Patent Abstract:
A securement device ( 10 ) secures a medical article ( 12 ) to the body of a patient and prevents longitudinal movement of the medical article ( 12 ) relative to the securement device ( 10 ). The securement device ( 10 ) includes a base portion ( 50 ) that is disposed over at least a part of a securement piece ( 20 ). The securement piece ( 20 ) forms a channel ( 19 ) configured to receive at least a portion of the medical article ( 12 ). The device ( 10 ) includes at least one actuator ( 40 ). The at least one actuator ( 40 ) is coupled with the securement piece ( 20 ) and configured to move the securement piece ( 20 ) between open position and a closed position. When the securement piece ( 20 ) is in the open position, it can receive at least a portion of the medical article ( 12 ). When the securement piece ( 20 ) is in the closed position, it prevents the received medical article ( 12 ) from moving in the longitudinal direction relative to the securement device ( 10 ). In some embodiments the securement piece ( 20 ) has engagement members ( 23 ) extending from the inner surface of the securement piece ( 20 ). In an embodiment, the securement device ( 10 ) includes an opening ( 28 ) that receives an outwardly extending member of the medical article ( 12 ).

Full Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Application No. 60/982,334, filed Oct. 24, 2007, entitled “Catheter Securement Device,” which is hereby incorporated by reference in its entirety. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    This invention relates to a securement device used to secure a medical article or medical article fitting to a patient. 
         [0004]    2. Description of the Related Art 
         [0005]    It is often necessary to introduce fluids and liquid medications directly into a blood vessel of a patient. Various types of medical articles, such as catheters, are often used in combination with connectors and syringes. A catheter is essentially a tube inserted through an incision in the skin into a blood vessel in the patient&#39;s body, generally without surgery. A simple intravenous (IV) line is usually acceptable for introduction of fluids and liquid medications into a blood vessel for short term general use. IV lines are typically inserted into a patient&#39;s arm by inserting a catheter or some other medical article, containing a needle, which pierces the skin, into a blood vessel. The needle is removed and discarded, while the medical article remains in the blood vessel. 
         [0006]    It is important to minimize movement of the inserted medical article. If the medical article is not properly secured in place, it may be inadvertently displaced from its intended location. Consequently, medication delivered through the IV line may be released at an incorrect position. Furthermore, repeated back and forth movement of the medical article, or pistoning, can cause irritation of the blood vessel, disrupt proper introduction of medications to the patient, and increase the potential for bleeding or infection at the medical article insertion site. If extensive movement occurs, the IV line could even come out of the patient, interrupting delivery of medication and requiring re-insertion, often with hospitalization. 
         [0007]    In the past, medical articles, such as catheters, were typically taped into place on the patient&#39;s skin. However, taping is time consuming and labor intensive. Tape also collects bacteria and must be frequently removed and replaced. More importantly, taping is not necessarily effective for securing a medical article in place on a patient. Sutures have also been used to attach medical articles to patients. With sutures, the medical article is stitched onto the skin. Sutures, however, can also be a source of infection, can cause pain and inflammation, and can make it more difficult to clean around the insertion site. Sutures also require time and skill to apply, and can cause scarring. 
         [0008]    More recently, manufactured medical article anchors or securing devices have become widely adopted. While various designs have been developed, these devices are typically relatively inefficient or difficult to operate or manipulate. Thus, engineering design challenges remain to providing reliable, secure, and efficient medical article anchoring devices. Accordingly, improved medical article anchoring devices are needed. 
       SUMMARY OF THE INVENTION 
       [0009]    One aspect of the present invention thus involves a retainer for a medical article. The retainer comprises a body member forming a channel configured to receive at least a portion of a medical article, the channel having a longitudinal axis. The body member moves between an open position and a closed position, the portion of the medical article being secured in the channel at least when the body member is in the closed position. The retainer further comprises at least one or more actuators coupled to the body member and configured to move the body member to the open position so as to receive the portion of the medical article in the channel. The retainer further comprises a base portion disposed over at least a portion of the body member, the base portion having one or more passageways configured to receive at least a portion of the one or more actuators. 
         [0010]    Another aspect is a retainer for a medical article. The retainer comprises a body member that forms a channel configured to receive at least a portion of a medical article, the channel having a longitudinal axis. The retainer further comprises a latch member configured to move between a lock position and an unlock position. The latch member compresses the body member towards the longitudinal axis so as to secure the received portion of the medical article when in the lock position. 
         [0011]    Another aspect of the present invention involves a retainer for a medical article. The retainer comprises a body member forming a channel configured to receive at least a portion of a medical article, the channel having a longitudinal axis. The body member is made of a first material and moves between an open position and a closed position, the portion of the medical article being secured in the channel at least when the body member is in the closed position. The retainer further comprises a base portion disposed over at least a portion of the body member, the base portion being made of a second material. The retainer also comprises at least one or more actuators coupled to the body member and being configured to move the body member to the open position so as to receive the portion of the medical article in the channel, at least a portion of the at least one or more actuators being made from a third material, the third material being different from at least one of the first material and second material. The retainer further comprises a pad supporting the base portion and having a lower surface, at least a portion of the lower surface being covered by an adhesive. 
         [0012]    Further aspects, features and advantages of the present invention will become apparent from the detailed description of the preferred embodiments that follows. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0013]    In the drawings, the same element number indicates the same element in each of the views. 
           [0014]      FIG. 1  is a perspective view of a securement device, according to one embodiment. 
           [0015]      FIG. 2  is a perspective view of the securement piece of the securement device shown in  FIG. 1 . 
           [0016]      FIG. 3  is a perspective view of the shell of the securement device shown in  FIG. 1 . 
           [0017]      FIG. 4  is a perspective view of the securement device shown in  FIG. 1  engaging a catheter fitting. 
           [0018]      FIG. 5  is a perspective view of the securement device shown in  FIG. 4  with the arms in a lowered position. 
           [0019]      FIG. 6  is a front-right perspective view of a securement device, according to another embodiment. 
           [0020]      FIG. 7  is a rear-right perspective view of the securement device shown in  FIG. 6 . 
           [0021]      FIG. 8  is a bottom perspective view of the securement device shown in  FIGS. 6-7 . 
           [0022]      FIG. 9  is a perspective view of the securement device shown in  FIGS. 6-8  engaging a catheter fitting. 
           [0023]      FIG. 10  is a perspective view of a securement device, according to another embodiment. 
           [0024]      FIG. 11  is a perspective view of the securement body and hinge element of the securement device shown in  FIG. 10 . 
           [0025]      FIG. 12  is a bottom perspective view of the cover of the securement device shown in  FIG. 10 . 
           [0026]      FIG. 13  is a top perspective view of the cover of the securement device shown in  FIG. 10 . 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0027]    Various embodiments of the invention will now be described. The following description provides specific details for a thorough understanding and enabling description of these embodiments. One skilled in the art will understand, however, that the invention may be practiced without many of these details. Additionally, some well-known structures or functions may not be shown or described in detail so as to avoid unnecessarily obscuring the relevant description of the various embodiments. 
         [0028]    The terminology used in the description presented below is intended to be interpreted in its broadest reasonable manner, even though it is being used in conjunction with a detailed description of certain specific embodiments of the invention. Certain terms may even be emphasized below; however, any terminology intended to be interpreted in any restricted manner will be overtly and specifically defined as such in this detailed description section. 
         [0029]    Where the context permits, singular or plural terms may also include the plural or singular term, respectively. Moreover, unless the word “or” is expressly limited to mean only a single item exclusive from the other items in a list of two or more items, then the use of “or” in such a list is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of items in the list. 
         [0030]    To assist in the description of these components of the securement device, the following coordinate terms are used. A “longitudinal axis” is generally parallel to a portion of the medical article retained by the securement device, as well as parallel to the axis of a channel of the securement piece, through which the medical article extends. A “lateral axis” is normal to the longitudinal axis. A “transverse axis” extends normal to both the longitudinal and lateral axes. In addition, as used herein, “the longitudinal direction” refers to a direction substantially parallel to the longitudinal axis; “the lateral direction” refers to a direction substantially parallel to the lateral axis; and “the transverse direction” refers to a direction substantially parallel to the transverse axis. Also, the terms “proximal” and “distal” are used consistently with the description of the exemplary application. Thus, proximal and distal are used in reference to the center of the patient&#39;s body. 
         [0031]    Turning now to the drawings, in a first embodiment, as shown in  FIGS. 1-5 , a securement device  10  is configured to receive, secure, or stabilize a medical article or medical article fitting  12 , for example, an IV (intravenous) catheter, peripheral IV catheter, IV hub, IV luer, IV adaptor or extension, or any other suitable medical article or fitting. A “medical article fitting” as used herein includes any type of medical article fitting, attachment, accessory, hub, connector, and so forth, whether integral with the medical article or as a separate piece from the medical article. Furthermore, the term “medical article” as used herein may refer to a medical article alone, a medical article fitting alone, or a medical article in combination with any type of medical article fitting. 
         [0032]    As shown in  FIG. 2 , the securement device  10  includes a substantially longitudinal securement piece  20  having a central opening  19  for receiving a medical article  12 . The securement piece  20  may be substantially arch-shaped, semi-cylindrical, or generally contoured to fit over or around a medical article  12 . An upper region of the securement piece  20  preferably slopes generally in the longitudinal direction at an angle suitable to facilitate insertion of a needle, catheter, or other medical article into a patient. In one embodiment, the angle may be about 4-10°, or 5-9°, or 6-8°. Accordingly, a medical article  12  may be positioned within the sloped or angled securement piece  20  and directed toward the patient at an angle allowing for optimum flow, delivery, or drainage of any fluid to or from the patient. 
         [0033]    One or more engagement members  23  or other protrusions extend from the inner surface of one or both side walls  24 ,  25  of the securement piece  20 . The engagement members  23  may extend from the inner surface at an angle of 0-90° relative to the side walls  24 ,  25 . Preferably, the engagement members  23  extend from the inner surface of the side walls  24 ,  25  at an angle of 25-65°, or 35-55°, or approximately 45°. 
         [0034]    In the illustrated embodiment, a row of engagement members  23  is positioned on the inner surface of each side wall  24 ,  25  of the securement piece  20 . The engagement members  23  are arranged in two pairs on each side wall  24 ,  25 , with the pairs extending in opposite directions, toward each other, at approximately 45° angles. Alternatively, every engagement member  23  may extend in the same direction as one another, or each engagement member may be oriented in a direction opposite its neighboring engagement members  23 . 
         [0035]    Positioned generally toward the center of the top portion  30  of the securement piece  20  is a clearance opening  28 . The clearance opening  28  is of a size sufficient to receive a tab or other extension from a medical article  12 . In one embodiment, the clearance opening  28  is of a size sufficient to allow the tab or extension to pass or extend through the clearance opening  28  without contacting the sides or perimeter bordering the clearance opening  28 . 
         [0036]    Extending from the bottom of the side walls  24 ,  25  of the securement piece  20  are one or more arm receptacles  29 . In the illustrated embodiment, a pair of arm receptacles  29  extend from each side wall  24 ,  25 . The arm receptacles  29  may be substantially semi-cylindrical or have any other configuration suitable for receiving ends of an actuator arm  40  or other member used to expand or “open” the securement piece  20 . In one embodiment, two spaced apart arm receptacles  29  extend from the bottom of each side wall  24 ,  25 . 
         [0037]    Two arms  40  are shown in the illustrated embodiment. The arms  40  are generally U-shaped and include substantially perpendicularly extending (relative to a centerline of the U-portion of the arm  40 ) end portions  41 . The arms  40  may alternatively be rectangular, circular, oval, or have any other shape or configuration suitable for attachment to the securement piece  20 , and for manipulation by a user to expand the securement piece  20 . 
         [0038]    As shown in  FIG. 2 , the end portions  41  of the arms  40  are securely positioned in the arm receptacles  29 . For example, the end portions  41  may be snapped or otherwise inserted into the arm receptacles  29  such that they are securely held therein, yet are permitted to freely rotate or pivot within the arm receptacles  29 . The arms  40  are preferably constructed of a hard, rigid material such as, for example, metal or plastic. The arms  40  may optionally be covered with a soft material  42 , for example, rubber, foam, or latex, to provide an aesthetically pleasing appearance and a comfortable gripping surface. The aim covering  42  also provides increased surface area to facilitate expanding or opening of the securement piece  20  via inward force applied to the arms  40 . The soft covering may optionally include ridges or ribs to increase traction and facilitate gripping and operation of the arms  40 . 
         [0039]    A shell  31  optionally covers or encases the securement piece  20 . The shell  31  is preferably made of a soft material, for example, rubber, foam, or latex, to provide a more aesthetically pleasing appearance and increased comfort for a patient. As shown in  FIG. 3 , the shell  31  includes a top portion  32 , which generally corresponds to and fits around the top portion  30  of the securement piece  20 . Extending downwardly from each corner of the top portion  32  is a shell wall  33 . One or more of the shell walls  33  optionally includes an inner portion  34  protruding inwardly toward the longitudinal axis of the securement piece  20 . The inner portions  34  may aid in preventing longitudinal movement of a medical article  12  through the securement piece  20 . Each shell wall  33  includes an opening  35  on its inner surface for receiving an arm receptacle  29  of the securement piece  20 . The opening  35  may have varying depths suitable for receiving arm receptacles  29  of varying sizes, or the opening  35  may be a hole that extends entirely through the wall  33 . 
         [0040]    In the illustrated embodiment, two base portions  50  extend laterally from the shell walls  33 . The base portions  50  may be rigid, or may be generally flexible or contoured to conform to a specific patient site. A hydro-colloidal pad or other cushion may optionally be attached to an underside of each of the base portions  50  for providing increased patient comfort. The specific pad shape and size may vary. The underside of each of the base portions  50  (or of the cushions, if present) preferably includes an adhesive layer covered by a peelable strip  52 . The peelable strips  52  are removable such that the adhesive may be exposed and the base portions  50  may be adhered to a desired securement site. 
         [0041]    Each base portion  50  preferably includes a separate peelable strip  52  such that the central opening  19  of the securement device  10  is not blocked by a peelable strip  52 . This allows the securement device  10  to be placed over the top of a medical article  12  before removing the strips  52  and adhering the device  10  to the patient. Alternatively, a single peelable strip may extend over the underside of both base portions  50 . In such an embodiment, the strip  52  is removed prior to attaching the securement device  10  to a medical article  12 . Alternatively, the securement device  10  may be affixed to a patient by applying adhesive tape over or around the device  10  or the base portions  50  and against the patient site. 
         [0042]    In use, the arms  40  are raised into the “up” position, as shown in  FIGS. 1 and 2 . An attendant squeezes the arms  40  toward each other, causing the central opening  19  in the securement piece  20  to widen so the securement device  10  may be placed over a medical article  12 . The attendant then releases the arms  40 , allowing the securement piece  20  to close or tightly conform around the medical article  12 , as shown in  FIG. 4 . In this position, the engagement members  23  (possibly in conjunction with the inner portions  34  of the shell walls  33 , depending on the configuration of the medical article  12 ) secure the medical article  12  in place and substantially prevent it from moving longitudinally within the securement device  10 . The attendant may then lower the arms  40 , into the position shown in  FIG. 5 , so they are not obtrusive. Finally, the attendant may remove the peelable strips  52 , exposing the adhesive, and press the base portions  50  against a patient to adhere the securement device  10  containing the medical article  12  to the patient&#39;s skin. 
         [0043]    Turning to  FIGS. 6-9 , in an alternative embodiment, a securement device  60  includes a substantially longitudinal securement body  62  including a central opening  64  for receiving a medical article  66 . The securement body  62  may be substantially arch-shaped, semi-cylindrical, or generally contoured to fit over or around a medical article. An upper region of the securement body  62  preferably slopes generally in the longitudinal direction at an angle suitable to facilitate insertion of a needle or other medical article into a patient. In one embodiment, the angle may be about 4-10°, or 5-9°, or 6-8°. Accordingly, a medical article may be positioned within the sloped or angled securement body  62  and be directed toward the patient at an angle allowing for optimum flow, delivery, or drainage of any fluid to or from the patient. 
         [0044]    The upper portion of the securement body  62  preferably includes a clearance opening  65 . The clearance opening  65  is of a size sufficient to receive a tab or other extension from a medical article  12 . In one embodiment, the clearance opening  65  is of a size sufficient to allow a tab or extension to pass or extend through the clearance opening  65  without contacting the sides or perimeter bordering the clearance opening  65 . The securement body  62  optionally includes one or more notches  69  for accommodating one or more laterally extending members of a medical article. In one embodiment, a latch receptacle  70  or similar opening may be included in a side wall of the securement body  62  for receiving a latch of an optional cover, as described below. 
         [0045]    One or more engagement members  67  or other protrusions preferably extend into the interior of the securement body  62 . The engagement members  67  may extend at an angle of 0-90° relative to the interior walls of the securement body  62 . Preferably, the engagement members  67  extend at an angle of 25-65°, or 35-55°, or approximately 45° relative to the interior walls. In the illustrated embodiment, two opposing engagement members  67  are positioned near the rear of, and extend into the interior of the securement body  62  at angles of approximately 45° relative to the side walls of the securement body  62 . Any other suitable number of engagement members  67  may alternatively be included on the securement body  62 . 
         [0046]    The securement body  62  further includes one or more base portions  68  extending laterally from lower side regions of the securement body  62 . The base portions  68  may be rigid, or may be generally flexible or contoured to conform to a specific patient site. A hydro-colloidal pad or other cushion may optionally be attached to an underside of each of the base portions  68  to provide increased patient comfort. The specific pad shape and size may vary. The underside of each of the base portions  68  (or of the cushions, if present) preferably includes an adhesive layer, which may be covered by one or more peelable strips (not shown), as described in the first embodiment. The one or more peelable strips are removable such that the adhesive may be exposed and the base portions  68  may be adhered to a desired securement site. 
         [0047]    In use, an attendant may pull the base portions  68  laterally away from each other to widen the central opening  64  so that it may be placed over a medical article  66 . The attendant may then release the base portions  68  so that the securement body  62  closes or securely conforms around the medical article  66 , as shown in  FIG. 9 . Alternatively, the attendant may snap the securement body  62  over top of the medical article  66 . The attendant may then remove the peelable strips, exposing the adhesive, and press the base portions  68  against a patient to adhere the securement apparatus  60  containing the medical article  66  to the patient&#39;s skin. 
         [0048]    As shown in  FIGS. 10-13 , in another embodiment, a securement device  80  includes a cover  82  or lid for covering and gripping the securement body  62 . The cover  82  is preferably attached to one of the base portions  68  via a hinge, pivot joint, or similar structure. The hinge may take various forms. For example, a hinge may include a tongue  84  on the cover  82  and a groove  86  formed in a hinge element  72  on the base portion  68 . A hinge may alternatively include a conventional pin-hinge mechanism, a snap-fitting mechanism including a snap-arm and a snap-receptacle, or any other suitable hinge or pivot joint. 
         [0049]    The cover  82  preferably includes a receiving region  87  configured to grip or squeeze the securement body  62 , and a lever  89  or handle for allowing an attendant to manipulate the cover  82 . The cover  82  further includes a latch element  88  for engaging the latch receptacle  70  in the securement body  62 . The latch element  88  is preferably supported on a release arm  90 , which is accessible via an opening  95  in the cover  82 . The release arm  90  is pressable toward the lever end of the cover  82  for releasing the latch element  88  from the latch receptacle  70 , which allows the cover  82  to be pivoted into the open position. 
         [0050]    Any other suitable latch mechanism may alternatively be included. For example, the lever end of the cover  82  may include a latch element for engaging a latch receptacle supported on the base portion  68  opposite the one supporting the hinge element  72 . Alternatively, a latch element may be positioned on the base portion  68  and a latch receptacle may be included in the cover  82 . In another alternative embodiment, the hinge may be omitted and the cover  82  or lid may snap over the securement body  62  into receiving elements on both base portions  68  via latch or lock elements at both ends of the cover  82 . 
         [0051]    In use, an attendant may pull the base portions  68  laterally away from each other to widen the central opening in the securement body  62  so that it may be placed over a medical article  66 . The attendant may then release the base portions  68  so that the securement body  62  closes or conforms around the medical article  66 , as shown in  FIG. 10 . Because the gripping cover  82  is included, the securement body  62  does not necessarily have to securely grip the medical article  66  without the aid of the cover  82 , but it may optionally do so. The attendant may then pivot the cover  82  to the closed position, in which the latch element  88  engages the latch receptacle  70 . In this closed position, the walls of the receiving region  87  grip or squeeze the outer walls of the securement body  62  toward the medical article  66  such that the engagement members  67  securely grip or squeeze the medical article  66 . The attendant may then remove the peelable strips, exposing the adhesive, and press the base portions  68  against a patient to adhere the securement device  80  containing the medical article  66  to the patient&#39;s skin. 
         [0052]    It is to be understood that not necessarily all objects or advantages disclosed herein may be achieved in accordance with any particular embodiment. Thus, for example, those skilled in the art will recognize that embodiments may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other objects or advantages as may be taught or suggested herein. In addition to the variations described herein, other known equivalents for each feature can be incorporated by one of ordinary skill in this art to construct a device and/or system in accordance with principles of this invention. 
         [0053]    While the illustrative embodiments have been described with particularity, it will be understood that various other modifications will be apparent to and can be readily made by those skilled in the art without departing from the spirit and scope of the invention. It is also contemplated that various combinations or sub-combinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the invention. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the disclosed invention. Thus, it is intended that the scope of the present invention herein disclosed should not be limited by the particular disclosed embodiments described above, but by a fair reading of the claims that follow.

Technology Classification (CPC): 0