Abstract:
A method of managing an access cite and site management device for an interventional cardiology access lumen having a cylindrical hub and a tubular portion extending from the cylindrical hub includes adhering an adhesive pad directly or indirectly to a patient at an intervention cardiology access site. After the adhering, an access lumen is deployed and a portion of the access lumen positioned against a retention pad that is supported by the adhesive pad. The retention pad has a surface configured to the portion of the access lumen.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation-in-part of International Patent Cooperation Treaty Application No. PCT/US2013/063802, filed on Oct. 8, 2013, which claims the benefit of U.S. provisional patent application Ser. No. 61/711,533, filed on Oct. 9, 2012; and this application claims the benefit of U.S. provisional patent application Ser. No. 62/100,125, filed on Jan. 6, 2015, the disclosures of which are hereby incorporated herein by reference in their entireties. 
     
    
     FIELD OF USE 
       [0002]    This invention is in the field of devices used to secure and properly retain sheaths and catheters that may be used during an interventional catheterization procedure. 
       BACKGROUND OF THE INVENTION 
       [0003]    During every interventional catheterization case there are sheaths and catheters that are used to gain access to the patient&#39;s vasculature. Once access is achieved, the sheaths and catheters are used to introduce fluids and devices directly into the patient vasculature. The devices may include, but are not limited to, guide wires, catheters, angioplasty balloons, and stent delivery systems. The sheaths and catheters remain in the patient&#39;s artery throughout the entire procedure, and multiple devices can be inserted and removed during the procedure. While inserting and removing devices, it is not uncommon for the sheath to move with the movement of the device. This movement is not ideal and can cause the sheath to slide out of position. The sheath can move farther into the artery or slide out of the artery depending on the movement. Either situation can create issues which negatively affect the procedure. 
         [0004]    If the sheath moves farther into the artery, the vessel can spasm and contract, making it difficult to insert and remove devices. The spasms can also make it difficult to remove the sheath. If the sheath loses its position by moving out of the vessel, artery access can be completely lost. 
         [0005]    Currently, to prevent the movement of the sheaths and catheters, tape is used to retain the sheath. Once artery access is gained, the sheath is taped to the skin to attempt to retain its position. Typically, the tape used is a polyurethane skin dressing. This process of using the dressing can be cumbersome. The dressing completely covers the sheath opening and must be modified to allow access to the proximal end, or opening, of the sheath. The modification of the dressing can weaken the structure of the dressing, and reduce the effectiveness during the repeated movements of devices through the sheath. 
         [0006]    Another issue is the adhesion of the dressing to the access site and sheath throughout the procedure. During the procedure, there typically is blood that may seep from the access site and/or proximal end of the sheath. The adhesives used on the dressings do not perform as well when exposed to fluids. The continued exposure to the fluids throughout the procedure can weaken the bond of the dressing to the sheath and the skin, and therefore lead to unwanted movement of the sheath. 
       SUMMARY OF THE INVENTION 
       [0007]    The present invention is a securement device and method whose goal is to securely retain the access lumen, such as a sheath or catheter, throughout the procedure without being affected by movement of the devices through the sheath. The device also has features which help maintain the adhesion of the device to the skin when fluids are seen during the procedure. The device is also designed to fit with various access lumen types. 
         [0008]    A method of managing an access site and site management device for an interventional cardiology access lumen having a cylindrical hub and a tubular portion extending from the cylindrical hub, according to an aspect of the invention, includes adhering an adhesive pad directly or indirectly to a patient at an intervention cardiology access site. After the adhering, an access lumen is deployed and a portion of the access lumen positioned against a retention pad that is supported by the adhesive pad. The retention pad has a surface configured to the portion of the access lumen. The access lumen is retained to the retention pad with a top retention strip. 
         [0009]    The retention pad surface configuration may have a receiving geometry complimentary to that of the hub. Typically, the retention pad surface will have a partial-circular shape configured to the size and shape of the cylindrical hub of the access lumen. The retention pad surface configuration may include side ribs that are configured to the size and shape of a side port of the access lumen. The side ribs may extend laterally in opposite directions from the partial-circular shape to allow the side port of the access lumen to extend in either lateral direction. 
         [0010]    Proximal access may be provided to an insertion hole in the access lumen that is positioned against the retention pad and retained by the top retention strip. The top retention strip may be an adhesive strip. The top retention strip may define a through-channel and the method includes passing an extension of the side port through the channel. The adhesive pad may include another through-channel that aligns with the through-channel in the top retention strip and the extension of the side port may pass through both through-channels. 
         [0011]    The adhesive pad may be adhered directly to the patient by wrapping the adhesive pad at least partially around the patient&#39;s extremity, such as the wrist or ankle. The adhesive pad may be adhered indirectly to the patient by adhering the adhesive pad to a drape at the intervention site. Access may be provided to an insertion opening at the hub of the retained access lumen. 
         [0012]    One embodiment of the invention is to make an access site management device which fits with all components from all sheath manufacturers. There are a few features that are common on all interventional sheaths. One feature is a round hub for insertion of interventional devices. The hub is cylindrical in shape with the proximal end of the hub having a hole for insertion of devices, and the distal end of the hub attaching to the tubular sheath which is inserted into the patient&#39;s artery. The other feature that is common is a side port attached to the hub of the sheath. The side port is used for injection fluids into the patient. The side port exits the hub normal to the axis of the sheath. These common features allow for a consistent, rigid attachment to a securement device. The securement device incorporates an overall circular cross-sectioned retention pad. This circular sectioned pad allows for engagement with the cylindrical hub of the sheath. Protruding normal to the axis of the circular section is a rib which engages with the side port of the sheath. Ideally, this rib contains a front and back side, which captures the side port, and prevents the movement of the sheath along the axis of the sheath. Therefore, as devices are moved in and out of the sheath, the sheath is held rigidly and prevents any movement. 
         [0013]    Another embodiment of the access site management device is the unique adhesive attachment. To prevent the inadvertent movement of the sheath during use, the securement device incorporates a circumferential adhesive strip which adheres to the skin at the access site and circumferentially to both sides of the device. This circumferential adhesion ensures strong adhesive bonds to the skin even if the access site and sheath encounter seeping blood. The device also incorporates a top adhesive which covers the sheath hub and side port, and ensures containment in the circular cross-sectioned pad. With the circular cross-sectioned pad with side ribs, and the adhesive bonds, any interventional sheath can be held rigidly throughout a procedure. 
         [0014]    An interventional cardiology access lumen site management device for use with an access lumen having a cylindrical hub and a tubular portion extending from said cylindrical hub, according to an aspect of the invention, includes an adhesive pad that is adapted to adhere directly or indirectly to a patient. A retention pad is supported with the adhesive pad. The retention pad has a surface configuration that is adapted to engage a portion of an access lumen and adapted to retain the access lumen. The site preparation device is adapted to adhere directly or indirectly prior to deployment of the access lumen and is adapted to secure the access lumen after deployment of the access lumen. A side port receiver is configured to the size and shape of a side port of the access lumen. 
         [0015]    These and other objects, advantages and features of this invention will become apparent upon review of the following specification in conjunction with the drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0016]      FIG. 1  is a perspective view of a sheath that is useful with the invention; 
           [0017]      FIG. 2  is a top plan view of the access site management device; 
           [0018]      FIG. 3  is a perspective view of the access site management device that is partially deployed showing engagement of the sheath side port in the device side channel; 
           [0019]      FIG. 4  is a perspective view of the access site management device that is fully deployed showing the adhesive attachment to the skin; 
           [0020]      FIG. 5  is the same view as  FIG. 4  taken from a different direction of the access site management device showing the adhesive attachment to the sheath with exposure of the proximal end of the sheath; 
           [0021]      FIG. 6  is a top plan view of an alternative embodiment of an access site management device; 
           [0022]      FIG. 7  is the same view as  FIG. 3  of the embodiment in  FIG. 6 ; 
           [0023]      FIG. 8  is a perspective view of another alternative embodiment taken from the top, front and right side thereof; 
           [0024]      FIG. 9  is a perspective view of the embodiment in  FIG. 8  taken from the top, front and left side thereof; 
           [0025]      FIG. 10  is a perspective view of the embodiment in  FIG. 8  taken from the bottom front and right side thereof; 
           [0026]      FIG. 11  is a perspective view of the embodiment in  FIG. 8  used with a method of managing an access site; 
           [0027]      FIG. 12  is the same view as  FIG. 11  illustrating replacement of an interventional sheath; 
           [0028]      FIG. 13  is the same view as  FIG. 12  showing unlocking of the side port; 
           [0029]      FIG. 14  is the same view as  FIG. 12  showing locking of the new side port; 
           [0030]      FIG. 15  is the same view as  FIG. 8  of another alternative embodiment; 
           [0031]      FIG. 16  is a side elevation view taken from the left side of the embodiment in  FIG. 15 ; 
           [0032]      FIG. 17  is a front elevation view of the embodiment in  FIG. 15 ; 
           [0033]      FIG. 18  is a perspective view of the embodiment in  FIG. 15  used with a method of managing an access site; 
           [0034]      FIG. 19  is a perspective view of the method in  FIG. 18  taken from a different direction than that of  FIG. 18 ; 
           [0035]      FIG. 20  is the same view as  FIG. 11  of yet another alternative embodiment; 
           [0036]      FIG. 21  is a view of the embodiment in  FIG. 20  taken from a different direction than the view in  FIG. 20 ; and 
           [0037]      FIG. 22  is the same view as  FIG. 20  illustrating assembly of the device to the sheath. 
       
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0038]    The present invention is embodied in an access site management device and method whose goal is to securely retain the sheath throughout the procedure without being affected by movement of devices through the sheath. 
         [0039]      FIG. 1  shows a typical interventional sheath  10 . A typical interventional sheath  10  contains a cylindrical hub  11 , a proximal side  12  with an insertion hole  13 . The sheath  10  has a side port  14  which exits the hub  11  normal to the axis of the hub. The sheath  10  has a tubular portion  15  which extends from the distal side  16  of the cylindrical hub  11 . 
         [0040]      FIG. 2  shows a top view of the securement device  20 . The securement device  20  has a circumferential adhesive pad  21  which can be directly connected with the patient by a wrap around an extremity, such as the wrist or ankle of a patient. Alternatively, adhesive pad  21  can be indirectly connected with the patient, such as by attachment of the pad to a drape around the procedure site. Attached to the adhesive pad  21  is the partial-circular cross-sectioned retention pad  22 . The retention pad  22  contains a partial-circular section  23  for locating and holding the hub of the sheath. The retention pad  22  also contains side ribs  24  which locate and hold the side port of the sheath. The securement device  20  also contains a top retention strip  25  for containing the sheath when placed into the retention pad. Retention strip  25  may be retained by adhesive, Velcro, clips, or the like. In the illustrated embodiment, retention strip  25  is retained by adhesive. 
         [0041]      FIG. 3  shows a perspective view of the securement device  20  with adhesive pad  21  retained to the patient&#39;s wrist. The adhesive pad can be attached to the patient prior to deploying the access lumen  10  thereby avoiding adherence problems from trying to apply adhesive over a site that has blood or other fluids present. Once adhesive pad  21  is attached to the patient directly or indirectly, sheath  10  is then inserted in the patient&#39;s vessel and cylindrical hub  11  is installed in the retention pad  22 . The figure shows the engagement of the sheath hub  11  in retention pad  22 , and the engagement of the side port  14  with the side ribs  24  of the retention pad  22 . 
         [0042]      FIG. 4  shows the application of retention strip  25  to retain sheath  10  to retention pad  22  after circumferential adhesion of the adhesive pad  21  around the wrist of the patient and deployment of sheath  10 . 
         [0043]      FIG. 5  shows the securement device  20  with the sheath  10  installed in the retention pad  22 . The figure shows the top adhesive  25  covering and containing the sheath  10  in the retention pad  22 . The figure shows the open access to the insertion hole  13  in the proximal side  12  of the sheath for access to insertion hole  13  during the interventional cardiology procedure. 
         [0044]    An alternative embodiment  120  shown in  FIGS. 6 and 7 , of an interventional cardiology access lumen site management device has the same features as site management device  20  except that it has an adhesive pad  121  that is similar to adhesive pad  21  except that it has a through-channel  132  defined therein. Site management device  120  further has a top retention strip  125  that is similar to top retention device  25  to retain a stent against a retention pad (not shown) that is similar to retention pad  22  with a partial circular surface (not shown) that is similar to section  23  formed therein. However, top retention strip  125  has a through-channel  130  that aligns with through-channel  132 . Through-channels  130 ,  132  accommodate a tubular extension of side port  14  of stent  10  to allow more freedom of movement of the extension of side port  14 . 
         [0045]      FIGS. 8 through 14  illustrate a securement device  220  including a retention pad  222  that may be manufactured in significant part of a polymeric material. The retention pad has an access slot  230 , a side port receiver  224  and a contact surface  225 . The contact surface has a retaining film thereon, such as an adhesive, a hydrogel, or a Velcro-type material that may be connected with an adhesive pad  421  shown in  FIG. 20 . Referring to  FIG. 11 , a sheath  10  is placed within a blood vessel and the hub  11  is located in the desired position on the anatomy. The sheath anchor  220  is placed over the hub by passing the hub through the access slot  230  and is adhered to the skin at the contact surface  225 . After the anchor device is placed on the skin, the hub is rotated through an angle so that the side port  14  of the sheath engages the side port  224  of device  220  as seen in  FIGS. 13 and 14 . This engagement prevents axial movement of the sheath thereafter. Sheath interchange may be completed by rotating the hub  11  so that the side port  14  is free from the side port  224  of device  220 , sliding the sheath out axially through the hub receiver  130  and thereafter replacing the sheath with another and re-engaging the side port in the side port receiver  120 . 
         [0046]    Referring to  FIGS. 15 through 19  inclusive, an alternate embodiment of the securement device  320  is shown. A retention pad  322  has a receiver  324  for the side port of the sheath and allows unimpeded access to the hub of the sheath during the procedure. 
         [0047]    Referring now to  FIGS. 20-22 , securement device  420  is shown in use. Securement device  420  has a skin adhesive contact pad  421  which is adhered to the skin prior to making an incision or penetrating the blood vessel, thereby eliminating the issues associated with adhesion to wet or bloody skin. The skin contact pad  421  has a first surface  425  to contact and adhere to the skin by means of an adhesive layer and a second surface  426  having a surface which can adhere to the lower surface  225  of the retention pad  222 . This may be a Velcro, hydrogel, adhesive, silicon, or other material. When the lower surface of the anchor  225  is brought into intimate contact with the contact surface  426  of the contact pad  421 , the two components form an assembly. The components may be detachably engaged if the two mating surfaces are of detachable materials, such as Velcro, or may be permanently engaged if the materials are of permanent bonding types, such as adhesive tape or other materials. This construction has the advantage that the contact pad is placed and adhered to dry skin prior to placing the sheath assembly. Further, the construction allows the hub to be placed axially in the optimal position and anchored at this position thereafter. The locking mechanism of engaging the side port of the sheath by rotation into the anchor body is the same as previously described. Skin contact pad  421  could alternatively be used with retention pad  322 . 
         [0048]    While the foregoing description describes several embodiments of the present invention, it will be understood by those skilled in the art that variations and modifications to these embodiments may be made without departing from the spirit and scope of the invention, as defined in the claims below. The present invention encompasses all combinations of various embodiments or aspects of the invention described herein. It is understood that any and all embodiments of the present invention may be taken in conjunction with any other embodiment to describe additional embodiments of the present invention. Furthermore, any elements of an embodiment may be combined with any and all other elements of any of the embodiments to describe additional embodiments.