Abstract:
A device is disclosed for providing an indication as to the relative position of a vessel or artery opening thereby facilitating the choice of which several closure techniques to use. A disclosed device includes an outer tube and a collapsible foot slidably disposed within a distal end of the outer tube. The device may further include one or more threaded suture needles, a biodegradable plug or other wound closing device that is connected to another shaft. The collapsed or folded foot is pushed distally out of the tube and through the opening in the vessel whereupon the foot expands. Pulling the expanded foot in the proximal direction provides an indication as to the orientation of the opening in the vessel, which assists in determining the type of closing procedure to be carried out.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application is a non-provisional patent application claiming priority under 35USC§119(e) to U.S. provisional patent application Ser. No. 60/888,208 filed on Feb. 5, 2007 
    
    
     FIELD OF THE DISCLOSURE 
     Methods and apparatuses are disclosed for determining the orientation of a vascular opening on the vessel and thereafter closing said vascular opening. More specifically, systems and methods are disclosed for accurately determining the location of a vascular opening on the vessel so that the appropriate closure technique is employed such as the appropriate suturing technique or plug or pledget technique. 
     BACKGROUND OF THE DISCLOSURE 
     Various surgical procedures are performed by medical specialists such as cardiologists and radiologists, utilizing percutaneous entry into a blood vessel. To facilitate cardiovascular procedures, a needle is introduced through the skin and into a target blood vessel, often the femoral artery. The needle forms a puncture through the blood vessel wall at the distal end of a tract that extends through the overlying tissue A guide wire is introduced through a bore of the needle before the needle is withdrawn over the guide wire. An introducer sheath is next advanced over the guide wire. The sheath and guide wire are left in place to provide access during subsequent procedures. 
     The sheath facilitates passage of a variety of diagnostic and therapeutic instruments and devices into the vessel and its tributaries. Such diagnostic procedures may include angiography, intravascular ultrasonic imaging, and the like. Typical interventional procedures include angioplasty, atherectomy, stent and graft placement, embolization, and the like. After a procedure is completed, the catheters, guide wire, and introducer sheath are removed, and it is necessary to close the vascular puncture to provide hemostasis and allow healing 
     The common technique for achieving hemostasis is to apply pressure, either manually or mechanically, on the patient&#39;s body in the region of the tissue tract and vascular puncture. Typically, pressure is applied manually and subsequently is maintained through the use of mechanical clamps and other pressure-applying devices. While effective in most cases, the application of external pressure to the patients skin presents a number of disadvantages. For example, when applied manually, the procedure is time-consuming and requires the presence of a medical professional for thirty minutes or more. For both manual and mechanical pressure application, the procedure is uncomfortable for the patient and frequently requires the administration of analgesics to be tolerable. 
     Moreover, complications from manual pressure application are common The application of excessive pressure can occlude the underlying artery, resulting in ischemia and/or thrombosis. Even after hemostasis has apparently been achieved, the patient must remain immobile and under observation for hours to prevent dislodgment of the clot and to assure that bleeding from the puncture wound does not resume. Renewed bleeding through the tissue tract is not uncommon which can result in hematoma, pseudoaneurisms, and arteriovenous fistulas. Such complications may require blood transfusion, surgical intervention, or other corrective procedures. The risk of these complications increases with the use of larger sheath sizes, which are frequently necessary in interventional procedures, and when the patient is anticoagulated with heparin or other drugs. 
     As a result, several alternatives to the manual pressure hemostasis technique have been proposed to address the problem of sealing the opening in vessel wall following percutaneous transcatheter procedures. For example, bioabsorbable, thrombogenic plugs comprising collagen and other materials have been used at the vessel wall opening to stop bleeding. These large hemostasis plugs stimulate blood coagulation at the vessel opening. Other techniques provide for the use of small dissolvable disks or anchors that are placed in the vessel to block or clamp the opening. 
     Additional techniques use needles and sutures to ligate the opening. The needle is and sutures are delivered through a catheter Obviously, any suturing procedure carried out through a catheter or tube requires a high level of skill. 
     Another technique involves the injection of a procoagulant into the opening with a balloon catheter blocking inside the vessel lumen. However, it is possible for the clotting agent to leak past the balloon into the vessel lumen and cause stenosis. 
     Lasers and radio-frequency (RF) energy have also been used to thermally fuse or weld the punctured tissue together. Other more recent techniques involve the use of high frequency ultrasound (HIFU) energy. 
     While all of the above procedures have advantages and disadvantages, no current procedure addresses the problem of informing the physician of the orientation of the opening on the vessel. Specifically, the operating physician typically does not know whether the needle that penetrates the vessel wall penetrated the vessel at the top, towards the right side of the vessel or towards the left side of the vessel (from the physician&#39;s perspective or from a top view). Knowledge of the orientation of the opening in the vessel would be beneficial for purposes of deciding which closure technique to employ Referring to figures and  1 - 5 , it would be beneficial for the physician to know whether (a) the opening passes through a top area of the vessel  24  as shown by the opening  21  of  FIGS. 1 ,  2  and  4 , or whether (b) the opening passes through either a right side of the vessel  24  as shown by the opening  22  of  FIGS. 1 ,  2  and  5 , or (c) whether the opening passes through a left side of the vessel  24  as shown by the opening  23  of  FIGS. 1 ,  2  and  3 . The orientation of the opening  21 ,  22  or  23 , from the physician&#39;s top view of the vessel or artery  24 , would be a factor in determining the correct closure technique. Specifically, certain closure techniques may be approptiate for a top orientation (or “top stick”) but not appropriate for side orientations (or “side sticks”) In summary, deciding between sutures, a plug, RF or HIFU may depend upon orientation of the opening. 
     Accordingly, there is a need for devices and methods for determining the orientation of a vascular opening created during an intravascular procedure so that the appropriate closure technique may be utilized upon completion of the intravascular procedure. 
     SUMMARY OF THE DISCLOSURE 
     In satisfaction of the aforenoted needs, devices are disclosed for determining an orientation of an opening in a vessel or artery for purposes of this disclosure, all orientations, e.g. top, right and left, are taken from a top plan view of a vessel or artery, or the physician&#39;s view looking downward on the vessel. 
     One disclosed device comprises an outer tube and a collapsible foot slidably disposed within a distal end of the outer tube. The foot is connected to a shaft which passes through the tube and exits a proximal end of the tube. The foot may be pushed distally out of the tube and through the opening in the vessel where it expands. After the expansion, the operator pulls the expanded foot in the proximal direction against the interior vessel wall. As the foot engages the interior vessel wall, the foot will twist or rotate. In the twisting of the foot, rotation is translated up the shaft, which may include markings that provide an indication as to the orientation of the opening in the vessel 
     In a refinement, the foot is heart shaped 
     In another refinement, the foot and shaft are made from a single piece of wire. Preferably, the wire is an alloy with a shape memory. Suitable shape memory alloys are known to those skilled in the art, examples of which are found in art related to the construction of expandable stents such as a nickel-titanium alloys including Nitinol®, and cobalt-chromium-nickel alloys including Elgiloy®. Alternatively, materials not generally considered “shape-memory” may be used, especially those having considerable elastic properties, including certain stainless steels, spring materials, other highly elastic materials, polymers or composites. Also, a suitable structure can be made from multiple materials, where one material has a highly elastic property. 
     In another refinement, the foot and shafts are made from polymers such as nylon, PEEK, Pebax® (polyether block amide), Teflon® (polytetrafluoroethylene (PTFE)) or acetal such as polyacetal, polyoxymethylene (POM) or polyformaldehyde. 
     In a related refinement, the wire comprises a first proximal end connected to a first shaft section connected to the foot that is connected to a second shaft section terminating at a second proximal end. 
     In a refinement, the shaft is connected to an indicator bar that provides an indication as to the orientation, i.e., left, top or right, of the opening. In a related refinement, the indicator bar has indicia marked thereon for indicating a first position of the foot when the opening is disposed on a left side of the vessel, a second position of the foot when the opening is disposed on a top of the vessel and a third position of the foot when the opening is disposed on a right side of the vessel. 
     In a related refinement, the outer tube has a window disposed towards a proximal end thereof and the indicator bar is positioned in alignment with the window so the indicia can be seen through the window. The “tube” may be a catheter, such as an introduction catheter 
     In a refinement, the tube accommodates a suturing mechanism. In a related refinement, the suturing mechanism comprises a plurality of threaded hook needles connected to or engaged by shafts for manipulating the position and movement of the needles. 
     In a refinement, the tube accommodates a plug, e.g., a bioabsorbable plug, for closing the opening Materials used for constructing such a plug are known to those skilled in the art. 
     In a refinement, the tube comprises two coaxial tubes wherein the inner tube holds the plug in the opening while the external tube is withdrawn 
     In a refinement, a disclosed device comprises an outer tube and a collapsible foot slidably disposed within a distal end of the outer tube The foot is connected to a first shaft that passes through the tube and exits a proximal end thereof. The device further comprises a threaded suture needle that is connected to a second shaft. The collapsed or folded foot may be pushed distally out of the tube and through the opening in the vessel whereupon the foot expands. Pulling the expanded foot in the proximal direction (i.e., pulling the shaft connected to the foot towards the proximal end of the tube or catheter) results in a twisting of the foot as it engages the vessel wall which provides an indication as to the orientation of the opening in the vessel, which can dictate or determine the type of suturing procedure. 
     In another refinement, a disclosed device comprised the collapsible or folded foot connected to a first shaft as well as a biodegradable plug connected to a second shaft. 
     In a refinement, the indicator bar provides notice to the operator or physician that the opening is in one of three positions-left, top or right. Accordingly, the indicator bar should have at least two indicia marked thereon (one indicia may be “blank”) for indicating the left, top and right positions. As an alternative, the indicator bar may indicate a relative position in degrees, mm or μm in deviation from a top stick (or top position). 
     Methods are disclosed for determining an orientation of an opening in a vessel wall. One disclosed method comprises inserting a device through a channel leading to the opening in the vessel. The device comprises an outer tube with a collapsible foot slidably disposed within a distal end of the outer tube as described above. The method further comprises applying a distally directed force to the shaft to push the foot through the opening or sheath, allowing the foot to expand in the vessel, applying a proximally directed force to the shaft to pull the expanded foot against the vessel wall, and viewing the indicator bar and determining if the opening is disposed on the left, top or right side of the vessel. 
     In a refinement, the method comprises causing the foot to rotate or twist as it engages the interior vessel wall which thereby causes the indicator bat to twist or rotate and viewing of the movement of the indicator bar is used to determine if the opening is disposed on the left, top or right side of the vessel from the physician&#39;s viewpoint. 
     In another refinement, a small thread can be attached to the tip of the heart-shaped foot so when a suture or plug is inserted, the foot can be withdrawn. Specifically, a proximally directed tug on this thread collapses the foot thereby enabling it to be removed from the vessel Removal of the foot is important and the “heart” shape of this embodiment lends itself to collapsability and therefore removability from the vessel 
     In a Refinement, the method further comprises suturing the opening with a suturing mechanism disposed in the outer tube. 
     In another refinement, the method further comprises plugging the opening with a bioabsorbable plug accommodated in the outer tube 
     Other advantages and features will be apparent from the following detailed description when read in conjunction with the attached drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       For a more complete understanding of the disclosed methods and apparatuses, reference should be made to the embodiment illustrated in greater detail on the accompanying drawings, wherein: 
         FIG. 1  is an end sectional view of a vessel illustrating three different orientations of a vessel opening created during an intravascular procedure including top, right side and left side orientations; 
         FIG. 2  is a partial top plan view of the vessel shown in  FIG. 1 ; 
         FIG. 3  is a sectional and perspective view of a vessel with an opening having a left side orientation or “left stick” opening; 
         FIG. 4  is a sectional and perspective view of a vessel with an opening having a top side orientation or “top stick” opening; 
         FIG. 5  is a sectional and perspective view of a vessel with an opening having a right side orientation or “right stick” opening; 
         FIG. 6A  is a sectional view of a section of a body, illustrating a catheter and opening orientation indicating device extending through a puncture that extends transdermally into the vessel having an internal diameter D; 
         FIG. 6B  is a partial view of the “foot” of the opening orientation indicating device particularly illustrating the width W of said foot; 
         FIG. 7A  is a perspective view of the indicating device like the one shown in  FIG. 6A , illustrating one retraction mechanism; 
         FIG. 7B  is a perspective view of another opening indicating orientation device like the device shown in  FIG. 6A , illustrating another retraction mechanism; 
         FIG. 7C  is a perspective view of the indicating device shown in  FIG. 6A  in a collapsed position; 
         FIG. 8  is a perspective view of yet another indicating device; 
         FIGS. 9A and 9B  are top perspective views of the indicating device and catheter or outer tube shown in  FIG. 6  passing towards and through an opening respectively with  FIG. 9B  showing the location of the indicating device disposed against an interior surface of the vessel wall after its expansion; 
         FIG. 10  is a side view of the indicating device and catheter as shown in  FIGS. 9A-9B ; 
         FIG. 11  is a partial plan view of a catheter section with a window disposed therein and a position indicator that comprises part of a disclosed vessel opening orientation indicating device, wherein the position indicator indicates that the vessel opening has a top orientation; 
         FIG. 12  is another partial plan view of the catheter section and position indicator shown in  FIG. 11 , but wherein the position indicator indicates that the vessel opening has a left side orientation; 
         FIG. 13  is another partial plan view of the catheter section and position indicator shown in  FIGS. 11 and 12 , but wherein the position indicator indicates that the vessel opening has a right side orientation; 
         FIG. 14  is a schematic illustration of a disclosed vessel opening orientation indicating device incorporated into a suturing device wherein the indicator and suturing needles are disposed inside the vessel; 
         FIG. 15  is a sectional view of a portion of a body, illustrating a catheter and vessel opening orientation indicating device extending through a puncture that extends transdermally into the vessel and that is equipped with one or more plugs for sealing the vessel opening; 
         FIG. 16  is a partial perspective view of an end of the tube with diametrically opposed to slots for accommodating hook-shaped needles and/or a vessel opening orientation indicating device made in accordance with this disclosure; and 
         FIG. 17  is a partial view of two hook-shaped needles connected to a loop or foot for indicating the orientation of the vessel opening. 
     
    
    
     It should be understood that the drawings are not necessarily to scale and that the disclosed embodiments are sometimes illustrated diagrammatically and in partial views. In certain instances, details which are not necessary for an understanding of the disclosed methods and apparatuses or which tender other details difficult to perceive may have been omitted. It should be understood, of course, that this disclosure is not limited to the particular embodiments illustrated herein 
     DETAILED DESCRIPTION 
       FIG. 6A  illustrates one use for the devices and methods disclosed herein. A patient&#39;s skin is shown at  27  with a channel  26  extending therethrough to the vessel  24  In opening  21  has been made in the vessel  24  through which an intravascular procedure has been carried out. As shown in greater detail below in connection with  FIGS. 7-10 , the device  30  has been inserted through the channel  26  and a collapsible wile foot  31  has been pushed out of a tube  41  into the vessel  24 , allowed to expand, and subsequently pulled proximally against the vessel wall  25  The position that the foot  31  assumes against the vessel wall  25  indicates to the physician the general orientation of the opening  21 . In the case as shown in  FIG. 6A , the opening  21  is along the top side of the vessel  24  or is classified as a “top stick.” When the foot  31  is pulled up against the interior vessel wall  25  in general alignment with the vessel  24 , the foot  31  will have twisted or rotated to achieve the position shown in  FIG. 6A  and this movement is translated to the physician by way of the shaft  32  or indicator bar  36  which is connected to the shaft  32 . The shaft  32  may comprise one or more shaft sections  35 ,  37  connected to the foot  31  (see  FIG. 7 ).  FIGS. 3-5  also show a foot  31  in general alignment with the vessel  24  thereby indicating predictability of the twisting of the foot  31  and shaft  32  as the foot  31  is located in the vessel  24  and pulled in a proximal direction so that the foot  31  is in general alignment with the vessel  24  as shown in  FIG. 6A . 
       FIG. 6A  also indicates a diameter D of the vessel  24 . This dimension is in contrast to the width W for the foot  31  shown in  FIG. 6B . The width W of the foot  31  should be less than the diameter D of the vessel  24 . Preferably, the width W should range from about 0.5 D to about 0.75 D preferably from about 0.6 D to about 0.7 D, most preferably about 0.66 D. 
       FIG. 7A  illustrates the probe-like device  30  that includes the heart-shaped foot  31  connected to the shaft  32  that comprises a pair of distally extending wire sections More specifically, the device  30  of  FIG. 7A  is fabricated from a single piece of shape memory wire  33  with a first proximal end  34  connected to a first shaft section  35  that, as shown in  FIG. 7A , passes through or is otherwise attached to the indicator bar  36 . The function and operation of the indicator bar  36  will be described in greater detail below in connection with  FIGS. 11-13 . Returning to  FIG. 7A , the first shaft section  35  is connected to the foot  31  which, in turn, is connected to a second shaft section  37  that terminates at a second proximal end  38  and that also passes through the indicator bar  36   
       FIG. 7A  also illustrates the employment of a string or thread  39  is coupled to the foot  31  and that extends upward along the shaft  32 . The string  39  is used to collapse the foot  31  prior to its removal from the vessel  24 . Another scheme for connecting the string  39   a  to a foot  31  is illustrated in  FIG. 7B . The string  39   a  is coupled to the “point” of the heart-shaped foot  31 . The collapsed foot  31  is illustrated in  FIG. 7C  Removability of the foot  31  from the vessel  24  is important and the collapsability/expandability/re-collapsability feature of the disclosed vessel opening orientation device  30  satisfies this concern 
     The foot  31  of  FIG. 7A  is heart-shaped, although other shapes can be utilized. For example, referring to  FIG. 8 , the foot  31   a  includes two symmetrical halves  31   a ′,  31   a ″ formed from a single piece of wire  33   a . Similar to the embodiment  30  of  FIG. 7 , the wire  33   a  of the device  30   a  of  FIG. 8  includes a first proximal end  34   a  that is connected to a first shaft section  35   a  which, in turn, is connected to the foot half  31   a ′ which is connected to the second foot half  31   a ″. The second foot half  31   a ″, in turn, is connected to the second shaft section  37   a , which terminates at the second proximal end  38   a . The shaft portions  35   a  and  37   a  both pass through the indicator bar  36   a  as shown 
       FIGS. 9A and 9B  illustrate the device  30  of  FIGS. 6 and 7  with an accompanying outer tube  41  that includes a distal end  42  through which the foot  31  extends In an initial position as shown in  FIG. 9A , the foot  31  is folded and accommodated proximally of the distal end  42  of the tube  41 . The tube  41  and device  30  are shown schematically as a tube  41  is being moved towards the opening  21  in the vessel  24 . When the tube  41  is in position inside the opening  21 , as shown in  FIG. 9B , force is applied to the shaft or shaft portions  35 ,  37  of the device  30  in a distal direction (or towards the opening  43 ) and the foot  31  is pressed outward from the tube  41  and into the vessel  44  through the opening  21  whereupon the foot  31  expands as shown in  FIG. 9B  Returning to  FIGS. 6 and 10 , after the foot  31  has as expanded in the vessel  24 , it can be pulled in the proximal direction and up against the interior wall  25  of the vessel  24  where it will rotate to the general position shown in  FIG. 6 . The rotation of the foot  31  is translated to the indicator bar  36  ( FIGS. 6 and 7 ) which, in turn, provides an indication to the physician or operator as to the orientation of the opening  21 . In other words, one type of rotation will indicate that the opening is a left stick, an other type of rotation will indicate that the opening is a top stick and another type of rotation will indicate that the opening is a right stick, all of which can be indicated using the simple indicator bar  36  or another type of indicating device as discussed below. 
     Turning to  FIGS. 11-13 , one type of indicator bar  36  that may be employed in with the disclosed devices is illustrated. The bar or block  36  is mounted on the shaft portion  32  of the device  30  which, in this case, includes the wire shaft sections  35 ,  37 . The block  36  may be visible to an operator or physician through a window  44  in the outer tube or sheath  41 . The block  36  preferably includes two or mole indicia shown in  FIGS. 11-13  at  45 ,  46 . By way of example only,  FIG. 11  could illustrate a situation where the opening  21  is in the top position or “top stick” position with both indicia  45 ,  46  clearly visible to the operator through the window  44   FIG. 12  could illustrate, for example, a “left stick” position with the solid line indicia  45  disposed towards the left and the dashed line indicia  46  disposed towards the center of the window  44   FIG. 13 , for example, could illustrate a “right stick” position with the solid line indicia  45  centered in the window  44  and the dashed line indicia  46  towards the light side of the window  44 . Obviously, numerous variations of this scheme can be employed and still fall within the spirit and scope of this disclosure. As another example, the indicia may indicate a degree of non-centeredness of the opening of wound in the vessel  24  such as a series of markings indicating the degree of the off-center position of the opening, either to the left or to the right. 
     Turning to  FIG. 14 , a more complex device  30   b  is disclosed which includes a foot  31   b  disposed inside a vessel  24 . In addition to the foot  31   b  and shaft portions  35   b ,  37   b , the outer tube  41   b  may also include a suturing mechanism such as a plurality of needles, in this case a plurality of hook-shaped needles  51  with accompanying thread or suture material  52  and equipped with a push bar or shaft  53 . The other tube  41   b  may also be equipped with slots  54  for accommodating the tips  55  of the needles  51  as well as a lock mechanism  56  to secure the needles  51  in place in the slots  54 . The lock mechanisms  56  may be spring biased as shown by the springs  57  and an indicator light  58  or other indication means such as flags, alignment markings, audible sounds, other visible indicia, etc may be employed to indicate to the physician when a needle  51  has either been secured in a slot  54  or has been removed or dislodged from a slot  54 . Other arrangements of needles and slots, or other grasping mechanisms as alternative to the slots could be used. For example, various numbers of needles, needles poking in from the outside of the vessel, interference fit tubes to grasp the needles, and so forth, while still utilizing the alignment features disclosed herein. 
     Turning to  FIG. 15 , as an alternative to a suturing mechanism, the outer tube  41   c  may accommodate one or more plugs  61 ,  62  along with the wire foot  31   c  and shaft  32   c  (as shown by the wire shaft sections  35   c ,  37   c ). An additional shaft  32   d  may be employed to hold the plugs  61 ,  62  in place as the outer tube  41   c  is withdrawn or it may be used to push the plugs  61  to  62  outward into position in the vessel opening  21   
       FIG. 16  is an end perspective view of an outer tube  41   e  equipped with diametrically opposed slot  61  for holding tips of hook-shaped needles  51   e  as shown in  FIG. 17  that are connected to a foot member  31   e  for purposes of linking the foot member  31   e  to the tube  41   e . The needles  51   e  may be threaded as indicated by the threads  52   e . The slots  61  in  FIG. 16  allows the tube  41   e  to extend into the vessel opening to seal the opening. However, if this technique is employed, it is necessary for the tube  41   e  to rotate with the foot  31   e . Hence, the slots  61  couple the tube  41   e  to the foot  31   e . In the other embodiments disclosed above, the tube  41  could be used to seal the vessel opening but it would not rotate as only the foot  31  and shaft  32  would rotate. 
     While the drawings show the foot  31  extending primarily at the heel of the opening  21 , the foot  31  could extend in both proximal and distal directions in the vessel  24 , and does not need to be symmetric in proximal and distal directions. It is preferred that the foot  31  be symmetric in the “right”-“left” directions so that it can rotate equally easily in either direction to indicate orientation 
     While only certain embodiments have been set forth, alternatives and modifications will be apparent from the above description to those skilled in the art. These and other alternatives are considered equivalents and within the spirit and scope of this disclosure and the appended claims