Patent Document

RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Application Ser. No. 60/997,461 filed on Oct. 7, 2007 and is a continuation-in-part of U.S. patent application Ser. No. 11/244,944 filed on Oct. 5, 2005, which is now U.S. Pat. No. 8,088,144, which claims the benefit of U.S. Provisional Application Ser. No. 60/677,859, filed May 4, 2005. This application is related to U.S. patent application Ser. No. 10/687,848 filed Oct. 17, 2003 and U.S. patent application Ser. No. 10/850,795, filed May 21, 2004, the disclosures of which are incorporated in their entirety herein. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates generally to apparatus and methods for sealing or closing passages through tissue, and more particularly to devices for sealing punctures or other openings communicating with body lumens, such as blood vessels, and to apparatus and methods for delivering or deploying such devices. 
     BACKGROUND OF THE INVENTION 
     Catheterization and interventional procedures, such as angioplasty and stenting, generally are performed by inserting a hollow needle through a patient&#39;s skin and muscle tissue into the vascular system. This creates a puncture wound in a blood vessel, frequently the femoral artery, which, once the interventional procedure has been completed, needs to be closed or sealed in a suitable manner. 
     Procedures and devices have been proposed for accomplishing such closure which involve the use of an introducer sheath that is placed in the tract of the puncture wound following which a closure delivering device is introduced through the introducer sheath to deploy a sealing element within the tract. An indicator wire may be used to locate the edge of the tract. After the closure delivering device deploys the sealing element, the indicator wire and the device are retracted. Examples of such procedures and devices are disclosed in application Ser. No. 10/687,848, filed Oct. 17, 2003 and Ser. No. 10/850,795 filed May 21, 2004. In these procedures and devices, it would be desirable to exploit features of the patient&#39;s anatomy to optimize sealing of the puncture wound. 
     SUMMARY OF THE INVENTION 
     A method for sealing a puncture, having an edge, in a wall of a lumen of a body comprising: deploying a deployment member of a sealing device through an elastic tissue membrane adjacent the wall of the lumen and the puncture, wherein the sealing device includes a sealing element; positioning the sealing element adjacent the wall of the lumen; retracting the deployment member relative to the sealing element to stretch the tissue membrane away from the wall of the lumen; retracting the deployment member relative to the sealing element to allow the tissue membrane to engage the sealing element; and retracting the device from the body. 
     In a preferred embodiment of the invention, the method is performed on a puncture wound in the femoral artery. In the noted embodiment, the elastic tissue membrane is a fascia layer and may comprise a portion of the femoral sheath. 
     In one aspect of the invention, the sealing element is positioned between the tissue membrane and the wall of the artery lumen when the membrane engages the sealing element. Alternatively, the sealing element partially protrudes from the tissue membrane when the membrane engages the sealing element. 
     Preferably, the membrane retains the sealing element at a desired position adjacent the wall of the lumen. Also preferably, the tissue membrane urges the sealing element against the wall of the lumen. 
     In a further embodiment of the invention, the sealing device further includes an indicator wire having a distal tip; and the method further comprises the steps of extending the indicator wire out of the deployment member when the sealing device is deployed through the puncture; adjusting the position of the sealing device until the indicator wire is adjacent to the edge of the lumen puncture; and retracting the indicator wire into the device. 
     In another aspect of the invention, the method for sealing a puncture comprises the steps of deploying a deployment member of a sealing device through an elastic membrane adjacent the wall of the lumen and the puncture, wherein the sealing device includes a sealing element; positioning the sealing element within the lumen; withdrawing the sealing element outside the lumen adjacent the wall of the lumen; frictionally engaging the membrane with the deployment member; retracting the deployment member relative to the sealing element to stretch the membrane away from the wall of the lumen; disengaging the deployment member from the membrane; and retracting the device from the body. 
     In a further aspect of the invention, the method for positioning a sealing element within a puncture comprises the steps of deploying a deployment member of a sealing device through an elastic membrane adjacent the wall of the lumen and the puncture; positioning a sealing element carried by the sealing device within the lumen, partially withdrawing the sealing element from the lumen such that the sealing element is disposed partially within the lumen and partially within the puncture when the membrane is elastically displaced; retracting the deployment member to elastically displace the membrane away from the wall of the lumen; deploying the sealing element by releasing it from the sealing device; disengaging the deployment member from the membrane, wherein the membrane elastically holds the sealing member within the puncture and partially within the lumen; and retracting the device from the body. 
     In yet another aspect of the invention, the method for positioning a sealing element adjacent a puncture comprises the steps of deploying a deployment member of a sealing device through an elastic membrane adjacent the wall of the lumen and the puncture; positioning a sealing element carried by the sealing device adjacent the wall of the lumen, wherein the sealing element is configured to be disposed between the wall of the lumen and the membrane when the membrane is elastically displaced; retracting the deployment member to elastically displace the membrane away from the wall of the lumen; deploying the sealing element by releasing it from the sealing device; disengaging the deployment member from the membrane, wherein the membrane elastically urges the sealing member against the wall of the lumen; and retracting the device from the body. 
     Other systems, methods, features and advantages of the invention will be or will become apparent to one with skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, methods, features and advantages be included within this description, be within the scope of the invention, and be protected by the accompanying claims. 
    
    
     
       DESCRIPTION OF THE DRAWINGS 
       In order to better appreciate how the above-recited and other advantages and objects of the present inventions are obtained, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments thereof, which are illustrated in the accompanying drawings. It should be noted that the components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. Moreover, in the figures, like reference numerals designate corresponding parts throughout the different views. However, like parts do not always have like reference numerals. Moreover, all illustrations are intended to convey concepts, where relative sizes, shapes and other detailed attributes may be illustrated schematically rather than literally or precisely. 
         FIG. 1  illustrates a side-view of a sealing element deployment device in accordance with a preferred embodiment of the present invention. 
         FIG. 2A  illustrates a side-view of a sealing element deployment device in accordance with a preferred embodiment of the present invention. 
         FIG. 2B  illustrates a side-view of a sealing element deployment device in accordance with a preferred embodiment of the present invention. 
         FIG. 2C  illustrates a side-view of a distal portion of the sealing element deployment device in accordance with a preferred embodiment of the present invention. 
         FIG. 2D  illustrates a side-view of a distal portion of the sealing element deployment device in accordance with a preferred embodiment of the present invention. 
         FIG. 3  illustrates a perspective view of components of a sealing element deployment device in accordance with a preferred embodiment of the present invention. 
         FIGS. 4(   a - b ) illustrate a distal portion-of the device in accordance with a preferred embodiment of the present invention. 
         FIGS. 5(   a - b ) illustrate a top view of a window portion of the sealing element deployment device in accordance with a preferred embodiment of the present invention. 
         FIG. 6  illustrates a perspective view of a window portion of the sealing element deployment device in accordance with a preferred embodiment of the present invention. 
         FIG. 7  illustrates a schematic view of the fascia being stretched away from the vessel wall by the deployment device in accordance with a preferred embodiment of the present invention. 
         FIG. 8  illustrates a schematic view of the fascia retaining the sealing element against the vessel wall in accordance with a preferred embodiment of the present invention. 
         FIG. 9  illustrates another schematic view of the fascia retaining the sealing element against the vessel wall in accordance with a preferred embodiment of the present invention. 
         FIG. 10  illustrates another schematic view the fascia retaining the sealing element against the vessel wall in accordance with a preferred embodiment of the present invention. 
         FIG. 11  is a photographic reproduction of a cross section of tissue showing the fascia retaining the sealing element against the vessel wall in accordance with a preferred embodiment of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     A device  100  for deploying a detachable sealing element  160  (shown in  FIG. 2 ) in a puncture wound is shown in  FIG. 1 , herein referred to as a closure device  100 . Examples of such a sealing element or plug  160  are described in U.S. application Ser. No. 10/687,848, filed Oct. 17, 2003, Ser. No. 10/850,795 filed May 21, 2004, and Ser. No. 11/038,995, filed Jan. 19, 2005, each of which applications are hereby incorporated by reference. Sealing element  160  occludes blood flow from a puncture. In a preferred embodiment, the sealing element  160  will be fabricated from a material which may expand upon contact with blood, such as a felt made from polyglycolic acid and/or polylactic acid polymers or copolymers or other materials such as collagens. The sealing element  160  may also have one or more hemostasis, antibiotic or other therapeutic agents added to it. 
     Alternatively, in other preferred embodiments, the sealing element  160  will be made in such a manner that it will expand spontaneously or upon removal of a restraining force. In still other embodiments, the sealing element  160  can be expandable mechanically, hydraulically or pneumatically. In all such embodiments, it is preferred that the sealing element  160  be fabricated from a bioabsorbable material. 
     A presently preferred embodiment employs needle-weaved polyglycolic acid (PGA) fibers that degrade through chemical hydrolysis of unstable bonds in the crystalline phase to lactic acid and glycolic acid, followed by enzymatic attack and participation in the Kreb&#39;s cycle to metabolize to carbon dioxide and water. In one embodiment, sealing element  160  exhibits modest expansion in the range of approximately 0-15%. 
     The closure device  100  for deploying the sealing element  160  includes a tubular elongate member  1 , herein referred to as the “housing,” which houses various components that will be described below. The device  100  also comprises a wire actuator  2  which is external and distal to the housing  1  and is slidably mounted and configured to actuate an indicator wire  6 , as described below. Extending through the distal end of the housing  1  is a deployment tube  7  configured to be received by an introducer sheath  300  known in the art. The deployment tube  7  is slightly longer than the introducer sheath  300 . The deployment tube  7  receives an indicator wire  6  (shown in  FIGS. 2   a  and  2   b ) and a plunger  80 , which operates as a backing member supporting a detachable sealing element  160  at a distal section of the deployment tube  7 . The plunger  80  preferably includes a channel through which the indicator wire  6  may be received within the tube  7 . The channel is preferably located on or near the edge or the periphery of the backing portion of the plunger  80 , i.e., near the internal surface of the deployment tube  7 . Optionally, an indicator wire tube or other lumen (not shown) may be provided within the interior of the deployment tube  7 . The indicator wire tube is preferably attached to the housing  1  at its proximal end, and extends through the deployment tube  7 . The indicator wire  6  then extends through the indicator wire tube or other lumen and exits the indicator wire tube at or near the distal end of the deployment tube  7 . (Additional details of the structure and operation of the plunger  80  are described in Ser. No. 10/850,795, filed May 21, 2004, which is incorporated by reference.) 
     The deployment tube  7  includes an inlet port  22  in the distal section of the tube  7 , configured to take in blood when exposed to a vessel, and the housing  1  includes an outlet port  23  communicatively coupled to the inlet port  22  for allowing the blood to exit outside of the puncture wound. Also extending out of the housing is a trigger  8  that preferably includes a rotary link  14  configured to deploy the detachable sealing element  160 . Before operation of the closure device  100 , the rotary link  14  is locked, i.e., the operator is prevented from actuating the rotary link  14  despite pressing the trigger  8 , as described below. 
     Turning to  FIGS. 2(A-D) , deployment of a detachable sealing element  160  within a puncture wound  400  using the closure device  100  is illustrated. An introducer sheath  300  is already deployed within the tract  410  of the wound  400  with its distal end  310  exposed within the lumen  420  of a blood vessel defined by a vessel wall  430 . The deployment tube  7  of the closure device  100  is inserted into the introducer sheath  300 . As shown, the distal end of deployment tube  7  has a uniform diameter and sealing element  160  is disposed within it. Upon substantially complete insertion, the device  100  is engaged with the introducer sheath  300 , and the distal section of the deployment tube  7  extends out of the distal end of the sheath  300 . When the inlet port  22  is exposed to the lumen  420  of the vessel  430 , blood will enter the inlet port  22  and travel out of the outlet port  23  extending out of the housing  1 . The blood exiting the outlet port  23  will be visible to the operator (not shown) of the device  100 , notifying the operator that the distal end of the deployment tube  7  is within the lumen  420  of the vessel  430  and outside of the tract  410  of the puncture wound  400 . 
     Also, upon substantially complete insertion, the wire actuator  2  of the device  100  is actuated by the proximal end of the sheath  300 , causing the wire actuator  2  to be pushed toward the housing  1 . The wire actuator  2  is mechanically coupled to the indicator wire  6  and configured to actuate the indicator wire  6  in the distal direction. Thus, as the wire actuator  2  is pushed towards the housing  1 , the wire actuator  2  causes the indicator wire  6  to extend out of the distal end of the deployment tube  7 . When the indicator wire  6  exits the tube  7 , the distal section of the wire  6  forms into a loop  5  located adjacent the distal tip of the tube  7 . The loop  5  of the wire  6  will come into contact with the vessel wall  430  near the edge  415  of the tract  410  when the device  100  and the sheath  300  are withdrawn, as shown in  FIG. 2   b.    
     Turning to  FIG. 2   b , after the device  100  is inserted and engaged into the sheath  300  as described above, the operator withdraws or pulls back the device  100  and sheath  300  within the tract  410 . When the distal section of the deployment tube  7  exits the lumen  420  and enters the tract  410 , the inlet port  22  is no longer exposed to the blood within the lumen  420  and thus, the blood flow out of the outlet port  23  ceases. This notifies the operator that the distal section of the deployment tube  7  has exited the lumen  420  and entered the tract  410  of the puncture wound  400 . The indicator wire&#39;s  6  resistance that is caused by the loop  5  engaging the vessel wall  430  will unlock the rotary link  14 , as described below, and optionally toggle the indicator window  13  to a state that indicates that the loop  5  has engaged the vessel wall  430  near the edge  415  of the tract  410 , which places the distal end of the deployment tube  7  at a desirable location within the tract  410  and substantially adjacent to the edge  415 . In the embodiment shown in  FIG. 2   b , the indicator window  13  toggles from a striped pattern,  FIG. 2   a , to a solid pattern, as described below. 
     The operator is then enabled to actuate the unlocked rotary link  14  to deploy the sealing element  160  by pressing the trigger  8 . Turning to  FIGS. 2C and 2D , the rotary link  14  actuates and withdraws both the wire  6  and the tube  7  while the sealing element  160  remains substantially in place by the pusher  80 , thereby deploying the sealing element  160 . The device  100  then disengages from the sealing element  160 , thus sealing or plugging the puncture wound  400 . Preferably, in one motion, the rotary link  14  is configured to withdraw the indicator wire  6  into the tube  7  before the tube  7  is withdrawn. Thus, the wire  6  is withdrawn before the sealing element  160  deployed, preventing the wire  6  from interfering with the deployment of the sealing element  160 , such as damaging or dislodging the sealing element  160 . 
     Turning to  FIG. 3 , a rack and pinion system for actuating the tube  7  and the wire  6  within the housing  1  of the device  100  is shown. The device  100  is shown not engaged to an introducer sheath  300 , and thus the wire actuator  2  is in its original state away from the housing  1 . The wire actuator  2  is coupled to a first rack  4  that is configured to engage a first gear  3  when the wire actuator  2  is actuated in the proximal direction as described above. The first gear  3  is attached to a second gear  16 , which causes a second rack  50  to move in the distal direction. The second rack  50  is engaged with the indicator wire  6 , causing the indicator wire  6  to extend out of the tube  7  when wire actuator  2  is actuated by engaging with the introducer sheath  300  as described above. The wire actuator  2  proximally withdraws the first rack  4 , which rotates the second gear  16  via the first gear  3 , which then advances distally the second rack  50 , thus advancing distally the indicator wire  6 , causing the indicator wire to extend out of the deployment tube  7 . 
     The first and second gears  3  and  16  share an axis that is secured by a bottom plate  101 . The bottom plate  101  is actuated by a trigger that includes a rotary link  14 . When the trigger  8  is pressed to deploy the plug  160 , the rotary link  14 , which includes an arcuate gear section  15  that engages and actuates the bottom plate  101  in the proximal direction, is actuated. A tube collar  115 , which is engaged to the deployment tube  7 , is anchored at a distal portion of the bottom plate  101 . When the bottom plate  101  is withdrawn proximally, the collar tube  115  is withdrawn as well, which in turn withdraws proximally the deployment tube  7 , which deploys the plug  160 . Proximally withdrawing the bottom plate  101  causes the first gear  3  to rotate along the first rack  4 , which is locked in place by the wire actuator  2  engaged with the introducer sheath  300 . Proximal to the wire actuator  2  is a post  116  that extends from the housing  1 . When the distal portion of the closure device  100  is inserted into the lumen of the introducer sheath  300 , a proximal portion of the introducer sheath  300  that defines a lip (not shown) engages the post  116 , which connects and locks the closure device  100  to the introducer sheath  300 . Thus, the second rack  50  is proximally withdrawn by the second gear  16 , which causes the indicator wire  6  to retract substantially simultaneously with the deployment tube  7 . The figures show that the first gear  3  has a smaller diameter than the second gear  16 . First and second gears  3  and  16  each provide a mechanical advantage to the control of the indicator wire  6  and deployment tube  7  respectively. Preferably, the mechanical advantage regarding the indicator wire  6  is 4:1 and the mechanical advantage regarding the deployment tube  7  is 2:1. Other mechanical advantage relationships may be used e.g., 3:1 for the indicator wire  6  and 1.5:1 for the tube  7 . It is preferred that the mechanical advantage for the indicator wire  6  be twice that for the tube  7 . Thus, when trigger  8  is depressed, the bottom plate  101  and tube collar  115  will withdraw the tube  7  more slowly than the indicator wire  6  is withdrawn into the device  100  and the indicator wire  6  will be retracted into the deployment tube  7  before the sealing element  160  is deployed and/or disengaged from the tube  7  and the device  100 . As described above, this advantageously prevents the indicator wire  6  from interfering with the deployment of the sealing element  160 . 
     One of ordinary skill in the art will appreciate that though a rack and pinion system is described and shown in  FIG. 3 , any suitable type of actuating system may be configured to retract the indicator wire  6  before a sealing element  160  is deployed and/or disengaged from the device  100  in accordance with a preferred embodiment of the present invention. For example, a hydraulic, electronic, and/or a pulley system may be used instead of or in addition to the rack and pinion system to retract the indicator wire  6  into the deployment tube  7  before the sealing element  160  is deployed and/or disengaged from the device  100 . 
     The housing  1  can also include an indicator assembly  200  coupled to a stationary top plate  150  of the device  100 . The indicator assembly  200  can indicate to the operator, via an indicator panel  13  in the top plate  150 , whether the distal end of the deployment tube  7  is in the desired location, e.g., near the edge  415  of the tract  410  of the puncture wound. In addition to, or in the alternative, the indicator assembly  200  may further lock the trigger  8  until the deployment tube  7  is in the desired location. In  FIGS. 4A and 4B , an implementation of the indicator assembly  200  of the device  100  is shown. The indicator assembly  200  comprises an indicator  20 , indicator spring  19  and lockout plate  17 . As can be seen from  FIG. 4A , a slidable lockout plate  17  engages groove  18  in rotary link  14 , thereby preventing substantial movement of rotary link  14 . The indicator spring  19  applies a proximal force on the lockout plate  17  to maintain the lockout plate&#39;s  17  position even after the indicator wire  6  is deployed from the tube  7 . 
     Turning to  FIG. 4B , the indicator wire  6  is fixedly attached to the lockout plate  17 , which is coupled to a block  9  via the indicator spring  19 . The block  9  is in a secured position, fixed to the housing  1  and/or the tube  7 . Because the indicator wire  6  is connected to the tube  7  and/or housing  1  via a spring  19  and slidable lockout plate  17 , the indicator wire  6  is capable of axial movement independent of the housing  1  and/or tube  7 . 
     During operation, after the indicator wire  6  has been deployed through the puncture wound  400  with the formed loop  5  exposed to the lumen  420  of a vessel defined by a vessel wall  430 , the operator is then ready to withdraw the device  100  and sheath  300  to deploy the sealing element  160  within the tract  410  of the puncture wound  400 . Even if blood stops flowing out of the outlet port  23 , that only indicates that the inlet port  22  is within the tract  410 , not necessarily that the sealing element  160  is desirably near the edge  415  of the tract  410 . However, the indicator wire  6  may provide such an indication. When the loop  5  of the wire  6  approaches the edge  415  of the tract  410 , the loop  5  will engage the vessel wall  430  near the edge  415  as the device  100  is withdrawn by the operator. When the loop  5  engages the vessel wall  430 , it will cause a force to be applied on the wire  6  toward the distal direction, or direction opposite that of the device  100  as its being withdrawn. This force will overcome the force of the spring  19  securing the lockout plate  17 , proximally withdraw the lockout plate  17  in the distal direction, and cause the lockout plate  17  to disengage from the groove  18  of the rotary link  14 , thereby unlocking the trigger  8 . When the trigger  8  is unlocked, because the loop  5  has caught the edge  415 , the distal end of the tube  7  is substantially adjacent to the edge  415  of the tract  410 , which is a desirable location for the deployment of the sealing element  160 . The operator is then enabled to deploy the sealing element  160 . 
     Even though a spring loaded system is described above for locking and unlocking the trigger  8 , one of ordinary skill in the art would appreciate that any locking mechanism may be employed in accordance with an embodiment of the present invention, such as a hydraulic and/or electronic system. 
     In addition to locking and unlocking the trigger  8 , the indicator assembly  200  may also provide a visual and/or audio notification to the operator that the distal end of the tube  7  is in a desirable position. As will be explained in more detail with regard to  FIGS. 4A ,  4 B,  5 A,  5 B, and  6 , indicator  20  can be seen through indicator panel  13 , which defines two windows  21 , on the top plate  150  and indicates to the user when the appropriate time to press trigger  8  with rotary link  14  has been reached. 
       FIGS. 5A and 5B  show a top view looking down through the windows  21 , indicator  20  is provided with opaque portions  22 . The windows  21  preferably have a shape consistent with the shape of markings  22  on the indicator  20 . Thus, prior to the indicator wire  6  being axially displaced opposite of the housing  1  and/or tube  7 , some or all of the windows  21  are clear, but when the indicator wire  6  is axially displaced opposite of the housing  1  and/or tube  7  as described above, markings  22  on the indicator  20  come into correspondence with the windows  21  of the indicator panel  13  as shown in  FIG. 5B . When this registration occurs, trigger  8  may be pressed. 
       FIG. 6  essentially shows the same thing as  FIGS. 5A and 5B , but from a perspective view. 
     One of ordinary skill in the art would appreciate that though windows  21  are described, the indicator panel  21  may also utilize other mechanisms, such as electronic circuitry, light emitted diodes (LED), and/or other visual and/or audio mechanisms known in the art. For example, the device  100  may be configured such that when the indicator wire  6  engages the vessel wall  430  near the edge  415  of the tract  410 , a circuit (not shown) is triggered within the housing  1  that causes a light to be emitted and/or an audio alarm to be invoked. 
     One of ordinary skill in the art would also appreciate that features of the anatomy of the patient&#39;s tissue can cooperate with the sealing element to facilitate the closure procedure. Preferably, the procedures of the invention position sealing element  160  so that structures located in the tissue between the patient&#39;s skin and the vessel wall  430  engage sealing element  160  and retain it against edge  415  of vessel wall  430 . 
     For example, the transversalis fascia and the iliac fascia surround the femoral artery, forming the femoral sheath. In this region, the fasciae are relatively thick, fibrous and elastic membranes. As a result, penetration of the fasciae tend to involve a smaller puncture followed by the expansion of the hole in the fasciae to accommodate the size of the instrument forming the puncture. Upon withdrawal of the instrument, the elastic nature of the fasciae will tend to return the hole to a smaller size than the original puncture. 
     As can be seen in  FIGS. 7-9 , methods of the invention use these characteristics of the fasciae to help retain sealing element  150  against edge  415  of vessel wall  430 . First,  FIG. 7  shows an alternate detail of the operation described above with reference to  FIGS. 2   c  and  2   d . Introducer sheath  300  has been inserted through puncture wound  400 , through fascia  440  and into lumen  420  of vessel  420 .  FIG. 7  shows the withdrawal of deployment tube  7  after sealing element  160  has been positioned adjacent edge  415  of blood vessel  430 . Introducer sheath  300  has been withdrawn already, and now deployment tube  7  is being withdrawn to leave sealing element  160  in position. As shown in  FIG. 7 , the elastic nature of fascia  440  tends to close about deployment tube  7  so that as tube  7  is withdrawn, friction pulls fascia  440  away from vessel wall  430 . 
       FIG. 8  shows that withdrawal of deployment tube  7  elastically displaces, or stretches, fascia  440  above sealing element  160 , so that sealing element  160  is positioned between vessel wall  430  and fascia  440 . When the range of travel of fascia  440  has been exceeded, fascia  440  pulls free from deployment tube and engages sealing element  160  has been placed adjacent edge  415  of vessel wall  430 . Given the elastic nature of fascia  440 , the size of the opening formed by introducer sheath  300  will have decreased so that the sheath cannot pass over sealing element  160 . Further, the expandable nature of sealing element  160  described above will tend to prevent it from passing through an opening in the fascia  440 . For example, needle-weaved PGA fibers absorb some blood volume. Accordingly, as can be seen in  FIG. 8 , fascia  440  forms a “tent” over sealing element  160 , holding it in position adjacent edge  415 . The elasticity of fascia  440  transmits force to sealing element  160  to urge it against vessel wall  430  and effectively close lumen  420 . 
     Alternatively,  FIG. 9  shows another embodiment of the invention. Here, fascia  440  has pulled free from deployment tube  7  before sealing element  160  has been completely exposed. However, fascia  440  has still been stretched away from vessel wall  430  and will constrict about sealing element  160 . The resulting friction of the tissue tract and the fascia retains the sealing element  160  in position adjacent edge  415  and urges sealing element  160  against vessel wall  430 . The expandable nature of sealing element  160  increases its engagement with fascia  440 . 
       FIG. 10  shows an alternative detail of the operation described above with reference to  FIGS. 7 and 8 .  FIG. 10  shows that after the deployment tube  7  is withdrawn and the sealing element  160  is completely exposed, a portion of the sealing element  160  may be positioned in lumen  420  of vessel  430  and the remaining portion positioned within tract  410  of the wound  400 . In other words, the sealing element may extend beyond edge  415  of vessel wall  430  and into the lumen  420 . The fascia  440  can form a tent completely over sealing element  160  as shown in  FIG. 8  or partially over sealing element  160  as shown in  FIG. 9 . 
     In addition to the interaction with the fascia  440 , sealing element  160  is also stabilized and retained in position by other factors, including contraction of tissue above the tract. 
       FIG. 11  is a photographic reproduction of a cross section of tissue showing placement of the sealing element. As can be seen, the sealing element is positioned between the fascia and the vessel wall. The elastic nature of the fascia helps retain the sealing element against the vessel wall and position it adjacent the puncture.  FIG. 10  also shows that sealing element is preferably sized so that it can be positioned between the vessel wall and the fascia while maintaining the fascia in an elastically displaced position. Generally, the sealing element should be small enough to fit between the vessel wall and the elastically displaced fascia, yet large enough so that the elastically displaced fascia transmits force to the sealing element, holding it against the vessel wall. 
     The procedures of the invention have successfully been used to seal femoral arteriotomies. In one clinical study, average time to hemostasis using the inventive procedure averaged 138±42 sec, with patients undergoing diagnostic catheterization achieving hemostasis in 138±46 sec (45-296 sec) and patients undergoing percutaneous coronary interventions achieving hemostatis in 139±36 sec (36-245 sec) in 42 successful procedures. Notably, 83% of the patients achieved hemostasis by 2 min. Within the same study, average time to ambulation averaged 2.8 hours, with patients undergoing diagnostic catheterization ambulating in 2.78±1.23 hours (0.98-7.02 hours) and patients undergoing percutaneous coronary interventions ambulating in 2.93±1.22 hours (2.17-6.32 hours). In this study, 92% of the patients ambulated within 4 hours. The noted study experienced a 97% success rate (36/37) excluding roll-ins, where hemostasis was achieved within 5 min of plug delivery without closure-related serious adverse effects. Overall, 42 closures were achieved in 47 patients. In the study, no device-related serious adverse effects, including death, stroke, surgical repair, infection requiring hospitalization or bleeding requiring transfusion, were observed and one non-device related effect, a myocardial infarction occurred. 
     In the foregoing specification, the invention has been described with reference to specific embodiments thereof. It will, however, be evident that various modifications and changes may be made thereto without departing from the broader spirit and scope of the invention. For example, preferred embodiments of the invention are directed to sealing femoral arteriotomies and reference is made to the fasciae surround the femoral artery, the femoral sheath. However, the invention can be applied to other lumens and membranes in the body as desired. Further, the reader is to understand that the specific ordering and combination of process actions described herein is merely illustrative, and the invention can be performed using different or additional process actions, or a different combination or ordering of process actions. As a further example, each feature of one embodiment can be mixed and matched with other features shown in other embodiments. Additionally and obviously, features may be added or subtracted as desired. Accordingly, the invention is not to be restricted except in light of the attached claims and their equivalents.

Technology Category: a