Patent Publication Number: US-11020566-B2

Title: Securement device for medical devices

Description:
This is a continuation-in-part application of Ser. No. 15/330,188, filed Aug. 19, 2016, which is a continuation-in-part application of Ser. No. 13/986,351, filed Apr. 23, 2013, issued as U.S. Pat. No. 9,526,869. Said patent applications are hereby incorporated herein by reference in their entirety. 
    
    
     TECHNICAL FIELD 
     The present invention pertains to a device for securing a medical implement to the body of a patient. 
     BACKGROUND ART 
     Medical implements such as catheters, tubes and lines often must be used on patients and left in place. Accordingly, these items can be attached to a patient by various devices such as those disclosed in U.S. Pat. Nos. 7,922,697 and 4,392,857. Other prior art patents include: U.S. Pat. Nos. 3,900,026; 3,645,835; 5,116,324; 5,372,589; 5,885,254; 6,841,715; 7,294,752; and 8,881,899 and U.S. Design Pat. No. 252,822. Other prior art patent publications include: US2002/0188255 and US2006/02648836. 
     Catheters and others intravascular access devices have been used in clinical applications for delivery of fluids and medications to the patients and for the removal of fluids from the patients. These devices can stay on patients for days, and in some cases, the therapy can be applied for months, requiring multiple catheterizations and removals. During catheterization, it is important to secure the catheter properly. The catheter can be secured with tape or specially designed securement devices. Securing with tape can produce undesirable effects of contamination and can cause an infection of the insertion site. Tape also permits micropistoning motion of the insertion device that can cause infiltration, phlebitis and infection. During the past years, several different catheter securement devices were introduced to the market with various degrees of success such as U.S. Pat. Nos. 4,392,857, 7,922,697, and 9,256,869. The following aspects should be considered when designing a securement device: proper catheter securement, ease of application and patient comfort. 
     However, these devices can be either overly complex, bulky or not compatible with various medical implements. Thus, a simpler and more versatile securement device that would provide better securement, ease of application and patient comfort with minimal movement and micro-pistoning when in situ is desired. 
     SUMMARY OF THE INVENTION 
     The present invention pertains to a device for securing a medical implement to the body of a patient. The device preferably comprises a base having a locking device and an articulation strap connected to a cover. The cover further comprises a gear rack, where the gear rack is insertable into the locking device. The base further comprises a top surface with an adhesive film and release paper and a bottom surface attached to a patient attachment member. The base also has a cutout section. The base is preferably sloped at an angle between five and ten degrees. The cover preferably has at least two living hinges and the articulation strap has at least two living hinges. The locking device further comprises a sliding surface. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The objects and features of the present invention, which are believed to be novel, are set forth with particularity in the appended claims. The present invention, both as to its organization and manner of operation, together with further objects and advantages, may best be understood by reference to the following description, taken in connection with the accompanying drawings. 
         FIG. 1  is a side view of a preferred embodiment of the invention in an open position; 
         FIG. 2  is a side view of a preferred embodiment of the invention in a closed position; 
         FIG. 3  is a top partially exploded view of a preferred embodiment of the securement member; 
         FIG. 4  is a top view of a preferred embodiment of the invention in an open position; 
         FIG. 5  is a top view of an alternative embodiment of the invention where the base pad further comprises a transparent window; 
         FIG. 6  is a top perspective view of a preferred embodiment of the invention in an open position with a catheter in place; 
         FIG. 7  is a side view of an alternative embodiment of the invention without pads in a closed position; 
         FIG. 8  is a top view of an alternative embodiment of the invention without pads in an open position; 
         FIG. 9  is a side view of an alternative embodiment of the invention without pads in an open position; 
         FIG. 10  is top view of a preferred embodiment of the securement device for peripheral IV catheters; 
         FIG. 11  is a top view of the preferred embodiment in  FIG. 10  showing longitudinal and transverse articulation of the luer interconnection cushion at the articulation point located between Luer interconnection cushion and a base; 
         FIG. 12  is a perspective top view of the preferred embodiment in  FIG. 10  showing transverse articulation of the luer interconnection cushion at the articulation point between the cushion and the base; 
         FIG. 13  is a top view of a peripheral IV catheter insertion in a patient; 
         FIG. 14  is a top view of the preferred embodiment in  FIG. 10  with an initial placement over a peripheral IV catheter insertion the cushion is over the Luer Lock and connecting line; 
         FIG. 15  is top view of the preferred embodiment in  FIG. 10  after the luer interconnection cushion by transverse and longitudinal movement at the articulation point, is moved under the luer lock interconnection and secured to the skin of the patient; 
         FIG. 16  is a top view of the preferred embodiment in  FIG. 10  where the cover is placed over the luer interconnect and attached to the luer interconnection cushion; 
         FIG. 17  is top perspective view of an alternative embodiment of a securement device for peripheral IV catheters where the cover is attached to the base along the lateral pivot; 
         FIG. 18  is side perspective view of the luer interconnection securement device without the insertion site protection and viewing window; 
         FIG. 19  is a side perspective view of the luer interconnection securement device holding the luer interconnection and without the insertion site protection and viewing window where the Luer lock hub is protruding through the window; 
         FIG. 20  is side view of the luer interconnection securement device holding the luer interconnection and without the insertion site protection and viewing window; 
         FIG. 21  is a top view of the catheter securement device shown in  FIG. 5  combined with the embodiment of a securement device for peripheral IV catheters shown in  FIG. 10  to provide a central IV catheter securement device with insertion site protection and viewing window; 
         FIG. 22  is a top view of an alternate embodiment of a securement member for a central IV catheter; 
         FIG. 23  is a perspective view of an alternative embodiment of a securement member for a central IV catheter; 
         FIG. 24  is a perspective view of an alternative embodiment of a securement member for central IV catheter in a locked position; 
         FIG. 25  is a top view of preferred embodiment with initial placement on the patient under a wing of the central IV catheter; 
         FIG. 26  is a top view of a preferred embodiment of a securement member for a central IV catheter showing transverse and longitudinal articulation of the cove and a transverse articulation of the gear ratchet strap prior to the engagement of a primary locking device with gear rack strap; 
         FIG. 27  is a perspective view of preferred embodiment of a securement member for a central IV catheter showing the engagement between the gear rack strap and the primary locking device; 
         FIG. 28  is a perspective view of a preferred embodiment of a securement member for a central IV catheter showing the application of vertical force on the cover to secure the medical implement between the cover and the base; 
         FIG. 29  is a perspective view of a preferred embodiment of a securement member for a central IV catheter showing the transverse and longitudinal movement of a gear rack strap prior to engagement with the secondary locking site; 
         FIG. 30  is a perspective view of preferred embodiment of a securement member for a central IV catheter showing the gear rack strap being engaged with the secondary locking site and sideways removal of release paper to secure the device to the skin of the patient; 
         FIG. 31  is a perspective view of the preferred embodiment of a securement member for a central IV catheter secured to a patient; 
         FIG. 32  is a top perspective view of an alternative preferred embodiment for a securement device for medical devices; 
         FIG. 33  is a side cross-sectional view of the alternative embodiment&#39;s base and locking device; 
         FIG. 34  is a front view of a gear rack on the alternative embodiment; 
         FIG. 35  is a side view of the gear rack relative to a cover; 
         FIG. 36  is a perspective side view of a preferred embodiment of an articulation strap; 
         FIG. 37  is a perspective side view of the alternative preferred embodiment of the securement device in a closing position; 
         FIG. 38  is a top perspective view of the alternative preferred embodiment in an opened position with a catheter in place; 
         FIG. 39  is a side view of the embodiment in a closing position with a catheter in place (the black arrow shows the articulation of the cover, the white arrows are actually preferably visible on the embodiment); 
         FIG. 40  is a top perspective view of the embodiment in a locking position (the black arrow shows the articulation of the cover, the white arrows are actually preferably visible on the embodiment); 
         FIG. 41  is a top perspective view of the embodiment in a locked position with a catheter in place (the black arrows shows the preferred direction for removal of release paper, the white arrows are actually preferably visible on the embodiment); and, 
         FIG. 42  is a top perspective view of the embodiment in an opening/unlocking position (the black arrow shows the articulation of the cover and disengagement of the gear rack, the white arrows are actually preferably visible on the embodiment). 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     Various embodiments are now described with reference to the drawings, wherein like reference numerals are used to refer to like elements throughout. In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of one or more embodiments. It may be evident, however, that such embodiment(s) may be practiced without these specific details. 
     In the following paragraphs, the present invention will be described in detail by way of example with reference to the attached drawings. Throughout this description, the preferred embodiment and examples shown should be considered as exemplars, rather than as limitations on the present invention. As used herein, the “present invention” refers to any one of the embodiments of the invention described herein, and any equivalents. Furthermore, reference to various feature(s) of the “present invention” throughout this document does not mean that all claimed embodiments or methods must include the referenced feature(s). The following description is provided to enable any person skilled in the art to make and use the invention and sets forth the best modes contemplated by the inventors of carrying out their invention. Various modifications, however, will remain readily apparent to those skilled in the art, since the general principles of the present invention have been defined herein specifically to provide an improved securement device for peripheral and central IV catheters. 
     Referring now to  FIG. 1 , a side view of a preferred embodiment of the invention  10  is shown in an open position. The preferred embodiment shown in  FIG. 1  has a base pad  20  with a top and bottom surface, where at least a portion of the bottom surface of the pad  20  has an adhesive. The adhesive is preferably suitable for attaching the device to the body of a patient and can be any hypoallergenic adhesive suitable for skin application. 
     A securement member  30  is preferably attached to the top surface of the base pad  20 . The securement member  30  shown in  FIG. 1  has a member base  32  with a gear rack  34  extending from a first side and a locking device  36  extending from a second side. The gear rack  34  shown in  FIG. 1  is connected to the member base  32  by a living hinge  50 . The locking device  36  shown in  FIG. 1  is connected to the member base by a set of living hinges  50 . The gear rack  34  preferably has notches  35  as shown in  FIG. 3 . The notches  35  are preferably used to interact with the locking device  36 . The locking device  36  shown has a lock case  37  with an open side and a ratchet  38 , where the ratchet  38  engages with the notches  35 . The locking device  36  can be disengaged by removing the ratchet  38  from the notches  35 , e.g. using the open side of the lock case  37 . 
     A center pad  40  is preferably mounted on the member base  32 . The center pad  40  is preferably a foam pad with a plastisol sleeve or plastisol film coating, or a non-skid pliable plastic material. A lock pad  45  is preferably mounted on the locking device  36  next to the lock  37 . The lock pad  45  is preferably a foam pad with a plastisol sleeve or plastisol film coating, or a non-skid pliable plastic material. The securement member  30  is preferably a single integrated unit created by injection molding of plastic such as nylon. The member base  32  is preferably rigid and the locking device  36  and gear rack  34  are preferably flexible. 
     Referring now to  FIG. 2 , a side view of the preferred embodiment shown in  FIG. 1  is shown in the closed position. As shown, the gear rack  34  is insert into the side opening of the lock case  37  on the locking device  36 . The gear rack  34  is preferably held in the lock case  37  by the engagement of the ratchet  38  on the notches  35  of the gear rack  34 . The securement member  30  can be adjusted for a looser or tighter fit around a medical implement, e.g. a catheter  100 , using the gear rack  34  and lock case  37  with ratchet  38 . Preferably, the pads  40  and  45  are deformable around the implement  100  for a tighter hold on the implement  100 . The living hinges  50  preferably bend to allow the securement member  30  to move between the open position in  FIG. 1  and the closed position in  FIG. 2 , and depending on the location and number of living hinges  50 , the hinges  50  allow the securement member  30  to form a desired geometry to secure objects of different geometry and size. The living hinges  50  allow the invention to close into a more compact form, namely the closed position, while keeping the device simple in operation. 
     Referring now to  FIG. 4 , a top view of a preferred embodiment of the invention  10  is shown in an open position. The preferred embodiment shown in  FIG. 4  is preferably for use to secure a central venous catheter and/or other catheters or tubes.  FIG. 6  shows a preferred embodiment in an open position with a catheter in place. 
     Referring now to  FIG. 5 , a top view of another preferred embodiment of the invention  10  is shown in an open position. In  FIG. 5 , the alternative embodiment is preferably used for securement of peripheral intravenous (“IV”) catheters and/or line. The base pad  20  still preferably uses an adhesive on its bottom side for attachment to a patient. However, the base pad  20  further comprises a transparent window  25  with hypoallergenic adhesive, where the window  25  is usually made of clear urethane co-polyester film. The securement member  30  is then preferably mounted at the perimeter of the pad  20 . 
     Referring now to  FIG. 7 , another alternative embodiment of the securement member  30  is shown in a closed position. This alternative embodiment preferably does not use pads as described above. Instead, the member base  32  and locking device  36  have teeth  33  protruding from interior surfaces, namely the base securement and lock securement surfaces. The alternative embodiment is shown in open position in  FIGS. 8 and 9 . The teeth  33  or other protrusions such as bumps preferably are used to grip items in the device such as medical implements, pads or bandages. Again, the alternative embodiment shown in  FIGS. 7-9  preferably has living hinges  50  that allow the securement member  30  to be more compactly closed into different sizes and geometries. 
     Alternative Embodiment for Securement Device for IV Catheters 
     Referring back to  FIG. 5  and paragraph  8 , an alternative embodiment for a securement device for IV catheters is shown and described. Referring now to  FIG. 10 , another alternative embodiment of a securement device for IV catheters is shown. The invention  200  has a base  210 , preferably comprising an insertion site window  220  bordering with foam structure  241  and separated from a luer interconnection cushion  230  by a partial gap  240  and connected to the luer interconnection cushion  230  by an articulation point  250 . The invention  200  further comprises a cover  260  having a luer interconnection window  270 . Preferably, the base  210  and cover  260  comprise adhesive foam padding such as DE foam with acrylic adhesive or other hypoallergenic adhesives. Preferably, the window  220  preferably comprises polyurethane film (or other film). Additionally, the base  210  has a top surface and a bottom surface where the bottom surface preferably has adhesive so the base can be affixed to patients. The cover  260  also preferably has adhesive so it can be adhered to the luer interconnection cushion  230  with the Luer lock connection protruding through the window to hold a peripheral IV catheter in place on a patient. 
     Referring now to  FIG. 11 , the luer interconnection cushion  230  for the embodiment shown in  FIG. 10  is shown with longitudinal and transverse articulation in relationship to the base  210 , which is attached to the patient. The articulation point  250  facilitates the longitudinal and transverse articulation, which permits cushion  230  to be moved from above the medical implement to below the medical implement when base  210  is already fixed to the patient. Referring now to  FIG. 12 , the luer interconnection cushion  230  for the embodiment shown in  FIG. 10  is shown with transverse articulation. This bi-direction articulation more easily allows the base  210  to be place over a typical catheter insertion point  300  as shown in  FIGS. 13 and 14 . The insertion site window  220  is placed over the catheter insertion site  300  and adhered to the skin  310  of the patient. As shown in  FIG. 14 , the luer interconnection cushion  230  lays over the luer lock  320 . However, by longitudinal and transverse movement of the luer interconnection cushion  230  at the articulation point  250 , the cushion  230  is placed under the luer lock  320  and secured to the skin of the patient  310  with the adhesive on the bottom layer as shown in  FIG. 15 . 
     Referring now to  FIG. 16 , the cover  260  is placed over the catheter hub and connecting line with Luer lock  320  protruding through the interconnection window  270  and is attached to the cushion  230  with adhesive. The luer lock  320  is preferably visible through the luer interconnection window  270 . By allowing the Luer lock hub to pass through the window  270 , less pressure is transferred to the skin and better securement is accomplished. 
     Referring now to  FIG. 17 , yet another alternative embodiment is shown. This embodiment  500  has a base  510 , preferably comprising an insertion site window  520  separated from a luer interconnection cushion  530  by a partial gap  540  and connected to the luer interconnection cushion  530  by an articulation point  550 . The embodiment  500  further comprises a cover  560  having a luer interconnection window  570 . The cover  560  is attached to the cushion  530  at a lateral pivot  580 . 
     Additionally, the base  510  has a top surface and a bottom surface where the bottom surface preferably has adhesive so the base can be affixed to patients. The cover  560  also preferably has adhesive so it can be adhered to the cushion  530  to hold a peripheral IV catheter or a central IV catheter in place on a patient. Velcro® also could be used instead of adhesive to secure a medical device between the cover  560  and the cushion  530 . The base  510  and cushion  530  also preferably have a number of breather holes  590 . 
     The articulation point  550  and the lateral pivot  580  provide multiple axes of articulation for the device  500  including longitudinal and traverse. Transverse articulation between the luer connection cushion  530  and the cover  560  occurs along the lateral pivot  580 . 
     Preferably, an independent anchoring strip  600  is used to secure any catheter or infusion needle associated tubing upstream of the insertion site. The independent anchoring strip is shown in  FIG. 16 . 
     Referring now to  FIG. 18 , another alternative embodiment is shown where the securement structure no longer has the insertion site window  220 , and, the cover  260  is attached to the cushion  230  at a lateral pivot  280 .  FIGS. 19 and 20  show the embodiment of  FIG. 18  securing a luer lock  320  visible through the window  270 . 
     Referring now to  FIG. 21 , another alternative embodiment is shown. This embodiment preferably comprises the embodiment of the  FIG. 5  catheter securement device described above along with the embodiment shown in  FIG. 10  for the securement device for a central IV catheter. The securement member  600  is attached to the cushion  230  to provide a combination device comprising a securement and insertion window with bio-occlusive dressing.  FIG. 21  further shows the articulation point  250  that also comprises a set of perforations that allow for cushion  230  to separate from the base  210 . This facilitates securement of the catheter at any distance from the base  210 . Also shown in  FIG. 21  is overlapping folded release paper  400  that preferably covers the bottom layer of the Luer interconnection cushion  230  to cover the adhesive and preserve the adhesive until the device  200  can be applied to a patient&#39;s skin and to provide for easy placement of insertion site window, over the catheter in situ, without the cushion sticking to the patient&#39;s skin. Also shown are breather holes  290  for the base  210  to provide improved airflow to the patient&#39;s skin while the device  200  is in place. 
     Referring now to  FIG. 22 , a top view of a preferred embodiment of a securement member is shown. The securement member comprises a base  601  and a cover  602 . The base  601  on one side extends to a gear rack strap  603  and, on the other side, is connected with the cover  602  by an articulation strap  604 . The cover  602  terminates with a locking device  605 . The base  601  has a top and a bottom surface. The bottom surface is attached to a Luer cushion  230  and the top surface accepts the catheter. The top surface has a non-skid structure and/or adhesive or adhesive film  606  placed over it. The base  601  also has a vertical ridge  607  which is positioned opposite to the open end and which has at least one cutout  608 . The base  601  is also sloped from the ridge  607  toward an open end. The ridge  607  has a centrally located cut out  608 . The gear rack strap  603  articulates with the base with one living hinge  610  that permits the gear rack strap  603  to move transversely from a horizontal to a vertical position in relationship to the base  601 . The gear rack strap  603  has several horizontal notches and several living hinges above the notches. The gear rack strap  603  extends from the base  601  in two parts. The first part  609  houses the living hinge  610  and a second part  611  houses the notches  612  and the living hinges  613  on the opposite side. The two parts are separated by a “V” shaped space  614  extending the second part  611  at an angle  615  that is different from an angle  626  of the first part. The living hinge  610  of the first part  609  is preferably parallel with the base. The second part  611  is on an angle  615  in relationship to the base. The angle  615  is greater than 90 degrees, e.g. 90 to 130 degrees, and depends on the slope angle of the base  601 . The angle  626  of the first part is preferably 90 degrees to the side of the base  601  but can be between 90 and 130 degrees. 
     The articulation strap  604  connecting the base  601  with the cover  602  comprises two parts. The first part  616  houses the living hinge  617  and the second part  618  houses another living hinge  619  which are separated from each other by a “V” shape space  620 , extending the second part  618  on an angle in relationship to the base  601 . These structures provide for living hinges  617 ,  619  to perform in a motion that brings the cover  602  in parallel to the sloped base  601 . Because of the angular offset to the second part  618  (see  FIG. 22 ), the structure provides for cover to articulate in a parallel plane with the sloped base  700 , securing the medical implement as shown in  FIG. 24 . The articulation strap  604  also includes a solid transverse member  627  that is a solid structure between the two living hinges  617 ,  619 . The articulation strap  604  provides for movement of the cover  602  from a horizontal to a vertical position utilizing living hinge  617  that is close to the base  601 , and vertical to horizontal over the base position using the living hinge  619  close to the cover  602 . The cover&#39;s bottom side may have at least one channel  621  to accommodate irregular catheter structure. The cover  602  terminates with the primary locking device  605 . The locking device  605  comprises a locking case  622  and a ratchet with teeth  623 . It has a side opening  624  to permit the sliding of the gear rack  611  into the locking case  622  and allows for engagement of gear rack notches  612  with the teeth of the ratchet  623 . 
     A secondary locking site  701  is shown in  FIG. 24 . This locking site  701  comprises an angle  703  centrally located on the top surface of the cover  602 . The short side of the angle  703  is vertically integrated with the cover, so that the long side of the angle  703  extends over the cover  602  creating a slot  702  between the top surface of the cover and the bottom surface of the angle  703 . The securement member is locked in place by joint action of the first and second locking site  701 . The first locking site, by interaction between gear rack notches  612  and ratchet teeth  623  locks and secures the medical implement between the base  601  and the cover  602 . The secondary locking site  701  uses the set of living hinges  613  and permits the gear rack strap  603  to bend 90° and to be placed into the slot  702  of the secondary locking site, preventing the gear rack strap  603  from disengaging from the ratchet of the locking device  605  as shown in  FIG. 24 . 
     Referring now to  FIG. 23 , a perspective view of a preferred embodiment of a securement member is shown. The surface  606  of the base  601  is sloped from the ridge  607  toward an open side. The gear rack strap  603  and articulation strap  604  are angled in relationship to the base  601 . The ridge  607  has at least one cut out  608 . 
     In application, the release paper  400  is removed from the top side of the device and device is placed under the wings of a catheter and attached by adhesive to the catheter. As shown in  FIG. 25 , a catheter  800  is aligned in the cut out position of the ridge  607  with wings  802  placed against the ridge  607 . To close, a user folds the cover  602  over the catheter wings  802  and pushes slightly forward towards the insertion site. As shown in  FIG. 26 , the gear rack strap  603  is placed in a vertical position. With the gear rack strap  603  in a vertical position, the user aligns the side opening  624  of the locking case  605  with the gear rack  603  to engage it as shown in  FIG. 27 . As shown in  FIG. 28 , a user then pushes the cover  602  towards the base  601  and secures the catheter  800 . As shown in  FIG. 29 , the user then moves the gear rack strap  603  over the cover  602  and pushes it into the slot  702  to lock the device closed. The user preferably places the securement device on the skin of a patient and removes the release paper  400  on site when securing the device to the patient&#39;s skin as shown in  FIG. 30 .  FIG. 31  shows the device in closed and locked position on the patient. 
     The alternative embodiments in  FIGS. 10-21  are designed to secure intravenous catheters, commonly referred to as peripheral and central IV catheters. These embodiments are designed for use in protecting IV catheter insertion sites as well as securing the I.V. catheters. These embodiments are capable of securing peripheral and central IV catheters at all sites where IV catheters are typically inserted. 
     Alternative Embodiment for Securement Device 
     Referring now to  FIG. 32 , an alternative embodiment for securement of a medical device to patient is shown. The embodiment comprises a securement member  700  and a patient attachment member  706 . The securement member  700  comprises a base  701  and a cover  702 . The base  701  on one side extends to a locking device  703  and, on the other side, is connected to a cover  702  by an articulation strap  704 . The cover  702 , at its lower side houses a gear rack  705 . The base  701  has a top and a bottom surface. The bottom surface is attached to the patient attachment member  706  and the top surface is covered with an adhesive film attached to a release paper  707 , to secure e.g. a catheter (not shown) during placement. The base  701  also has a vertical ridge  708 , which is positioned opposite to the open end and which has at least one cutout  709 . The securement member  700  is preferably made of nylon but can be made from other plastics. 
     Referring now to  FIG. 33 , a side view of the alternative embodiment in  FIG. 32  is shown.  FIG. 33  further shows locking device  703  in relationship to the base  701 . The base  701  is preferably sloped from the ridge  708  toward an open end, and the locking device is aligned with the slope of the base  701 . The slope angle of the base  701  is preferably 5-10 degrees. 
     Referring now to  FIG. 34 , a front view of the alternative embodiment is shown.  FIG. 34  further shows the gear rack  705  and the cover  702 . The gear rack  705  is preferably affixed perpendicularly (90 degrees) to the bottom surface of the cover  702  without any articulation. The gear rack  705  preferably has multiple horizontal notches. The horizontal notches  710  are preferably parallel with the slope of the base  701 . The cover&#39;s bottom side, preferably has at least one channel  717  to accommodate, e.g. an irregular catheter structure (not shown). The cover&#39;s top side, preferably has at least one living hinge  718  (two living hinges  718  are shown in  FIG. 34 ), making the cover  702  flexible to accommodate different size catheters. 
     Referring now to  FIG. 35 , a side view of the gear rack  705  and cover  702  is shown. The gear rack  705  is preferably angled at greater than 90 degrees to the bottom surface of the cover  702 . The horizontal notches  710  are preferably parallel to the bottom surface of the cover  702  and are open on one side and closed by a ridge  711  on the other side. 
     Referring now to  FIG. 36 , a perspective view of the articulation strap  704  for this alternative embodiment is shown. The articulation strap  704  connecting the base  701  with the cover  702  comprises two parts. The first part  712  houses the living hinge  713  and the second part  714  houses another living hinge  715 . Living hinges  713  and  715  are separated from each other by a space  716 , extending the second part  714  at the same angle as the slope of the base  701  (5 to 10 degrees). These structures preferably provide for living hinges  713  and  715  that can allow the cover  702  to move in parallel to the sloped base  701 . The articulation strap  704  also includes a solid transverse member  716 , which is a solid structure between two living hinges  713  and  715 . The articulation strap  704  provides for movement of cover  702  from a horizontal to a vertical position utilizing living hinge  715  that is close to the base  701 . The strap  704  also provides for movement of cover  702  from a vertical to horizontal position over the base position, using the living hinge  713  close to cover  702 . 
     Referring now to  FIG. 37 , a perspective view of the alternative embodiment securement member  700  in closing position is shown. The base  701  terminates with locking device  703 . The locking device  703  preferably comprises a locking case  719 , a ratchet with teeth  720 , top opening  721  and a side opening  722 . The top opening  720  permits the gear rack  705  to slide into the locking case  719 , and allows for engagement of gear rack notches  711  with the teeth of the ratchet  720 . Locking case  719  also has a sliding surface  723  to facilitate entry of the gear rack  705  into top opening  721 , aligning the gear rack  705  with the ratchet  720 , and engaging gear notches  711  with ratchet teeth  720 , securing the medical implement (not shown) between the cover  702  and the base  701 . The side opening  722  preferably permits the sliding of gear rack  705  out of locking case  719  and allows for disengagement of gear rack notches  711  from teeth of ratchet  720 , resulting in unlocking the cover  702  from the base  701 . Thus, this permits removal of the medical implement from the securement member  700 . 
     In application, the release paper  707  is removed from the top side of the adhesive film and the securement device  700  is placed under the wings  1001  of a catheter  1000  and attached by adhesive to the catheter  1000 . As shown in  FIG. 38 , a catheter  1000  is preferably aligned in the cutout portion  709  of the ridge  708  with wings  1001  placed against the ridge  708 . Referring now to  FIG. 39 , a preferred closing action of the device  700  is shown. To close the securement member  700  and secure the catheter  1000 , a user preferably folds the cover  702  over the catheter  1000 . This aligns the gear rack  705  with top opening  721  and pushes the cover  702  over/against the base  701 , to lock the cover  702  to the base  701  and secure the catheter  1000 . Vertical force is preferably applied to the cover  702  to engage and lock gear rack  705  to ratchet  720 . 
     Referring now to  FIG. 40 , to attach the patient attachment member  706  to the skin of a patient, a user preferably places the securement device  700 , with the catheter  1000  locked into the device  700 , on a designated area on the patient and removes the release paper  726 . Referring to  FIGS. 41 and 42 , to open/unlock the securement member  700  (shown locked in  FIG. 41 ), a user preferably pushes the cover  702  at the notch area  727  horizontally to dis-engage the gear rack  705  from the ratchet  720  (as shown in  FIG. 42 ). Horizontal force is applied to the cover  702  to dis-engage the gear rack  705  from the ratchet  720 . This is the preferred method of removing the catheter  1000  from the securement member  700 . 
     Thus, an improved securement device for medical devices is described above that is a simpler and more versatile securement device that provides better securement, ease of application and patient comfort with minimal movement and micro-pistoning when in situ. In each of the above embodiments, the different positions and structures of the present invention are described separately in each of the embodiments. However, it is the full intention of the inventor of the present invention that the separate aspects of each embodiment described herein may be combined with the other embodiments described herein. Those skilled in the art will appreciate that adaptations and modifications of the just-described preferred embodiment can be configured without departing from the scope and spirit of the invention. Therefore, it is to be understood that, within the scope of the appended claims, the invention may be practiced other than as specifically described herein. 
     Various modifications and alterations of the invention will become apparent to those skilled in the art without departing from the spirit and scope of the invention, which is defined by the accompanying claims. It should be noted that steps recited in any method claims below do not necessarily need to be performed in the order that they are recited. Those of ordinary skill in the art will recognize variations in performing the steps from the order in which they are recited. In addition, the lack of mention or discussion of a feature, step, or component provides the basis for claims where the absent feature or component is excluded by way of a proviso or similar claim language. 
     While various embodiments of the present invention have been described above, it should be understood that they have been presented by way of example only, and not of limitation. Likewise, the various diagrams may depict an example architectural or other configuration for the invention, which is done to aid in understanding the features and functionality that may be included in the invention. The invention is not restricted to the illustrated example architectures or configurations, but the desired features may be implemented using a variety of alternative architectures and configurations. Indeed, it will be apparent to one of skill in the art how alternative functional, logical or physical partitioning and configurations may be implemented to implement the desired features of the present invention. Also, a multitude of different constituent module names other than those depicted herein may be applied to the various partitions. Additionally, with regard to flow diagrams, operational descriptions and method claims, the order in which the steps are presented herein shall not mandate that various embodiments be implemented to perform the recited functionality in the same order unless the context dictates otherwise. 
     Although the invention is described above in terms of various exemplary embodiments and implementations, it should be understood that the various features, aspects and functionality described in one or more of the individual embodiments are not limited in their applicability to the particular embodiment with which they are described, but instead may be applied, alone or in various combinations, to one or more of the other embodiments of the invention, whether or not such embodiments are described and whether or not such features are presented as being a part of a described embodiment. Thus the breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments. 
     Terms and phrases used in this document, and variations thereof, unless otherwise expressly stated, should be construed as open ended as opposed to limiting. As examples of the foregoing: the term “including” should be read as meaning “including, without limitation” or the like; the term “example” is used to provide exemplary instances of the item in discussion, not an exhaustive or limiting list thereof; the terms “a” or “an” should be read as meaning “at least one,” “one or more” or the like; and adjectives such as “conventional,” “traditional,” “normal,” “standard,” “known” and terms of similar meaning should not be construed as limiting the item described to a given time period or to an item available as of a given time, but instead should be read to encompass conventional, traditional, normal, or standard technologies that may be available or known now or at any time in the future. Likewise, where this document refers to technologies that would be apparent or known to one of ordinary skill in the art, such technologies encompass those apparent or known to the skilled artisan now or at any time in the future. 
     A group of items linked with the conjunction “and” should not be read as requiring that each and every one of those items be present in the grouping, but rather should be read as “and/or” unless expressly stated otherwise. Similarly, a group of items linked with the conjunction “or” should not be read as requiring mutual exclusivity among that group, but rather should also be read as “and/or” unless expressly stated otherwise. Furthermore, although items, elements or components of the invention may be described or claimed in the singular, the plural is contemplated to be within the scope thereof unless limitation to the singular is explicitly stated. 
     The presence of broadening words and phrases such as “one or more,” “at least,” “but not limited to” or other like phrases in some instances shall not be read to mean that the narrower case is intended or required in instances where such broadening phrases may be absent. The use of the term “module” does not imply that the components or functionality described or claimed as part of the module are all configured in a common package. Indeed, any or all of the various components of a module, whether control logic or other components, may be combined in a single package or separately maintained and may further be distributed across multiple locations. 
     As will become apparent to one of ordinary skill in the art after reading this document, the illustrated embodiments and their various alternatives may be implemented without confinement to the illustrated examples. For example, block diagrams and their accompanying description should not be construed as mandating a particular architecture or configuration. 
     The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.