WO2012045042A1

WO2012045042A1 - Medical article securement systems

Info

Publication number: WO2012045042A1
Application number: PCT/US2011/054426
Authority: WO
Inventors: Rafael V. Andino; Robert A. Szurgot; James Spitler; Allison Amis Guyton; H. Shaw Strothers; Grayson Byrd; Anna Marie Frey
Original assignee: Venetec International, Inc.
Priority date: 2010-10-01
Filing date: 2011-09-30
Publication date: 2012-04-05

Abstract

A medical article, such as a catheter, is secured with respect to a patient. The medical article may have an in-line valve, and may be temporarily adhered directly to the patient. A stabilization device may be used in combination with the medical article to provide for securement of the medical article for greater periods of time. The medical article may comprise a hub having structure that complements the stabilization device to inhibit motion of the medical article relative to the patient.

Description

MEDICAL ARTICLE SECUREMENT SYSTEMS

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Application No. 61/389,151, filed October 1, 2010, entitled "MEDICAL ARTICLE SECUREMENT SYSTEM," and to U.S. Provisional Application No. 61/389,144, filed October 1, 2010, entitled "MEDICAL ARTICLE SECUREMENT SYSTEMS," both of which are hereby incorporated by reference in their entireties.

BACKGROUND

Field

[0002] This disclosure relates generally to techniques, systems, and devices for securing a catheter or other medical article to a patient.

Description of the Related Art

[0003] Medical patients are often in need of repetitious administering of fluids or medications, or repetitious draining of fluids. It is very common in the medical industry to utilize medical tubing to provide various liquids or solutions to a patient. For example, medical tubing such as a catheter is often used to introduce fluids and medications directly into the patient or to withdraw fluids from the patient. In many cases, the catheter remains in place for many days.

[0004] Some catheters, such as peripheral intravenous catheters, may be introduced into a vein of a patient such as in a forearm or hand, for example using a needle to pierce the skin. Upon introduction of the catheter into the vein, blood may flow from the vein back into the catheter. In some situations, this phenomenon is known as blood flashback. Such flashback may expose a medical provider to the patient's blood or may contaminate or obstruct flow through a catheter hub.

[0005] A catheter may be attached initially to a patient for a brief period of time and then subsequently reattached or replaced with another catheter that is attached to the patient for a longer period of time. For example, a patient entering an emergency room of a hospital is initially medically screened to determine if an emergency medical condition exists. Depending on the results of the medical screening, the hospital may need to stabilize the patient to prevent deterioration in the patient's condition while the patient waits to be examined by a physician or a specialist called in response to the medical screening. The physician or specialist will then perform a full examination of the patient and prescribe a course of treatment.

[0006] Because the time between the initial examination and the subsequent full examination may be brief, the hospital may temporarily attach a catheter to the patient using a technique which is not intended for long term securement of the catheter. For example, for short term or brief placement of a catheter, the catheter or medical tubing may be secured to the patient using tape. Medical providers commonly place long pieces of tape across the catheter, often in a crisscross pattern, to temporarily secure the catheter. Securing a catheter with tape upon the patient, however, has certain drawbacks especially if the catheter is then left on the patient for a longer period of time. For example, taped connections often collect contaminants and dirt. This potentially can lead to infection of the patient, particularly at an insertion site where the catheter is inserted into the patient. Normal protocol therefore requires periodic tape changes in order to inhibit germ growth.

[0007] Periodic tape changes may also be necessary when replacing or repositioning the catheter if the tape is used for long term securement. The frequent removal and reapplication of adhesive tape to the skin of the patient can excoriate the skin. Such repeated applications of tape over the catheter can additionally lead to the build up of adhesive residue on the outer surface of the catheter. This residue can result in contaminants adhering to the catheter itself, increasing the likelihood of infection of the insertion site. This residue can also make the catheter stickier and more difficult to handle.

[0008] To add to the above problems, valuable time is spent applying and reapplying the tape to secure the catheter. For example, medical providers often remove their gloves when taping because the taping procedure can be difficult and cumbersome when wearing gloves, especially when the catheter has become sticky from repeated tape applications. Not only does this further lengthen the procedure, but it also may subject the medical provider to possible infection and increase the risk of needle-stick. [0009] Further, the catheter may have raised regions on its outer surface which would not contact the patient's skin if the catheter was secured with a stabilization device instead of tape. However, when the catheter is secured with tape, these raised regions may press into the patent's skin causing discomfort and pressure on the medical article that may potentially occlude at least a portion of the lumen extending through the medical article.

[0010] Furthermore, tape often fails to limit catheter motion relative to the patient and, therefore, contributes to motion related complications like phlebitis, infiltration, and catheter migration. Also, the removal of taped dressings can itself cause undesired motion of the catheter upon the patient. Thus, a patient is subjected to a risk each time that the catheter is intentionally or unintentionally moved or adjusted. In some situations, a catheter that is maintained in position for any length of time beyond a short period will require frequent reapplication of tape in an effort to decrease undesired movement of the catheter. Not only does the movement of the catheter subject the patient to risk, but the act of reapplying tape may be detrimental, as discussed above. Thus, for long term placement of a catheter, it is preferred to reduce the degree of movement caused by the periodic removal and replacement of tape by instead employing a stabilization device and/or a device designed to provide long term securement.

[0011] There remains a need for an improved securement system that can be used with a patient to overcome the problems associated with current designs. There is a need for a medical article that reduces exposure to blood from a patient. Further, there is a need for a simple, inexpensive system in which the catheter may be easily secured, for either a short period of time or for a lengthy period of time, to reduce unintentional movement of the medical article relative to the patient.

SUMMARY

[0012] The devices, systems, and methods of the present disclosure have several features, no single one of which is solely responsibly 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 disclosure provide several advantages over other securement systems.

[0013] One aspect is a securement system comprising a medical article having an elongated body and a pair of wings extending from opposite sides of the body, and a first adhesive disposed on a bottom surface of the pair of wings. The securement system further includes a stabilization device having a retainer and a pair of anchor pads. The retainer comprises a channel and a lower opening. At least a portion of the body passes through the lower opening and into the channel to secure the body within the retainer. The pair of anchor pads comprise a second adhesive.

[0014] Another aspect is a medical article for securing in a retainer. The retainer has a channel and a lower opening for receiving at least a portion of the medical article. The channel has a length measured in a longitudinal direction. The medical article comprises an elongated body and a pair of abutment surfaces. The pair of abutment surfaces are recessed into the elongated body so as to form an annular groove around at least a portion of the elongated body. The annular groove is sized to receive the portion of the retainer. The medical article further comprises an adhesive surface configured for attachment to skin of a patient.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The above mentioned and other features of this disclosure 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 disclosure. The drawings contain the following figures:

[0016] Figure 1 is a perspective view of a securement system in accordance with a preferred embodiment of the present invention and shows a medical article secured within a stabilization device including a retainer for securing the medical article relative to a patient.

[0017] Figure 2 is a perspective view of the medical article from Figure 1 without the stabilization device.

[0018] Figure 3 is a top view of the medical article from Figure 2.

[0019] Figure 4 is a back view of the medical article from Figure 2.

[0020] Figure 5 is a front view of the medical article from Figure 2. [0021] Figure 6 is a bottom view of the medical article from Figure 2.

[0022] Figure 7 is a side view of the medical article from Figure 2.

[0023] Figure 8 is a perspective view of the stabilization device from Figure 1 showing the retainer and the pair of anchor pads without the medical article of Figure 2.

[0024] Figure 9 is a top view of the stabilization device from Figure 8.

[0025] Figure 10 is a top view of the retainer from Figure 8 without the anchor pads.

[0026] Figure 11 is a back view of the retainer from Figure 8.

[0027] Figure 12 is a front view of the retainer from Figure 8.

[0028] Figure 13 is a bottom view of the retainer from Figure 8.

[0029] Figure 14 is a side view of the retainer from Figure 8.

[0030] Figure 15 is a perspective view of the securement system from Figure 1 and shows the stabilization device disposed above the medical article.

[0031] Figure 16 is an exploded perspective view of a securement system in accordance with another embodiment of the present invention and shows a medical article and a stabilization device including a retainer for securing the medical article relative to a patient.

[0032] Figure 17 is a perspective view of the securement system from Figure 16 with the medical article secured within the retainer.

[0033] Figure 18 is a back view of the retainer from Figure 16.

[0034] Figure 19 is a top view of the retainer from Figure 16.

[0035] Figure 20 is a back view of the medical article from Figure 16.

[0036] Figure 21 is a top view of the medical article from Figure 16.

[0037] Figure 22 is a side view of the securement system from Figure 16 with the medical article penetrating a patient's skin.

[0038] Figure 23 is an exploded perspective view of a securement system in accordance with another embodiment of the present invention and shows a medical article and a stabilization device including a retainer in a folded configuration for receiving a medical article. [0039] Figure 24 is a perspective view of the securement system from Figure 23 with the medical article secured within the retainer and the retainer in an unfolded configuration.

[0040] Figure 25 is a top view of the retainer from Figure 24.

[0041] Figure 26 is a back view of the medical article from Figure 23.

[0042] Figure 27 is a side view of the securement system from Figure 24 with the secured medical article penetrating a patient's skin.

[0043] Figure 28 is an exploded perspective view of a securement system in accordance with another embodiment of the present invention and shows a medical article and a stabilization device including a retainer for securing the medical article relative to a patient.

[0044] Figure 29 is a perspective view of the securement system from Figure 28 with the medical article secured within the retainer.

[0045] Figure 30 is a top view of the securement system from Figure 29.

[0046] Figure 31 is a top view of the medical article from Figure 28.

[0047] Figure 32 is a side view of the medical article from Figure 28 penetrating a patient's skin.

[0048] Figure 33 is a side view of the securement system from Figure 29 with the medical article received within the retainer.

[0049] Figure 34 is a side view of a medical article having a generally cylindrical hub.

[0050] Figure 35 is an exploded front view of a securement system in accordance with another embodiment and shows the medical article from Figure 34 and a retainer in an open configuration for receiving the medical article.

[0051] Figure 36 is front view of the securement system of Figure 35 with the medical article secured within the retainer and the retainer in a closed configuration.

[0052] Figure 37 is a front view of another embodiment of a securement system including a medical article having a non-circular shaped hub secured within a retainer.

[0053] Figure 38 is a side view of the securement system from Figure 36. [0054] Figure 39 is a perspective view of the securement system from Figure 38 with movable flaps added to a lower surface of the retainer.

[0055] Figure 40 is a top view of the securement system from Figure 39 with the flaps folded away from the retainer body and toward the patient's skin.

[0056] Figure 41 is a perspective view of the securement system from Figure 40.

[0057] Figure 42 is an exploded perspective view of a securement system in accordance with another preferred embodiment of the present invention and shows a securement system including a retainer for securing a medical article relative to a patient.

[0058] Figure 43 is a side view of the securement system from Figure 42 with the medical article penetrating a patient's skin prior to being secured in the retainer.

[0059] Figure 44 is a perspective view of the securement system from Figure 42 with the medical article secured within the retainer.

[0060] Figure 45 is a side view of the securement system from Figure 44 with the medical article penetrating the patient's skin.

[0061] Figure 46 is an exploded perspective view of a securement system in accordance with another preferred embodiment of the present invention and shows a stabilization device including a retainer for securing a medical article relative to a patient.

[0062] Figure 47 is a side view of the securement system from Figure 46 with the medical article penetrating a patient's skin prior to being secured in the retainer.

[0063] Figure 48 is a perspective view of the securement system from Figure 46 with the medical article secured within the retainer.

[0064] Figure 49 is a side view of the securement system from Figure 48 with the medical article penetrating the patient's skin.

[0065] Figure 50 is an exploded perspective view of a securement system in accordance with another preferred embodiment of the present invention and shows a stabilization device including a retainer for securing a medical article relative to a patient.

[0066] Figure 51 is a side view of the securement system from Figure 50 with the medical article penetrating a patient's skin prior to being secured in the retainer.

[0067] Figure 52 is a back side view of the securement system from Figure 50 without anchor pads attached to the retainer. [0068] Figure 53 is a perspective view of the securement system from Figure 50 with the medical article secured within the retainer.

[0069] Figure 54 is a side view of the securement system from Figure 53 with the medical article penetrating the patient's skin.

[0070] Figure 55 is an exploded perspective view of a securement system in accordance with another preferred embodiment of the present invention and shows a stabilization device including a retainer for securing a medical article relative to a patient.

[0071] Figure 56 is a side view of the securement system from Figure 55 with the medical article penetrating a patient's skin prior to being secured in the retainer.

[0072] Figure 57 is a perspective view of the securement system from Figure 55 with the medical article secured within the retainer.

[0073] Figure 58 is a side view of the securement system from Figure 57 with the secured medical article penetrating the patient's skin.

DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS

[0074] The following description and examples illustrate preferred embodiments of the present securement systems disclosed in the context of use with exemplary medical articles. More specifically, the embodiments relate to securement systems and related techniques that stabilize a medical article in position upon a patient. The embodiments of the securement systems are illustrated with medical articles having a female luer-lock fitting for connecting a catheter and/or catheter hub to a medical line. The principles of the present disclosure, however, are not limited to catheters such as those shown. Although, the embodiments of the securement systems are illustrated with intravenous catheters, connectors, 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 designs, 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 component, e.g., a catheter hub or a connector, or a combination of components, e.g., a catheterization assembly.

[0075] One skilled in the art may also find additional applications for the devices and systems disclosed herein. Accordingly, the illustration and description of the securement systems in connection with a catheter is merely exemplary of one possible application of the securement systems and techniques disclosed. For ease of description, the term catheter or hub is used herein to generically refer to the above listed medical articles, for example but without limitation, and should not be construed in a limited manner.

[0076] The preferred embodiments of the present disclosure advantageously provide securement systems for securing a medical article relative to a patient. The securement systems described herein are especially adapted to arrest at least transverse movement of a catheter and/or catheter hub, as well as hold the catheter and/or hub against the patient. The securement systems accomplish this without meaningfully impairing (i.e., substantially occluding) fluid flow through the catheter or an attached medical line.

[0077] In at least some embodiments, the catheter may be secured directly to a patient, for example for short term securement. The catheter may further be stabilized for long term securement using additional securement means. As described below, retention mechanisms to accomplish such short or long term securement include, among others, an adhesive surface of the catheter configured for placement against the skin of the patient and/or a retainer configured to receive at least a portion of the catheter and having a lower surface which is secured to the patient. For example, the retainer can include one or more lower adhesive regions for securing the retainer to the patient and/or one or more non- adhesive structures. Non-adhesive structures include, for example, one or more straps which may encircle the patient or one or more hooks or other similar structures which mechanically attach to the patient's skin.

[0078] With reference now to Figure 1, an embodiment of a securement system 100 includes a medical article 200 and a stabilization device 800. In Figure 1, the medical article 200 is illustrated as being secured within the stabilization device 800, as will be described in additional detail below.

[0079] 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 Figure 1. A "longitudinal axis" is generally parallel to the portion of the medical article 200 secured or retained by the stabilization device 800. A "lateral axis" is normal to the longitudinal axis and is generally parallel to the skin of a patient when the medical article 200 and/or the stabilization device 800 are attached to the patient. 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. The terms "upper," "lower," "top," "bottom," "underside," "upperside" and the like, which may also be used to describe the medical article 200, are used in reference to the illustrated orientation of embodiments. For example, the term "upperside" is used to describe the portion of the medical article that is located above a plane that passes through a longitudinal axis of the medical article. The term "underside" is used to describe the portion of the medical article that is located below the plane that passes through the longitudinal axis of the medical article. Brief introductions to some of the features of the securement system 100 are described below.

[0080] As can be seen in a perspective view of the medical article 200, as shown in Figure 2, the medical article 200 is illustrated as a catheter having a hub 210, a cannula 220 extending in a generally longitudinal direction from a proximal end of the hub 210, and a connecting member 230, such as a female luer-lock fitting, protruding from a distal end of the hub 210. Of course the features of the medical article are not limited to those illustrated and thus, for example, need not include a specific type of connecting member or any connecting member on the distal end of the hub 210.

[0081] The medical article 200 further comprises wings 212a and 212b extending in generally lateral directions from a body 214 of the hub 210. The medical article 200 may include a contact surface or pad 216 raised with respect to the body 214 to facilitate the medical provider to manipulate the securement system 100.

[0082] A lumen extends through at least a portion of the hub 210 to allow liquid to flow from the cannula 220 to the connecting member 230 or vice versa. In some embodiments, the hub 210 comprises a valve that in line with the cannula 220 and the connecting member 230. In one embodiment, the valve is a one-way valve that prevents the flow of fluid in one direction. The flow of fluid in the other direction may be activated when a certain pressure is applied to the valve. In this way, retrograde flow of the fluid will be inhibited. In some embodiments, the valve comprises a normally closed diaphragm that allows flow in only one direction. The diaphragm may be constructed from a silicone material, for example.

[0083] In some embodiments, the valve is configured to allow fluid to flow from the connecting member 230 towards the cannula 220 and to prevent fluid from flowing from the cannula 220 towards the connecting member 230. Such a configuration allows for the introduction of fluids such as medicaments into a patient's bloodstream when the cannula 220 is inserted into the patient's vasculature. This configuration, however, will prevent flow from being forced through the hub 210 towards the connecting member 230, for example due to flashback when inserting the cannula 220 into a patient's vein. The prevention of backward blood flow decreases the likelihood of the medical provider being exposed to blood of the patient, and may reduce the likelihood that the connecting member 230 or medical article connected thereto will become occluded or stuck in position due to the drying of blood. In other embodiments, the valve is configured to allow fluid to flow from the cannula 220 towards the connecting member 230 and to prevent fluid from flowing from the connecting member 230 towards the cannula 220.

[0084] As described above, the cannula 220 may be inserted into a patient's vasculature, for example to administer medicaments or to withdraw fluids. In some embodiments, the cannula 220 or a portion thereof comprises or is coated with an antimicrobial agent. The antimicrobial agent may comprise a silver material, for example a silver salt, colloid, or complex. In one embodiment, one or more oligodynamic metal salts, oxides, or combination of salts and oxides are used. [0085] The connecting member 230 is configured to engage with a mating connecting member, such as a male luer-lock fitting. The male luer-lock fitting may be disposed on another medical article configured for connection to the medical article 200 such as a connector fitting or extension set. The engagement of the two connecting members provides a seal that inhibits fluid from leaking at the interconnection of the medical article 200 and another medical article. Other means of engaging with or connecting to a separate medical article may be included on the medical article 200.

[0086] As can be seen in a top view of the medical article 200 in Figure 3, the body 214 is illustrated as being tapered. The body 214 is shown as being wider near a distal end of the hub 210 and narrower near a proximal end of the hub 210. In some embodiments, the in-line one-way valve described above may be located near the proximal end within the wider portion of the hub 210. In some embodiments, one or both of the lateral sides of the body 214 extend substantially straight or linearly from the distal end of the hub 210 to the proximal end when viewed from above. In other embodiments, one or both of the lateral sides of the body 214 have a curvilinear configuration when viewed from above.

[0087] As can be seen in a side view of the medical article 200 in Figure 7, the body 214 is sloped so as to be taller near a distal end of the hub 210 and shorter near a proximal end of the hub 210. Not only does this shape allow for a valve to be implemented within the hub 210 in some embodiments, but the size of proximal end of the hub 210 is reduced so as to decrease the likelihood of interfering with a medical provider who is manipulating the medical article 200. In the illustrated embodiment, the body 214 is configured to support the cannula 220 at an angle with respect to a bottom surface 219 of the hub. For example, at least a portion of the cannula may be maintained at a 7 degree or 14 degree angle relative to the skin of the patient. In some embodiments, the body 214 is not sloped.

[0088] As can also be seen in the side view, a recess 218 is disposed in the body 214. In the illustrated embodiment, the recess 218 is disposed in sidewall 252a. Although not shown, a corresponding recess may be formed in the opposite sidewall 252b of the body 214. The recess(es) is configured to engage with a detent or series of detents or protrusions from the stabilization device 800, as will be further described below. In the illustrated embodiment, the recess 218 comprises an elongated depression or groove. The recess 218, however, may be configured in any number of sizes and shapes. In some embodiments, a series or array of recesses are formed in the body 214.

[0089] As can be seen in a front view of the medical article 200 in Figure 5, the top side of the body 214 is curved. In the illustrated embodiment, the top surface of the body 214 extends through an arc of approximately 160 degrees. The bottom portions of the arc meet with the sidewalls 252a and 252b, which are canted such that the bottom portions thereof are spaced farther apart than the top portions thereof. Of course the top surface may extend through a greater or lesser arc. In some embodiments, the top of the body 214 is not curved. For example, the top of the body 214 may be substantially planar. In some embodiments, the sidewalls 252a and 252b are not canted relative to each other.

[0090] Turning now to the wings 212a and 212b, a bottom surface 254 of the wings 212a and 212b can be seen in a view of the underside of the medical article 200 in Figure 6. The bottom surface 254 or a portion thereof can be coated with an adhesive to create an adhesive surface for attachment to skin of the patient. The adhesive on the bottom surface 254 of the wings 212a and 212b is intended to provide shorter term securement. In contrast, a lower adhesive surface of the anchor pads 802a and 802b of the stabilization device 800 can provide longer term securement to the patient. Thus, two different adhesives may be used on the securement system 100 with different bonding strengths. The bonding strength of the adhesive on the bottom surface 254 of the wings 212a and 212b may be lower than the bonding strength of the adhesive on the anchor pads 802a and 802b.

[0091] The adhesive may comprise a medical-grade adhesive and can be either diaphoretic or nondiaphoretic, depending upon the particular application. The adhesive may be a solid layer or may be configured as an intermittent layer such as in a pattern of spots or strips. The adhesive may be covered with a release liner, described below, prior to attachment to the patient.

[0092] The bottom surface 254 of the wings 212a and 212b is configured to rest on the patient. As can be seen in the front view in Figure 5, the bottom surface 254 is illustrated as being substantially planar. In other embodiments, the bottom surface 254 may be contoured to complement a curvature of the patient's body. For example, the bottom surface 254 may be slightly concave so as to substantially match the shape of the back of a patient's hand.

[0093] The medical article 200 may be attached or secured to the patient by pressing the wings 212a and 212b against the patient's skin when the adhesive is exposed. Such attachment may be beneficial, for example, for securing the medical article 200 for a short period of time. This securement requires no additional structure and may be easily performed by a medical provider upon deciding that immobilization of the medical article 200 is desired. The medical article 200 thus may be quickly and simply secured to the patient.

[0094] Further, the bottom surface 219 of the body 214 is configured to rest against the patient when the wings 212a and 212b are adhered to the patient. Although the bottom surface 219 is illustrated as being substantially planar, the bottom surface 219 may be contoured. In the illustrated embodiment, the bottom surface 219 is raised or offset slightly with respect to the bottom surface 254. This configuration may angle the body 214 with respect to the patient's skin when the wings 212a and 214a are attached, thereby maintaining an incident angle of the cannula 220 with respect to the skin. Additionally, a retainer may be configured to interact with the surfaces of the step created by the raised bottom surface 219. In other embodiments, the bottom surfaces 219 and 254 are flush with each other.

[0095] The medical article 200 is thus configured for placement against and securement directly to the patient's skin. In some embodiments, the bottom surface 254 and/or the bottom surface 219 has an antimicrobial agent disposed thereon. Exemplary antimicrobial agents are described above.

[0096] Returning to the top view in Figure 3, it can be seen that the wings 212a and 212b extend from the body 214 in a generally lateral direction. A proximal wall of the wings 212a and 212b is substantially linear, while a distal wall of the wings 212a and 212b is angled relative to the longitudinal axis of the medical article 200. The proximal and distal walls are connected by a curve. This shape may provide sufficient surface area for the medical provider to apply downward pressure when attaching the medical article 200 to the patient, while reducing possible interference with a stabilization device, described below. The wings 212a and 212b may extend from the body a distance sufficient to inhibit rocking of the medical article 200 when the wings 212a and 212b are attached to the patient.

[0097] A top surface of the wings 212a and 212b is substantially flat and depressed as compared to the body 214, as can be most easily seen in the front view in Figure 5. This arrangement allows the medical provider to easily grip the medical article 200 on opposite lateral sides and apply downward pressure. In some embodiments, the wings 212a and 212b are configured with a different shape or size than is illustrated.

[0098] As shown in Figures 2 and 7, the area in which the wings 212a and 212b join one another forms a lip comprising an abutment surface 256. The abutment surface 256 is configured to inhibit at least longitudinal movement of the medical article 200 when secured within a retainer as described below. In the illustrated embodiment, the abutment surface 256 is curvilinear.

[0099] The contact surface 216 can be seen most easily in the side view of the medical article 200 in Figure 7. In the illustrated embodiment, the contact surface 216 is curved upward and may extend over a portion of the body 214. This configuration of the contact surface 216 may allow the medical provider to apply direct pressure to the contact surface 216, for example to ease insertion of the cannula 220 into a patient's vein. In some embodiments, the medical provider may press on the contact surface 216 to aid in disconnecting the medical article 200 from a retainer as described below.

[0100] The proximal facing outer edges of the contact surface 216 wrap around the sidewalls 252a and 252b so as to form a lip 258 extending from the body 214. The lip 258 comprises an abutment surface configured to inhibit at least longitudinal movement of the medical article 200 in the proximal direction relative to the retainer. In the illustrated embodiment, the abutment surface is curvilinear, for example as can be seen in the top view of the medical article 200 in Figure 3. When viewed from the back of the medical article 200, as shown in Figure 4, it can be seen that the lip 258 has a cross-sectional shape that is similar to the body 214, but larger in size.

[0101] The elements of the hub 210 and connecting member 230 may comprise a plastic material. For example, one or more of the wings 212a and 212b, body 214, and contact surface 216 may comprise a plastic. In one embodiment, at least the body 214 is constructed from the plastic. Other materials that may be used include polymers or composites, or any other material suitable for placement against the patient's skin. In some embodiments, at least the body 214 is substantially rigid. In some embodiments, the hub 210 is formed as a unitary structure.

[0102] An element of the hub 210 may comprise an elastomer. For example, the contact surface 216 and/or the wings 212a and 212b may comprise an elastomeric material. In some embodiments, a portion of the hub 210 is configured to conform to a contour of the patient's skin. For example, the bottom surfaces 219 and/or 254 may be heat moldable and configured to respond to an increase in heat caused by placing the medical article 200 in close proximity to the skin of the patient.

[0103] Figure 8 illustrates an embodiment of the stabilization device 800 including anchor pads 802a and 802b, and a retainer 810. The stabilization device 800 is configured to fit over a portion of the medical article 200 to stabilize the medical article 200. The stabilization device 800 provides further securement when it is desirable to attach the medical article 200 to the patient for lengthy periods of time.

[0104] The anchor pads 802a and 802b each have a lower adhesive surface which may adhere to the skin of a patient and an upper layer. The upper layer is configured to support at least the retainer 810. In combination, the lower adhesive surface, upper layer, 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 pads 802a and 802b may be configured as flexible structures configured to conform to the surface of the patient's skin.

[0105] The lower adhesive surface or layer may be a medical-grade adhesive and can be either diaphoretic or nondiaphoretic, depending upon the particular application. The lower adhesive surface of the anchor pads 802a and 802b is preferably a medical adhesive intended to provide long term securement to the patient. In contrast, the adhesive on the bottom surface 254 of the wings 212a and 212b is intended to provide shorter term securement. Thus, two different adhesives may be used as part of the securement system 100. [0106] The lower adhesive surface may have additional types of medical adhesives laminated thereto. The adhesive surface may be a solid layer or may be configured as an intermittent layer such as in a pattern of spots or strips.

[0107] The lower adhesive surface can be applied to the anchor pads 802a and 802b during manufacture, and may be further covered with a release liner (not shown), described below. Alternatively, it is possible to apply a double-sided adhesive tape to the anchor pads 802a and 802b before application.

[0108] The upper layer 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 constitutes the upper layer of the anchor pads 802a and 802b. In the alternative, the upper layer may comprise an upper paper or other nonwoven cloth layer, and an inner foam layer may be placed between the upper layer and lower adhesive surface.

[0109] A removable release liner may cover the lower adhesive surface before use. The release liner may resist tearing and be divided into a plurality of pieces to assist removal of the release liner and ease attachment of the anchor pads 802a and 802b to the patient's skin. For example, the release liner may be divided into two adjacent pieces. The liner may be made of a paper, plastic, polyester, or similar material. For example, the release liner may comprise a material made of polycoated, siliconized paper, or another suitable material such as high density polyethylene, polypropylene, polyolefin, or silicon coated paper.

[0110] As can be seen in a top view of the stabilization device 800 in Figure 9, the shape of each of the anchor pads 802a and 802b resembles a square having rounded outside corners and a cutout 804 formed in an inside proximal corner thereof. The cutouts 804a and 804b are configured to accept the wings 212a and 212b, respectively. Thus, when the medical article 200 is secured within the retainer 810, a portion of the anchor pads 802a and 802b will be adjacent to at least a portion of the wings 212a and 212b, respectively, as shown in Figure 1 so as to maximize the contact area between the securement system 100 and the patient. The wings 212a and 212b, and the anchor pads 802a and 802b, are therefore complementary. This increases the surface area over which the securement system 100 may be adhered, and increases the likelihood that pressure applied to the securement system 100 in any given direction will be distributed across the various elements of the system 100.

[0111] The retainer 810 includes a body member 812 and mounting feet 814a and 814b that extend in a generally lateral direction from either side of the body member 812, as can be see in a back view of the retainer 810 in Figure 11. The retainer 810 may be placed over the body 214 to arrest movement of at least the hub 210 relative to the retainer.

[0112] As can be seen in Figure 11, an inner surface 816 of the body member 812 faces towards the patient's skin when in use and preferably defines a channel 852. The channel 852 extends through the body member 812 in a longitudinal direction. The lower side of the retainer 810 includes an access or lower opening 830 for insertion of the medical article 200.

[0113] The inner surface 816 is formed so as to substantially match at least a portion of the outer surface of the body 214 of the medical article 200. Thus, in the illustrated embodiment, the inner surface 816 is curved at the top and canted near the mounting feet 814a and 814b. The inner surface 816 is therefore complementary to the top surface and sidewalls 252a and 252b of the body 214. When the hub 210 is inserted into the retainer 810, the body 214 will be held in contact with at least a portion of the inner surface 816. In some embodiments, the inner surface 816 of the body member 812 includes an adhesive layer to releasably adhere a received portion of the hub 210 relative to the retainer 810.

[0114] As shown in Figure 10, the body member 812 of the retainer 810 is formed such that its longitudinal length Li is substantially the same as a distance Di between the abutment surface 256 and the lip 258 of the hub 210 (shown in Figure 3). In this way, the distal surface of the body member 812 forms an abutment surface 822, and is curvilinear, as can be seen in Figure 11. At least a portion of the abutment surface 822 follows the shape of the lip 258. Similarly, the proximal surface of the body member 812 forms an abutment surface 826, as can be seen in a front view of the retainer 810 in Figure 12. The abutment surface 826 is also curvilinear, and at least a portion of the abutment surface 826 follows the shape of the abutment surface 256. [0115] The retainer 810 may further comprise one or more detents 818. The detents 818 may extend inwardly from the inner surface 816 towards the channel 852. The detents 818 are sized and shaped so as to fit within the recess 218 formed in the hub 210. As can be seen in a bottom view of the retainer 810 in Figure 13, the retainer 810 is illustrated as having four detents 818a-818d, where two detents extend from each side of the body member 812. In some embodiments, a fewer or greater number of detents may be employed.

[0116] The detents 818 may comprise an abutment surface on a proximal and/or distal wall thereof. Further, an abutment surface may be formed on an uppermost surface of the detents 818. These abutments surfaces are configured to abut a surface of the recess 218 in order to transfer force between the retainer 810 and the medical article 200. In this way, the detents 818 may abut at least a portion of a recess 218 to inhibit movement of the medical article relative to the retainer 810.

[0117] The detents are shows as being symmetrically aligned on either side of the body member 812. Other configurations of the detents 818 may be implemented, however. In some embodiments, the detents are arranged in a longitudinal line or as an array. In some embodiments, one or more detents are formed on the medical article 200 and corresponding recesses are formed on the retainer 810.

[0118] The body member 812 may comprise a generally rigid structure (at least in comparison to foam or tape) that is somewhat flexible in nature. This will allow the body member 812 to flex outward when receiving the hub 210, for example due to the detents 818 being pressed against the sidewalls 252a and 252b. When the detents 818 are aligned with the recess 218, however, a resiliency of the body member 812 may cause the walls to be pulled in toward the channel 852, thereby causing the detents 818 to be lodged within the recess 218 and snapping the retainer 810 in place about the medical article 200. To release the medical article 200 from the retainer 810, a medical provider may flex the body member 812 in an outward direction again.

[0119] Openings, such as the openings 832 and 834 shown in the top view of the retainer 810 in Figure 10, may be formed in the retainer 810. These openings may allow for a greater flexing of the body member 812. A central rib 836 formed along the length of the body member 812, however, may maintain structure stability and provide a surface for the medical provider to press when fitting the retainer 810 about the medical article 200. Ridges 838, seen most clearly in Figures 11 and 12, may strengthen the body member 812 and decrease the likelihood of plastic deformation while flexing the body member 812. Although four openings 832a, 832b, 834a, and 834b and two ridges 838a and 838b are illustrated, a greater or fewer number of openings and/or ridges may be formed. Further, the size, shape, and/or location of each of the openings 832 and 834 and ridges 838 may be varied.

[0120] The body member 812 is attached to the upper surfaces of the anchor pads 802a and 802b via the mounting feet 814a and 814b, respectively, as is shown in Figure 8. Thus, the mounting feet 814a and 814b may support the body member 812 in a position above the patient. The body member 812 may be secured to the upper surfaces by a solvent bond adhesive, such as cyanoacrylate or other bonding material. One such adhesive is available commercially as Part No. 4693 from 3M.

[0121] Each mounting foot 814a and 814b may comprise 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 foot. The glue dam may be omitted from the outer edge of each mounting foot 814a and 814b to allow any excess glue or adhesive to seep out from under the mounting foot during the manufacturing process in a lateral direction away from the retainer 810.

[0122] As can be seen in the top view of the retainer 810 in Figure 10, the proximal wall of the mounting feet 814a and 814b is angled to mirror the angle of the wings 212a and 212b, respectively. The proximal wall forms abutment surfaces 824a and 824b for contacting the wings 212a and 212b, as seen in Figure 12.

[0123] Thus, as can be seen in a side view of the retainer 810 in Figure 14, a profile of the retainer 810 substantially mirrors a profile of the hub 210, as shown in the side view of the medical article 200 in Figure 7. The retainer 810 may thus be disposed over the body 214 between the wings 212a and 212b, and the contact surface 216. When the anchor pads 802a and 802b are attached to the patient so as to position the retainer 810 about the medical article 200, the stabilization device 800 will inhibit motion of the medical article 200 relative to the patient. For example, the abutment surfaces 822, 824, and 826, and/or abutments surfaces on the detents 818 may be disposed in contact with or in close proximity to surfaces of the hub 210 so as to inhibit at least longitudinal movement of the medical article 200. The inner surface 816 may inhibit transverse and/or lateral movement of the medical article 200, as may the detents 818. In addition, a portion of the contact surface 216 may extend over an area of the retainer 810 or contact an area of the central rib 836, which may further inhibit transverse motion of the medical article 200. Further, an interface between a curvature of the abutment surface 256 and the abutment surface 826, and/or between the lip 258 and the abutment surface 822, may inhibit rotation of the medical article 200 with respect to the securement system 800, as may the detents 818, for example.

[0124] A base surface 842 of the retainer 810, shown in Figures 11 and 12, is configured to rest on the patient (with the anchor pads 812a and 812b therebetween). The base surface 842 may be configured to complement the bottom surface 254 of the wings 212a and 212b and/or the bottom surface 219 of the medical article 200. In some embodiments, the base surface 842 and the bottom surface 254 form a substantially uniform support surface at least in an area where the two structures meet when the medical article 200 is secured within the stabilization device 800. The base surface 842 may appear flush with the bottom surface 254 and/or the bottom surface 219 at the area where the two structures meet, or a tangent of a curve of the base surface 842 and a tangent of a curve of the bottom surface 254 or 219 in the area where the two structures meet may be substantially identical. In other embodiments, a contour of the bottom surfaces 254 and/or 219 matches a contour of the base surface 842, for example due to each of these surfaces extending through an arc having a common radius. In some embodiments, base surface 842 is configured to interact with the step created by a raised bottom surface 219 of the medical article 200 to create a substantially uniform support surface. In some embodiments, the retainer 810 is configured to hook under the step. Cooperation of the surfaces 219, 254, and/or 824 may allow the securement system 100 to rest on the patient without substantially rocking. The securement system 100 may be placed flush against the patient in some embodiments.

[0125] As illustrated in Figures 11 and 12, the base surface 842 may have a concave curved shape when viewed from the front and rear sides. The degree of curvature may be varied depending on an intended location of usage or application of the stabilization device 800. For example, many common sites for insertion of medical lines are located on anatomical regions exhibiting convex curvature, such as a dorsal side of a hand, an arm, a leg, a contact surface, etc. A concave base surface may reduce the likelihood of the retainer 810 rocking once placed upon the patient via the anchor pads 812a and 812b. In other embodiments, the base surface 842 is substantially planar.

[0126] As described above with respect to the body member 812, the retainer 810 may comprise a generally rigid structure (at least in comparison to foam or tape) that is somewhat flexible in nature. The flexibility may be due to its structure and/or to the material used to form the retainer 810. Suitably rigid but flexible materials 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 may be utilized.

[0127] The body member 812 and mounting feet 814a and 814b may be integrally formed to comprise a unitary retainer. This may be accomplished in any of a variety of ways well known to those skilled in the art. For example, the entire retainer can be injection molded in order to reduce fabrication costs. The illustrated retainer 810 may be formed by injection molding using polyethylene or polypropylene material. The retainer 810, however, may comprise a non-unitary body member 812 and mounting feet 814a and 814b. In this manner, the body member 812 and one or both of the mounting feet 814a and 814b may be formed separately and then coupled together. Additionally, the body member 812 and mounting feet 814a and 814b may have other forms or other orientations relative to one another than illustrated. The body member 812 may be clear or transparent to facilitate alignment of the retainer 810 with the hub 210.

[0128] Figure 15 illustrates a perspective view of the securement system 100, showing the stabilization device 800 separated from and disposed above the medical article 200. As discussed above, the medical article 200 may first be adhered to the skin of a patient, for example, for immediate securement of the medical article 200 to the patient to stabilize the patient's condition for a short period of time. In order to provide further stabilization to the medical article 200 and further inhibit movement thereof relative to the patient, for example, when restricting the movement of the medical article 200 for a lengthy period of time, a medical provider may first align the securement system 800 over the hub 210. The medical provider may then lower the stabilization device 800 and press the stabilization device over the hub 210 to trap the body 214 within the retainer 810 or snap the retainer 810 in place about the body 214. In some embodiments, the medical provider angles the retainer 810 when lowering the securement system 800 so that a distal portion of the retainer 810 is able to slide under an overhang of the contact surface 216. The anchor pads 802a and 802b may be adhered to the patient to secure the stabilization device and the received medical article 200 to the patient. In some situations, the medical article 200 may first be connected to the stabilization device 800, and the wings 212a and 212b and/or the anchor pads 802a and 802b thereafter adhered to the patient.

[0129] When the retainer 810 is secured about the medical article 200 and the anchor pads 802a and 802b are attached to the skin of the patient, the medical article 200 is inhibited from moving substantially in either the lateral or transverse directions relative to the patient. Longitudinal movement of the medical article is inhibited by engagement between at least one abutment surface on the retainer 810 and a corresponding contact, mating, or abutment surface on the medical article 200. The abutment surfaces on the retainer 810 may be located at the proximal and/or distal ends of the retainer 810. Each abutment surface may be used to arrest movement in one longitudinal direction. In some embodiments, the shape of the medical article and a corresponding shape of the retainer 810 may also be used to arrest longitudinal movement of the medical article 200 with respect to the retainer 810. Additional Embodiments

[0130] As understood from the above description of the embodiment of the securement system 100 shown in Figures 1-15, the securement system 100 arrests longitudinal movement of the medical article 200 relative to a patient by an adhesive layer on the wings 212a and 212b and via interaction between the medical article 200 and the stabilization device 800. In some embodiments, this interaction can include the engagement of an abutment surface on the stabilization device 800 with an abutment surface on the medical article 200. For example, a detent of the stabilization device 800 can extend at least partially into a receptacle of the medical article 200 so as to engage the stabilization device 800 with the medical article. Further, the stabilization device 800 may include an adhesive layer for securing the retainer 810 relative to the patient's skin.

[0131] Figures 16, 17, and 22 illustrate another embodiment of a securement system 2100 including a medical article 2200 and a stabilization device 2800. As can be seen in Figures 16, 17, and 21, the medical article 2200 is illustrated as a catheter having a hub 2210, a cannula 2220 extending in a generally longitudinal direction from a proximal end of the hub 2210, and a connecting member 2230, such as a female luer-lock fitting, protruding from a distal end of the hub 2210.

[0132] As shown in Figure 20, the hub 2210 of the medical article 2200 includes a body 2214 having sidewalls 2252a and 2252b and a bottom surface 2219. In some embodiments, the bottom surface 2219 may be generally planar such that the medical article 2200 may be placed flat on a planar surface. For example, the body 2214 may rest flat on a patient's skin without the use of a retainer and the flat shape of the bottom surface 2219 may inhibit rotation and/or rocking of the body relative to the patient. The bottom surface 2219 can include one or more adhesive layers for releasably securing the hub 2210 to the skin of a patient and/or to another component of the securement system 2100, e.g., the retainer 2810. In some embodiments, the sidewalls 2252a and 2252b are canted relative to the flat bottom surface 2219. In this way, the body 2214 may have a generally triangular shaped cross section defined by the sidewalls 2252a and 2252b, and the bottom surface 2219. As described in more detail below, the body 2214 can have a cross sectional shape that is complementary to a channel or track of the retainer 2810 to enable a secure fit between the two components of the securement system 2100.

[0133] The stabilization device 2800 includes a retainer 2810 supported by one or more anchor pads 2802, as shown in Figures 16 through 19. Similar to the anchor pads described above with reference to Figures 1 through 15, the anchor pad 2802 can comprise 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 2802. While not illustrated, the anchor pad 2802 can include suture holes in addition to the adhesive layer to further secure the anchor pad to the patient's skin. [0134] The retainer 2810 includes a channel or track 2826 configured to receive at least a portion of the body 2214 of the medical article 2200, as shown in Figure 16. As shown in Figure 17, when received within the track 2826, the hub 2210 of the medical article 2200 is inhibited from moving laterally and transversely relative to the retainer 2810. In this way, when the retainer 2810 is secured relative to a patient by the anchor pad 2802, the medical article 2200 received within the track 2826 is secured relative to the patient.

[0135] The track 2826 may extend longitudinally and may be sized and shaped to complement the shape of the body 2214. For example, the track 2826 may define at least a portion of a triangular shape sized to receive a portion of the body 2214 that is similarly shaped. In this way, the complementary shapes of the track 2826 and the body 2214 may interact to inhibit lateral and transverse movement of the medical article 2200 relative to the retainer 2810, as well as rotation of the medical article about its longitudinal axis.

[0136] As shown in Figures 16, 18, and 19, the retainer 2810 can include an abutment surface 2828 disposed near the distal end of the track 2826. The abutment surface 2828 can define a distal end of the track 2826 so as to limit longitudinal movement of the medical article 2200 in a distal direction beyond the abutment surface. The body 2214 can include a distal facing abutment surface 2856 that contacts the abutment surface 2828 of the retainer 2810 to limit movement of the medical article 2200 in the distal direction, as shown in Figures 16 and 17. The retainer 2810 and/or body 2214 can comprise smooth materials to allow for the body to easily slide into the track 2826. The bottom surface of the track 2826 can be angled relative to the lower surface of the anchor pad 2802 such that the hub 2210 is angled relative to the anchor pad when the medical article 2200 is received within the retainer 2810. In this way, the cannula 2220 may extend into the patient's skin 2150 at an angle, as illustrated in Figure 22, when the stabilization system 2800 is used to secure and stabilize the medical article 2200 relative to the patient.

[0137] Turning now to Figures 23 through 27, another embodiment of a securement system 3100 includes a medical article 3200 and a stabilization device 3800. As can be seen in Figure 23, the medical article 3200 is illustrated as a catheter having a hub 3210, a cannula 3220 extending from a proximal end of the hub, and a connecting member 3230, such as a female luer-lock fitting, disposed at a distal end of the hub 3210. [0138] As shown in Figure 26, the hub 3210 includes a body 3214 having sidewalls 3252a and 3252b and a bottom surface 3219. The body 3214 can be formed of various materials, for example, hard plastic, and can comprise various shapes. In some embodiments, the bottom surface 3219 may be generally planar such that the medical article 3200 may be placed flat on a planar surface. For example, the body 3214 may rest flat on a patient's skin without the use of a retainer. In this way, the flat shape of the bottom surface 3219 may inhibit rotation of the body relative to the patient. The bottom surface 3219 can include one or more adhesive layers for releasably securing the hub 3210 to the skin of a patient. In some embodiments, the sidewalls 3252a and 3252b are canted relative to the flat bottom surface 3219. As illustrated, the body 3214 has a generally triangular shaped cross section defined by the sidewalls 3252a and 3252b, and the bottom surface 3219.

[0139] The stabilization device 3800 includes a retainer 3810 disposed over a pair of anchor pads 3802a and 3802b, as shown in Figures 23 through 25. In some embodiments, the retainer 3810 is formed of one or more soft materials, e.g., one or more rubbers, configured to allow for the easy removal of occlusive wrappings and/or bandages therefrom. The retainer 3810 can be integrally formed with the anchor pads 3802a and 3802b. Alternatively, the retainer 3810 can be separately formed from one or both of the anchor pads 3802a and 3802b and may then be removably or immovably attached to one or both of the anchor pads.

[0140] The anchor pads 3802a and 3802b can be disposed on opposite sides of a channel 3826 extending through the retainer 3810 from a proximal side to a distal side, as shown in Figure 25. The channel 3826 can be sized and shaped so as to receive at least a portion of the body 3214 of the medical article 3200. In some embodiments, an inner surface of the channel 3826 defined by the retainer 3810 has a shape that is complementary to the shape of the body 3214. In this way, the hub 3210 can be positioned within the channel 3826 such that lateral and transverse movement of the medical article 3200 relative to the retainer 3810 is inhibited. Thus, when the stabilization device 3800 is secured relative to a patient by the anchor pads 3802a and 3802b, the medical article 3200 can also be secured relative to the patient. [0141] As shown in Figure 24, the retainer 3810 can include an abutment surface 3829 disposed on the distal facing side of the retainer. The abutment surface 3829 can abut or otherwise engage a portion of the connecting member 3230 of the medical article 3200 so as to inhibit longitudinal movement of the medical article relative to the retainer 3810 in the proximal direction. In this way, the abutment surface 3829 may inhibit longitudinal movement of the medical article 3200 relative to a patient when the securement system 3100 is disposed on the patient's skin.

[0142] As shown in Figures 23 and 24, the retainer 3810 can be manipulated between at least two configurations. Figure 23 illustrates the retainer 3810 in the first configuration in which a longitudinal opening of the channel 3826 is enlarged to receive at least a portion of the medical article 3200. Figure 24 illustrates the retainer 3810 in the second configuration in which the longitudinal opening of the channel is closed to allow the retainer 3810 to grip the medical article 3200 and to inhibit movement of the medical article relative to the stabilization device 3800. The retainer 3810 can include a hinge portion 3828, as shown in Figures 24 and 25, about which lateral portions of the retainer 3810 can rotate when the retainer is manipulated between the first configuration and the second configuration. In some embodiments, the hinge portion 3828 is a living hinge or a thinned portion of the retainer 3810 disposed above the channel 3826. In some embodiments, the retainer 3810 comprises a resilient material, e.g., rubber, such that the retainer 3810 is biased toward the first configuration.

[0143] In some embodiments, the channel 3826 is disposed within the retainer 3810 so as to extend at an angle relative to the anchor pads 3802a and 3802b. Additionally, the cannula 3220 may extend from the hub 3210 at an angle relative to the bottom surface 3219. In this way, the cannula 3220 may extend into the patient's skin 3150 at an angle, as illustrated in Figure 27, when the retainer 3810 is used to secure and stabilize the medical article relative to the patient.

[0144] Figures 28 through 33 illustrate another embodiment of a securement system 4100 including a medical article 4200 and a stabilization device 4800. As can be seen in Figures 31 and 32, the medical article 4200 is illustrated as a catheter having a hub 4210, a cannula 4220 extending in a generally longitudinal direction from a proximal end of the hub 4210, and a connecter member 4230, such as a female luer-lock fitting, protruding from a distal end of the hub 4210. The hub 4210 includes a body portion 4214, a first raised region 4213, and a second raised region 4215. The first and second raised regions 4213 and 4215 can be formed from the same material(s) as the body 4214 or can comprise a different material than the body 4214. For example, the first and second raised regions 4213 and 4215 can comprise one or more flexible elastomers and the body 4214 can comprise a hard plastic.

[0145] The first and second raised regions 4213 and 4215 are spaced apart or offset from one another so as to receive at least a portion of a stabilization device 4800 therebetween. Further, the first and second raised regions 4213 and 4215 extend outwardly from the body portion 4214 so as to form distal and proximal facing abutment surfaces that extend from the body portion 4214. For example, the second raised region 4215 includes a distal facing abutment surface 4219 and a proximal facing abutment surface 4217 disposed on an opposite side of the second raised region. Similarly, the first raised region 4213 includes a distal facing abutment surface 4212 that faces the second raised region 4215.

[0146] As shown in Figure 32, the first raised region 4213 includes a bottom surface 4277 and the second raised region 4215 includes a bottom surface 4279. The bottom surfaces 4277 and 4279 may be generally flat and co-planar with one another such that the medical article 4200 may be placed flat on a generally planar surface, e.g., on a portion of a patient's skin 4150. In this way, the hub 4210 may rest flat on the patient's skin 4150 without the use of a retainer. Also, the flat shape of the bottom surfaces 4277 and 4279 may inhibit rotation and/or rocking of the hub 4210 relative to the patient.

[0147] In some embodiments, the bottom surfaces 4277 and 4279 can optionally include one or more adhesive layers for releasably securing the hub 4210 to the skin 4150 of the patient without requiring the use of the stabilization device 4800. Because the first and second regions 4213 and 4215 extend from the body 4214, the portion of the body 4214 disposed between the first and second raised regions 4213 and 4215 may be offset from the patient when bottom surfaces 4277 and 4279 are disposed on the patient's skin 4150. In some embodiments, the lumen of the medical article extending through the body 4214 may extend at an angle relative to the bottom surfaces 4277 such that the cannula 4220 extends into the patient's skin 4150 at an angle, for example, 7 degrees, relative to the patient's skin. [0148] The stabilization device 4800 includes a retainer 4810 disposed over a pair of anchor pads 4802a and 4802b, as shown in Figures 28 through 30. The retainer 4810 includes a retainer body 4812 and a pair of supports 4814a and 4814b that couple the retainer body with the anchor pads 4802a and 4802b. In some embodiments the retainer body 4812 can be integrally formed with the supports 4814a and 4814b. Alternatively, the retainer body 4812 can be formed separately from the supports 4814a and 4814b and may be formed of different materials than the supports. For example, the retainer body 4812 may comprise a material that is more rigid than the material(s) used to form the supports 4814a and 4814b.

[0149] As shown in Figure 28, the anchor pads 4802a and 4802b are disposed on opposite sides of a channel 4826 extending through the retainer 4810 from a proximal side to a distal side. The channel 4826 can be sized and shaped so as to receive at least a portion of the body 4214 of the medical article 4200, as shown in Figures 29 and 30. For example, the distance between the proximal side and distal side of the retainer body 4812 can be selected to fit between the first and second raised regions 4213 and 4215. In some embodiments, the distal side of the retainer body 4812 may abut the abutment surface 4217 of the second raised region 4215. Further, the proximal side of the retainer body 4812 may abut the abutment surface 4212 of the first raised region 4213. In this way, the retainer body 4812 may fit between the first and second raised regions 4213 and 4215 so as to inhibit longitudinal and transverse movement of the hub 4210 relative to the stabilization device 4800. In some embodiments, an inner surface of the channel 4826 defined by the retainer body 4812 has a shape that is complementary to the shape of the body 4214. Thus, the hub 4210 can be positioned within the channel 4826 such that lateral, longitudinal, and transverse movement of the medical article 4200 relative to the stabilization device 4800 is inhibited. Accordingly, when the retainer 4810 is secured relative to a patient by the anchor pads 4802a and 4802b, the medical article 4200 can also be secured relative to the patient's skin 4150, as shown in Figure 33.

[0150] Figure 34 illustrates another embodiment of a medical article 5200 including a hub 5210, a fitting 5230 disposed at a distal end of the hub 5210, and a cannula 5220 extending longitudinally from a proximal end of the hub 5210. As shown in Figure 35, the medical article 5200 may form part of a securement system 5100 along with a retainer 5810. In some embodiments, the hub 5210 of the medical article 520 has a circular or round cross-sectional shape.

[0151] The stabilization device 5800 includes a retainer 5810 having a retainer body 5814 that defines a channel 5826 between a proximal side of the retainer body 5814 and a distal side of the retainer body. The retainer body 5814 can be manipulated at least between a first configuration and a second configuration. Figure 35 illustrates the retainer body 5814 in the first configuration in which a longitudinal opening of the channel 5826 is enlarged to receive at least a portion of the hub 5210. Figure 36 illustrates the retainer body 5814 in the second configuration in which the longitudinal opening of the channel is closed to allow the channel to grip the hub 5210 and to inhibit movement of the medical article relative to the retainer 5810. In some embodiments, the retainer body 5814 comprises a resilient material, e.g., rubber, such that the retainer body 5814 is biased toward the first configuration.

[0152] To facilitate the manipulation of the retainer body 5814 between the first and second configurations, the retainer body can include a hinge portion 5828 about which opposing lateral portions 5822a and 5822b of the retainer body can rotate, as shown in Figures 35 and 36. In such an embodiment, the opposing lateral portions 5822a and 5822b of the retainer body 5814 can rotate together about the hinge portion 5828 and/or can rotate independently about the hinge portion 5828. In some embodiments, the hinge portion 5828 is a living hinge or a thinned portion of the retainer 5810 disposed above the channel 5826.

[0153] The opposing lateral portions 5822a and 5822b can be generally L- shaped so as to include base segments 5819a and 5819b. As shown in Figure 36, the base segments 5819a and 5819b can be shaped and sized so as to extend beneath the hub 5210 when the retainer body 5814 is in the second configuration. In this way, the base segments 5819a and 5819b can collectively support and cradle the hub 5210. In some embodiments, the base segments 5819a and 5819b may be inclined or slanted in the longitudinal direction. Thus, the base segments 5819a and 5819b may support the medical article 5200 at an angle relative to the bottom surfaces of the base segments such that the cannula 5820 of the medical article may extend into a patient's skin 5150 at an angle, as illustrated in Figure 38. [0154] In some embodiments, an inner surface of the retainer body 5814 can include one or more contoured portions 5831 that are sized and shaped so as to complement portions of the outer shape of the hub 5210 of the medical article 5200. For example, as shown in Figure 35, the retainer body 5814 can include one or more portions 5831 that are rounded to match the outer shape of the hub 5210 when in the second or closed configuration. In this way, the inner surface of the retainer body 5814 can contact a larger portion of the hub 5210, at least in the second configuration, to inhibit longitudinal, lateral, and transverse movement of the medical article relative to the retainer 5810.

[0155] As shown in Figure 38, in some embodiments, the retainer body 5814 includes a transverse opening or window 5840. In this way, the retainer body 5814 may provide transverse access to a portion of the hub 5210 secured by the lateral sides of the retainer body 5814 and the base segments of the retainer body. Such a window 5840 may be utilized to access an outwardly extending member, e.g., an access port, of the medical article 5200 while the medical article is secured relative to the patient's skin 5150.

[0156] As shown in Figure 40, in some embodiments, the fitting 5230 of the medical article 5200 may extend beyond the hub 5210. In such embodiments, the fitting 5230 may include a proximal facing abutment surface that faces a distal facing abutment surface of the retainer body 5814. The abutment surfaces of the fitting 5230 and the retainer body 5814 can act to inhibit, if not prevent, longitudinal movement of the medical article 5200 relative to the retainer 5810 in the proximal direction, e.g., toward the insertion site.

[0157] In some embodiments, the base segments of the retainer body 5814 have bottom surfaces that are substantially flat such that the retainer 5810 may rest on the patient's skin 5150 without rocking. The bottom surfaces of the retainer 5810 optionally include one or more adhesive layers to secure the retainer 5810 to the patient's skin 5150.

[0158] Additionally, the retainer can include flaps 5802a and 5802b that fold away from the retainer body 5814 as shown in Figures 39 through 41. In this way, the flaps 5802a and 5802b may be folded away from the retainer body 5814 and adhered to the patient to stabilize the retainer 5810 relative to the patient's skin. In some embodiments, the flaps 5802a and 5802b include an adhesive layer disposed on a surface of the flaps that faces away from the retainer body 5814. Thus, the flaps 5802a and 5802b may be utilized to secure the retainer body 5814 relative to the patient's skin when in the folded down configuration. To protect the adhesive portions of the flaps 5802a and 5802b, a release liner may be disposed over the flaps when the flaps are in the folded up configuration before use.

[0159] In operation, a process for securing the medical article 5200 relative to the patient's skin 5150 can begin by manipulating the retainer body 5814 to the first configuration illustrated in Figure 35 and inserting the hub 5210 into the channel 5826 of the body 5814. The retainer body 5814 may then move to the second configuration illustrated in Figure 35 to grip the medical article 5200 within the channel 5826. The medical article 5200 may then be inserted into the patient's skin 5150 and the flaps 5802a and 5802b may be used to stabilize and secure the retainer 5810 relative to the patient.

[0160] Figure 37 illustrates another embodiment of a securement system 5600 including a retainer 5910 and a medical article 5500. The medical article 5500 is similar to the medical article 5200 of Figures 34 though 36 except that the hub 5510 of medical article 5500 has a generally triangular cross-sectional shape. Similarly, the retainer 5910 is similar to the retainer 5810 of Figures 35 and 36 except that the inner surface of the retainer body 5914 has a generally triangular shape that complements the shape of the hub 5510. In this embodiment, the flat surfaces of the triangular hub 5510 and the complementary inner surfaces of the retainer body 5914 directly engage one another to inhibit rotational movement of the medical article 5500 relative to the retainer 5910.

[0161] Figures 42 through 45 illustrate another embodiment of a securement system 6100 including a medical article 6200 and a stabilization device 6800. As can be seen in Figure 42, the medical article 6200 includes a hub 6210, a cannula 6220 extending from the proximal end of the hub, and a fitting 6230 positioned near the distal end of the hub 6210 for fluidly connecting the medical article 6200 to a medical line or extension set.

[0162] The hub 6210 can be formed of various materials, for example, hard plastic, and can comprise various shapes. As illustrated, the hub 6210 includes lateral supports or wings 6212a and 6212b that extend from body 6214. The hub 6210 can further include an outwardly extending member or index 6216 which extends away from the body 6214. The outwardly extending member 6216 can be clocked around the circumference of the hub 6210 so as to coincide with the clocking of the bevel in the tip of the needle. As shown in Figures 43 and 45, the wings 6212a and 6212b extend laterally away from the hub 6210 to form a flat surface which may rest upon a patient's skin 6150 and may inhibit rotation or rocking of the medical article 6200 relative to the patient's skin.

[0163] In some embodiments, the wings 6212a and 6212b can include one or more adhesive layers for releasably securing the hub 6210 to the patient's skin 6150. Thus, the medical article 6200 may be releasably secured relative to a patient without the use of the stabilization device 6800. As shown in Figures 43 and 45, the wings 6212a and 6212b can support the body 6214 of the medical article 6200 such that the cannula 6220 may be inserted into the patient's skin 6150 at an angle.

[0164] The stabilization device 6800 includes a retainer 6810 supported by a pair of anchor pads 6802a and 6802b, as shown in Figures 43 and 44. The anchor pads 6802a and 6802b are situated on opposite sides of a channel 6826 defined by a body 6814 of the retainer 6810. The body 6814 includes a slot 6816, shown in Figure 42, sized and shaped to receive at least a portion of the outwardly extending member 6216 therethrough. In this way, the retainer 6810 may be placed over at least a portion of the hub 6210 as shown in Figures 44 and 45 such that the body 6214 of the hub 6210 is at least partially received within the channel 6826. When disposed within the channel 6826, lateral and transverse movement of the medical article 6200 relative to the retainer 6810 is inhibited by the retainer body 6814. Further, longitudinal movement of the medical article 6200, in the proximal and distal directions, is inhibited by the abutments between the outwardly extending member 6216 and the retainer body 6814 on the distal and proximal ends of the slot 6816. Thus, contact between the retainer body 6814 and the hub 6210 may inhibit lateral, transverse, and longitudinal movement of the medical article 6200 relative to the stabilization device 6800.

[0165] The anchor pads 6802a and 6802b extend laterally away from the retainer 6810. In some embodiments, the anchors pads 6802a and 6802b can comprise 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. In use, the adhesive layers of the anchor pads 6802a and 6802b can be utilized to secure the retainer 6810 to the patient's skin 6150 as shown in Figure 45. Further, the adhesive layers of the anchor pads 6802a and 6802b may contact the wings 6212a and 6212b of the hub 6210 such that the anchor pads are adhered to the patient's skin 6150 and the medical article 6200, as shown in Figures 44 and 45. In this way, the adhesive layers of the anchor pads 6802a and 6802b may provide another means for inhibiting lateral, transverse, and longitudinal movement of the medical article 6200 relative to the stabilization device 6800 while also securing the securement system 6100 to the patient.

[0166] Figures 46 through 49 illustrate another embodiment of a securement system 7100 including a stabilization device 7800 and a medical article 7200. As can be seen in Figures 46 and 47, the medical article 7200 is illustrated as a catheter having a hub 7210, a cannula 7220 extending in a generally longitudinal direction from a proximal end of the hub 7210, and a connecting member 7230, such as a female luer-lock fitting, protruding from a distal end of the hub 7210. The hub 7210 includes a body portion 7214, a first raised region 7213, and a second raised region 7215. The first and second raised regions 7213 and 7215 can be formed from the same material(s) as the body 7214 or can comprise a different material than the body 7214. For example, the first and second raised regions 7213 and 7215 can comprise one or more flexible elastomers and the body 7214 can comprise a more rigid material, e.g., a hard plastic.

[0167] The first and second raised regions 7213 and 7215 are spaced apart or offset from one another in the longitudinal direction. Further, the first and second raised regions 7213 and 7215 extend outwardly from the body portion 7214 so as to form distal and proximal facing abutment surfaces that extend from the body portion 7214. For example, as shown in Figure 46, the second raised region 7215 includes a proximal facing abutment surface 7217 that faces the first raised region 7213. Additionally, the first raised region 7213 includes a distal facing abutment surface 7212 that faces the second raised region 7215. In this way, the first raised region 7213 and the second raised region 7215 can at least partially define a groove therebetween over at least a portion of the body portion 7214.

[0168] As shown in Figure 47, the first raised region 7213, the body 7214, and the second raised region 7215 can define a bottom surface of the hub 7210. The bottom surface may be generally flat such that the medical article 7200 may be placed flat on a planar surface, e.g., on a portion of a patient's skin 7150. In this way, the hub 7210 may rest flat on the patient's skin 7150 without the use of a retainer or stabilization device. Additionally, the flat bottom may inhibit rotational movement of the hub 7210 relative to the patient.

[0169] In some embodiments, the bottom surface of the hub 7210 can optionally include one or more adhesive layers for releasably securing the hub 7210 to the skin of the patient 7150 without requiring the use of the stabilization device 7800. In some embodiments, the lumen of the medical article extending through the body 7214 may extend at an angle relative to the bottom surfaces such that the cannula 7220 extends into the patient's skin 7150 at an angle, for example, 7 degrees, relative to the patient's skin, as shown in Figures 47 and 49.

[0170] As shown in Figures 46 and 47, in some embodiments, the hub 7210 includes an outwardly extending member 7216 which extends away from the second raised region 7215. As discussed below, the outwardly extending member 7216 can provide an additional abutment surface for inhibiting longitudinal movement of the medical article 7200 relative to the stabilization device 7800. Additionally, the outwardly extending member 7216 may provide a contact surface or pad which can be utilized by the medical provider to manipulate the medical article 7200 during use.

[0171] The stabilization device 7800 includes a retainer 7810 supported over a pair of anchor pads 7802a and 7802b, as shown in Figures 46 through 49. The retainer 7810 includes a retainer body 7812 and a pair of supports 7814a and 7814b that couple the retainer body with the anchor pads 7802a and 7802b. In some embodiments, the retainer body 7812 can be integrally formed with the supports 7814a and 7814b. Alternatively, the body 7812 can be formed separately from the supports 7814a and 7814b and may be formed of different materials than the supports. For example, the retainer body 7812 may comprise a material that is more rigid than the material(s) used to form the supports 7814a and 7814b.

[0172] As shown in Figure 46, the supports 7814a and 7814b can include longitudinally extending rails 7813a and 7813b to rigidly support the retainer 7810 above the anchor pads 7802a and 7802b. That is to say, the rails 7813a and 7813b can reduce the lateral flexibility of the retainer body 7812 and reduce lateral movement of the retainer body 7812 relative to the anchor pads 7802a and 7802b. [0173] Further, as shown in Figure 48, the rails 7813a and 7813b can be spaced from one another so as to cradle the medical article 7200 on opposite lateral sides. In some embodiments, the rails 7813a and 7813b can have a longitudinal length that exceeds a longitudinal length of the retainer body 7812 such that the rails limit lateral movement of the medical article 7200 at positions that are proximal and/or distal to the retainer body.

[0174] The anchor pads 7802a and 7802b are disposed on opposite sides of a channel 7826 extending through the retainer 7810 from a proximal side to a distal side, as shown in Figure 46. The channel 7826 can be sized and shaped so as to receive at least a portion of the body 7214 of the medical article 7200. For example, the distance between the proximal side and distal side of the retainer body 7812 can be selected to fit between the first and second raised regions 7213 and 7215. In some embodiments, the distal side of the retainer body 7812 may abut the abutment surface 7217 of the second raised region 7215. Further, the proximal side of the retainer body 7812 may abut the abutment surface 7212 of the first raised region 7213. In this way, the retainer body 7812 may fit between the first and second raised regions 7213 and 7215 so as to inhibit longitudinal and transverse movement of the hub 7210 relative to the stabilization device 7800. Additionally, in some embodiments, the transversely extending member 7216 of the medical article 7200 may abut the distal side of the retainer body 7812. In such embodiments, the retainer body 7812 need not fit completely between the first and second raised regions 7213 and 7215 as illustrated.

[0175] In some embodiments, an inner surface of the channel 7826 defined by the retainer body 7812 has a shape that is complementary to the shape of the body 7214. Thus, the hub 7210 can be positioned within the channel 7826 such that lateral, longitudinal, and transverse movement of the medical article 7200 relative to the stabilization device 4800 is inhibited. Accordingly, when the stabilization device is secured relative to a patient by the anchor pads 7802a and 7802b, the medical article 7200 can also be secured relative to the patient's skin 7150, as shown in Figure 49.

[0176] Figures 50 through 54 illustrate another embodiment of a securement system 8100 including a stabilization device 8800 and a medical article 8200. As can be seen in Figures 50 and 51, the medical article 8200 is illustrated as a catheter having a hub 8210, a cannula 8220 extending in a generally longitudinal direction from a proximal end of the hub 8210, and a connecting member 8230, such as a female luer-lock fitting, protruding from a distal end of the hub 8210. The hub 8210 includes a body portion 8214, a first raised region 8213, and a second raised region 8215.

[0177] The first and second raised regions 8213 and 8215 are spaced apart or offset from one another in the longitudinal direction. Further, the first and second raised regions 8213 and 8215 extend outwardly from the body portion 8214 so as to form distal and proximal facing abutment surfaces that extend from the body portion 8214. For example, the second raised region 8215 includes a proximal facing abutment surface 8217 which faces the first raised region 8213. Additionally, the first raised region 8213 includes a distal facing abutment surface 8212 that faces the second raised region 8215. In this way, the first raised region 8213 and the second raised region 8215 can at least partially define a groove therebetween over at least a portion of the body portion 8214.

[0178] As shown in Figure 51, the first raised region 8213, the body 8214, and the second raised region 8215 can define a bottom surface of the hub 8210. The bottom surface may be generally flat such that the medical article 8200 may be placed flat on a planar surface, e.g., on a portion of a patient's skin 8150. In this way, the hub 8210 may rest flat on the patient's skin 8150 without the use of a retainer or stabilization device. In some embodiments, the lumen of the medical article extending through the body 8214 may extend at an angle relative to the bottom surfaces such that the cannula 8220 extends into the patient's skin 8150 at an angle, for example, 7 degrees, relative to the patient's skin when the cannula is inserted therein.

[0179] With continued reference to Figures 50 and 51, in some embodiments, the hub 8210 includes an outwardly extending member or index 8216 which extends away from the second raised region 8215. As discussed below, the outwardly extending member 8216 can provide an additional abutment surface for inhibiting longitudinal movement of the medical article 8200 relative to the stabilization device 8800. Additionally, the outwardly extending member 8216 may provide a contact surface or pad which can be utilized by the medical provider to manipulate the medical article 8200 during use.

[0180] As shown in Figures 51 and 54, the medical article 8200 includes an antimicrobial tip 8290 disposed proximal to the first raised region 8213. The antimicrobial tip 8290 can be sized and shaped as to cover the insertion site into the patient's skin 7150. In this way, the antimicrobial tip 8290 acts to protect the patient from organisms disposed outside of the patient's skin 8150 after the cannula 8220 has been inserted therethrough. The antimicrobial tip 8290 may comprise a silver material, for example a silver salt, colloid, or complex. In one embodiment, one or more oligodynamic metal salts, oxides, or combination of salts and oxides are used. Of course the antimicrobial tip 8290 may be incorporated into any of the other embodiments disclosed herein.

[0181] The stabilization device 8800 includes a retainer 8810 supported by a pair of anchor pads 8802a and 8802b, as shown in Figures 50 and 51. The retainer 8810 includes a body 8812 and a pair of supports 8814a and 8814b that couple the body 8812 to the anchor pads 8802a and 8802b.

[0182] The anchor pads 8802a and 8802b are disposed on opposite sides of a channel 8826 extending through the retainer 8810 from the proximal end to the distal end. The channel 8826 can be sized and shaped so as to receive at least a portion of the body 8214 of the medical article 8200. For example, the distance between the proximal end and distal end of the body 8812 can be selected to fit between the first and second raised regions 8213 and 8215. In some embodiments, the distal end of the body 8812 abuts the abutment surface 8217 of the second raised region 8215. Further, the proximal end of the body 8812 may abut the abutment surface 8212 of the first raised region 8213. In this way, the body 8812 fits between the first and second raised regions 8213 and 8215 so as to inhibit longitudinal and transverse movement of the hub 8210 relative to the stabilization device 8800. Additionally, in some embodiments, the outwardly extending member 8216 of the medical article 8200 abuts the distal end of the body 8812. In such embodiments, the body 8812 need not fit completely between the first and second raised regions 8213 and 8215 as illustrated.

[0183] As shown in Figure 51, the retainer 8810 can include a proximal end or edge 8819 formed at least in part by the body 8812 and the supports 8814a and 8814b. The proximal end 8819 can have a contour or shape that matches or otherwise complements the shape or profile of the distal facing abutment surface 8212 of the first raised region 8213. In this way, the engagement between the proximal end 8819 and the first raised region 8213 can inhibit transverse, lateral, and rotational movement of the medical article 8200 relative to the retainer 8810, in addition to relative longitudinal movement. Accordingly, when the stabilization device 8800 is secured relative to a patient by the anchor pads 8802a and 8802b, the medical article 8200 can also be secured relative to the patient's skin 8150, as shown in Figure 54.

[0184] As shown by Figures 52 and 53, the retainer 8810 can be manipulated between at least two configurations. Figure 52 illustrates the retainer 8810 in a first configuration in which a longitudinal opening of the channel 8826 is enlarged to receive at least a portion of the medical article 8200. Figure 53 illustrates the retainer 8810 in the second configuration in which the longitudinal opening of the channel 8826 is closed to allow the channel to grip the medical article 8200 and to inhibit movement of the medical article relative to the retainer 8810. The retainer 8810 can include a hinge portion 8828 about which lateral portions of the retainer 8810 can rotate when the retainer is manipulated between the first configuration and the second configuration. In some embodiments, the hinge portion 8828 is a living hinge or a thinned portion of the retainer 8810 disposed above the channel 8826.

[0185] Figures 55 through 58 illustrate another embodiment of a securement system 9100 including a stabilization device 9800 and a medical article 9200. As can be seen in Figures 55 and 56, the medical article 9200 is illustrated as a catheter having a hub 9210, a cannula 9220 extending in a generally longitudinal direction from a proximal end of the hub 9210, and a connecting member 9230, such as a female luer-lock fitting, protruding from a distal end of the hub 9210. The hub 9210 includes a body portion 9214, wings 9212a and 9212b extending in generally lateral directions from the body portion 9214, and a contact surface or pad 9216 raised with respect to the body portion 9214.

[0186] The pair of wings 9212a and 9212b is spaced apart from the contact surface 9216 in the longitudinal direction. In this way, the pair of wings 9212a and 9212b forms a distal facing abutment surface 9213 and the contact surface 9216 forms a proximal facing abutment surface 9217, as shown in Figure 56. As such, the pair of wings 9212a and 9212b and the contact surface 9216 can at least partially define a groove therebetween over at least a portion of the body portion 9214.

[0187] As shown in Figure 56, the hub 9210 can have a substantially flat bottom surface such that the medical article 9200 may be placed flat on a planar surface, e.g., on a portion of a patient's skin 9150. In this way, the hub 9210 may rest flat on the patient's skin 9150 without the use of a retainer or stabilization device. In such situations, the wings 9212a and 9212b can be sized and shaped to provide stability to the medical article 9200 such that rocking and/or rotation of the medical article relative to the patient's skin 9150 is inhibited or limited. In some embodiments, the lumen of the medical article extending through the body portion 9214 may extend at an angle relative to the bottom surface such that the cannula 9220 extends into the patient's skin 9150 at an angle, for example, 7 degrees, relative to the patient's skin 9150 when the cannula is inserted therein.

[0188] In some embodiments, one or more recesses 9218 are formed in the sidewalls of the body portions 9214 of the hub 9210. The recesses are configured to engage with one or more detents of the stabilization device 9800. In this way, engagement between the one or more recesses 9218 and the stabilization device 9800 can act to limit movement of the medical article 9200 relative to the stabilization device in the lateral, longitudinal, and transverse directions.

[0189] With continued reference to Figures 55 and 56, the stabilization device 9800 includes a retainer 9810 supported by a pair of anchor pads 9802a and 9802b. The retainer 9810 includes a body 9812 and a pair of supports 9814a and 9814b that couple the retainer body with the anchor pads 9802a and 9802b. In some embodiments, the supports 9814a and 9814b optionally include transversely extending ribs 9815a and 9815b configured to provide stabilization to the body 9812 without discomforting the patient.

[0190] The anchor pads 9802a and 9802b are disposed on opposite sides of a channel 9826 extending through the retainer 9810 from the proximal side to the distal side, as shown in Figure 55. The channel 9826 can be sized and shaped so as to receive at least a portion of the body 9214 of the medical article 9200. For example, the distance between the proximal side and distal side of the retainer body 9812 can be selected to fit between the pair of wings 9212a and 9212b and the contact surface 9216. In this way, the body 9812 fits over the hub 9210 so as to inhibit longitudinal and transverse movement of the hub relative to the stabilization device 9800, as shown in Figures 57 and 58.

[0191] 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 securement system, and securement systems that include one or more of the features herein described can be designed for use with a variety of medical articles.

[0192] The various embodiments of the securement systems described above thus provide a means to secure and/or stabilize a catheter or other medical article to a patient. The catheter can be secured directly to the patient, and may be further stabilized within a retainer for use with the catheter.

[0193] 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.

[0194] Furthermore, the skilled artisan will recognize the interchangeability of various features from the many 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 securement systems and techniques in accordance with principles of the present invention.

[0195] Although this invention has been described in terms of certain preferred embodiments and suggested possible modifications thereto, other embodiments and modifications 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 or several embodiments can be used with another or several embodiments. It is further understood that not all of the aspects or elements described in connection with a particular embodiment need to be utilized in connection with that or another embodiment. Accordingly, the scope of the invention is intended to be defined only by the claims which follow.

Claims

WHAT IS CLAIMED IS:

1. A securement system comprising:

a medical article having an elongated body and a pair of wings extending from opposite sides of the body, and a first adhesive disposed on a bottom surface of the pair of wings; and

a stabilization device having a retainer and a pair of anchor pads, the retainer comprising a channel and a lower opening, at least a portion of the body passing through the lower opening and into the channel to secure the body within the retainer, the pair of anchor pads comprising a second adhesive.

2. The securement system of Claim 1 , wherein the medical article comprises a luer-lock fitting.

3. The securement system of Claim 1 , wherein the medical article comprises a contact surface raised above the body.

4. The securement system of Claim 1 , wherein the bottom surface of the pair of wings and a base surface of the retainer are aligned when the medical article is disposed within the channel.

5. The securement system of Claim 1 , wherein at least a portion of the pair of anchor pads extend in a proximal direction beyond the pair of wings when the portion of the medical article is disposed in the channel.

6. The securement system of Claim 1 , wherein the anchor pads extend over at least a portion of the pair of wings and a portion of a patient's skin when the securement system is attached to the patient.

7. The securement system of Claim 1 , wherein the first adhesive has different bond strength than the second adhesive.

8. The securement system of Claim 1 , wherein the medical article comprises first and second abutment surfaces disposed on opposite sides of the retainer when the medical article is secured within the retainer.

9. The securement system of Claim 8, wherein the retainer comprises at least one abutment surface which is arranged so as to contact one of the first and second abutment surfaces and inhibit motion of the medical article in at least one longitudinal direction.

10. The securement system of Claim 8, wherein the first and second abutment surfaces together form walls of a groove in the body, the groove extending in a direction around at least a portion of a circumference of the body.

11. The securement system of Claim 8, wherein the retainer fits over the body portion between the first and second abutment surfaces.

12. The securement system of Claim 1, wherein the retainer comprises at least one detent.

13. The securement system of Claim 12, wherein the medical article comprises a recess sized and shaped to receive the at least one detent when the portion of the medical article is disposed in the channel.

14. A securement system comprising:

a medical article comprising an adhesive surface configured for attachment to skin of a patient and a body member having a recess; and

a stabilization device comprising

at least one anchor pad having an adhesive surface configured for attachment to the skin of the patient, and

a body being supported by the at least one anchor pad and having a channel for receiving at least a portion of the medical article, a portion of the body being sized so as to be disposed within the recess of the medical article at least when the medical article is disposed within the channel so as to inhibit movement of the medical article relative to the body.

15. The securement system of Claim 14, wherein the portion of the body has a longitudinal length which generally matches a width of the recess.

16. The securement system of Claim 14, wherein the adhesive surface of the medical article and the adhesive surface of the at least one anchor pad define a substantially uniform contact surface for securing the medical article and stabilization device to the patient.

17. The securement system of Claim 14 further comprising at least one wing extending from the body member of the medical article.

18. The securement system of Claim 17 further comprising at least one support coupled to the at least one anchor pad and configured to abut the at least one wing.

19. A medical article for securing in a retainer, the retainer having a channel and a lower opening for receiving at least a portion of the medical article, the channel having a length measured in a longitudinal direction, the medical article comprising:

an elongated body and a pair of abutment surfaces, the pair of abutment surfaces being recessed into the elongated body so as to form an annular groove around at least a portion of the elongated body, the annular groove being sized to receive the portion of the retainer; and

an adhesive surface configured for attachment to skin of a patient.

20. The medical article of Claim 19, wherein at least one of the pair of abutment surfaces is curvilinear.

21. The medical article of Claim 19, wherein the adhesive surface is contoured.

22. The medical article of Claim 19 further comprising a cannula coated with an antimicrobial material.

23. The medical article of Claim 22, wherein the antimicrobial material covers at least a portion of an outer surface of the cannula.

24. The medical article of Claim 19 further comprising an in-line valve configured to prevent fluid flow in one direction through the elongated body.