Abstract:
Disclosed herein is an insertion site protection device that attaches to an access device. Specifically, the invention is a retention device for access lines and needles used for long-term access of drug delivery portals and pumps used to treat patients for a variety of diseases. The device will allow the clinician to visualize the skin at the insertion site for signs and symptoms of complications such as infection and adds an extra level of securement to help lessen the risk of inadvertent explant of the needle from the fully implanted access device. This is desired as the inadvertent removal of the needle may cause permanent damage to the access device, shortening the devices lifespan or necessitating device replacement as well as damage the skin and tissues over the device causing injury or infection to the patient and making the insertion site unusable.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit under Title 35 United States Code §119(e) of U.S. Provisional Patent Application Ser. No. 61/868,496; Filed: Aug. 21, 2013, and U.S. Provisional Patent Application Ser. No. 61/887,428; Filed: Oct. 6, 2013, the full disclosures of which are incorporated herein by reference. 
     
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    Not applicable 
       THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT 
       [0003]    Not applicable 
       INCORPORATING-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISC 
       [0004]    Not applicable 
       SEQUENCE LISTING 
       [0005]    Not applicable 
       FIELD OF THE INVENTION 
       [0006]    The present invention generally relates to a device and method of use directed to an insertion site protection device used to attach an access. More specifically, the invention generally relates to a retention device for access lines and needles (hereafter called access lines) used for ling term access of drug delivery portals and pumps used to treat patients for a variety of diseases. 
       BACKGROUND OF THE INVENTION 
       [0007]    Without limiting the scope of the disclosed device and method, the background is described in connection with a novel system and approach directed to a long term implant access line retention device and method of use. 
         [0008]    It is common in the treatment of patients to utilize catheters, drug delivery portals, and pumps to introduce fluids and medications directly into the patient or to withdraw fluids from the patient. Often, it becomes desirable to maintain such access over an extended period of time during the treatment of a patient. In order to keep the access line properly positioned for the duration of the treatment, the access line can be secured to the patient in a variety of ways. Most commonly, the primary retention method involves taping the access line to the patient. 
         [0009]    Securing an access line with tape upon the patient has certain drawbacks. For one, the tape is ineffective at preventing rotation of the access line. Also, the use of tape as the primary retention method at the insertion site can retain dirt or other contaminant particles, potentially leading to infection of the patient. The tape often blocks the insertion site from inspection and cleaning, leading to poor or insufficient maintenance. Additionally, removal of taped dressings can cause undesired motion of the access lines, and irritation of the insertion site. 
         [0010]    Taped dressings also require periodic changes. The frequent, often daily, removal and reapplication of adhesive tape to the skin of the patient can excoriate the skin area around the dressing. Such repeated applications of tape over the catheter or access line can additionally lead to the build-up of adhesive residue on the outer surface of the catheter or access line. This residue can also make the access line stickier and more difficult to handle for medical attendants. 
         [0011]    While the primary approach may fulfill its unique purpose, it does not fulfill the need for a practical and effective means for providing a long term implant access line retention device where the access line can remain in place over an extended period of time, remain safe from unintended motion, and accomplish this without using tape as the primary retention method. 
         [0012]    The present invention therefore proposes a novel system and method of use for securing retention lines which addresses the aforementioned drawbacks found in the prior art. 
       BRIEF SUMMARY OF THE INVENTION 
       [0013]    The present invention, therefore, provides a device and method of use for a long term implant access line retention device and method of use. 
         [0014]    In one embodiment, the device is comprised of at least one anchor pad including a lower adhesive surface configured to attach to a patient&#39;s skin with a circular opening positioned therein, a plurality of ties and latches for access line retention, and a retainer for the access line tubing to be therein constrained. The shape of the device is preferentially rectangular with a plurality of legs that achieve the securement through means of the lower adhesive surface, certain portions of which are specifically non-adhesive to prevent excessive attachment to the patient. In another embodiment, the device is made from materials that allow for the site to be fully viewable through utilization of clear materials such as silicone. In yet another embodiment, the device is also comprised of an antimicrobial coating or material or the means to interface with existing antimicrobials (such as Chlorhexidine) or antimicrobial patches in order to protect the insertion site from infection. In another embodiment the device is also comprised of an elastomeric belt preferentially shaped to accommodate a large variety of infusion set styles through the compliance of the device. In another embodiment, the device is further comprised of an infusion set as an integrated feature with a needle stick prevention feature upon removal. In yet another embodiment the device involves an access line retention system that includes either the use of an elastomeric belt preferentially shaped to accommodate a large variety of infusion set styles through the compliance of the retention system. In an additional embodiment the invention involves a an access line retention system in which the infusion set is an integrated feature of the device, and the retention device features form a needle stick prevention feature upon removal. The invention may also be used to stabilize needles in access sites during hemodialysis. 
         [0015]    In summary, the present invention generally relates to a device and method of use directed to a long-term implant access line retention device. More specifically, the invention generally relates to a retention device for access lines and needles (hereafter called access lines) used for ling term access of drug delivery portals and pumps used to treat patients for a variety of diseases. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
         [0016]    For a more complete understanding of the features and advantages of the present invention, reference is now made to the detailed description of the invention along with the accompanying figures in which: 
           [0017]      FIG. 1  is an illustration of a drug delivery portal in accordance with embodiments of the disclosure; 
           [0018]      FIG. 2  is a side illustration of a port placement beneath the skin being accessed by a needle in accordance with embodiments of the disclosure; 
           [0019]      FIG. 3  is a side view of an infusion set used for accessing ports and other long term implant devices illustrating the extension tubing, the luer, winged hub, and the huber needle in accordance with embodiments of the disclosure; 
           [0020]      FIG. 4  is a top view of the long term implant access line retention device in accordance with embodiments of the disclosure; 
           [0021]      FIG. 5  is a side view of the retention clip and belt of the long term implant access line retention device in accordance with embodiments of the disclosure; 
           [0022]      FIG. 6  is a side view of the tubing clamp of the long term implant access line retention device in accordance with embodiments of the disclosure; 
           [0023]      FIG. 7  is a top view of the long term implant access line retention device illustrating an infusion set in place via the retention clips and belts with the infusion set tubing in the tubing clamp in accordance with embodiments of the disclosure; 
           [0024]      FIG. 8  is a side view of the of the long term implant access line retention device illustrating an infusion set in place via the retention clips and belts with the infusion set tubing in the tubing clamp and the port under the skin in accordance with embodiments of the disclosure; 
           [0025]      FIG. 9  is an isometric view of the long term implant access line retention device illustrating the infusion set and elastomeric belt retained by locking clips. In accordance with embodiments of the disclosure; 
           [0026]      FIG. 10  is a front view of the long term implant access line retention device illustrating the infusion set, elastomeric belt, and elastomeric belt retention locking clips in accordance with embodiments of the disclosure; 
           [0027]      FIG. 11  is an isometric view of the long term implant access line retention device illustrating the elastomeric belt, elastomeric belt retention locking clip, thumb tab, locking clip, and infusion set tubing notch in accordance with embodiments of the disclosure; 
           [0028]      FIG. 12  is an isometric view of the long term implant access line retention device illustrating an integrated infusion set with an adhesive substrate attached to the skin of the user in accordance with embodiments of the disclosure; 
           [0029]      FIG. 13  is a side view of the long term implant access line retention device illustrating the integrated infusion with an adhesive substrate attached to the skin of the individual in accordance with embodiments of the disclosure; 
           [0030]      FIG. 14  is an isometric view of the long term implant access line retention device illustrating the integrated infusion set with an adhesive substrate in accordance with embodiments of the disclosure; 
           [0031]      FIG. 15  is an isometric view of the long term implant access line retention device illustrating the integrated infusion set with an adhesive layer and a frame in accordance with embodiments of the disclosure; 
           [0032]      FIG. 16  is a front view of the long term implant access line retention device illustrating the infusion set with an elastomeric belt retained by locking clips in accordance with embodiments of the disclosure; 
           [0033]      FIG. 17  is an isometric view of the long term implant access line retention device illustrating the belt retention clip, thumb tab, locking clip, and infusion set tubing clamp in accordance with embodiments of the disclosure; 
           [0034]      FIG. 18  is an isometric view of the long term implant access line retention device illustrated with an integrated infusion set attached directly to the adhesive substrate with backer tab in accordance with embodiments of the disclosure; 
           [0035]      FIG. 19  is side view of the long term implant access line retention device illustrated with an integrated infusion set attached directly to the adhesive substrate with backer tab in accordance with embodiments of the disclosure; 
           [0036]      FIG. 20  is an isometric view of the long term implant access line retention device illustrated with an integrated infusion set attached directly to the adhesive substrate after removal in accordance with embodiments of the disclosure; 
           [0037]      FIG. 21  is a top view of the long term implant access line retention device illustrated with an integrated infusion set and an adhesive substrate in accordance with embodiments of the disclosure; 
           [0038]      FIG. 22  is a side view of the long term implant access line retention device illustrated with an integrated infusion set and an adhesive substrate in accordance with embodiments of disclosure; 
           [0039]      FIG. 23  is an isometric view of the long term implant access line retention device illustrated with an integrated infusion set and an adhesive substrate. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0040]    Disclosed herein is an improved device and method of use for a long term implant access line retention device. The numerous innovative teachings of the present invention will be described with particular reference to several embodiments (by way of example, and not of limitation). 
         [0041]    Reference is first made to  FIG. 1 , an illustration of a drug delivery portal in accordance with embodiments of the disclosure. Shown here in an anatomical fashion is the position of the long term implanted medication port  1  in the patient&#39;s upper right chest under the clavicle. The long term implant access line retention device is meant to be placed on the patient&#39;s skin over the long term implanted medication port so that the needle used to access the device can be secured to the patient as to limit accidental removal of the needle causing trauma both to the patient and the long term implanted medication port septum.  FIG. 1  illustrates a drug delivery portal  1  also called a port showing a typical sub-clavian vein  2  placement with associated anatomy. This is provided for clarification of one type of access the subject device is expected to be used for. 
         [0042]    Reference is next made to  FIG. 2 , a side illustration of a port placement beneath the skin  11  being accessed by a needle  12  in accordance with embodiments of the disclosure. Shown here is how the long term implanted medication port  10  is accessed with a needle  12  through the patient&#39;s skin  11 . The needle  12  is inserted through the patient&#39;s skin  11  into the septum of the long term implanted medication port  10  with the needle  12  tip residing in the reservoir of the long term implanted medication port  10 . 
         [0043]    Reference is now made to  FIG. 3 , a side view of an infusion set used for accessing ports and other long term implant devices illustrating the extension tubing  21 , the luer  22 , winged hub  23 , and the huber needle  24  in accordance with embodiments of the disclosure. Seen here is a depiction of an access needle  24  and it&#39;s tubing extension  21  that is used to access the long term implanted medication port. The needle  24  is what is termed to be a “non-coring needle” with an offset bevel. The access device is controlled by holding the device by the “head”  23  which allows the accessing clinician to control the insertion of the needle into the long term implanted medication port. The clamp is engaged during the period of time when medications or fluids are not being infused through the device and is released or “opened” when medications and/or fluids are being infused into the patient through the long term implanted medication port. The luer connection  22  is where the clinician connects the tubing that is attached or inserted into a bag of medication, or in some cases a syringe of medication, that will be administered to the patient through the long term implanted medication device. 
         [0044]    Reference is now made to  FIG. 4 , a top view of the long-term implant access line retention device in accordance with embodiments of the disclosure. In this depiction you will note the presence of five (5) “legs”  31  as part of the device&#39;s body element  30  that is placed over the implant device in the patient after cleansing the skin with the intent to sterilize the area for insertion of a needle through the long term implant access retention device into the long term implanted medication port present in the patient&#39;s chest. The legs portion of the body  31  and/or the central body portion  30  attaches to the patient by an attachment means such as having an adhesive on the lower portion or sides of the legs  31  and/or central body portion  30  in contact with the patient. Once inserted into the long-term implanted medication port, the needle assembly is secured by pulling over the device the tie down or belts  33  (two illustrated in this figure) and securing it into the locking assembly  32  (two illustrated in this figure) thus securing the needle to the patient&#39;s chest. That is the tie down or belts  33  is an attachment element providing a means for securing the needle assembly to the patient by locking the tie down or belt element  33  into the locking element  32  or may be referred to as a locking assembly  32  which are also referred to and may be as an example and not a limitation, a tie down, arm, belt retention clamps. In an embodiment, as illustrated, the arms  33  rotate about their proximal end (connecting portion which is opposite of the end which is held down by the locking assembly  32 ). The tubing of the needle assembly is then locked into the “tail” of the device via the tubing retention clamp  34 . The body element  30  also has an opening portion to view the skin at the insertion site for signs and symptoms of complications such as infection as well as allow access to site for a needle as an example. In this illustration, the opening portion is approximately in the center of the body element  30  between the two attachment elements  33  and on the left side of the two locking elements  32 . In another embodiment, the opening portion is provided by the shape of the body element  30  and is not within the interior portion of the body element  30 . That is the body element  30  is shaped so that the body element  30  does not cover the access site. This will be discussed in more detail with the following figures. 
         [0045]    Reference is now made to  FIG. 5 , a side view of the retention clamp or clip (locking element)  40  and a tie down or belt (attachment element)  41  of the long-term implant access line retention device in accordance with embodiments of the disclosure. Seen here are the locking mechanism that ensures the access needle is secured in place. The tie down or belt  41  is attached to the opposite side of the center section of the long-term implant access retention device. The locking portion of the tie down or belt  40  is positioned on the opposite side of the long term implant access retention device so that when the tie down or belt  41  is passed over the needle assembly is can be secured in place with the retention clamps or clips  40 . 
         [0046]    Reference is now made to  FIG. 6 , a side view of the tubing retention clamp  50  of the long-term implant access line retention device in accordance with embodiments of the disclosure. Here seen is the tubing retention clamp  50  and the tubing hole  51 . The tubing of the needle assembly is passed through the gap  52  that is sized just smaller than the outer diameter of the tubing on the needle assembly to ensure securement in the tubing well or hole  51  of the tubing retention clamp  50 . 
         [0047]    Reference is now made to  FIG. 7 , a top view of the long term implant access line retention device illustrating an infusion set in place via the locking assembly  62  and belts or tie downs  63  with the infusion set tubing  64  in the tubing retention clamp  65  in accordance with embodiments of the disclosure. Here seen is the long-term implant access line retention device deployed. The needle assembly wing  61  is seen in the flat position post insertion of the needle assembly into the long-term implanted medication port. The belts or tie down  63  has passed over the needle assembly and is locked into the locking portion of the tie down mechanism or locking assembly  62 . The extension tubing of access needle assembly  64  can be seen secured into the tubing retention clamp  65 . 
         [0048]    Reference is now made to  FIG. 8 , a right side view of the of the long term implant access line retention device illustrating an infusion set in place via the tie down and belt retention clips  72  and belts or tie downs  73  with the infusion set tubing  74  in the tubing retention clamp  75  and the port  76  under the skin  77  in accordance with embodiments of the disclosure. Here seen is a side view of the long-term implant access line retention device deployed through the patients skin  77  into the long term implanted medication port  76 . Again note the access needle assembly  73  with the tie down pulled over the access needle assembly and locked into the locking portion of the tie down mechanism  72 . Again note the tubing of the access needle assembly  75  has been inserted into the tubing retention clamp  74 . 
         [0049]    Reference is now made to  FIG. 9 , an isometric top view of the long term implant access line retention device illustrating the infusion set and elastomeric belt retained by locking clips. in accordance with embodiments of the disclosure. Illustrated in this view of the long term implant access line retention device  80  includes and adhesive layer  91  and a frame  92  which are permanently attached. The adhesive layer includes finger elements or leg portions  91  (finger like features) which allow for the adhesive to conform to a patient&#39;s anatomy while the frame allows for the infusion set to be rigidly constrained. The infusion set  81  is shown in place locked down using an elastomeric belt  82 . The belt is designed to restrain the infusion set, and prevent unintentional displacement stretching across the infusion set, with enough flexibility to accommodate the large variety of infusion set styles. The belt  82  is retained by locking clips  83 , and the belt  82  is substantially ladder shaped with a central feature  84  designed to conform to the infusion sets hub shape  85  and a finger tab feature  90  that allows for the band to be stretched into position and locked down. The central shape includes a window  86  designed to allow visualization of the insertion site for inspection and cleaning. Said window may take on various shapes such as but not limited to circular, oval, obloid, or rectangular. Also included is a circular window opening shape  89  which has also been referred to as the body element&#39;s opening portion around the site that is preferentially sized and shaped to provide for direct site visualization and an area for placement of an antimicrobial patch. The infusion set tubing  87  is restrained in the tubing retention clamp  88  to prevent unintentional rotation of the infusion set. 
         [0050]    Reference is now made to  FIG. 10 , a front view of the long term implant access line retention device illustrating the infusion set  101 , elastomeric belt  102 , and elastomeric belt retention locking clips  103  in accordance with embodiments of the disclosure. In this view of the long term implant access line retention device  100 , the relationship of the infusion set  101  can be seen as it is expected to be in place and locked down by the elastomeric belt  102 . The belt  102  is shown stretched over and retained by locking clips  103 . One side of the belt in an embodiment is preferentially permanently attached. Also shown is the needle  104  which would be implanted through the skin and in a drug delivery port or similar device. The finger tab  105  is shown in the locked down position, laying flat against the adhesive layer. A user of the device would be able to pull up on the finger tab  105 . 
         [0051]    Reference is now made to  FIG. 11 , an isometric top view from the front of the long term implant access line retention device illustrating the elastomeric belt  121 , elastomeric belt retention locking clips  123 , 124 , thumb tab  125 , and infusion set tubing retention clip  129  in accordance with embodiments of the disclosure. Illustrated here is the long term implant access line retention device  120  with no infusion set in place as it would be prior to placement. The elastomeric belt  121  is shown in the unlocked position with the primary locking clips  123  shown as the band is positioned when open, and the other locking clip  124  can be seen. The belt will be pulled into position using the thumb tab  125  into locking clip  124  to retain the infusion set. Also shown is the infusion set tubing retention clamp  129  which prevents rotational movement. 
         [0052]    Reference is now made to  FIG. 12 , an isometric view of the long term implant access line retention device illustrating an integrated infusion set with an adhesive substrate attached to the skin of the user in accordance with embodiments of the disclosure. Illustrated here is the long term implant access line retention device  130  with an integrated infusion set  131  attached directly to the adhesive substrate  132  stuck to the skin  135  such that the infusion set wings  133  include hinging elements  134  or may be referred to as living hinges  134  designed to allow the infusion set wings  133  to fold over the needle when the infusion set  131  is removed. The adhesive substrate will then stick the two wings  133  together, making the needle inaccessible, and thus safe from unintentional needle stick. 
         [0053]    Reference is now made to  FIG. 13 , a side view of the long term implant access line retention device illustrating the integrated infusion with an adhesive substrate attached to the skin of the individual in accordance with embodiments of the disclosure. Illustrated here is the long term implant access line retention device  140  with an integrated infusion set  141  attached directly to the adhesive substrate  142  stuck to the skin  146  such that the infusion set wings  143  are designed to allow the infusion set wings to fold over the needle  144  when the infusion set is removed. The drug delivery port  145  is shown with the needle  144  in place. 
         [0054]    Reference is now made to  FIG. 14 , an isometric view of the long term implant access line retention device illustrating the integrated infusion set with an adhesive substrate in accordance with embodiments of the disclosure. Illustrated here is the long term implant access line retention device  150  with an integrated infusion set  151  attached directly to the adhesive substrate  152  such that the infusion set wings  153  include living hinges  154  designed to allow the infusion set wings to fold over the needle  155  when the infusion set is removed. The device is shown in its closed position with the wings  153  folded and covering the needle  155  and the adhesive substrate  152  sticking the two wings  153  together, making the needle inaccessible  155 , and thus safe from unintentional needle stick. 
         [0055]    Reference is now made to  FIG. 15  an isometric view of the long term implant access line retention device  140  which includes and adhesive layer  151  and a frame  152  which are permanently attached. The adhesive layer includes finger like features which allow for the adhesive to conform to a patient&#39;s anatomy while the frame  152  allows for the infusion set  141  to be rigidly constrained. The infusion set  141  is shown in place locked down using an elastomeric belt  142 . The belt is designed to restrain the infusion set, and prevent unintentional displacement stretching across the infusion set, with enough flexibility to accommodate the large variety of infusion set styles. The belt  142  can alternately be a cable tie, plastic clip, hook and loop, or other similar securement method. The belt is retained by locking clips  143 , and is substantially ladder shaped with a central feature  144  designed to conform to the infusion sets hub shape  145  and a finger tab feature  150  that allows for the band to be stretched into position and locked down. The central shape includes a window  146  designed to allow visualization of the insertion site for inspection and cleaning. Said window may be circular, oval, obloid, or rectangular. Also included is a semi-circular window  149  around the site that is preferentially sized and shaped to provide for direct site visualization and an area for placement of an antimicrobial patch. The opening  153  in the semi-circular window allows for passage of the device into place after the needle has been inserted. The infusion set tubing  147  is restrained in the tubing retention clamp  148  to prevent unintentional rotation of the infusion set  141 . 
         [0056]    Reference is now made to  FIG. 16  a front view of the long term implant access line retention device  160  wherein the relationship of the infusion set  161  can be seen as it is expected to be in place and locked down by the elastomeric belt  162 . The belt  162  is shown stretched over the infusion set  161  and retained by locking clips  163 . In an embodiment, one side of the belt  162  is preferentially permanently attached at bond point  166 . Also shown is the needle  164  which would be implanted through the skin and in a drug delivery port or similar device. The finger tab  165  is shown as it will be in the locked down position, laying flat against the adhesive layer. 
         [0057]    Reference is now made to  FIG. 17  you can see an isometric view of the long term implant access line retention device  180  with no infusion set in place as it would be prior to placement. The elastomeric belt  181  is shown in the unlocked position with the primary locking clips  183  shown as the band or belt  181  is positioned when open, and the other locking clip  184  can be seen. The belt  181  will be pulled into position using the thumb tab  185  into locking clip  184  to retain the infusion set. Also shown is the infusion set tubing retention clamp  189  which prevents rotational movement. 
         [0058]    Reference is now made to  FIG. 18  an isometric view of the long term implant access line retention device  190  with an integrated infusion set  191  attached directly to the adhesive substrate  192  and attached to a backer  195  with a tab to allow for removal of said backer after insertion of needle. The infusion set  191  incorporates flexible joint  196  allowing for flexing of the needle portion to accommodate varying depths of delivery port. The infusion set wings  193  include living hinges  194  designed to allow the infusion set wings to fold over the needle when the infusion set  191  is removed. The adhesive substrate  192  will then stick the two wings  193  together, making the needle inaccessible, and thus safe from unintentional needle stick. The wings  193  can also be locked by means of a clip or stay to retain the two wings together. 
         [0059]    Reference is now made to  FIG. 19  a side view of the long term implant access line retention device  200  with an integrated infusion set  201  attached directly to the adhesive substrate  202  and attached to a backer  206  with a tab to allow for removal of said backer after insertion of needle. The infusion set wings  203  are designed to allow folding over the needle  204  when the infusion set  201  is removed. The drug delivery port  205  is shown with the needle  204  in place. The infusion set  201  incorporates flexible joint  206  allowing for flexing of the needle  204  portion to accommodate varying depths of delivery port. The infusion set  201  incorporates flexible joint  206  allowing for flexing of the needle portion  204  to accommodate varying depths of delivery port  205 . 
         [0060]    Reference is now made to  FIG. 20  an isometric view of the long term implant access line retention device  210  with an integrated infusion set  211  attached directly to the adhesive substrate  212 . The infusion set wings  213  include living hinges  214  designed to allow the infusion set wings  213  to fold over the needle  215  when the infusion set  211  is removed. The device is shown in its closed position with the wings  213  covering the needle and the adhesive substrate  212  sticking the two wings  213  together, making the needle  215  inaccessible, and thus safe from unintentional needle stick. The infusion set  211  incorporates flexible joint  216  allowing for flexing of the needle portion  215  to accommodate varying depths of delivery port. 
         [0061]    Reference is now made to  FIG. 21  a top view of the long term implant access line retention device  220  with an integrated infusion set  221  attached directly to the adhesive substrate  222  such that the infusion set wings  223  include living hinges  224  designed to allow the infusion set wings  223  to fold over the needle when the infusion set  221  is removed. The adhesive layer  222  and wings  223  are also shown in phantom lines (dashed) such that the device can be seen in its open and closed positions. The phantom lines illustrate the closed or folded position. 
         [0062]    Reference is now made to  FIG. 22  a side view of the long term implant access line retention device  230  with an integrated infusion set  231  attached directly to the adhesive substrate  232  such that the infusion set wings  233  include living hinges  234  designed to allow the infusion set wings  233  to fold over the needle  235  when the infusion set  231  is removed. The adhesive layer  232  and wings  233  are also shown in phantom lines (dashed) such that the device can be seen in its open and closed positions. The infusion set  231  incorporates flexible joint  236  allowing for flexing of the needle portion to accommodate varying depths of delivery port. The phantom lines illustrate the closed or folded position. 
         [0063]    Reference is now made to  FIG. 23  an isometric front view of the long term implant access line retention device  240  with an integrated infusion set  241  attached directly to the adhesive substrate  242  such that the infusion set wings  243  include living hinges  244  designed to allow the infusion set wings  243  to fold over the needle  245  when the infusion set  241  is removed. The adhesive layer  242  and wings  243  are also shown in phantom lines (dashed) such that the device can be seen in its open and closed positions. The phantom lines illustrate the closed or folded position. 
         [0064]    In brief, as described herein provides for an effective and efficient device and method of use for a long-term implant access line retention device. 
         [0065]    The disclosed device and method of use is generally described, with examples incorporated as particular embodiments of the invention and to demonstrate the practice and advantages thereof. It is understood that the examples are given by way of illustration and are not intended to limit the specification or the claims in any manner. 
         [0066]    To facilitate the understanding of this invention, a number of terms may be defined below. Terms defined herein have meanings as commonly understood by a person of ordinary skill in the areas relevant to the present invention. 
         [0067]    Terms such as “a”, “an”, and “the” are not intended to refer to only a singular entity, but include the general class of which a specific example may be used for illustration. The terminology herein is used to describe specific embodiments of the invention, but their usage does not delimit the disclosed device or method, except as may be outlined in the claims. 
         [0068]    Any embodiments comprising a one component or a multi-component device having the structures as herein disclosed with similar function shall fall into the coverage of claims of the present invention and shall lack the novelty and inventive step criteria. 
         [0069]    It will be understood that particular embodiments described herein are shown by way of illustration and not as limitations of the invention. The principal features of this invention can be employed in various embodiments without departing from the scope of the invention. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, numerous equivalents to the specific device and method of use described herein. Such equivalents are considered to be within the scope of this invention and are covered by the claims. 
         [0070]    All publications and patent applications mentioned in the specification are indicative of the level of those skilled in the art to which this invention pertains. All publications and patent application are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. 
         [0071]    In the claims, all transitional phrases such as “comprising,” “including,” “carrying,” “having,” “containing,” “involving,” and the like are to be understood to be open-ended, i.e., to mean including but not limited to. Only the transitional phrases “consisting of” and “consisting essentially of,” respectively, shall be closed or semi-closed transitional phrases. 
         [0072]    The device and/or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While the device and methods of this invention have been described in terms of preferred embodiments, it will be apparent to those skilled in the art that variations may be applied to the device and/or methods and in the steps or in the sequence of steps of the method described herein without departing from the concept, spirit, and scope of the invention. 
         [0073]    More specifically, it will be apparent that certain components, which are both shape and material related, may be substituted for the components described herein while the same or similar results would be achieved. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope, and concept of the invention as defined by the appended claims.