14.
  • Toward the distal end of the device 400, the adapter 412 includes a split septum unit 420 which can be configured to provide needleless luer access. The adapter member 412 has a lumen extending longitudinally from the male luer connector 411 at the proximal end to the split septum unit 420 at the distal end. The male luer connector 411 and the lumen of the adapter member 412 cooperate to allow a fluid connection from the catheter, through the body member 402, and to the split septum unit 420.
  • Anchor Pad
  • In some embodiments, the anchor pad or pads, for example pads 106 a, 106 b, can comprise a generally rectangular shape. In some embodiments, the anchor pads can have a scalloped region located at a corner of each anchor pad, to ease the process of aligning the stabilization device with a catheter insertion site in the patient's skin. Those of skill in the art will recognize that a variety of anchor pad shapes can also be used.
  • Each anchor pad desirably comprises a laminate structure with an upper plastic, paper or foam layer (e.g., closed-cell polyethylene foam) and a lower adhesive layer. The lower adhesive layer constitutes a lower surface of the anchor pad. The lower surface desirably is a medical-grade adhesive and can be either diaphoretic or nondiaphoretic, depending upon the particular application. Such foam with an adhesive layer is available commercially from Avery Dennison of Painsville, Ohio. While not illustrated, the anchor pads can include suture holes in addition to the adhesive layer to further secure the anchor pad to the patient's skin.
  • In other variations, a hydrocolloid adhesive or zinc oxide-based adhesive can advantageously be used upon the anchor pads for attaching the anchor pads to the skin of the patient. The hydrocolloid or zinc oxide-based adhesive can be used either alone or in combination with another medical grade adhesive (e.g., in combination with the adhesive available from Avery Dennison). Hydrocolloid and zinc oxide-based adhesives have less of a tendency to excoriate the skin of a patient when removed. This can be particularly important for patients whose skin is more sensitive or fragile, such as neonates and those with a collagen deficiency or other skin related condition.
  • In another variation, each anchor pad comprises a laminate structure with an upper woven layer and a lower adhesive layer. The upper layer can be polyester or other suitable polymer or textile materials. One particular suitable material is a woven polyester available commercially under the name “Tricot” from Tyco. The lower adhesive layer constitutes the lower surface of the anchor pad. The lower surface desirably is a medical-grade adhesive and can be either diaphoretic or nondiaphoretic, depending upon the particular application.
  • A surface of the upper foam layer constitutes an upper surface of the anchor pads. The upper surface can be roughened by corona-treating the foam with a low electric charge. The roughened or porous upper surface can improve the quality of the adhesive joint (which is described below) between the mounting wings and the anchor pads. In a further variation, the flexible anchor pad can comprise an upper paper or other woven or nonwoven cloth or plastic layer in lieu of a roughened upper foam surface.
  • In some embodiments, the anchor pads preferably are arranged with respect to the stabilization device such that the proximal tip of the adapter does not extend beyond the front edge of the mounting wings.
  • A removable paper or plastic release liner desirably covers the adhesive lower surface before use. The liner preferably resists tearing and desirably is divided into a plurality of pieces to ease attachment of the pad to a patient's skin. The liner comprises a folded over portion to define a pull tab. The pull tab can be utilized to remove the paper or plastic release liner from their adhesive lower surface before use. A healthcare provider uses the pull tab by grasping and pulling on it so that the liner is separated from the lower surface. The pull tab overcomes any requirement that the healthcare provider pick at a corner edge or other segment of the liner in order to separate the liner from the adhesive layer.
  • The pull tab of course can be designed in a variety of configurations. For example, the pull tab can be located along a center line of the anchor pad; or alternatively, the pull tab can be located along any line of the anchor pad in order to ease the application of the anchor pad onto the patient's skin at a specific site. For example, an area of a patient's skin with an abrupt bend, such as at a joint, can require that the pull tab be aligned toward one of the lateral ends of the anchor pad rather than along the center line. In some embodiments, the pull tab extends from a bottom surface of the anchor pads and along an outer line.
  • The fold that forms the pull tab preferably occurs laterally beyond the inner (medial) edge on each anchor pad rather than at the inner edge of the anchor pad. Thus, the spacing between the folds of the release liners is less than the spacing between the inner edges of the anchor pads. The projection of the release linear beyond the anchor pad inner edge provides an area onto which any adhesive, which is used to attach the stabilization device to the anchor pad, can run while lessening the occurrence of such adhesive contacting the fold. Cracks often occur at the fold and presence of adhesive in such cracks can create delimitation of the release liner and incomplete removal of the release linear when peeled away from the corresponding anchor pad.
  • Additionally, the distal side of each release linear can be cut to increase a “view window” through which a healthcare provider can see when aligning the stabilization device near the insertion site. Preferably, the resulting relief originates from the inner edge of the release linear generally at a right angle thereto and then transitions into a shape that generally matches the shape of the adjacent region of corresponding anchor pad. The initial right-angle cut of this relief reduces instances of the release linear ripping when properly pulled in the lateral direction away from the stabilization device.
  • It is to be understood that not necessarily all such objectives or advantages may be achieved in accordance with any particular embodiment using the systems described herein. Thus, for example, those skilled in the art will recognize that the systems may be developed in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other objectives or advantages as may be taught or suggested herein.
  • Furthermore, the skilled artisan will recognize the interchangeability of various features from different embodiments. Although these techniques and systems have been disclosed in the context of certain embodiments and examples, it will be understood by those skilled in the art that these techniques and systems may be extended beyond the specifically disclosed embodiments to other embodiments and/or uses and obvious modifications and equivalents thereof. Additionally, it is contemplated that various aspects and features of the invention described can be practiced separately, combined together, or substituted for one another, and that a variety of combination and subcombinations of the features and aspects can be made and still fall within the scope of the invention. Thus, it is intended that the scope of the systems disclosed herein disclosed should not be limited by the particular disclosed embodiments described above but by a fair reading of the claims which follow.

Claims (20)

1. A catheter stabilization device comprising:
at least one anchor pad having a lower surface at least partially covered by an adhesive for contacting a patient's skin;
at least one mounting wing disposed on the at least one anchor pad;
an adapter member having a longitudinal axis, a proximal portion, and a distal portion, the adapter member comprising a first connector forming at least part of the proximal portion, a second connector forming at least part of the distal portion, and a lumen extending from the first connector to the second connector, the first connector being configured to connect to a hub of a catheter near an insertion site; and
at least one support member supporting the adapter member away from the at least one mounting wing.
2. The catheter stabilization device of claim 1, wherein the adapter member extends beyond a portion of the anchor pad at least in a proximal direction.
3. The catheter stabilization device of claim 1, wherein the first connector comprises a male luer connector and a spin nut.
4. The catheter stabilization device of claim 1, wherein the second connector comprises a female luer connector.
5. The catheter stabilization device of claim 1, wherein the second connector comprises a mechanical valve.
6. The catheter stabilization device of claim 1, wherein the second connector comprises an extension set.
7. The catheter stabilization device of claim 1, wherein the second connector comprises a split septum.
8. The catheter stabilization device of claim 1 further comprising first and second anchor pads spaced apart in a lateral direction.
9. The catheter stabilization device of claim 8 further comprising first and second mounting wings disposed, respectively, on the first and second anchor pads.
10. The catheter stabilization device of claim 9, wherein the support member connects the first and second mounting wings.
11. The catheter stabilization device of claim 9 further comprising first and second support members spaced apart in a longitudinal direction.
12. The catheter stabilization device of claim 1, wherein the adapter member is disposed at an angle with respect to a lower surface of the mounting wing.
13. A method of stabilizing a catheter near an insertion site on a patient, the method comprising:
providing a stabilization device having an anchor pad, a base member disposed on the anchor pad, an adapter member, and a support member supporting the adapter member over the base member, the adapter member comprising a first connector at its proximal end, a second connector at its distal end, and a lumen extending from the first connector to the second connector;
connecting the first connector to a hub of a catheter; and
adhering the stabilization device to the patient's skin near the insertion site.
14. The method of claim 13, wherein the first connector comprises a male luer connector and a spin nut.
15. The method of claim 13, wherein the second connector comprises a female luer connector.
16. The method of claim 13, wherein the second connector comprises a mechanical valve.
17. The method of claim 13, wherein the second connector comprises an extension set.
18. The method of claim 13, wherein the second connector comprises a split septum.
19. A retainer comprising:
an adapter having proximal and distal ends and a lumen extending therebetween;
a first connector formed on the proximal end of the adapter, the first connector being configured to secure to a catheter;
a second connector formed near the distal end of the adapter, the second connector being selected from the group consisting of a mechanical valve, an extension set, and a split septum;
at least one mounting wing disposed below the adapter; and
at least one support member supporting the adapter away from the at least one mounting wing.
20. The catheter stabilization device of claim 19 further comprising at least one anchor pad having a lower surface at least partially covered by an adhesive for contacting a patient's skin, the at least one mounting wing being disposed on the at least one anchor pad.
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Application Number Priority Date Filing Date Title
US17892809P true 2009-05-15 2009-05-15
US61178928 2009-05-15
US13/320,381 US20120197205A1 (en) 2009-05-15 2010-05-14 Universal stabilization device
PCT/US2010/035004 WO2010132837A1 (en) 2009-05-15 2010-05-14 Universal stabilization device

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Application Number Priority Date Filing Date Title
US13/320,381 US20120197205A1 (en) 2009-05-15 2010-05-14 Universal stabilization device

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US20120197205A1 true US20120197205A1 (en) 2012-08-02

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WO2010132837A1 (en) 2010-11-18
CN102438681B (en) 2015-05-06
EP2429617A1 (en) 2012-03-21
US20120123343A1 (en) 2012-05-17
CN102438682A (en) 2012-05-02
US8679066B2 (en) 2014-03-25
CN102438681A (en) 2012-05-02
WO2010132843A1 (en) 2010-11-18
CN104857610A (en) 2015-08-26

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