Abstract:
A seal assembly that seals opening in the wall of a blood vessel has a first sealing element for placing inside the lumen of the blood vessel and to engage the interior wall surface, a shaft integrally formed with the first sealing element and fixed in a predetermined configuration relative to the first sealing element, an outer floating element slidingly movable along the shaft; and a second sealing element, the second sealing element slidingly movable relative to the first sealing element along the shaft to engage the outer floating element and position the outer floating element against the exterior surface and the first sealing element against the interior surface of the blood vessel to seal the opening in the blood vessel.

Description:
[0001]    This application is a continuation-in-part application of application Ser. No. 13/746,278, filed on Jan. 21, 2013, issued on Sep. 22, 2015 as U.S. Pat. No. 9,138,215, the contents of which are incorporated by reference in their entirety. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The present invention relates generally to a sealing device for the closure of puncture holes in blood vessels and, in particular, to a sealing device that does not require a sheath change and is simple to operate. 
         [0004]    2. Technical Background 
         [0005]    For many diagnostic and interventional procedures it is necessary to access arteries or veins. Vessel access is accomplished either by direct vision or percutaneously. In either case, the target vessel is punctured with a hollow needle containing a tracer wire. When the intravascular positioning of the tracer wire has been verified, the hollow needle is removed leaving the tracer wire. Next, a sheath containing a dilator is pushed in over the tracer wire. The dilator enlarges the puncture opening to facilitate the insertion of the larger diameter sheath into the blood vessel. The sheath usually consists of a hollow tube with an open distal end and a hemostatic valve at a proximal end, which remains outside the body and blood vessel. The hemostatic valve is made of a compliant material and is designed in such a way as to allow devices such as catheters to be inserted and withdrawn from the blood vessel with minimal blood loss. After the sheath has been inserted into the blood vessel, the dilator is removed leaving a clear passageway in the sheath for the catheter. The sheath is removed from the blood vessel after the procedure is finished resulting in bleeding at the puncture site that must be staunched. 
         [0006]    Traditionally, pressure is applied at the puncture site to allow the blood to clot, thereby stopping the bleeding. Depending on the amount of anticoagulants that may have been administered to the patient during and prior to the procedure, the time that the pressure must be maintained varies from 15 minutes to more than an hour. Once bleeding has stopped, a pressure bandage is placed over the site of the puncture in an attempt to protect the integrity of the clot. The pressure bandage must remain in place for some time, usually from 8 to 24 hours. During this period of time the patient must remain in bed, sometimes requiring an overnight hospital stay. 
         [0007]    To shorten the length of time required for the patient to become ambulatory and to lessen complications that may arise from the traditional method of sealing the opening, several closure devices have been developed. One such device, as described in U.S. Pat. No. 5,620,461, is a foldable sheet with an attachment thread that is inserted into the opening in the blood vessel and an arresting element that is applied over the attachment element against the outside of the blood vessel. Another such device is described in U.S. Pat. Nos. 6,045,569 and 6,090,130, and includes an absorbable collagen plug cinched down against an absorbable intervascular anchor via an absorbable suture. The absorbable intervascular anchor has an elongated rectangular shape that requires it to be inserted into the puncture wound with its longitudinal axis approximately parallel to the sheath axis. This requires it to be rotated ninety degrees after insertion so that blood flow obstruction is minimized. A specially designed sheath is necessary to assure proper rotation, thus resulting in an otherwise unnecessary sheath change. The long dimension of the anchor is thus larger than the cannula inside diameter (ID) and the width is smaller than the ID. The collagen plug is in an elongated state prior to deployment and is forced into a ball shape via a slipknot in the suture, which passes through the collagen, and a tamper that applies a distal force to it. The anchor acts as a support for the suture cinch which forces the collagen ball shape up against the exterior blood vessel wall and the anchor. Blood flow escaping around the anchor is slowed down and absorbed by the collagen material and thus forms a clotting amalgamation outside the blood vessel that is more stable than the traditional method of a standalone clot. The added robustness of the amalgamation clot allows earlier ambulation of the patient. 
         [0008]    The device raises several issues. It is not a true sealing device but rather a clotting enhancement device, as opposed to a device with two flat surfaces exerting sealing pressure on both the interior and exterior of the blood vessel, a much more reliable technique. In either case, bleeding occurs during the time between removal of the sheath and full functionality of the deployed device. Thus “instant” sealing pressure from two flat surfaces is desirable over a method that relies to any extent on clotting time. One such device is disclosed by Bates et. al. in U.S. Pat. No. 8,080,034. The &#39;034 device comprises an internal sealing surface pivoting on a rigid post to accommodate the longitudinal dimension of the seal inside the sheath ID. The exterior seal (second clamping member) is slidable along the rigid post and pivotal such that it, along with the internal seal, sandwiches the wall of the blood vessel via a locking ratchet. One problem with this design is that the pivoting feature increases the cross-sectional dimension of the seal thus requiring a larger diameter sheath than would be otherwise needed. In addition, the pivoting internal seal has no means to assure that the seal pivots to the correct sealing position as the ratchet closes. This could cause the internal seal to exit the blood vessel in the collapsed configuration as the user withdraws the deploying device. In addition no specific mechanism for the release of the seals from the deployment instrument is disclosed, other than a general statement “any known means.” 
         [0009]    The seals are released by the user cutting the suture thread in the device described in U.S. Pat. No. 6,045,569. 
         [0010]    It is known that the opening in the blood vessel closes to some extent after the sheath is removed, thus allowing smaller seal surfaces than would otherwise be required. What is less known is that the opening does not close as quickly as a truly elastic material such as natural rubber or latex. For this reason, seal surfaces of closure devices that are activated in less than a second, or perhaps even longer, after sheath removal must be physically larger than the sheath outside diameter to avoid embolization of the seals because of the delayed blood vessel closure. The design of seals that are deployed through a sheath ID with dimensions larger than the sheath OD upon deployment is a challenge since the preferred material for seals are bio-absorbable and thus have limited mechanical properties. 
         [0011]    An active sealing assembly comprising solid, flat interior and exterior elements that sandwich the blood vessel wall to insure hemostasis and yet have major dimensions that exceed the interior diameter of the introducer sheath to compensate for slow, partial closure of the wound upon removal of the sheath thereby minimizing leakage and avoiding embolization of the sealing components offers a design challenge. Components can be introduced through the sheath internal diameter (ID) longitudinally and rotated into a position adjacent to the blood vessel wall such that the longitudinal dimension exceeds the sheath ID with little or no concern regarding the mechanical properties of the material. The devices in the &#39;461 and &#39;034 patents are examples. As noted previously, these solutions have severe limitations. 
         [0012]    Another method of accomplishing the desired result of obtaining a deployed seal larger than the sheath ID is to fold the seal elements while they traverse the sheath ID and reopen them upon deployment. Optimally, the major dimension of the seal elements should be 1.5 to 2 times larger than the outside diameter of the sheath. The &#39;569 Patent discloses an external seal made of an elongated pliable collagen plug that swells upon absorbing blood leaking from the wound and is tamped into more or less of a ball larger than the opening of the wound. The internal seal is inserted longitudinally through a special sheath which, with the aid of an attachment thread, rotates the seal parallel to the blood vessel surface. 
         [0013]    The &#39;569 device requires removing the catheter sheath and replacing it with a custom sheath prior to deployment, resulting in additional blood loss. The tamping force used to deploy the collagen against the anchor is left to the surgeon&#39;s feel, sometimes resulting in inadequate deployment and other times resulting in the collagen being pushed through the puncture wound and into the blood vessel along with the anchor. Inadequate tamping results in excessive bleeding with the potential for painful hematoma and over tamping can require a surgical procedure to remove the device from the blood vessel lumen. In addition, the absorption rate of the suture, the collagen, and the anchor may be different owing to the fact that they are formed from different materials, sometimes resulting in the premature detachment of the anchor, which can move freely in the blood stream and become lodged in the lower extremities of the body, again requiring surgical removal. 
         [0014]    U.S. Pat. No. 5,350,399 discloses umbrella-shaped foldable bio-compatible seals that are not bioabsorbable. 
         [0015]    It would be desirable therefore to provide a vessel-sealing device that actually seals the blood vessel and does not rely on the clotting of the blood. It is also desirable to provide a closure device that is deployable through the catheter sheath with minimal steps requiring less than 2 minutes for hemostasis. It would be also desirable to provide a reliable, active vessel-sealing device comprising a bio-absorbable seal assembly with deployed major dimensions larger than the sheath outside diameter. 
       SUMMARY OF THE INVENTION 
       [0016]    Disclosed herein is a seal assembly for sealing an opening in the wall of a blood vessel, the blood vessel having an interior wall surface, exterior wall surface, and a lumen, the seal assembly the includes a first sealing element for placing inside the lumen of the blood vessel, a shaft formed with the first sealing element as a single one-piece component, the shaft fixed in a predetermined configuration relative to the first sealing element, the shaft having a length sufficient to extend through the opening of the blood vessel and at least a portion of any overlying tissue, a flexible member surrounding at least a portion of the shaft adjacent the first sealing element, an outer floating element slidingly movable along the shaft, the outer floating element having a proximal surface and a distal surface, and a second sealing element, the second sealing element slidingly movable relative to the first sealing element along the shaft to engage the outer floating element and configured to position the distal surface of the outer floating element against the exterior wall surface and the flexible gasket against the interior wall surface of the blood vessel to seal the opening in the blood vessel. 
         [0017]    In some embodiments, the flexible member is secured to a proximally facing surface of the first sealing element. 
         [0018]    In some embodiments, the shaft has at least two sides, the at least two sides each having a groove along a portion thereof and the outer floating element has an aperture to receive the shaft therethrough, the aperture generally being rectangular and having two protrusions extending into the aperture and configured to the groove on a respective side of the shaft. 
         [0019]    In some embodiments, each of the protrusions has a first surface capable of engaging a first wall of the groove and a second surface capable of engaging a second wall of the groove and when the first surface engages the first wall of the groove, the distal surface of the outer floating element is disposed relative to the first wall at an angle of between 35 and 55 degrees. 
         [0020]    In other embodiments, the device includes an inserter, the inserter includes a housing have a first portion and a second portion, the first portion and second portion having a proximal end and a distal end, a longitudinal opening extending through the housing when the first and second portion are connected to one another and opening at the proximal and distal ends, and an aperture in one of the first and second portions, the aperture configured to receive a portion of the first sealing element when the first and second portion are connected to one another and the seal assembly is inserted therein. 
         [0021]    In another aspect, the present invention is directed to method of sealing an opening in the wall of a blood vessel, the blood vessel having an interior wall surface, exterior wall surface, and a lumen, the method including providing a seal assembly for sealing the opening in the blood vessel, the seal assembly operatively connected to an insertion device and comprising a first sealing element for placing inside the lumen of the blood vessel, a shaft formed with the first sealing element as a single one-piece component, the shaft fixed in a predetermined configuration relative to the first sealing element, the shaft having a length sufficient to extend through the opening of the blood vessel and at least a portion of any overlying tissue, a flexible member surrounding at least a portion of the shaft adjacent the first sealing element, an outer floating element slidingly movable along the shaft, the outer floating element having a proximal surface and a distal surface, and a second sealing element, the second sealing element slidingly movable relative to the first sealing element along the shaft to engage the outer floating element and configured to position the distal surface of the outer floating element against the exterior wall surface and the flexible gasket against the interior wall surface of the blood vessel to seal the opening in the blood vessel, inserting a portion of the seal assembly into the lumen of the blood vessel, and retracting the seal assembly and insertion device until the first seal element and flexible member engages the interior wall surface of the blood vessel and causes the insertion device to automatically actuate thereby pushing the second sealing element and the outer floating element toward the exterior wall surface to position the outer floating element against the exterior surface and causing the shaft to break at a reduced portion disposed within the shaft. 
         [0022]    Additional features and advantages of the invention will be set forth in the detailed description which follows, and in part will be readily apparent to those skilled in the art from that description or recognized by practicing the invention as described herein, including the detailed description which follows, the claims, as well as the appended drawings. 
         [0023]    It is to be understood that both the foregoing general description and the following detailed description of the present embodiments of the invention are intended to provide an overview or framework for understanding the nature and character of the invention as it is claimed. The accompanying drawings are included to provide a further understanding of the invention and are incorporated into and constitute a part of this specification. The drawings illustrate various embodiments of the invention and, together with the description, serve to explain the principles and operations of the invention. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0024]      FIG. 1  is a perspective view of one embodiment of a sealing device according to the present invention; 
           [0025]      FIG. 2  is a perspective view of a portion of the sealing device of  FIG. 1  illustrating the seal assembly thereof; 
           [0026]      FIG. 3A  is a side plan view of the first sealing element and the shaft; 
           [0027]      FIG. 3B  is a bottom plan view of the first sealing element and the shaft; 
           [0028]      FIG. 3C  is a cross section view of the shaft at the location of the reduced portion; 
           [0029]      FIG. 3D  is a partial side view of the shaft at the location of the reduced portion; 
           [0030]      FIG. 4A  is a cross section view along a longitudinal axis of a second sealing element of the seal assembly of  FIG. 2 ; 
           [0031]      FIG. 4B  is a cross section view of the second sealing element of the seal assembly of  FIG. 2  that is orthogonal to the view in  FIG. 2 ; 
           [0032]      FIG. 5A  is a perspective view of a sheath introducer used with the sealing device of  FIG. 1 ; 
           [0033]      FIG. 5B  is an exploded, perspective view of the sheath introducer of  FIG. 5A ; 
           [0034]      FIG. 6  is a cross section view of the seal assembly constrained in a sheath introducer; 
           [0035]      FIG. 7  is a top view of the sealing device with the sheath introducer of  FIG. 5A ; 
           [0036]      FIG. 8  is a perspective view of the sealing device inserted into a blood vessel; 
           [0037]      FIG. 9  is partial cross section view of a vessel with the sealing device inserted therein; 
           [0038]      FIG. 10  is perspective view of the sealing device inserted into the blood vessel just before the sealing device is activated; 
           [0039]      FIG. 11  is a perspective view of the seal assembly blocking the opening in the blood vessel after activation of the sealing device; 
           [0040]      FIG. 12  is a stress-strain curve that illustrates the maximum strain without permanent deformation (yield point) is 4% for materials used in the seal assembly of  FIG. 1 ; 
           [0041]      FIG. 13A  illustrates a representation of strain that would be introduced into the first sealing element on the top side thereof if constrained in the sheath introducer of  FIG. 5A ; 
           [0042]      FIG. 13B  illustrates a representation of strain that would be introduced into the first sealing element on the bottom side thereof if constrained in the sheath introducer of  FIG. 5A ; 
           [0043]      FIG. 13C  is a legend for the strain representations of the first sealing element constrained in the introducer; 
           [0044]      FIG. 14  is a perspective view of another embodiment of a sealing device according to the present invention; 
           [0045]      FIG. 15  is a perspective view of a portion of the sealing device of  FIG. 14  illustrating the seal assembly thereof; 
           [0046]      FIG. 16A  is an exploded, perspective view of the first sealing element and the shaft; 
           [0047]      FIG. 16B  is a perspective view of the first sealing element and the shaft of  FIG. 16A  in an assembled state; 
           [0048]      FIG. 16C  is a top view of the first sealing element and shaft looking down the shaft; 
           [0049]      FIG. 17  is a perspective view of the seal assembly of  FIG. 15 ; 
           [0050]      FIG. 18  is a side view of the of the seal assembly of  FIG. 15 ; 
           [0051]      FIG. 19  is a bottom view of the of the seal assembly of  FIG. 15 ; 
           [0052]      FIG. 20  is a cross section view of the shaft at the location of the reduced portion; 
           [0053]      FIG. 21  is a partial side view of the shaft at the location of the reduced portion 
           [0054]      FIG. 22A  is a cross section view along a longitudinal axis of a second sealing element of the seal assembly of  FIG. 16 ; 
           [0055]      FIG. 22B  is a cross section view of the second sealing element of the seal assembly of  FIG. 16  that is orthogonal to the view in  FIG. 24A ; 
           [0056]      FIG. 23A  is a side view of a cross section of another embodiment of an outer floating member; 
           [0057]      FIG. 23B  is a top view of the outer floating member of  FIG. 22A ; 
           [0058]      FIG. 24A  is a side view of cross section view of the outer floating member in  FIG. 22A  in a first position relative to the shaft; 
           [0059]      FIG. 24B  is a side view of cross section view of the outer floating member in  FIG. 22A  in a second position relative to the shaft; 
           [0060]      FIG. 25  is an exploded, perspective view of the sheath introducer for use with the seal assembly of  FIG. 16 ; 
           [0061]      FIG. 26  is a cross section view of the seal assembly constrained in the inserter of  FIG. 26 ; 
           [0062]      FIG. 27  is a top view of the seal assembly in the bottom portion of the inserter; 
           [0063]      FIG. 28  is a perspective view of the sealing device inserted into a blood vessel; 
           [0064]      FIG. 29  is partial cross section view of a vessel with the sealing device inserted therein; 
           [0065]      FIG. 30  is perspective view of the sealing device inserted into the blood vessel just before the sealing device is activated; and 
           [0066]      FIG. 31  is a perspective view of the seal assembly blocking the opening in the blood vessel after activation of the sealing device; 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0067]    Reference will now be made in detail to the present preferred embodiment(s) of the invention, examples of which are illustrated in the accompanying drawings. Whenever possible, the same reference numerals will be used throughout the drawings to refer to the same or like parts. 
         [0068]    Referring to  FIGS. 1 and 2 , closure device  10  comprises two handle halves  12 , 14  housing an automatic mechanism detailed in co-pending application titled “Vessel Sealing Device with Automatic Deployment,” assigned Atty Docket SHJO-017 and assigned Ser. No. 13/746,276, the contents of which are incorporated herein by reference in their entirety. The automatic mechanism is coupled to the seal assembly  20  by a flexible pusher  16  and a flexible shaft  18 . See also  FIG. 6 . Seal assembly  20  has a first sealing element  22 , a knobbed rigid shaft  24 , an outer floating element  26 , and a second sealing element  28 . Knobbed, rigid shaft  24  has a proximal section  30  and a distal section  32  separated by a weakened notch feature  34 , which is configured to separate seal assembly  20  from the rest of the closure device  10  once the automatic deployment and sealing process is complete. The length of the distal section  32  of knobbed shaft  24  is dictated by the thickness of the vessel wall that can be accommodated (see  FIG. 10 ). The first sealing element  22  also has a distal section  40  configured to interface with the inside wall of a vessel to be sealed (see also  FIG. 9 ), a knobbed, rigid distal shaft section  32  (which is a part of the knobbed, rigid shaft  24 ), and ankle section  42  joining the distal section  40  to the knobbed, rigid distal shaft section  32 . The ankle section  42  is attached to distal section  40  at an angle α, which is preferably at an angle of about 45°. Although other angles may be used, the value of angle α may cause other values of the seal assembly to be changed, as discussed in detail below. 
         [0069]    A more detailed view of the first sealing element  22  and the knobbed rigid shaft  24  are illustrated in  FIGS. 3A-3D . The first sealing element  22  has the distal section  40 , ankle section  42  and the knobbed, rigid distal shaft section  32 . The distal section  40  has a proximal or top surface  50 , a bottom surface  52  and an outer peripheral surface  56 . The proximal or top surface  50  is preferably configured to engage the interior wall surface  142  of the blood vessel  140  (see  FIG. 9 ), which means that the top surface  50  is preferably flat. However, the top surface  50  can be of any configuration (e.g., flat, convex, etc) and still come within the scope of the present invention. The bottom surface  52  is preferably flat, but may have other configurations. As noted below, the exact configuration of the surfaces  50 , 52  may also depend on the strain that is placed on them prior to and during insertion. The outer peripheral surface  56  is preferably continuous in that it has no discontinuities. That is, the outer peripheral surface  56  is smooth and has no sharp angles (e.g., 30, 45 or 90° angles). Since the distal section  40  is to be deformed prior to insertion into the blood vessel  140 , any sharp angles tend to create stress points, potentially causing the distal section  40  to be bent/deflected beyond its ability to return to its original configuration. The distal section  40  has a thickness that increases from the front (or distal) end  58  to the rear (or proximal) end  60 . In the embodiment illustrated in the figures, the thickness increases from 0.28 mm at the front end  58  to 0.30 mm at the rear end  60 . However, other thicknesses and tapered shapes fall within the scope of the present invention. 
         [0070]    Illustrated in  FIGS. 3C and 3D  are a cross section of the knobbed rigid shaft  24  at the ankle  42  and partial side view of the knobbed rigid shaft  24  showing the weakened notch feature  34 , respectively. The cross section of the ankle  42  in  FIG. 3C  illustrates the shape of the ankle  42 , the knobs  62  on the upper  64  and the lower  66  surface, and the smooth sides  68 , 70  of the knobbed rigid shaft  24 , which cooperates with the other portions of the first sealing element  22  to ensure that the outer floating element  26  and the second sealing element  28  are properly positioned, as discussed in more detail below. 
         [0071]    The weakened notch feature  34  is illustrated in  FIG. 3D . The weakened notch feature  34  has a smaller cross section than any other portion of the knobbed rigid shaft  24 . This allows for the knobbed rigid shaft  24  to be broken at this point upon activation of the insertion device in the co-pending application by exerting a force in the direction of the length of the knobbed rigid shaft  24 , causing the knobbed rigid shaft  24  to break at the weakened notch feature  34 . In order to prevent the weakened notch feature  34  from breaking prematurely, a c-shaped ring  72  is clipped into the weakened notch feature  34 , as illustrated in  FIG. 6 . The width of notch feature  34  is sized to equal the space between knobs  62  so that second seal  28  can easily transition over notch feature  34  upon automatic activation of device  10 . The c-shaped ring  72  prevents the knobbed rigid shaft  24  from being tilted off center and breaking prematurely. The c-shaped ring  72  is preferably made from a bio-absorbable material since the c-shaped ring  72  can separate from both the proximal section  30  and the distal section  32  of the knobbed rigid shaft  24  upon breaking of the weakened notch feature  34  and there is no efficient way to retrieve it from the patient. 
         [0072]    Second sealing element  28  is shown in more detail in  FIGS. 4A and 4B . The second sealing element  28  has a proximally facing surface  80  and a sloped distally facing surface  82 . An internal opening  84  defined by the internal surface  86  extends between the proximally facing surface  80  and the sloped distally facing surface  82 . The internal surface  86  has extending therefrom and into the internal opening  84  projections  88  that interface with and engage the knobs  62  with an interference fit such that second sealing element  28  and knobbed rigid shaft  24  function as a one way latch assuring an adequate compression force regardless of the blood vessel wall thickness. 
         [0073]    As can be best seen in  FIG. 2 , the proximal or top surface  50  of first sealing element  22  lies in a first plane A and the sloped distally facing surface  82  of second sealing element  28  lies in a second plane B. Preferably, the first plane A and the second plane B are parallel to one another. 
         [0074]    Referring to  FIG. 4B , the internal opening  84  of second sealing element  28  (and floating foot  26 ) have two flat surfaces  90  on opposite sides of the internal opening  84  that interface with flat surfaces  68 , 70  of knobbed rigid shaft  24  to provide rotational stability of the seal assembly components  26 , 28  thus assuring that the sloped distally facing surface  82  and the fully deployed floating foot  26  remain parallel with the distal section  40  of the first sealing element  22  and the proximal or top surface  50  in particular. 
         [0075]      FIGS. 5A and 6B  depict introducer or outer sleeve  100 , which is configured to protect seal assembly  20  from damage when inserting seal assembly  20  through a hemostatic valve, which, as discussed below and in more detail in the co-pending application, is one method in which the seal assembly is inserted into the patient. Introducer  100  comprises two halves,  102 , 104 , which when assembled together form a generally cylindrical body having two different diameters. Front section  106  of introducer  100  has a smaller diameter than rear section  108 . Front section  106  with the smaller diameter is configured to be inserted into hemostatic valve and rear section  108 , having the larger diameter remains proximal to the hemostatic valve. While the two halves  102 , 104  can be assembled according to any typical manner, pins  110  on one of the two halves  102 , 104  are configured with a press fit into corresponding mating holes  112  thus holding halves  102 , 104  firmly together. 
         [0076]    The introducer  100  has an opening  114  that extends between the front section  106  and the rear section  108 . However, within the opening  114  are also grooves  116  that are configured to accept seal assembly  20 . The opening  114  is also configured to receive at least a portion of pusher  16  of the seal device  10 .  FIG. 6  is a cross section of seal assembly  20  in the initial position inside introducer  100  prior to insertion into a sheath  120 . The front end  58  and the rear end  60  of the distal portion  40  of first sealing element  22  are deformed into a configuration such that the distal portion  40  of first sealing element  22  is able to pass through the inside dimension of cannula  122  upon insertion of closure device  10  resulting in the configuration shown in  FIG. 6 . The initial position of introducer  100  is shown in  FIG. 7 . After exit from distal end of cannula  122 , the front end  58  and the rear end  60  of the distal portion  40  of first sealing element  22  return to the initial configuration as shown in  FIG. 2  owing to the configuration shown in  FIG. 6  not exceeding the elastic limit of the material from which the seal assembly  20  is constructed. 
         [0077]      FIG. 8  depicts closure device  10  inserted into sheath  120 , the distal end of which is inside blood vessel  140 . Proximal end of sheath  120  comprises hemostatic valve  132  attached to a funnel shaped section transitioning into cannula  122  at the distal end. 
         [0078]    A method of using the current invention, in conjunction with  FIGS. 9-11 , is as follows: providing a sheath introducer  100  that surrounds and deforms seal assembly  20  such that seal assembly seal  20  can pass through sheath valve  132 . See also  FIGS. 6 &amp; 8 . Inserting pusher  16  through sheath  120 , including valve  132  and cannula  122 , causes at least a portion of seal assembly  20  to exit the distal end of cannula  122  and into blood vessel  140 . A portion of the second sealing element  28  and the pusher  16  may be disposed within the blood vessel  140 . See  FIG. 10 . Pulling on the closure device  10 , the proximal or top surface  50  of the distal portion  40  of first sealing element  22  engages the interior blood vessel wall  142 . This would also remove the second sealing element  28  and the pusher  16  from within the blood vessel  140 . See  FIG. 10 . Continuing to pull on the sealing assembly  20  triggers an automatic mechanism in the closure device  10 , which pushes pusher  16 , and which in turn pushes second sealing element  28 , and floating foot  26  (if present) distally such that floating foot  26  is in contact with outer wall of blood vessel  140 . This will sandwich the second sealing element  28  against floating foot  26 , blood vessel  140  and distal portion  40  of first sealing element  22  such that the opening in blood vessel  140  is hemostatically sealed, as shown in  FIG. 11 . 
         [0079]    To configure distal portion of first sealing element  22  such that the elastic limit of the bio-absorbable material is not exceeded when deformed in introducer  100  and deployed through cannula  122 , material studies were undertaken. Bio-absorbable materials comprising different mole ratios of Lactide and Glycolide are commonly used for molded implant parts. These materials exhibit different properties such as glass transition temperature and absorption time; however the initial strength and flexibility are similar. As an example, molded samples 1.6 mm thick by 4 mm wide by 10 mm long of 85:15 L-Lactide:Glycolide with inherent viscosity of 2.1 dl/gm were tested in an Instron® Universal Tensile testing Machine Model 3340 according to ASTM E-8M-04 Standard at a crosshead speed of 2 inches/minute. A typical example of the stress strain curve is shown in  FIG. 12 . Of particular interest is the fact that the maximum strain without permanent deformation (yield point) is seen to be 4% for materials of this type and particularly for 85:15 L-Lactide:Glycolide with inherent viscosity of 2.1 dl/gm. Therefore, to assure no permanent deformation occurs for seal assembly  20  the maximum strain while undergoing insertion into the blood vessel through sheath  120  must be below 4%. It is worth noting that the yield point was independent of sterilization radiation level up to 50 KGy the maximum strain at break decreased with radiation level however. 
         [0080]    The strain induced into a sample under different stress loads is dependent on the material basic mechanical properties but as importantly the geometric configuration. From a practical stand point closure devices are most often used in 6 French or smaller sheaths for cardiac procedures and up to 18 French or larger for AAA procedures. It is noted that when the first sealing element  22  for a 6 French closure device, is molded from 85:15 L-Lactide:Glycolide with inherent viscosity of 2.1 dl/gm, the present design stays within the strain limits. In fact, Finite Element Analysis (FEA) of variations of the present design indicate that the continuous outer periphery and the thickness taper from 0.28 to 0.30 in distal portion of first sealing element  22 , along with the oval configuration of ankle  42  are critical in keeping the strain below 4% in the deformed state inside introducer  100 , given the overall size and shape of the sealing assembly.  FIGS. 13A-C  illustrate by a grayscale map the strain in sealing assembly  20  constrained in introducer  100 . It can be seen that the maximum strain is below 4% for this configuration and material. 
         [0081]    Turning to another embodiment, a closure device  300  is illustrated in  FIGS. 14-32 , comprises two handle halves  312 , 324  housing an automatic mechanism detailed in co-pending application titled “Vessel Sealing Device with Automatic Deployment,” assigned Atty Docket SHJO-017 and assigned Ser. No. 13/746,276, the contents of which are incorporated herein by reference in their entirety. The closure device  300  is similar to the closure device disclosed in co-pending application Ser. No. 13/746,276 and the embodiment above, with a different seal assembly  320 . 
         [0082]    More specifically and referring to  FIG. 15 , closure device  300  comprises two handle halves  312 , 314  that housing automatic mechanism  150 . The automatic mechanism  150  interfaces with safety latch  152 , which has a safety slide  154  that interacts with safety cage  156  via pin  158 . The safety latch  152  operates such that with safety slide  154  in the distal most position automatic mechanism  150  cannot be activated. The proximal most position of safety slide  154  allows automatic activation. The pin  158  is in the center of the underside of safety slide  154  and passes through handle opening  160  of handle half  312  and engages slot  162  of safety cage  156 . With the safety slide  154  in the full distal position, the pin  158  forces safety cage  156  such that leg  164  is forced into a slot  166  in pusher  170  that locks the movable pusher  170  against distal movement. In this position, safety slide  154  covers the word “READY” (or any other word, mark or appropriate indicia) and exposes the word “SAFE” (or any other word, mark or appropriate indicia) embossed on handle half  312 . In this position, the safety latch  152  prevents the automatic mechanism  150  from premature firing during shipment or handling. With safety slide  154  in the proximal-most position, the pin  158  forces safety slide  154  to the right, thus removing leg  164  from the slot  166  in pusher  170 . In this position the automatic mechanism  150  is free to initiate when first sealing element  320  interacts with the inside of a vessel wall. In this configuration safety slide  154  covers the word “SAFE” and exposes the word “READY” on handle half  312 . 
         [0083]    Flexible pusher rod  316  is a cannulated cylinder, the proximal end of which is connected by an adhesive or by another appropriate method to the movable pusher  170 . The movable pusher  170  has a front portion  172  with an opening  174  for engagement with the flexible pusher rod  16  and to allow the flexible shaft  218  to pass through front portion  172 . The pusher  170  also has a rear portion  176  that is divided into an upper portion  176   a  and a lower portion  176   b,  the upper portion  176   a  and a lower portion  176   b  defining an opening  178  therebetween. 
         [0084]    The automatic mechanism  150  also includes a shaft retaining element  180  that, in the initial or preactivation stage, is disposed in opening  178  defined by the upper portion  176   a  and a lower portion  176   b  of pusher  170 . The shaft retaining element  180  also has an opening  182  passing therethrough to allow the flexible shaft  318  to pass therethrough and extend proximally in the automatic mechanism  150 . However, the flexible shaft  318  is fixedly attached to the shaft retaining element  180 . The flexible shaft  318  therefore extends almost the entire length of the device  300 . As noted above, the flexible shaft  318  is also connected to the knobbed rigid shaft  326  of the seal assembly  320 . A tensile force on the flexible shaft  318  causes the automatic mechanism  150  to fire. 
         [0085]    The automatic mechanism  150  also has a spring  190 , which is illustrated as a cylindrical spring, but could be any resilient element and have any configuration. The spring  190  engages, at its proximal end, the proximal end of the handle  312 , 314 . The spring  190  is disposed around a spring retainer  194  and engages at its distal end, the front end  196  of the spring retainer  194 . The spring  190  is biased against the front end  196  of the spring retainer  194  to push the spring retainer  194  against the pusher  170 , as described in more detail below. 
         [0086]    The automatic mechanism  150  also has two retention elements  200  that are rotatably mounted in the housing  312 , 314 . The two retention elements  200  are illustrated as being generally triangular, but could be of any shape or configuration as long as they perform the functions noted below. The retention elements  200  are disposed to engage the front end  196  of the spring retainer  194  and the shaft retaining element  180 . In fact, each of the two retention elements  200  engage a notch  202  on either side of the shaft retaining element  180 . The retention elements  200  each have an end portion  204 , preferably a flat surface, that engages an internal surface of the notches  202 . The retention elements  200  are disposed on round projections  206  extending upward from the handle  314 . The projections  206  could also project downward from the handle  312 . 
         [0087]    With regard to the use of the device  300 , the disclosure of the use of the device is discussed in detail in the co-pending Ser. No. 13/746,276, the content of which is incorporated herein by reference and summarized again below. 
         [0088]    The automatic mechanism is coupled to the seal assembly  320  by a flexible pusher  316  and a flexible shaft  318 , as in the prior embodiment. Seal assembly  320  has a first sealing element  322 , a flexible member  324 , a knobbed rigid shaft  326 , an outer floating element  328 , and a second sealing element  330 . Knobbed, rigid shaft  326  has a proximal section  332  and a distal section  334  separated by a weakened notch feature  336 , which is configured to separate seal assembly  320  from the rest of the closure device  300  once the automatic deployment and sealing process is complete. The length of the distal section  334  of knobbed shaft  326  is dictated by the thickness of the vessel wall that can be accommodated. The first sealing element  322  also has a distal section  340  configured to, with the assistance of the flexible member  324 , interface with the inside wall of a vessel to be sealed; a knobbed, rigid distal shaft section  334  (which is a part of the knobbed, rigid shaft  326 ); and ankle section  342  joining the distal section  340  to the knobbed, rigid distal shaft section  334 . The ankle section  342  is attached to distal section  340  at an angle α, which is preferably at an angle of about 45°. See  FIG. 18 . Although other angles may be used, the value of angle α may cause other values of the seal assembly to be changed. Applicant also notes the that the first sealing element  322  is formed with the distal section  340 , ankle section  342 , and the knobbed, rigid shaft  326  at the same time and from the same material. As such, the first sealing element  322  is an integrally formed element and the distal section  340  is not designed to move relative to the knobbed, rigid distal shaft section  334  at any time, except through deformity. As indicated in the parent patent, the first sealing element is preferably a one single-piece component. 
         [0089]    A more detailed view of the first sealing element  322  and the knobbed rigid shaft  326  is presented in  FIGS. 16A-21 . The first sealing element  322  has the distal section  340 , ankle section  342  and the knobbed, rigid distal shaft section  334 . The distal section  340  has a proximal or top surface  350 , a bottom surface  352  and a heel  356 . The top surface  350  can be of any configuration (e.g., flat, convex, etc) and still come within the scope of the present invention. The bottom surface  352  is preferably flat, but may have other configurations as well. The heel  356  preferably has a greater thickness than the remainder of the distal section  340  and, as discussed below is disposed into a cavity in the inserter. The distal section  340  has a thickness that increases from the front (or distal) end  358  to the rear (or proximal) end  360 . In the embodiment illustrated in the figures, the thickness increases from 0.28 mm at the front end  358  to 0.30 mm at the rear end  360 . However, other thicknesses and tapered shapes fall within the scope of the present invention. 
         [0090]    A top view of the knobbed, rigid shaft  326  and the first sealing element  322  is illustrated in  FIG. 16C . The knobbed, rigid shaft  326  has a proximal end  338  that may be connected to the flexible shaft  318  in any appropriate fashion, e.g., glued, soldered, press-fit, friction fit, etc. Alternatively, the flexible shaft  318  may also be integral with the knobbed, rigid shaft  326 , i.e., be formed at the same time with the same material making it an “integral” piece. The knobbed, rigid shaft  326  has knobs  362  along the upper surface  364  and the lower surface  366 . The knobbed, rigid shaft  326  also has opposite sides  368 , 370 , each side of which includes a groove  372  that runs along the length of the knobbed, rigid shaft  326  between the ankle section  342  and the proximal end  338 . The grooves  372  are preferably rectangular (or square) in cross section for reasons that will become apparent below. As such each of the grooves  372  have a front (or first) surface  374  and a rear (or second) surface  376 . It is noted that the front surface  374  faces the rear portion of the knobbed, rigid shaft  326 , while the rear surface  376  faces the front of the knobbed, rigid shaft  326 . The grooves  372  cooperate with the other portions of the seal assembly  320  to ensure that the outer floating element  328  and the second sealing element  330  are properly positioned, as discussed in more detail below. Since the grooves  372  are smaller than the sides  368 , 370 , the sides  368 , 370  present a flat surface for the outer floating element  328 , discussed below. 
         [0091]    Illustrated in  FIGS. 20 and 21  is a cross section of the knobbed, rigid shaft  326  at the weakened notch feature  336 . The weakened notch feature  336  has a smaller cross section than any other portion of the knobbed rigid shaft  326 . This allows for the knobbed, rigid shaft  326  to be broken at this point upon activation of the insertion device  300  by exerting a force in the direction of the length of the knobbed, rigid shaft  326 , causing the knobbed, rigid shaft  326  to break at the weakened notch feature  336 . In order to prevent the weakened notch feature  336  from breaking prematurely, a c-shaped ring may be clipped into the weakened notch feature  336  as noted above. The width of notch feature  336  is sized to equal the space between knobs  362  so that second seal  328  can easily transition over notch feature  336  upon automatic activation of device  300 . The c-shaped ring prevents the knobbed, rigid shaft  326  from being tilted off center and breaking prematurely. 
         [0092]    In  FIG. 21 , the groove  372  in the knobbed, rigid distal shaft section  334  preferably flares outward at  372   a  at the weakened notch feature  336 , to ensure that the outer floating element  328  and its components float over the weakened notch feature  336  during operation without skiving on a portion of the groove  372  at that location. 
         [0093]    The flexible member  324 , along with distal section  340 , assists in sealing the opening in the vessel wall. The flexible member  324  is illustrated as being a circular member having an opening  378  in a middle portion thereof. The flexible member  324  has a thickness t, which is preferably around 0.2 millimeters. Since the flexible member  324  is preferably made from 70% L-lactide 30% caprolactone copolymer, it is able to being deformed as described below. As illustrated in  FIGS. 16B and 17 , the flexible member  324  is disposed around the ankle portion  342  and against the top surface  350  of the distal section  340 . Preferably, the flexible member  324  is attached to the top surface  350  of the distal section  340 . It can be attached in any number of ways, including heat-staking or welding the flexible member  324  to the top surface  350 , using an approved adhesive between the flexible member  324  and the top surface  350  flexible member  324 . Alternatively, the opening  378  could be slightly smaller than the diameter of the ankle portion  342 , preventing the flexible member  324  from moving along the length of the knobbed, rigid shaft  326  at the ankle portion  342 . As explained in more detail below, the flexible member  324  is disposed between the distal section  340  and the inner wall of the vessel. See, e.g.,  FIG. 30 . 
         [0094]    While the opening  378  is a contained opening, it is also possible that there be a slit (or small path) from the outside of the flexible member  324  allowing the flexible member to be disposed around the ankle portion  342  without having to slide it the length of the knobbed, rigid shaft  326 . 
         [0095]    Second sealing element  330  is shown in more detail in  FIGS. 22A and 22B . The second sealing element  330  has a proximally facing surface  380  and a sloped distally facing surface  382 . An internal opening  384  defined by the internal surface  386  extends between the proximally facing surface  380  and the sloped distally facing surface  382 . The internal surface  386  has extending therefrom and into the internal opening  384  projections  388  that interface with and engage the knobs  362  with an interference fit such that second sealing element  330  and knobbed, rigid shaft  326  function as a one way latch assuring an adequate compression force regardless of the blood vessel wall thickness. 
         [0096]    Referring to  FIG. 22B , the internal opening  384  of second sealing element  330  have two flat surfaces  390  on opposite sides of the internal opening  384  that interface with flat surfaces  368 , 370  of knobbed rigid shaft  326  to provide rotational stability of the seal assembly components  328 , 330 , thus assuring that the sloped distally facing surface  382  and the fully deployed outer floating foot  328  remain parallel with the distal section  340  of the first sealing element  322  and the proximal or top surface  350  in particular. 
         [0097]    The outer floating element  328  is illustrated in detail in  FIGS. 23A-24B . The outer floating element  328  is generally rectangularly shaped and has a rectangularly shaped central aperture  400  and two protrusions  402  that extend from the longest side walls  404  into the aperture  400 . The outer floating element  328  has a top surface  406  and a bottom surface  408 , which are generally parallel to one another. The protrusions  402  are configured to engage and allow the outer floating element  328  to travel along the knobbed, rigid shaft  326  in the grooves  372 . The protrusions are somewhat tear drop shaped, but have two flat surfaces, a first flat surface  410  and a second flat surface  412 . The outer floating element  328  also has two inclined surfaces  414  and  416 , one at either end of the outer floating element  328  and defines the ends of the aperture  400 . The first flat surface  410  is at an angle β relative to the top and bottom surfaces  406 , 408  of outer floating element  328 . See  FIG. 23A . Preferably angle β is about a 45 degree angle but could be anywhere between 35 and 55 degrees and still fall within the scope of the present invention. The second flat surface  412  makes an angle γ relative to the top and bottom surfaces  406 , 408 . See  FIG. 23A . Preferably angle γ is about a 19 degree angle but could be anywhere between 15 and 25 degrees and still fall within the scope of the present invention. As would be obvious, the two inclined surfaces  414  and  416  are also parallel to the second flat surface  412  as will be explained below. 
         [0098]    Turning to  FIGS. 24A and 24B , the positioning of the outer floating element  328  will be explained. In both figures, the dotted lines correspond to the surfaces of the knobbed, rigid shaft  326  presented to the outer floating element  328 . In particular, the two middle lines correspond to the front (or first) surface  374  and the rear (or second) surface  376  of the groove  372 . Thus, the two protrusions  402  will slide along between those two middle lines. The two outside lines correspond to the upper  364  surface and the lower  366  surface of the outer floating element  328 . In  FIG. 24A , the outer floating element  328  is illustrated in its stored version—to be inserted into, or already in the inserter. Thus, in the position of  FIG. 24A , the outer floating element  328  has, relative to the rest of the seal assembly  320 , the smallest profile and will allow it to pass through a smaller cannula. 
         [0099]      FIG. 24B  illustrates the outer floating element  328  relative to the knobbed, rigid shaft  326  after it exits the cannula. That is, the outer floating element  328  has been engaged by the second sealing element  330  (not shown in the figures) and because the size of the projections  402  relative to the groove  372 , the outer floating element  328  can rotate (clockwise in FIG.  24 B) relative to the knobbed, rigid shaft  326  to be in a position to engage the outside of the vessel. See, e.g.,  FIGS. 30 and 31 . 
         [0100]    An inserter  450  is illustrated in  FIGS. 25-27 . The embodiment of the inserter  450  illustrated has a first portion  452  and a second portion  454 , which are illustrated as a top half and a bottom half. Naturally, the portions  452 , 454  could have other names (e.g., side portions) and still fall within the scope of the present invention. The inserter  450  has a proximal end  456  and a distal end  458 . When the portions  452 , 454  are assembled, a longitudinal opening  460  is created that extends through the inserter  450 . The inserter  450  preferably has at the proximal end  456  a proximal section  462  that has a constant diameter outer surface and a constant diameter for the longitudinal opening  460  at the proximal section  462 . The proximal section  462  of each of the portions  452 , 454  has a number of projections  464  and openings  466 . The projections  464  of one portion  452 , 454  correspond to the openings  466  of the other portion  452 , 454 , thereby allowing the two portions  452 , 454  to be brought together and aligned for use. Forward of the proximal section  462  is a reduced diameter area  468 , which then increases in diameter at  470  creating a shoulder  472  before tapering back down to a smaller outer diameter at the distal end  458 . 
         [0101]    The longitudinal opening  460  in inserter  450  allows for the seal assembly  320  to be loaded therein, sterilized, stored, and then used by a doctor. Typically, if a seal assembly is contained within a confined space and then sterilized, the sterilization causes the seal assembly to maintain the configuration in which it is sterilized. Even if the material normally was some shape memory (allowing the material to spring back to its original shape or configuration), the sterilization has been found by the inventor to prevent the materials from returning to their original configuration. Thus, the current inserter  450  allows for the seal assembly  320  to be loaded without any real change in configuration. The longitudinal opening  460  has been designed to hold the first sealing element  322 , a flexible member  324 , a knobbed rigid shaft  326 , an outer floating element  328 , and a second sealing element  330  without this issue. To do so, however, the portion  454  has an aperture  474  to allow for the heel  356  of the distal section  340  to be disposed therein. While the aperture  474  is illustrated as extending through the portion  454 , it is possible that there only be a depression, groove, or dimple that does not penetrate all the way through the portion  454 . 
         [0102]    Turning to  FIG. 26 , a cross section of the inserter  450  with the seal assembly  320  disposed therein illustrates the position of the seal assembly  320  within the inserter  450 . As should be clear, the cross section is through the center of both portions  452 , 454 . It should also be noted that the distance D1 of between the two portions  452 , 454  of the longitudinal opening  460  is generally constant. The position of the outer floating element  328  relative to the knobbed, rigid shaft  326  and the position of the flexible member  324  relative to the distal section  340  allow the inserter to have a minimum size. 
         [0103]      FIG. 27  illustrates the seal assembly  320  within the inserter  450  from above the inserter  450 . In this view, it is clear that the diameter D2 of the longitudinal opening  460  is larger in the horizontal plane; allowing the flexible member  324  to hold its original configuration. The longitudinal opening  460  at the proximal section  462  is also sized to allow the outer floating element  328  and the second sealing element  330  to pass therethrough. The longitudinal opening  460  at the distal end  458  is smaller than the diameter D2, but the flexible member  324  and the distal section  340  can be deformed and then return to their to original shape for use in the patient. 
         [0104]    A method of using the current invention in conjunction with  FIGS. 28-31  is as follows: The device  300 , and in particular the seal assembly  320  is inserted into inserter  450  that surrounds seal assembly  320  such that seal assembly  320  can pass through sheath valve  132  and to the sheath  120 . This allows for the simultaneous removal of the device  300  and the sheath  120 , if the sheath is not removed prior to the activation of the automatic mechanism. Inserting pusher  316  through sheath  120 , including valve  132  and cannula  122 , causes at least a portion of seal assembly  320  to exit the distal end of cannula  122  and into blood vessel  140 . See  FIG. 29 . The sheath  120  may then be removed from the device  300 . Pulling on the closure device  300 , the flexible member  324  and the distal portion  340  of first sealing element  322  engages the interior blood vessel wall  142 . See  FIG. 30 . This would also remove the second sealing element  330 , the outer floating element  328 , and the pusher  316  from within the blood vessel  140 . Continuing to pull on the sealing assembly  320 , and therefore flexible shaft  318 , triggers the automatic mechanism  150  in the closure device  300 , which pushes pusher  316 , and which in turn pushes second sealing element  330 , and the outer floating element  328  distally such that the outer floating element  328  is in contact with outer wall of blood vessel  140 . This will sandwich the outer floating element  328 , the blood vessel  140  and the flexible member  324  between the first and second sealing elements  322 ,  330  such that the opening in blood vessel  140  is hemostatically sealed, as shown in  FIG. 31 . 
         [0105]    It will be apparent to those skilled in the art that various modifications and variations can be made to the present invention without departing from the spirit and scope of the invention. Thus, it is intended that the present invention cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.