Abstract:
The invention provides a device for securing an invasive medical implementation, such as a catheter, to a patient. The device generally combines an adherent surface that attaches the device to the skin and a flexible clasping means to grasp the catheter and reversibly secure it to the device.

Description:
FIELD OF THE INVENTION 
       [0001]    The invention generally relates to a device for securing an invasive medical implementation to a subject. Specific embodiments allow a user to secure a catheter to a patient rapidly and without the aid of prior surgical tapes, glues, dressings and/or foams. 
       BACKGROUND 
       [0002]    Medical implementations such as catheters, medical lines, tubing and like articles are routinely used to move fluids to and from patients. A catheter typically includes a hard part which remains exterior to the patient, and a soft part, at least a portion of which is inserted into the patient. The hard part can include a connection point (sometimes called a hub) to which other medical implementations (eg., a syringe, fluid supply tube) can be joined. Following installation and securement (“catheterization”), the catheter is a convenient means for administering fluids such as drugs or withdrawing blood or other body fluids from the patient. 
         [0003]    According to prior practice, a caregiver uses glue, foam, surgical tape, dressing or a combination thereof to secure the catheter against the skin of the patient. Typically, the caregiver covers the catheter insertion site with a dressing after swabbing the area with antiseptic. The entire procedure can take several minutes or more. In addition, catheterization can require frequent disconnection between of the catheter as new medical lines are added or replaced, thereby stressing securing tapes, glues or foams. In settings involving long-term catheter use, the caregiver must frequently clean the insertion site about the inserted (indwelling) catheter, change the dressings, and apply fresh antiseptic. 
         [0004]    There has been increasing recognition that caregivers spend too much time securing catheters to patients. Moreover, prior practice has not been able to prevent catheter dislodgement and/or infection near insertion sites. Catheters that are taped or glued in place are readily pulled out during “routine” dressing changes. Surgical tapes and foams can be uncomfortable or irritating for some. Many patients cannot rest comfortably knowing that a secured catheter may dislodge from the insertion time during sleep. Young or elderly patients are especially vulnerable to these and related shortcomings. 
         [0005]    It is becoming clear that prior catheter securement devices and procedures have not optimally served patients. These and other drawbacks have created a need for a more rapid and reliable device for securing catheters to patients. Accordingly, it would be desirable to have a device that can be used to secure a catheter to the skin of a patient that does not rely on use of prior tapes, glues, dressings and/or foams. It would be further desirable to have methods of using such a device so that the catheter can be rapidly and reliably secured to the patient. 
       SUMMARY 
       [0006]    In broad terms, the invention provides a device for securing an invasive medical implementation such as a catheter to a patient. The device generally combines (1) an adherent surface that attaches the device to the skin and (2) a flexible clasping means to grasp the catheter and secure it to the device. Securement is typically reversible. Preferred practice of the invention avoids use of prior tapes, glues, dressings and/or foams to secure the medical implementation to the patient. Use of the invention can substantially reduce catheter securement times, thereby enhancing the reliability, comfort, and safety of catheterization. The invention is relatively simple to use and can be employed by experienced and inexperienced caregivers alike. 
         [0007]    Accordingly, and in one aspect, the invention provides a device for securing a catheter to an insertion site of a patient. In one embodiment, the device includes at least one of and preferably all of the following as operably linked components: 
         [0000]    (a) a flexible base comprising a sealed patient contacting surface,
 
(b) a solid portion joined to the flexible base and comprising a clasping means for securing the catheter; and
 
(c) a handle adapted to remove, with one digit (finger or thumb), a seal from the patient contacting surface. Preferably, the handle is joined to the seal which seal protects the adhesive on at least part of the surface sufficient to attach the secured catheter to the patient insertion site. In a particular invention embodiment, the device will be referred to herein as a “catheter clip” or like phrase.
 
         [0008]    In another aspect, the invention provides a unitary package that includes the device wherein the device is preferably sterile and includes a packing material substantially resistant to penetration by microorganisms, viruses and the like. 
         [0009]    In yet another aspect, the invention provides a method of securing a catheter to an insertion site of a patient. In one embodiment, the method includes at least one of and preferably all of the following steps: 
         [0000]    (a) providing a device comprising: 
         [0010]    (i) a flexible base comprising a sealed patient contacting surface, 
         [0011]    (ii) a solid portion joined to the flexible base and comprising a clasping means for securing the catheter to the device, 
         [0012]    (iii) a handle region joined to the flexible portion and adapted to remove, with one hand, a seal from the patient contacting surface, thereby exposing the adhesive for releasably securing the catheter to the insertion site of the patient, 
         [0000]    (b) removing, with at least one digit, the seal from the patient contacting surface of the flexible portion to expose the adhesive,
 
(c) guiding the device over the catheter,
 
(d) contacting the flexible base (patient contacting surface) to the patient sufficient to adhere the device thereto; and
 
(e) actuating the clasping means to grasp the catheter (preferably at or around the solid part), thereby securing the catheter to insertion site of the patient.
 
         [0013]    Further uses and advantages of the invention will be apparent from the following Drawings and discussion. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0014]      FIG. 1A  is a drawing (top view) showing a catheter clip of the invention. 
           [0015]      FIG. 1B  is a drawing (top view) showing the catheter clip securing a catheter having lateral wings for stabilizing the catheters and connecting hubs. 
           [0016]      FIG. 2  is a drawing (cross-sectional view) of the catheter clip securing a catheter against the skin of a patient. 
       
    
    
     DETAILED DESCRIPTION 
       [0017]    In the present section, the invention is illustrated with regard to one or more particular embodiments. These embodiments are intended merely to illustrate certain principles of the invention and not to limit the invention or use thereof in any way. 
         [0018]      FIG. 1A  shows a particular embodiment of the invention (“catheter clip”) for securing a catheter to a skin insertion site of a patient. The catheter clip  10  includes a solid portion  50  joined to a flexible base  20 . The flexible base  20  includes an underlying patient contacting surface  41  (see  FIG. 2 ) that is at least partially sealed with a suitable sealing medium such as paper or a plastic. The solid portion  50  includes a clasping means  51  adapted to grasp and securing the catheter to the catheter clip  10 . The clasping means  51  may include or consist of nearly any suitable plastic material provided it flexibly resists extension by a user. A cover  40  is in actuating contact with a handle  30  attached to the flexible base  20 . The handle  30  and the cover  40  are in sealing contact with a seal formed on at least part of the patient contacting surface  41 . Preferably, the seal will protect an adhesive on at least part of the patient contacting surface  41 , preferably substantially all of it. The amount of adhesive on the patient contacting surface  41  is not critical provided it is sufficient to attach the catheter clip  10  to the patient. 
         [0019]    Referring again to  FIG. 1A , the solid portion  50 , flexible base  20  and the handle  30  together define an open chamber  52  that includes a distal end  53  (shown contacting a first centerpoint) for receiving the catheter and a proximal end  54  (shown contacting a second centerpoint) for accepting the catheter from the distal end  53  toward the skin insertion site  90  (see  FIG. 1B ). The first centerpoint of the distal end  53  and the second centerpoint of the proximal end define an axis  55  surrounded by the open chamber  52 . In preferred use, a catheter (typically the hard part) is placed along the axis  55  for securement to the catheter clip  10  by the clasping means  51 . As shown, the open chamber  52  further includes a top  56  defined by at least part of the solid portion  50  and a bottom  57  (see  FIG. 2 ) opposite the top  56  and defined by the handle  30  and the flexible base  20 . In the embodiment shown, the top  56  is in actuating contact with the clasping means  51 , wherein actuation of the top  56  is sufficient to flex the clasping means  51  so that it grasps and secures the hard part of a catheter to the catheter clip  10 . 
         [0020]    The flexible base  20  and optionally the solid portion  50  further define a compartment  70  positioned at or near the insertion site  90 . The compartment  70  is typically adapted to at least partially surround the patient insertion site including completely surrounding it. According to  FIG. 1A , the top  56  substantially extends from the clasping means  51  to the compartment  70 . Optionally, the compartment  70  is in sealing contact with the seal of the patient contacting surface  41 . In one embodiment, the compartment  70  will include an effective amount of an antimicrobial (antiseptic) agent sufficient to minimize or eliminate infection at the insertion site. Suitable examples include certain alcohols and phenols known to have antiseptic properties (eg., isopropyl alcohol, phenol), iodine tinctures, chlorhexidine, povidone-iodine (Betadine®) and the like. Preferably, the agents are provided in the compartment  70  in a liquid, semi-liquid or cream format. Topical use antibiotics (eg., bacitracin zinc, polymysin B sulfate, and/or neomycin sulfate), preferably in cream form, can also be used alone or in combination with other antimicrobial agents. 
         [0021]    In the embodiment shown in  FIG. 1A , the flexible base  20  is substantially planar. Preferably, the flexible base  20  is composed of a material (or composite) of sufficient rigidity so that self-folding is minimized or eliminated. To further minimize self-folding, the catheter clip  10  includes extensions  60 ,  61 , and  62  of the solid portion  50  which are positioned to help keep the flexible base  20  substantially extended. Additional rigidity is provided by firming contact between the extensions  60 ,  61  and  62  and the flexible base  20 . 
         [0022]      FIG. 1B  shows the catheter clip  10  with a catheter  140  secured to the patient insertion site  90  which catheter  140  is composed of a catheter hard part  110  with a connecting hubs  111 ,  112 , lateral wings  100  for stabilizing the catheter and a catheter soft part  80  extending from the insertion site  90  toward and under the skin  120 . The catheter  140  is secured to the catheter clip  10  by actuation of clasping means  51  as previously described. The catheter clip  10  is secured to the patient through the adhesive of the patient contacting surface  41 . 
         [0023]    Referring now to  FIG. 2 , the catheter clip  10  is shown in cross-section with the catheter  140  secured to the patient insertion site  90 . Also shown is the top  56  of the solid portion  50  with a protrusion  130  that extends acutely from the axis  55  (see also  FIG. 1A ) and is in actuating contact with the clasping means  51 . The protrusion  130  is adapted to receive at least one digit from a user which digit engages protrusion  130  to flex the clasping means  51 , grasp the catheter  140  (preferably along the hard part  110 ), and secure it to the catheter clip  10 . 
         [0024]    According to one use of the catheter clip  10 , a caregiver inserts the soft part  80  of the catheter  140  under the skin  120  at the patient insertion site  90 . Subsequently, the caregiver uses a finger to remove cover  40  and the handle  30  in sealing contact with the adhesive along the patient contacting surface  41  of the flexible base  20 , thereby removing the seal and exposing the adhesive. The catheter clip  10  is then guided around the patient insertion site  90  to reversibly attach the invention to the skin  120  of the patient. Using the same or different finger, the caregiver engages the protrusion  130  to flex the clasping means  51  and grasp the hard part  110  of the catheter  140 , thereby releasably securing the catheter  140  to the catheter clip  10 . The procedure is readily reversible. In one approach, the patient contacting surface  41  is removed from the patient. The clamping means  51  is flexed by the user to allow removal of the catheter  140  from the invention. 
         [0025]    Manufacture 
         [0026]    The invention can be readily made using one or a combination of approaches. In one method, the hard part of the catheter clip  10  is molded as a single-piece system with the clasping means  51  capable of convenient and repeated flexure. The hard part of the catheter clip  10  can be molded from a single polymer material in a one-shot injection molding operation. Many suitable materials could be used such as nearly any moldable plastic that is capable of being formed as provided herein and retaining its shape during use. More specific materials include, but are not limited to, many acrylic and polycarbonate materials, styrenes, and ABS. Other suitable materials include certain polyesters, nylons, and other polymer materials such as certain polyethylenes and polypropylenes. Certain memory plastics may also be used provided intended results are achieved. If two different materials are used, the device can be made by a two-shot process whereby both materials are injected at different gates into the mold cavity. Other processes are also feasible, such as insert molding. MRI compatible materials may be suitable for some invention applications. 
         [0027]    Once the hard part of the catheter clip  10  is made, it can be joined using standard approaches to the soft part of the device which generally includes the flexible base  20 . 
         [0000]    The flexible base  20  can be made using one or a combination of conventional approaches. In one method, the flexible base  20  comprises a relatively thin film, such as a thin urethane or silicone film, adhered to the handle  30  and cover  40 . The handle  30  and cover  40  can be made somewhat stiffer than the flexible base  20  facilitate handling. The handle  30  and the cover  40  may extend beyond an edge or edges of the thin film, so that the flexible base  20  can be handled relatively easily. In one embodiment, substantially all of the undersurface of the flexible base  20  (ie., the patient contacting surfacem41) is adhesively coated and contacted with a separate release seal which extends beyond the perimeter of the thin film and is in sealing contact with the handle  30  and cover  40 . Nearly any adhesive suitable for topical medical use can be applied to the thin film using standard methods. Examples include, but are not limited to, an acrylic adhesive containing an acrylic acid alkyl ester as a main component, a rubber adhesive containing a natural rubber and/or a synthetic rubber as a main component, as well as “pressure sensitive adhesives” (PSAs). See also U.S. Pat. Nos. 7,094,944; 6,936,661; and 6,805,961 and references disclosed therein for other suitable adhesives. 
         [0028]    As will be apparent, the seal may protect the adhesive on at least part of the patient contacting surface  41  (e.g., less than about 50%, for instance, about 5%, 10%, 20% or about 30%), preferably substantially all of the surface (e.g., about 80%, 90%, 95% up to about 100%). The amount of adhesive on the patient contacting surface is not critical provided intended results are achieved. 
         [0029]    Additional Embodiments 
         [0030]    As will be appreciated, other embodiments of the catheter clip  10  are within the scope of the invention. For instance, and referring now to  FIG. 1A , the clasping means  51  is shown as an integral part of the solid portion  50 . However in another embodiment, clasping means  51  may be joined to solid portion  50  through an elastic or semi-elastic polymer such as a memory plastic. Alternatively, the clasping means  51  can include or be joined to the solid portion  50  through a spring or related mechanism. 
         [0031]    In another embodiment of the catheter clip  10 , the top  56  includes means (e.g., a spring or a rod) to position the clasping means  51  to a site desired by the user. It will be appreciated that in other embodiments, the top  56  and the clasping means  51  may be the same component. 
         [0032]    In another embodiment, the compartment  70  can be quite small and be just sufficient to surround the insertion site of the catheter. In this embodiment, it will not be necessary to make the compartment  70  so that it is in sealing contact with other components of the device. Also in this embodiment, the use of an antimicrobial may not be necessary. Instead, it may be applied to the skin surface by the user. 
         [0033]    Nearly any configuration of the protrusion  130  is acceptable provided intended results are achieved. For instance, and in one embodiment, the protrusion  130  will extend substantially perpendicular to the axis  55  of the open chamber  130 . 
         [0034]    In yet another embodiment of the catheter clip  10 , only one or two of the extensions  60 ,  61 , and  62  will be used to provide rigidity to the flexible base  20 . In yet another embodiment, the flexible base  20  will be of sufficient rigidity so that none of extensions  60 ,  61  and  62  are needed. 
       Incorporation by Reference 
       [0035]    The contents of all references (including literature references, issued patents, published patent applications, and co-pending patent applications) cited throughout this application are hereby expressly incorporated herein in their entireties by reference. 
       Equivalents 
       [0036]    It will be appreciated that those skilled in the art, upon consideration of this disclosure, may make modifications and improvements within the spirit and scope of the invention. Moreover, those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents of the specific embodiments of the invention described herein. Such equivalents are intended to be encompassed by the following claims.