Medical article securement device

Information

  • Patent Grant
  • 9962524
  • Patent Number
    9,962,524
  • Date Filed
    Thursday, March 8, 2012
    12 years ago
  • Date Issued
    Tuesday, May 8, 2018
    6 years ago
Abstract
A securement system includes a securement device which permits various medical articles, for example, an indwelling catheter and one or more medical lines, to be fluidly connected to one another. The securement device can be releasably secured relative to an anchor pad which itself is secured to a patient. In this way, the securement system can secure an interconnection of medical articles relative to a patient.
Description
BACKGROUND OF THE INVENTION

Field of the Invention


This application relates in general to a securement device for a medical article. More particularly, the device disclosed herein can interconnect various medical articles with one another. Additionally, the device can releasably secure to a patient's skin.


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. When introducing fluid into a patient, the fluid (e.g., parenteral liquid, medication, etc.) typically drains from a container positioned above the patient to feed under gravity or is delivered via an infusion pump. The fluid flows through a medical line and into, for example, an indwelling catheter inserted into the patient. The inserted medical article and medical line are often releasably secured to each other by a conventional T-connection.


A T-connection generally includes a male connector with a tapered conical portion that is adapted to fit into a correspondingly shaped receptacle of a female connector (i.e., a hub). A spin nut is commonly disposed on the male connector and is rotatable relative to the tapered conical portion. The spin nut includes internal threads adapted to engage external threads on the female connector to lock the connectors together. When properly engaged, the conical portion fits tightly within the receptacle to produce a sealed interconnection.


SUMMARY

The systems, devices, and methods of the present invention have several features, no single one of which is solely responsible for its desirable attributes. Without limiting the scope of this invention as expressed by the claims which follow, its more prominent features will now be discussed briefly. After considering this discussion, and particularly after reading the section entitled “Detailed Description of Certain Embodiments,” one will understand how the features of this invention provide several advantages over existing medical devices.


In one embodiment, a medical article securement system includes a retainer that has a first lumen defined between a first port and a second port, and a second lumen fluidly connected to the first lumen. The system further includes an anchor pad that has an upper surface and a lower surface. At least a portion of the lower surface is covered by adhesive. The system further comprises interengaging structure releasably securing the retainer to the anchor pad.


In another embodiment, a method of securing a medical article to a patient includes providing a retainer having a first lumen defined between a first port and a second port, and a second lumen fluidly connected to the first lumen. The method further includes providing an anchor pad having an upper surface and a lower surface. At least a portion of the lower surface is covered by adhesive. The method further includes releasably engaging the retainer to the anchor pad.


In yet another embodiment, a device for fluidly connecting a plurality of medical articles to an anchor includes a first lumen, a second lumen, a manifold connecting the first lumen to the second lumen, and at least one guiderail configured to slidably engage with the anchor.





BRIEF DESCRIPTION OF THE DRAWINGS

The above mentioned and other features of the invention will now be described with reference to the drawings of several embodiments of the present securement systems. The illustrated embodiments of the securement systems are intended to illustrate, but not to limit the invention. The drawings contain the following figures:



FIG. 1 is a perspective view of a securement system including an anchor pad and a securement device or retainer releasably secured thereto.



FIG. 2 is a perspective view of the anchor pad from FIG. 1 with the securement device removed.



FIG. 3 is a top plan view of the securement device of FIG. 1 separate from the anchor pad.



FIG. 4 is a side view of the securement device of FIG. 3.



FIG. 5 is a front view of the securement device of FIG. 3.



FIG. 6 is a rear view of the securement device of FIG. 3.



FIG. 7 is a bottom plan view of the securement device of FIG. 3.



FIG. 8 is a cross-sectional view of the securement device of FIG. 3 taken along line 8-8.



FIG. 9 is an exploded perspective view of the securement system showing the securement device aligned with the anchor pad of FIG. 1 prior to engaging the securement device with the anchor pad.



FIG. 10 is a cross-sectional view of the securement system of FIG. 1 with the anchor pad attached to the skin of a patient.



FIG. 11 is a close-up view of the guiderails of the securement device slidably engaged with the grooves of the anchor pad from FIG. 10.



FIG. 12 is an exploded perspective view of the securement system of FIG. 1 schematically depicted as attaching to two medical lines and an intravenous catheter.





DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS

The following description and examples illustrate certain embodiments of the present securement systems disclosed in the context of a catheterization system, and in particular in the context of a catheterization system utilizing a T-connector securement device. The catheterization system can include a catheter and one or more medical lines. More specifically, the embodiments relate to a securement system and related techniques that secure an interconnection of medical articles relative to a patient. Although, the embodiments of the securement systems are illustrated with intravenous catheters and medical lines, it will be understood by those of skill in the art in view of the present disclosure that the securement systems described herein can be used with other types of medical articles, including, but not limited to catheters and catheter hubs of various design, either with or without connectors or extension sets, such as central venous catheters, peripherally inserted central catheters, hemodialysis catheters, Foley catheters, as well as other designs of catheter hubs and catheter adaptors. Other medical articles may include surgical drainage tubes, feeding tubes, chest tubes, nasogastric tubes, rectal drains, external ventricular drains, chest tubes, any other sort of fluid supply or medical lines, connector fittings, and scopes, as well as electrical wires or cables connected to external or implanted electronic devices or sensors. The medical articles can each be a single medical article or a combination of medical articles.


One skilled in the art may also find additional applications for the devices, systems, and methods disclosed herein. Accordingly, the illustration and description of the securement systems in connection with a catheter and one or more medical lines is merely exemplary of one possible application of the securement systems and techniques disclosed.


The securement systems described with reference to the figures are especially adapted to arrest at least longitudinal movement of a medical article relative to an insertion site. The securement systems accomplish this without meaningfully impairing (i.e., substantially occluding) fluid flow through a lumen of the medical article or impairing insertion of a medical article, for example, a catheter. The securement systems may include retention mechanisms, for example, threaded fittings and male or female luer-lock connection fittings, to releasably secure one or more medical articles to the securement device.


With reference now to FIG. 1, an embodiment of a securement system 100 includes an anchor pad 102 and a securement device or retainer 110. The securement device 110 may be fixed or releasable with the pad 102. For example, the securement device 110 illustrated in FIG. 1 is releasably secured to the anchor pad 102 via a channel 108 (see FIG. 2) extending in a lateral direction. Alternatively, the securement device 110 may be releasably secured to the anchor pad 102 in a transverse direction relative to the anchor pad with, for example, hook and loop fasteners.


The securement device 110 includes one or more channels 120. For embodiments that include two or more channels, the two channels may be interconnected within the securement device 110. For example, the illustrated securement device 110 includes a first channel 120 defining an internal lumen and a second channel 130 defining an internal lumen. The two lumens interconnect within the securement device 110. In this way, the securement device 110 fluidly interconnects two or more medical articles attached to the securement device 110. The first channel 120 includes an inlet port 122 and an outlet port 124. The second channel 130 includes an inlet port 132 at a first end and interconnects with the first channel 120 at a second end. In this way, the ports 122, 124, 132 are fluidly interconnected with one another. Each of the channels 110, 120 may have additional inlet and outlet ports depending on factors including the number of medical articles, desired flow arrangement through the securement device 110, the intended application of the securement device 110, and desired mixing of fluids through the securement device 110.


The anchor pad 102 is configured to be secured to a patient's skin and can include a release liner 104 disposed over an adhesive layer 106. As will be described in further detail below, in this way, medical articles can be interconnected with one another via the securement device 110 with the assembled securement device and medical articles being releasable from the anchor pad 102.


To assist in the description of the components of embodiments of the securement systems, the following coordinate terms are used, consistent with the coordinate axes illustrated in FIG. 1. A “longitudinal axis” is generally parallel to the first channel 120 of the securement device 110. A “lateral axis” is normal to the longitudinal axis and is generally parallel to the plane of the anchor pad 102. A “transverse axis” extends normal to both the longitudinal and lateral axes. In addition, as used herein, “the longitudinal direction” refers to a direction substantially parallel to the longitudinal axis; “the lateral direction” refers to a direction substantially parallel to the lateral axis; and “the transverse direction” refers to a direction substantially parallel to the transverse axis. The terms “proximal” and “distal” are used in reference to the center of the patient's body, as will be understood by one of skill in the art.


Anchor Pad


As can be seen in FIG. 2, the anchor pad 102 includes a releasable engagement structure for engaging with the securement device 110. Releasable engagement structures include hook and loop fasteners, grooves, channels, keyway, or other attachment structures known to a person having ordinary skill in the art. The engagement structure of the anchor pad 102 illustrated in FIG. 2 is a recess or channel 108. The channel 108 is disposed in an upper surface 103 of the pad 102 to receive and engage at least a portion of the securement device 110. As discussed in more detail below with reference to FIGS. 9-11, the channel 108 can include one or more grooves 109 to slidingly receive at least a portion of the securement device 110. For example, the anchor pad 102 can include two grooves 109 disposed on opposite sides of the channel 108 for receiving guiderails on the securement device 110. In this way, the guiderails of the securement device 110 slidingly engage the grooves 109 of the channel 108.


In some embodiments, the channel 108 extends from a first lateral side of the anchor pad 102 and terminates before reaching the second lateral side of the anchor pad 102. In such embodiments, the channel 108 forms an abutment surface 107 which prevents further lateral movement of the securement device 110 once the securement device 110 abuts against the surface 107. In other embodiments, the channel 108 extends through the anchor pad 102 from one lateral side to the other. Those of skill in the art will appreciate that the channel 108 can be oriented differently with respect to the coordinate axes of the securement system 100. For example, the channel 108 can extend longitudinally or at an angle relative to the longitudinal and lateral axes of the anchor pad 102.


The size and shape of the anchor pad 102 can vary depending on where the anchor pad 102 is intended to be positioned on a patient. For example, in some embodiments the securement system 100 may be intended for placement on a patient's hand and in other embodiments, the securement system 100 may be intended for placement on a different part of a patient, for example, a patient's back. The anchor pad 102 may be any size or shape that allows attachment of the anchor pad 102 to a patient's skin and that is configured to support at least the securement device 110. In the illustrated embodiment, the size and shape of the anchor pad 102 is selected to support at least two medical lines and a catheter. In some embodiments, the anchor pad 102 is configured to support more than two medical lines and/or additional medical articles, for example, two extension sets and two medical lines. In such an embodiment, the size and shape of the anchor pad 103 may be increased to provide support for the additional medical line.


The anchor pad 102 has a lower adhesive surface 106 for adhering to the skin of a patient and an upper surface 103. The anchor pad 102 is configured to support at least the securement device 110, as described above. In combination, the lower adhesive surface 106, the upper surface 103, and possibly one or more intermediate layers may comprise a laminate structure. A suitable laminate that comprises a foam or woven material with an adhesive layer is available commercially from Avery Dennison of Painsville, Ohio. The anchor pad 102 may be configured as a flexible structure which conforms to the surface of a patient's skin.


The lower adhesive surface 106 or layer may be a medical-grade adhesive and can be either diaphoretic or nondiaphoretic, depending upon the particular application. The lower adhesive surface 106 may have additional types of medical adhesives laminated thereto. In some embodiments, the lower adhesive layer 106 comprises an anti-bacterial or anti-microbial material. For example, the lower adhesive layer may comprise one or more oligodynamic metal salts or oxides, or a combination of salts and oxides. In some embodiments, the lower adhesive layer 106 comprises a silver material, for example a silver salt, colloid, or complex. The adhesive layer 106 may be a solid layer or may be configured as an intermittent layer such as in a pattern of spots or strips. The lower adhesive layer 106 can be applied to the anchor pad 102 during manufacture, and may be further covered with a release liner 104.


The upper surface 103 may comprise a foam (e.g., closed-cell polyethylene foam) or woven material (e.g., tricot) layer. A surface of the foam or woven material layer can constitute the upper surface 103 of the anchor pad 102. In the alternative, the upper surface 103 may comprise an upper paper or other nonwoven cloth layer, and an inner foam layer may be placed between the upper surface 103 and lower adhesive layer 106.


A removable release liner 104 may cover the lower adhesive layer 106 before use. The release liner 104 may resist tearing and be divided into a plurality of pieces to assist removal of the release liner and ease attachment of the anchor pad 102 to a patient's skin. The release liner 104 may be divided into two adjacent pieces. The liner 104 may be made of a paper, plastic, polyester, or similar material. For example, the release liner 104 may comprise a material made of polycoated, siliconized paper, or another suitable material such as high density polyethylene, polypropylene, polyolefin, or silicon coated paper.


Securement Device


With reference now to FIGS. 3-8, the securement device 110 includes a first channel or lumen 120 defined between an inlet port 122 and an outlet port 124. The securement device 110 also includes at least a second channel or lumen 130. The second channel 130 connects to the first channel 120 between the inlet port 122 and the outlet port 124. The second channel 130 can also include an inlet port 132 that is disposed at an opposite end of the channel than the interconnection with the first channel 120. Those of skill in the art will appreciate that the ports 122, 124, 132 may be configured as inlet ports and/or outlet ports depending upon the application of the securement device 110.


In some embodiments, the first channel 120 is perpendicular to the second channel 130 and in other embodiments, the first and second channels intersect to form obtuse or acute angles therebetween. In one embodiment, the first channel 120 extends at an angle of between about 5° and about 30° to a bottom planar surface 114 of the securement device 110 to facilitate the insertion of a connected catheter to a patient at a desired angle, for example, 7°.


The outlet port 124 of the first channel 120 is configured to engage the distal end of a hub of a catheter or another connector. The inlet port 122 of the first channel 120 can include a male luer-lock connection fitting and a spin nut configured to connect to a medical line or a female luer-lock connection of another medical article, for example, an extension set. Similarly, the inlet port 132 of the second channel 130 can include a male luer-lock connection fitting and a spin nut configured to connect to a medical line or a female luer-lock connection of another medical article.


In some embodiments, the outlet port 124 is connected to an intravenous catheter and the inlet ports 122, 132 are connected to separate medical lines. Such a configuration advantageously provides for the fluid connection of two or more channels for introduction of two or more fluids into the body of a patient. For example, a first medical line can be fluidly coupled to inlet port 122 in order to introduce a first fluid to a patient through a catheter and a second medical line can be fluidly coupled to inlet port 132 in order to introduce a second fluid to the patient through the same catheter. In another example, the interconnection or plenum of the first and second channels 120, 130 provides for the infusion of fluid through a first inlet port 122 and aspiration and/or flushing through a second inlet port 132. In other embodiments, a catheter is connected to outlet port 124, a medical line is connected to inlet port 122, and inlet port 132 is unused or capped.


In some embodiments, the securement device 110 can include one or more valves, membranes, or septums. For example, the first channel 120 and/or second channel 130 can optionally include one or more integral one-way valves to permit the passage of fluid therethrough in a single direction, for example, in a direction toward the patient. The inlet ports 122, 132 can also optionally include needle stick membranes or septums configured to allow a syringe needle to penetrate through the membrane and into the respective channels 120, 130. For example, one or more fluids can enter the interconnection or plenum formed in the securement device 110 via a needle stick membrane and can subsequently be introduced into a patient through an intravenous catheter fluidly connected to the outlet port 124.


The body of the securement device 110 can comprise various shapes configured to house an interconnection of the first and second channels 120, 130. For example, the body of the securement device 110 can be substantially bell shaped with a generally planar bottom surface 114 as illustrated in FIG. 4. Such a shape may be pleasing to the eye and provide an ergonomic gripping configuration to allow a healthcare provider to easily manipulate the securement device 110 and a corresponding catheterization system. Further, the base of such a shape may provide for firm support and stability when the securement device 110 is disposed on an anchor pad 102 as discussed in further detail below. Those having skill in the art will appreciate that the body of the securement device 110 can comprise other shapes, for example, the body can be generally cylindrical, conical, frustoconical, or any other suitable three dimensional shape. The body of the securement device 110 can comprise various materials, for example, hard plastics, rubbers, foams, and/or composites.


As shown in FIGS. 4-8, the securement device 110 includes structure for releasably engaging with the anchor pad 102. For example, the illustrated embodiment includes guiderails 112 extending downwardly from the bottom surface 114 of the securement device 110. Of course a single guiderail, such a T-shaped guiderail, could also be used.


The guiderails 112 can comprise various shapes that are complimentary to corresponding grooves or tracks in the anchor pad 102. For example, the securement device 110 can include two substantially L-shaped rails that are each configured to be received within, and slidably engage, a groove 109 in the anchor pad 102. In this way, the guiderails 112 releasably couple the securement device 110 to the anchor pad 102 while permitting the securement device 110 to slide or translate in at least two directions relative to the anchor pad 102. As discussed above with reference to FIG. 2, in some embodiments sliding of the securement device 110 relative to the anchor pad 102 may be prevented by one or more abutment surfaces 107.


The securement system 100 can optionally include one or more timers 150 so as to be accessible by the healthcare provider. In some embodiments, the timer 150 is disposed on an outer surface of the securement device 110 and optionally includes a display 152.


The timer 150 may be configured to measure elapsed time and can be activated manually by a user, remotely by a user, and/or by a triggering event, for example, the connection of one or more medical articles to the securement device 110 and/or the passage of fluid through a lumen in the securement device 110. The timer 150 indicates a time-based characteristic of the medical article or line, such as, for example, the length of time the medical article or line has been in place on the patient. In some implementations, the timer 150 measures a flow rate of fluid into the patient and compares the measured flow rate to a target flow rate. Thus, the timer 150 may be used to verify that the lumens of the medical lines, securement device, and/or catheter are not occluded or partially occluded.


The timer 150 can be flexible or rigid, and can be disposed directly on the securement device 110. In some embodiments, the timer 150 is disposed on the anchor pad 102. By prominently positioning the timer 150, the timer can provide an easy-to-use and reliable visual indicator of elapsed time. The timer 150 can be a battery-operated timer or a chemically-active timer. Embodiments of a chemically active timer 150 can change color or provide another visual response when exposed to air or a selected chemical for a given length of time.


In some implementations, the timer 150 is activated by a healthcare provider at generally the same time a catheter is connected to the outlet port 124 (or just prior to or just after insertion). The activated timer 150 may then provide a visual indication of the length of time elapsed or period since the catheter was connected to the securement device 110. The timer 150 may provide, in addition to or instead of a visual response, an audible indication or alarm of a given length of time. For example, the timer 150 may beep, chirp, or otherwise emit sound indicative of a time-based characteristic.


The period between indication outputs from the timer 150 can be fixed or variable. For example, the timer 150 can provide an indication after a first time period and then provide a second indication after a second time period. The first and second time periods may have the same or different durations. The first indication may be the same or different than the second indication. For example, the timer 150 can provided an audible indication after the first time period and a visual indication after the second time period. Thus, the timer 150 can be used to signal when the medical line should be replaced and/or re-sited.


The securement device 110 can optionally include one or more pressure sensors or transducers configured to measure the pressure of an infusate flowing through the securement device 110. For example, the securement device 110 can include a pressure sensor coupled with the inlet or outlet ports 122, 132, 124 to measure the pressure of flowing fluid. In some embodiments, a pressure transducer provides an audible or visual indication or alarm when the pressure of the infusate exceeds a given threshold or is below a given threshold. For example, a pressure transducer may be configured to provide an audible alarm when pressure changes as a function of infiltration or extravasation. A spike or increase in the sensed pressure may indicate that the vein has been infiltrated.


The securement device 110 can optionally include one or more flow sensors or meters configured to sense a rate of fluid flow through the first channel 120 and/or second channel 130. For example, the securement device 110 can include a flow sensor coupled with the outlet port 124 to measure a rate of infusate flow therethrough. The one or more flow sensors can be configured to provide an audible or visual indication or alarm when a flow rate through the first channel 120 and/or second channel 130 exceeds a given threshold or is below a given threshold. For example, a flow sensor can be configured to provide an audible alarm when a flow rate through the connection device 110 is below a certain threshold such that the patient is not receiving sufficient fluid or infusate delivery.


The optional timers, pressure transducers, and/or flow sensors can include stored memory elements including one or more libraries of stored settings. For example, drug or medication libraries with stored settings relating to each individual drug or medication can be stored on memory elements to provide threshold values to the optional timers, pressure transducers, and/or flow sensors. In some embodiments, such memory elements can be configured to trigger an audible or visual indication or alarm when a given dosage has been met and/or when a pressure or flow characteristic of a given infusate deviates from an expected value.


Method of Use


The following discussion of the method of use will be with reference to FIGS. 9-12, and will be in the context of intravenous catheterization. As the following discussion will illustrate, however, it is understood that the securement system 100 can be used in other medical procedures as well. The discussion of the method of use is intended to augment the above description, and, thus, should be read together.


A healthcare provider typically begins the catheterization process by positioning the catheter hub 202 at a desired location above a vein. The healthcare provider introduces a needle or other stylus through a cannula portion of the catheter hub 202 and into the skin of the patient at a desired incident angle. For intravenous use, the catheter hub 202 commonly has an incident angle of approximately 7°. The healthcare provider then inserts the cannula of the catheter hub 202 into the patient and withdraws the needle or stylus. Part of the catheter hub 202 remains exposed above the skin. The healthcare provider can then connect the distal end of the catheter hub 202 to the outlet port 124 of the securement device 110. In some embodiments, the outlet port 124 can include internal threads to allow the hub 202 to be threadably secured to the outlet port 124. As discussed above, upon introducing the catheter into the patient's vein, the timer 150 may be manually, automatically, and/or remotely activated to measure an elapsed time. In some embodiments, the timer 150 may be activated upon connection of the catheter hub 202 to the securement device 110 or upon connection of a medical line to the catheter hub 202 via the securement device 110.


With the securement device 110 and the catheter hub 202 connected to one another, the healthcare provider may next align the guiderails 112 of the securement device 110 with the grooves 109 in the recess 108 of the anchor pad 102. With the guiderails 112 aligned with the grooves 109, the healthcare provider slides the securement device 110 relative to the anchor pad 102 to secure the securement device 110 to the anchor pad 102 via the engagement between the grooves 109 and the guiderails 112. As shown in FIG. 11, the complimentary shapes of the guiderails 112 and the grooves 109 may inhibit transverse and longitudinal movement of the securement device 110 relative to the anchor pad 102 when the securement device 110 is slidably engaged with the anchor pad 102. Lateral sliding movement of the securement device 110 relative to the anchor pad 102 may be limited in at least one direction by one or more abutment surfaces of the anchor pad 102 as discussed above.


Before or after the securement device 110 is slidably engaged with, and releasably secured to, the anchor pad 102, the healthcare provider removes the releasable liner 104 which initially covers the adhesive lower layer of the anchor pad 102. The healthcare provider attaches the pad 102 to the patient's skin proximate to the indwelling catheter. The healthcare provider positions the anchor pad 102 over the placement site and places the exposed bottom layer against the patient's skin 200 so as to adhere the anchor pad 102 to the patient. Light pressure over the anchor pad 102 and/or securement device 110 assures good adhesion between the anchor pad 102 and the patient's skin 200. The anchor pad 102, due to its flexibility, conforms to the contours of the patient's skin. Additionally, the anchor pad 102 can be attached to the patient before the securement device 110 is secured to the anchor pad 102. With the securement device 110 and the anchor pad 102 slidably engaged with one another, and the anchor pad 102 adhered to the patient's skin 200, movement of the catheter 202 may be limited in at least the longitudinal direction.


The healthcare provider may then connect additional medical articles to the securement device 110. For example, the healthcare provider may connect a primary medical line 206 to inlet port 122 to establish a fluid connection between the catheter hub 202 and the medical line 206. The healthcare provider may optionally connect a secondary medical line 204 to inlet port 132 to fluidly connect the medical line 204 to the catheter hub 202 via the securement device 110. Alternatively, the inlet port 132 may be used to aspirate or flush the catheter hub 202, medical line 206, or securement device 110. In this way, the components of catheterization system including the catheter hub 202 and the medical lines 204, 206 can be fluidly interconnected by the securement device 110 and the resultant interconnection can be secured relative to the patient's skin 200 by the securement device 110 and the anchor pad 102.


In some embodiments, the healthcare provider may dispose a sterile dressing over the insertion site and at least a portion of the catheter hub 202. The optional dressing can be attached to and/or integrated with the anchor pad 102 or securement device 110. The dressing can be configured to fold, bend, or rotate down over the insertion site area.


The present securement systems thus provide a sterile, needle-, and tape-free way to fluidly connect components of a catheterization system and to secure the interconnection to patient. These systems eliminate the use of tape, and if prior protocol required suturing, they also eliminate accidental needle sticks, suture-wound-site infections and scarring. In addition, the systems can be configured to be used with any of a wide variety of catheters, fittings, tubes, wires, and other medical articles. Patient comfort is also enhanced and application time is decreased with the use of the present securement systems.


It is to be noted that the figures provided herein are not drawn to any particular proportion or scale, and that many variations can be made to the illustrated embodiments. Those of skill in the art will recognize that the disclosed aspects and features shown herein are not limited to any particular embodiment of a stabilization system, and stabilization systems that include one or more of the features herein described can be designed for use with a variety of medical articles.


The various embodiments of the securement systems described above in accordance with the present invention thus provide a means to releasably secure a connector fitting or extension set to a patient. An insertion site of a catheter attached to the connector fitting or extension set may be covered with an integrated dressing.


Of course, it is to be understood that not necessarily all objects or advantages may be achieved in accordance with any particular embodiment of the invention. Thus, for example, those skilled in the art will recognize that the invention may be embodied or carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other objects or advantages as may be taught or suggested herein.


Furthermore, the skilled artisan will recognize the interchangeability of various features from different embodiments. In addition to the variations described herein, other known equivalents for each feature can be mixed and matched by one of ordinary skill in this art to construct stabilization systems and techniques in accordance with principles of the present invention.


Although this invention has been disclosed in the context of certain embodiments and examples, it will be understood by those skilled in the art that the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. Thus, it is intended that the scope of the present invention herein disclosed should not be limited by the particular disclosed embodiments described above, but should be determined only by a fair reading of the claims that follow.

Claims
  • 1. A medical article securement system comprising: a retainer defining a first lumen between a first port and a second port, and a second lumen fluidly connected to the first lumen;an anchor pad having an upper surface and a lower surface, at least a portion of the lower surface being covered by adhesive;interengaging structure releasably securing the retainer to the anchor pad; anda timer configured to be activated by fluid flow through the retainer.
  • 2. The system of claim 1, further comprising a recess disposed on one of the retainer and the anchor pad.
  • 3. The system of claim 2, further comprising at least one guiderail configured to engage with the recess.
  • 4. The system of claim 3, wherein the at least one guiderail is disposed on one of the retainer and the anchor pad, and the recess is disposed on the other of the retainer and the anchor pad.
  • 5. The system of claim 3, wherein the recess comprises a groove configured to receive at least a portion of the at least one guiderail.
  • 6. The system of claim 5, wherein the groove has a shape that is complimentary to the at least one guiderail.
  • 7. The system of claim 5, wherein the retainer slidably engages the anchor pad at least when the at least one guiderail is received within the groove.
  • 8. The system of claim 1, wherein the timer is chemically activated.
  • 9. The system of claim 1, further comprising a pressure sensor configured to measure a pressure of fluid that flows through the retainer.
  • 10. The system of claim 9, wherein the pressure sensor is configured to indicate when the measured pressure exceeds a threshold value.
  • 11. The system of claim 1, further comprising a flow sensor configured to measure a flow rate through the retainer.
  • 12. The system of claim 1, wherein the retainer comprises a valve.
  • 13. The system of claim 1, wherein the first lumen extends at an angle of between 5° and 30° relative to the upper surface of the anchor pad when the retainer is releasably secured to the anchor pad.
  • 14. A medical article securement system comprising: a retainer defining a first lumen between a first port and a second port, and a second lumen fluidly connected to the first lumen;an anchor pad having an upper surface and a lower surface, at least a portion of the lower surface being covered by adhesive;interengaging structure releasably securing the retainer to the anchor pad; anda timer configured to be activated by connecting a medical article to the retainer.
  • 15. The system of claim 1, further comprising a recess disposed on one of the retainer and the anchor pad.
  • 16. The system of claim 15, further comprising at least one guiderail configured to engage with the recess.
  • 17. The system of claim 16, wherein the recess comprises a groove configured to receive at least a portion of the at least one guiderail.
  • 18. The system of claim 17, wherein the groove has a shape that is complimentary to the at least one guiderail.
  • 19. The system of claim 18, wherein the retainer slidably engages the anchor pad at least when the at least one guiderail is received within the groove.
  • 20. The system of claim 14, wherein the timer is chemically activated.
  • 21. The system of claim 14, further comprising a pressure sensor configured to measure a pressure of fluid that flows through the retainer.
  • 22. The system of claim 21, wherein the pressure sensor is configured to indicate when the measured pressure exceeds a threshold value.
  • 23. The system of claim 14, further comprising a flow sensor configured to measure a flow rate through the retainer.
  • 24. The system of claim 14, wherein the retainer comprises a valve.
  • 25. The system of claim 14, wherein the first lumen extends at an angle of between 5° and 30° relative to the upper surface of the anchor pad when the retainer is releasably secured to the anchor pad.
CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application Ser. No. 61/452,014, filed Mar. 11, 2011, and entitled MEDICAL ARTICLE SECUREMENT DEVICE, which is hereby expressly incorporated by reference in its entirety.

US Referenced Citations (315)
Number Name Date Kind
2402306 Turkel Jun 1946 A
2525398 Collins Oct 1950 A
2533961 Rousseau et al. Dec 1950 A
3046984 Eby Jul 1962 A
3064648 Bujan Nov 1962 A
3167072 Stone et al. Jan 1965 A
3194235 Cooke Jul 1965 A
3245567 Knight Apr 1966 A
3288137 Lund Nov 1966 A
3394954 Sarns Jul 1968 A
3493238 Ludwig Feb 1970 A
3529597 Fuzak Sep 1970 A
3589361 Loper et al. Jun 1971 A
3630195 Santomieri Dec 1971 A
3677250 Thomas Jul 1972 A
3686896 Rutter Aug 1972 A
3766915 Rychlik Oct 1973 A
3812851 Rodriguez May 1974 A
3817240 Ayres Jun 1974 A
3826254 Mellor Jul 1974 A
3834380 Boyd Sep 1974 A
3856020 Kovac Dec 1974 A
3863631 Baldwin Feb 1975 A
3900026 Wagner Aug 1975 A
3901226 Scardenzan Aug 1975 A
3906946 Nordstrom Sep 1975 A
3920001 Edwards Nov 1975 A
3934576 Danielsson Jan 1976 A
3942228 Buckman et al. Mar 1976 A
3973565 Steer Aug 1976 A
4004586 Christensen et al. Jan 1977 A
D243477 Cutruzzula et al. Feb 1977 S
4020835 Nordstrom et al. May 1977 A
4037599 Raulerson Jul 1977 A
4059105 Cutruzzula et al. Nov 1977 A
4079738 Dunn et al. Mar 1978 A
4082094 Dailey Apr 1978 A
4114618 Vargas Sep 1978 A
4116196 Kaplan et al. Sep 1978 A
4123091 Cosentino et al. Oct 1978 A
4129128 McFarlane Dec 1978 A
4133312 Burd Jan 1979 A
4142527 Garcia Mar 1979 A
4161177 Fuchs Jul 1979 A
D252822 McFarlane Sep 1979 S
4170993 Alvarez Oct 1979 A
4193174 Stephens Mar 1980 A
4194504 Harms et al. Mar 1980 A
D256162 Haerr et al. Jul 1980 S
4224937 Gordon Sep 1980 A
4230109 Geiss Oct 1980 A
4250880 Gordon Feb 1981 A
4275721 Olson Jun 1981 A
4314568 Loving Feb 1982 A
4316461 Marais et al. Feb 1982 A
4324236 Gordon et al. Apr 1982 A
4326519 D'Alo et al. Apr 1982 A
4333468 Geist Jun 1982 A
4362156 Feller, Jr. et al. Dec 1982 A
4392853 Muto Jul 1983 A
4397647 Gordon Aug 1983 A
4398757 Floyd et al. Aug 1983 A
4405163 Voges et al. Sep 1983 A
4405312 Gross et al. Sep 1983 A
4435174 Redmond et al. Mar 1984 A
4435175 Friden Mar 1984 A
4439193 Larkin Mar 1984 A
D273993 Schulte et al. May 1984 S
4449975 Perry May 1984 A
4453933 Speaker Jun 1984 A
4470410 Elliott Sep 1984 A
4474559 Steiger Oct 1984 A
4480639 Peterson et al. Nov 1984 A
4484913 Swauger Nov 1984 A
4516968 Marshall et al. May 1985 A
4517971 Sorbonne May 1985 A
4561857 Sacks Dec 1985 A
4563177 Kamen Jan 1986 A
4585435 Vaillancourt Apr 1986 A
4585444 Harris Apr 1986 A
4631056 Dye Dec 1986 A
4632670 Mueller, Jr. Dec 1986 A
4633863 Filips et al. Jan 1987 A
4645492 Weeks Feb 1987 A
4650473 Bartholomew et al. Mar 1987 A
4660555 Payton Apr 1987 A
4666434 Kaufman May 1987 A
4669458 Abraham et al. Jun 1987 A
4693710 McCool Sep 1987 A
4711636 Bierman Dec 1987 A
4723948 Clark et al. Feb 1988 A
4737143 Russell Apr 1988 A
4742824 Payton et al. May 1988 A
4743231 Kay et al. May 1988 A
4752292 Lopez et al. Jun 1988 A
4792163 Kulle Dec 1988 A
4795429 Feldstein Jan 1989 A
4826486 Palsrok et al. May 1989 A
4834702 Rocco May 1989 A
4834716 Ogle, II May 1989 A
4838858 Wortham et al. Jun 1989 A
D302304 Kulle et al. Jul 1989 S
4846807 Safadago Jul 1989 A
4852844 Villaveces Aug 1989 A
4857058 Payton Aug 1989 A
4863432 Kvalo Sep 1989 A
4878897 Katzin Nov 1989 A
4880412 Weiss Nov 1989 A
4895570 Larkin Jan 1990 A
4897082 Erskine Jan 1990 A
4898587 Mera Feb 1990 A
4919654 Kalt Apr 1990 A
4934375 Cole et al. Jun 1990 A
4941882 Ward et al. Jul 1990 A
4955864 Hajduch Sep 1990 A
4966582 Sit et al. Oct 1990 A
4976698 Stokley Dec 1990 A
4976700 Tollini Dec 1990 A
4981469 Whitehouse et al. Jan 1991 A
4981475 Haindl Jan 1991 A
4997421 Palsrok et al. Mar 1991 A
5024665 Kaufman Jun 1991 A
5037397 Kalt et al. Aug 1991 A
5037398 Buchanan Aug 1991 A
5037405 Crosby Aug 1991 A
5074847 Greenwell et al. Dec 1991 A
D323390 Paine et al. Jan 1992 S
5084026 Shapiro Jan 1992 A
5098048 Chen Mar 1992 A
5105807 Kahn et al. Apr 1992 A
5112313 Sallee May 1992 A
5116324 Brierley et al. May 1992 A
5120320 Fayngold Jun 1992 A
5135506 Gentelia et al. Aug 1992 A
5137519 Littrell et al. Aug 1992 A
5147322 Bowen et al. Sep 1992 A
5156641 White Oct 1992 A
5163913 Rantanen-Lee et al. Nov 1992 A
5167630 Paul Dec 1992 A
5192273 Bierman et al. Mar 1993 A
5192274 Bierman Mar 1993 A
5195981 Johnson Mar 1993 A
5215532 Atkinson Jun 1993 A
5238010 Grabenkort et al. Aug 1993 A
5248306 Clark et al. Sep 1993 A
5263943 Vanderbrook Nov 1993 A
5267967 Schneider Dec 1993 A
5290248 Bierman Mar 1994 A
5306253 Brimhall Apr 1994 A
5306256 Jose Apr 1994 A
D347060 Bierman May 1994 S
5314411 Bierman et al. May 1994 A
5328487 Starchevich Jul 1994 A
5330438 Gollobin et al. Jul 1994 A
5336195 Daneshvar Aug 1994 A
5341411 Hashimoto Aug 1994 A
5344414 Lopez et al. Sep 1994 A
5354282 Bierman Oct 1994 A
5356379 Vaillancourt Oct 1994 A
5356391 Stewart Oct 1994 A
5370627 Conway Dec 1994 A
5380293 Grant Jan 1995 A
5380294 Persson Jan 1995 A
5380301 Prichard et al. Jan 1995 A
5382239 Orr et al. Jan 1995 A
5382240 Lam Jan 1995 A
5395344 Beisang, III et al. Mar 1995 A
5413120 Grant May 1995 A
5413562 Swauger May 1995 A
D359120 Sallee et al. Jun 1995 S
5456671 Bierman Oct 1995 A
5470321 Forster et al. Nov 1995 A
D364922 Bierman Dec 1995 S
5484425 Fischell et al. Jan 1996 A
5496283 Alexander Mar 1996 A
5507535 McKamey et al. Apr 1996 A
5531695 Swisher Jul 1996 A
D375355 Bierman Nov 1996 S
D375356 Bierman Nov 1996 S
5577516 Schaeffer Nov 1996 A
5578013 Bierman Nov 1996 A
D377831 Bierman Feb 1997 S
5605546 Wolzinger et al. Feb 1997 A
5620427 Werschmidt et al. Apr 1997 A
5626565 Landis et al. May 1997 A
5643217 Dobkin Jul 1997 A
5681290 Alexander Jul 1997 A
5664581 Ashley Sep 1997 A
5685859 Kornerup Nov 1997 A
5686096 Khan et al. Nov 1997 A
5690616 Mogg Nov 1997 A
5690617 Wright Nov 1997 A
5693032 Bierman Dec 1997 A
5702371 Bierman Dec 1997 A
5722959 Bierman Mar 1998 A
5728053 Calvert Mar 1998 A
5755225 Hutson May 1998 A
5800402 Bierman Sep 1998 A
5800410 Gawreluk Sep 1998 A
5810781 Bierman Sep 1998 A
5814021 Balbierz Sep 1998 A
D399954 Bierman Oct 1998 S
5827230 Bierman Oct 1998 A
5827239 Dillon et al. Oct 1998 A
5833666 Davis et al. Nov 1998 A
5833667 Bierman Nov 1998 A
5855591 Bierman Jan 1999 A
5885251 Luther Mar 1999 A
5885254 Matyas Mar 1999 A
5897519 Shesol et al. Apr 1999 A
5947931 Bierman Sep 1999 A
6050934 Mikhail et al. Apr 2000 A
D425619 Bierman May 2000 S
6099509 Brown, Jr. et al. Aug 2000 A
6113577 Hakky et al. Sep 2000 A
6132398 Bierman Oct 2000 A
6132399 Shultz Oct 2000 A
6139532 Howell et al. Oct 2000 A
D433503 Powers et al. Nov 2000 S
6213979 Bierman Apr 2001 B1
6213996 Jepson et al. Apr 2001 B1
6224571 Bierman May 2001 B1
6228064 Abita et al. May 2001 B1
6231547 O'Hara May 2001 B1
6231548 Bassett May 2001 B1
6258066 Urich Jul 2001 B1
6270086 Lloyd Aug 2001 B1
6283945 Bierman Sep 2001 B1
6290676 Bierman Sep 2001 B1
6332874 Eliasen et al. Dec 2001 B1
6361523 Bierman Mar 2002 B1
6375639 Duplessie et al. Apr 2002 B1
6413240 Bierman et al. Jul 2002 B1
6428515 Bierman et al. Aug 2002 B1
6428516 Bierman Aug 2002 B1
6436073 Von Teichert Aug 2002 B1
6447485 Bierman Sep 2002 B2
6447486 Tollini Sep 2002 B1
6471676 DeLegge et al. Oct 2002 B1
6482183 Pausch et al. Nov 2002 B1
6491664 Bierman Dec 2002 B2
6500154 Hakky et al. Dec 2002 B1
D469530 Gomez Jan 2003 S
D470936 Bierman Feb 2003 S
6517522 Bell et al. Feb 2003 B1
6551285 Bierman Apr 2003 B1
6572588 Bierman et al. Jun 2003 B1
6582403 Bierman et al. Jun 2003 B1
6616635 Bell et al. Sep 2003 B1
6626890 Nguyen et al. Sep 2003 B2
6652487 Cook Nov 2003 B1
6663600 Bierman et al. Dec 2003 B2
6673046 Bierman et al. Jan 2004 B2
6689104 Bierman Feb 2004 B2
D492411 Bierman Jun 2004 S
6770055 Bierman et al. Aug 2004 B2
6786892 Bierman Sep 2004 B2
6809230 Hancock et al. Oct 2004 B2
6824527 Gollobin Nov 2004 B2
6827705 Bierman Dec 2004 B2
6827706 Tollini Dec 2004 B2
6827707 Wright et al. Dec 2004 B2
6834652 Altman Dec 2004 B2
6837875 Bierman Jan 2005 B1
6866652 Bierman Mar 2005 B2
D503977 Bierman Apr 2005 S
6951550 Bierman Oct 2005 B2
6972003 Bierman et al. Dec 2005 B2
6979320 Bierman Dec 2005 B2
6981969 Chavez et al. Jan 2006 B2
7014627 Bierman Mar 2006 B2
7018362 Bierman et al. Mar 2006 B2
7070580 Nielsen Jul 2006 B2
7090660 Roberts et al. Aug 2006 B2
D528206 Bierman Sep 2006 S
7144387 Millerd Dec 2006 B2
7153291 Bierman Dec 2006 B2
7354421 Bierman Apr 2008 B2
7491190 Bierman et al. Feb 2009 B2
7935083 Bierman et al. May 2011 B2
20020068904 Bierman et al. Jun 2002 A1
20020099360 Bierman Jul 2002 A1
20020111601 Thompson Aug 2002 A1
20020133121 Bierman Sep 2002 A1
20030055382 Schaeffer Mar 2003 A1
20030163096 Swenson et al. Aug 2003 A1
20030181870 Bressler et al. Sep 2003 A1
20030229313 Bierman Dec 2003 A1
20040102736 Bierman May 2004 A1
20040111067 Kirchhofer Jun 2004 A1
20040204685 Wright et al. Oct 2004 A1
20050096606 Millerd May 2005 A1
20050182367 Walborn Aug 2005 A1
20050215953 Rossen Sep 2005 A1
20050288635 Davis et al. Dec 2005 A1
20060015076 Heinzerling et al. Jan 2006 A1
20060064063 Bierman Mar 2006 A1
20060079740 Silver et al. Apr 2006 A1
20060135944 Bierman Jun 2006 A1
20060184127 Bierman Aug 2006 A1
20060184129 Bierman Aug 2006 A1
20060217669 Botha Sep 2006 A1
20060247577 Wright Nov 2006 A1
20060264836 Bierman Nov 2006 A1
20060270994 Bierman Nov 2006 A1
20060270995 Bierman Nov 2006 A1
20070016166 Thistle Jan 2007 A1
20070083153 Haar Apr 2007 A1
20070250021 Brimhall et al. Oct 2007 A1
20080045905 Chawki Feb 2008 A1
20080300543 Abriles et al. Dec 2008 A1
20100049139 Kiyono et al. Feb 2010 A1
20100298777 Nishtala Nov 2010 A1
20120265147 Andino et al. Oct 2012 A1
20130079723 Andino Mar 2013 A1
Foreign Referenced Citations (21)
Number Date Country
1311977 Dec 1992 CA
1318824 Jun 1993 CA
2 341 297 Apr 1975 DE
0 114 677 May 1989 EP
0 356 683 Jul 1989 EP
0 169 704 Nov 1989 EP
0 367 549 May 1990 EP
0 263 789 Jun 1991 EP
0 247 590 Dec 1993 EP
0 720 836 Jul 1996 EP
2922458 Apr 2009 FR
2 063 679 Jun 1981 GB
2 086 466 May 1982 GB
2 178 811 Feb 1987 GB
WO 9005559 May 1990 WO
9421319 Sep 1994 WO
9715337 May 1997 WO
9955409 Nov 1999 WO
2004016309 Feb 2004 WO
09032008 Mar 2009 WO
10132837 Nov 2010 WO
Non-Patent Literature Citations (21)
Entry
“Definition of Battery.” Oxford Dictionaries. http://www.oxforddictionaries.com/us/definition/american_english/battery.
International Search Report from PCT/US2007/077302 dated Mar. 28, 2008.
National Patent Services, Search Report re Patent Validity Study of U.S. Pat. No. 5,827,230, pp. MDG 001319-MDG 001320, May 23, 2006.
Cravens, et al., Urinary Catheter Management, American Family Physician, vol. 61, No. 2, pp. MDG 000273-MDG 000282, Jan. 15, 2000.
Dale® Foley Catheter Holder brochure, pp. MDG 000344-MDG 000346, 2002.
Grip-LokTM Universal Tubing Securement brochure, pp. MDG 000348-MDG 000349, undated.
M.C. Johnson Co., Cath-Secure® brochure, pp. MDG 000357-MDG 000360, undated.
Grip-Lok Universal Tubing Securement brochure, pp. MDG 000364-MDG 000366, 2005-2006.
Expert Discusses Strategies to Prevent CAUTIs, Infection Control Today, pp. MDG 000603-MDG-000609, Jun. 2005.
U.S. Appl. No. 13/577,425, filed Sep. 17, 2012, Non-Final Office Action of dated May 21, 2015.
U.S. Appl. No. 13/577,425, filed Sep. 17, 2012, Final Office Action of dated Sep. 8, 2015.
U.S. Appl. No. 13/577,425, filed Sep. 17, 2012, Advisory Action of dated Dec. 4, 2015.
U.S. Appl. No. 13/498,121, filed Jul. 3, 2012 Final Office Action dated Nov. 5, 2015.
U.S. Appl. No. 13/320,381, filed Feb. 27, 2012 Non-Final Office Action dated Aug. 26, 2015.
U.S. Appl. No. 13/320,381, filed Feb. 27, 2012 Final Office Action dated Dec. 17, 2015.
PCT/US2011/026897 filed Mar. 2, 2011 International Search Report dated Apr. 26, 2011.
PCT/US2010/051664 filed Oct. 6, 2010 International Search Report and Written Opinion dated Dec. 2, 2010.
PCT/US2010/035004 filed May 14, 2010 International Search Report and Written Opinion dated Jul. 21, 2010.
AU 2010303477 filed Oct. 6, 2010 Examiner's Search Report dated Oct. 22, 2015.
U.S. Appl. No. 13/320,381, filed Feb. 27, 2012 Non-Final Office Action dated Jul. 29, 2016.
U.S. Appl. No. 13/498,121, filed Jul. 3, 2012 Non-Final Office Action dated Jun. 3, 2016.
Related Publications (1)
Number Date Country
20120232490 A1 Sep 2012 US
Provisional Applications (1)
Number Date Country
61452014 Mar 2011 US