Abstract:
An apparatus to intervascularly promote hemostasis at a blood vessel puncture site with an inner lumen pressure and an outer lumen pressure has a flexible plug having a center, a top surface, and a bottom surface, and a release mechanism coupled to the center to position and release the flexible plug intervascularly at the blood vessel puncture site. The inner lumen pressure is greater than the outer lumen pressure to forceably secure the flexible plug around the blood vessel puncture site.

Description:
FIELD OF THE INVENTION  
       [0001]     The invention relates to facilitating hemostasis at a puncture site. More particularly, the invention relates to facilitating hemostasis at a puncture site by utilizing the pressure difference between the inside and the outside of the blood vessel. Even more particularly, the invention relates to facilitating hemostasis at a puncture site by deploying a hemostatic plug within the blood vessel and utilizing the pressure difference between the inside and the outside of the blood vessel to secure the hemostatic plug around the puncture site.  
       BACKGROUND OF THE INVENTION  
       [0002]     A large number of diagnostic and interventional procedures involve the percutaneous introduction of instrumentation into a vein or artery. For example, coronary angioplasty, angiography, atherectomy, stenting of arteries, and many other procedures often involve accessing the vasculature through a catheter placed in the femoral artery or other blood vessel. Once the procedure is completed and the catheter or other instrumentation is removed, bleeding from the punctured artery must be controlled.  
         [0003]     Traditionally, external pressure is applied to the skin entry site to stem bleeding from a puncture wound in a blood vessel. Pressure is continued until hemostasis has occurred at the puncture site. In some instances, pressure must be applied for up to an hour or more during which time the patient is uncomfortably immobilized. In addition, a risk of hematoma exists since bleeding from the vessel may continue beneath the skin until sufficient clotting effects hemostasis. Further, external pressure to close the vascular puncture site works best when the vessel is close to the skin surface but may be unsuitable for patients with substantial amounts of subcutaneous adipose tissue since the skin surface may be a considerable distance from the vascular puncture site.  
         [0004]     There are several approaches to close the vascular puncture site including the use of anchor and plug systems as well as suture systems. The use of an anchor and plug system addresses these problems to some extent but provides other problems including: 1) complex and difficult application; 2) partial occlusion of the blood vessel by the anchor when placed properly; and 3) complete blockage of the blood vessel or a branch of the blood vessel by the anchor if placed improperly. Another problem with the anchor and plug system involves re-access. Re-access of a particular blood vessel site sealed with an anchor and plug system is not possible until the anchor has been completely absorbed because the anchor could be dislodged into the blood stream by an attempt to re-access the site.  
         [0005]     Internal suturing of the blood vessel puncture requires a specially designed suturing device. These suturing devices involve a significant number of steps to perform suturing and require substantial expertise. Additionally, when releasing hemostasis material at the puncture site and withdrawing other devices out of the tissue tract, the user typically must pull or tug on the devices which may reposition the hemostasis material or cause damage to the surrounding tissue or vascular puncture site. Moreover, approaches to sealing the puncture utilizing suture systems only partially occlude the blood vessel puncture thereby allowing blood to seep out of the puncture thereby causing hematoma.  
       BRIEF DESCRIPTION OF THE INVENTION  
       [0006]     An apparatus to intervascularly promote hemostasis at a blood vessel puncture site with an inner lumen pressure and an outer lumen pressure has a flexible plug having a center, a top surface, and a bottom surface, and a release mechanism coupled to the center to position and release the flexible plug intervascularly at the blood vessel puncture site. The inner lumen pressure is greater than the outer lumen pressure to forceably secure the flexible plug around the blood vessel puncture site.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0007]     The accompanying drawings, which are incorporated into and constitute a part of this specification, illustrate one or more embodiments and, together with the detailed description, serve to explain the principles and implementations of the invention.  
         [0008]     In the drawings:  
         [0009]      FIGS. 1A and 1B  illustrate an embodiment of the hemostatic pressure plug.  
         [0010]      FIG. 2A  and  FIG. 2B  illustrate the hemostatic pressure plug with a guidewire.  
         [0011]      FIGS. 3A, 3B , and  3 C illustrate the hemostatic pressure plug with an embodiment of a release mechanism.  
         [0012]      FIGS. 4A, 4B ,  4 C, and  4 D illustrate the hemostatic pressure plug positioned at a puncture site within the lumen of a blood vessel.  
         [0013]      FIG. 5  is a side view of  FIG. 4D  illustrating the hemostatic pressure plug intervascularly positioned around an irregularly shaped blood vessel lumen.  
         [0014]      FIGS. 6A, 6B ,  6 C, and  6 D illustrate embodiments of release mechanisms.  
         [0015]      FIGS. 7A, 7B , and  7 C illustrate the hemostatic pressure plug used with an attachment mechanism.  
         [0016]      FIGS. 8A, 8B , and  8 C illustrate yet another embodiment of a release mechanism in accordance with an embodiment of the present invention.  
         [0017]      FIGS. 9A and 9B  illustrate yet another embodiment of a releasable mechanism used with a placement tube.  
         [0018]      FIGS. 10A, 10B , and  10 C illustrate still another embodiment of a releasable mechanism in an attached and detached mode.  
         [0019]      FIG. 11  illustrates another embodiment of the hemostatic pressure device.  
         [0020]      FIG. 12  illustrates a method for promoting hemostasis at a puncture site.  
         [0021]      FIG. 13  illustrates another method for promoting hemostasis at a puncture site.  
     
    
     DETAILED DESCRIPTION  
       [0022]     Embodiments are described herein in the context of a hemostatic pressure plug. Those of ordinary skill in the art will realize that the following detailed description is illustrative only and is not intended to be in any way limiting. Other embodiments will readily suggest themselves to such skilled persons having the benefit of this disclosure. Reference will now be made in detail to implementations as illustrated in the accompanying drawings. The same reference indicators will be used throughout the drawings and the following detailed description to refer to the same or like parts.  
         [0023]     In the interest of clarity, not all of the routine features of the implementations described herein are shown and described. It will, of course, be appreciated that in the development of any such actual implementation, numerous implementation-specific decisions must be made in order to achieve the developer&#39;s specific goals, such as compliance with application- and business-related constraints, and that these specific goals will vary from one implementation to another and from one developer to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking of engineering for those of ordinary skill in the art having the benefit of this disclosure  
         [0024]     Providing hemostasis at a blood vessel puncture site is important for procedures such as percutaneous access to prevent bleeding and hematoma of a mammalian body or patient. Thus, a solution to facilitate hemostasis intervascularly at a puncture site may be achieved by deploying a flexible hemostatic plug within the blood vessel and utilizing the pressure difference between the inside and the outside of the blood vessel.  
         [0025]     Referring now to  FIGS. 1A and 1B , which illustrate an embodiment of the hemostatic pressure plug.  FIG. 1A  is a prospective view of the plug  10 . The plug  10  is illustrated as being circular in shape, however, any shape may be used such as a square, oval, triangle, and any other shape. A release mechanism  12  may be releasably positioned near the center of the plug  10 .  FIG. 1A  illustrates the release mechanism  12  as a thread, string, or suture. However, other release mechanisms, as further described in detail below, may be used. As illustrated in  FIG. 1B , a side view of  FIG. 1A , the thread or string  12  may be threaded through the plug  10  and held in position at the plug bottom  14  with a knot  16  at one end of the thread  12 . However, the thread may be held in position within the plug by other means such as with the use of any adhesives or biocompatible polymers such as PGA, gelatin, mannitol and the like. Once the plug  10  is positioned at the puncture site as described in detail below, the thread  12  may be cut below the patient&#39;s skin line by depressing the patient&#39;s skin and cutting the thread  12 .  
         [0026]     The plug  10  may have any diameter necessary to facilitate hemostasis at a puncture site. By way of example only and not intended to be limiting, a plug having a diameter of 3 mm to 6 mm may plug a blood vessel puncture having a diameter of 2.0 mm. The plug may also be formed with radial slits or cuts throughout the plug to provide for a more secure seal within an irregular blood vessel lumen ( FIG. 5 ). The slits may be positioned about every 45° apart. The thickness of the plug may vary between 0.2 mm to 1.0 mm. The thinner the plug, the easier it is to deploy compared to thicker plugs. Further, if the plug is too thick or rigid, it may not be flexible enough to circumferentially cover and seal the puncture thereby resulting in blood oozing out of the puncture.  
         [0027]      FIGS. 2A  is a prospective view and  FIG. 2B  is a side view illustrating the hemostatic pressure plug with a guidewire. A guidewire  18  may be inserted at any position within the plug  10 , however, it is advantageous to locate the guidewire  18  near the center of the plug  10  to provide for easier deployment and positioning of the plug  10 .  
         [0028]     When the guidewire  18  is removed from the plug  10 , a hole will be formed in the plug  10  through which blood may flow through. However, the plug  10  may be made of any self-sealing biocompatible material as further described below. Thus, the hole may self-seal itself closed to prevent any flow of blood through the hole. Additionally, the guidewire hole may be surrounded by an expandable hemostatic material, such as foam and other materials as further discussed below, such that when the guidewire is removed from the hole, blood will cause the hemostatic material to expand and swell to seal the hole.  
         [0029]      FIGS. 3A, 3B , and  3 C illustrate the hemostatic pressure plug with an embodiment of a release mechanism.  FIG. 3A  is a prospective view of the plug  20  having a release mechanism  22  looped through the plug  20 . The release mechanism  22  may be a thread or string as illustrated in  FIGS. 1A and 1B  above. However, in contrast to  FIGS. 1A and 1B , the release mechanism is not tied in a knot at the plug bottom  24 . Rather, the string is inserted through a first opening  28  from the plug top  26  through the plug bottom  24 . The string is then inserted through a second opening  30  at the plug bottom  24  through the plug top  26  there by forming a loop through the plug  20 . The first opening  28  and second opening  30  are positioned near the center of the plug  20 . Thus, when the plug  20  is deployed and positioned at the puncture site as described in detail below, the thread  22  may be easily withdrawn from the patient by merely pulling or withdrawing one end of the thread  22 . Alternatively, the release mechanism  22  may form a continuous loop through the plug by tying the ends of the string together as illustrated in  FIG. 3C  or both ends of the release mechanism  22  may be attached to the plug bottom  24  with knots (not shown) or any other means as described above.  
         [0030]      FIGS. 4A, 4B ,  4 C, and  4 D illustrate the hemostatic pressure plug positioned at a puncture site within the lumen of a blood vessel. There are many methods known to those of ordinary skill in the art to deploy the plug at the puncture site. Thus, not every method will be discussed herein so as to not overcomplicate the present disclosure. However, a brief description of a few methods will be provided herein for illustratory purposes only and are not meant or intended to be limiting in any way.  
         [0031]      FIG. 4A  illustrates the plug  44  positioned within a first hollow tube  42 , such as a sheath or an introducer. A second hollow tube  40 , such as a pusher, may be positioned around the center of the plug  44  whereby the plug  44  surrounds one end of the pusher  40  and the release mechanism  46  may be received within the a lumen  41  of the pusher  40 . The pusher  40  and plug  44  may then be inserted into the lumen  45  of the sheath  42 . Although  FIG. 4A  is illustrated with the use of a sheath, the plug  44  may also be inserted into the tissue tract without the use of a sheath.  
         [0032]     As illustrated in  FIGS. 4B and 4C  the plug  44  and release mechanism  46  are inserted into the sheath  42  and simultaneously pushed toward the blood vessel  48  with the pusher  40 ,  56 . As illustrated in  FIG. 4B , the pusher  40  or the sheath  42  may have an entrance port  47  for bleed back indication to locate the blood vessel puncture site, as further described below. As illustrated in  FIG. 4C , the pusher  56  may be a second deployment device having expandable members  58   a ,  58   b  at the pusher bottom. The expandable members  58   a ,  58   b  assist to expand the plug  44  intervascularly or within the blood vessel lumen  50 . This prevents the plug  44  from folding onto itself.  
         [0033]     Referring to  FIG. 4D , once the plug is exposed within the blood vessel lumen  50 , the pusher  40 ,  56  and sheath  42  may be removed from the tissue tract  52 . The plug  44  may be pulled closer to the puncture  54  by pulling both ends of the release mechanism  46  away from the blood vessel or patients skin. However, only a slight tug or pull is necessary. The pressure P i  within the blood vessel lumen  50  is greater than the pressure P o  within the tissue tract  52 . This pressure difference causes the plug  44  to be sucked into the puncture in the direction of arrow A thereby surrounding the puncture  54  and blocking blood flow out of the puncture  54 . It is also this pressure difference which allows the plug  44  to be securely positioned around the puncture  54 . A user may know when the plug  44  is positioned around the puncture through visual indication, such as lack of bleeding out of the tissue tract or a bleed back indicator as discussed below, or tactile feel, such as when the user feels an increase in tension when pulling on the release mechanism. When visual indication is used to determine whether the plug is secured around the puncture site, it is preferable that a large amount of bleed back outflow be observed, such as greater than 1 cc/sec of outflow. Bleed back, as further described in detail below may be observed out of the sheath, pusher, or tissue tract. Once positioned around the puncture  54 , the release mechanism may be withdrawn out of the patient by withdrawing one end of the thread in the direction of arrow B.  
         [0034]      FIG. 5  is a side view of  FIG. 4D  illustrating the plug intervascularly positioned around an irregularly shaped blood vessel lumen. As described above, the pressure inside P i  the blood vessel lumen  60  is greater than the pressure outside P o  the blood vessel (i.e. such as the tissue tract  62 ). This pressure difference, the flexibility of the plug  44 , and its circumferential coverage and extension over the puncture  66  securely positions the plug  44  against the blood vessel wall  64  and around the puncture  66 , even if the blood vessel wall  64  is irregular in shape. This is important to provide a tight and secure seal around the puncture  66  to prevent blood from oozing out of the blood vessel  60 . Current devices with rigid anchors, especially those which do not provide circumferential coverage around the puncture site are prone to blood leaking or oozing out of the blood vessel.  
         [0035]      FIGS. 6A, 6B ,  6 C, and  6 D illustrate embodiments of release mechanisms.  FIG. 6A  illustrates the plug  70  utilizing the same release mechanism described in  FIGS. 3A and 3B . A thread or string  72  may be positioned near the center the of plug  70 . A first end  76  of the thread may be attached to the plug bottom  74  with a knot  78  or any other secure means. The second end  80  of the thread  72  may be attached to an O-ring  82 . The release mechanism  84  may be looped through the o-ring  82  whereby once the plug  70  is positioned around the puncture, the release mechanism  84  may be withdrawn from the patient as described above with reference to  FIGS. 3A, 3B , and  4 D. In this embodiment, it is preferable that the thread  72  and o-ring  82  be made of any absorbable, biocompatible material as further described below. Additionally,  FIG. 6A  is illustrated using an o-ring, however, the o-ring is not intended to be limiting as any other device may be used. For example, as illustrated in  FIG. 6B , the plug  70  may be formed with a resilient extension member  86  having an opening  88 . The release mechanism  84  may be looped through the opening  88 . Alternatively, the release mechanism may be secured to extension member  86  by tying one end of the release mechanism  84  to itself after being looped through opening  88 .  
         [0036]      FIG. 6C  illustrates the use of a hemostatic material removably attached to the plug. The hemostatic material  90  may be removably attached near the center of the plug  70  with the use of any biocompatible polymers such as PGA, gelatin, mannitol and the like. Alternatively, the hemostatic material  90  may be incorporated into the plug  70 . The hemostatic material  90  may be a gelatin sponge or collagen which may further be contained in a gelatin capsule  98  as described below. In another embodiment, the extension member  92  may be surrounded with hemostatic material (not shown) which in turn may be contained in a gelatin capsule  98 . As illustrated in  FIG. 6D , when the plug  70  is positioned around the puncture  132  and the capsule is exposed to blood or other fluids, the capsule will dissolve thereby releasing the hemostatic material  90 . The hemostatic material may then absorb the fluids and expand to provide hemostasis at the puncture site  132 .  
         [0037]     The capsule  98  may be advantageously made from gelatin and formulated to have flexibility (like a gel-cap vitamin E) or be stiff like a typical 2-piece oral capsule. Capsules are made to dissolve within a predetermined time, with a dissolution time between 10 seconds and 10 days, and normally between one minute and 10 minutes. Also, the capsule  98  can be formulated to be inert (e.g. non thrombogenic, non-bacteriostatic) or to provide/deliver therapeutic benefit (e.g. bacteriostatic, clot acceleration which may include clot accelerators such as thrombin, calcium based compounds, chitosan, and may also include antibiotics or radiopaque substances). The capsule  98  can vary in characteristics along its length. For example, the distal region can be inert while the proximal region comprises therapeutic material.  
         [0038]     The release mechanism  84  may be looped through the capsule  98  or looped through an extension member  92 , having an opening  96 , attached to the capsule top  94 . The capsule  90  may plug the puncture to ensure that blood will not flow out the blood vessel  14  and may swell slightly to securely control the puncture.  
         [0039]      FIGS. 7A, 7B , and  7 C illustrate the hemostatic pressure plug used with an attachment mechanism. Referring to  FIG. 7A , the plug  100  may be used with an attachment mechanism  102  looped near the center of the plug  100  illustrated without a release mechanism for clarity. However, any type of release mechanism may be used with the attachment mechanism  102 . The attachment mechanism  102  may be a plurality of hooks that are compressed when enclosed within the lumen of a tube and expand when exposed. The hooks grasp the outside of the blood vessel and/or the tissue tract to secure the plug  100  to the puncture. The hooks may be flexible to prevent puncturing the blood vessel wall  112  or the hooks may be strong enough to puncture and attach into the blood vessel wall  112 . As illustrated in  FIG. 7B , the plug  100  may be pushed through the sheath  104  with a pusher  106 . The release mechanism  108  and hooks  102  may be positioned within the pusher  106 . Once the plug  100  is positioned at the puncture site  110 , as illustrated in  FIG. 7C , the pusher may be withdrawn thereby exposing the hooks  102 , which expand and grasp the outside of the blood vessel  112 . The attachment mechanism  102  ensures that the plug  100  will remain in position within the blood vessel lumen  114 . The description of the attachment mechanism as releasable hooks is not intended to be limiting. Other attachment mechanisms maybe utilized to secure the plug to the blood vessel such as barbs, and the like.  
         [0040]     The attachment mechanism may be encased with an expandable hemostatic material, such as a sponge or foam and other materials as further discussed below. When the hooks are released, the expandable hemostatic material may swell and expand to seal any holes which may be formed from the hooks as well as the puncture and adjacent tissue tract. This will further provide another mechanism to securely block blood flow out of the blood vessel.  
         [0041]      FIGS. 8A, 8B , and  8 C illustrate yet another embodiment of a release mechanism. As shown in  FIG. 8A , the plug  120  may have a releasable mechanism, generally numbered as  122 , near the center of the plug  120 . The release mechanism  122 , may have an entrance port  123  for bleed back indication to locate the blood vessel puncture site, as further described below. The releasable mechanism  122  has a first connector  160  having a first end  162  and a second end  164  and a second connector  166  having a top  168  and a bottom  170 . The first connector  160  has a first notch  172  at the second end  164  to releasably mate with the second connector bottom  170 . The first connector  160  may be attached near the center of the plug  120 . The second connector  166  has a second notch  174  at the bottom  170  to releasably mate with the first connector second end  164 . The first connector  160  and second connector  166  may have a lumen  176   a  and  176   b  to receive a guidewire  178  or any other device. Once the first connector  160  and the second connector  166  are mated at the first notch  172  and second notch  174 , the guidewire  178  may be placed through the releasable mechanism lumen  176   a  and  176   b . The guidewire  178  may assist in preventing the first connector  160  and the second connector  166  from separating but will also allow the releasable mechanism to move axially along the length of the guidewire  178 . Although  FIG. 8A  is illustrated with the use of a guidewire, the release mechanism  122  may be used without a lumen  176   a ,  176   b  and guidewire  178  and may be engaged with other devices such as a pusher or sheath, and released when the device is withdrawn.  
         [0042]      FIGS. 8B and 8C  illustrate the releasable mechanism of  FIG. 8A  in a detached mode. Once the plug  120  is positioned at the puncture site, the guidewire  178  is withdrawn and the releasable mechanism may be detached by detaching the second connector bottom  170  from the first notch  172  and the first connector top  164  from the second notch  174 . The releasable mechanism may be detached by a gentle pull or by twisting the releasable mechanism such that the second connector bottom  170  is positioned opposite the first notch  172  and the first connector top  164  is positioned opposite the second notch  174 . The method of detaching the releasable mechanism  122  is not meant to be limiting as there may be different ways to release the mechanism. However, this provides a low-force, stable way to release the plug  120  at the blood vessel puncture site and withdraw any devices used such as the guidewire  178 .  
         [0043]     Alternatively, as illustrated in  FIG. 8C , a hemostatic material  130  may be positioned around the first connector  160  above the entrance port  123 . The hemostatic pressure plug  120  may be delivered through a tissue tract with the use of a sheath already in the lumen until the entrance port  123  and plug  120  are exposed through the blood vessel lumen. Blood entering the entrance port  123  will travel through lumens  176   a ,  176   b  and out an exit port (not shown) such that bleed back may be observed by a user which is an indication that the plug  120  is within the blood vessel lumen. The user may then withdrawn the plug  120  with the use of the release mechanism until the bleed back indication ceases, which is an indication of the location of the blood vessel puncture.  
         [0044]     When the guidewire  178  is removed from the plug  120 , a hole will be formed in the plug  120  that will allow blood to flow through. However, the plug  120  may be made of any self-sealing absorbable material as further described below. Thus, the hole may self-seal itself closed to prevent any flow of blood through the hole. Additionally, the guidewire hole may be made of an expandable hemostatic material, such as foam and other materials as further discussed below, such that when the guidewire  178  is removed from the hole, the expandable hemostatic material may swell and expand to seal the hole. Alternatively, as illustrated in  FIGS. 8A and 8C , the hemostatic material  130  may be positioned within lumen  176   a  or surrounding a portion of first connector  160 . When the guidewire  178  is removed and blood enters the lumen  176   a , the hemostatic material will swell and expand to seal the hole and puncture.  
         [0045]      FIGS. 9A and 9B  illustrate yet another embodiment of a releasable mechanism used with a placement tube.  FIG. 9A  illustrates the plug  124  having a release mechanism  200  with a foot  204  at one end. The release mechanism  200  may be releasably attached to the center of the plug  124 . The release mechanism  200  may be used with a placement tube  206  having a recess  212  in its wall to mate with a foot  204 . The recess  212  may extend partially into the wall of the placement tube  206  as shown in  FIG. 9A  or the recess  214  may extend through the entire wall of the placement tube  206  as shown in  FIG. 9B . The recess,  212  or  214 , is preferably located near the placement tube bottom  216 , but may be positioned at any location along the placement tube  206 .  
         [0046]     As shown in  FIG. 9A , the foot  204  is held and engaged within the recess  212  by a guidewire  218 . Once the plug  124  is positioned at the puncture site, the release mechanism may be released by removing the guidewire  218  as shown in  FIG. 9B . Removing the guidewire  218  will cause the foot  204  to disengage from the recess  214 . This provides for an efficient and simple release mechanism to release the plug  124  without any tugging or pulling that may reposition the plug or cause damage to the surrounding tissue or puncture site.  
         [0047]     When the guidewire  218  is removed from the plug  124  a hole will be formed in the plug  124  that will allow blood to flow through. However, the plug  124  may be made of any self-sealing absorbable material as further described below. Thus, the hole may self-seal itself closed to prevent any flow of blood through the hold. Additionally, the guidewire hole may be made of an expandable hemostatic material, such as foam and other materials as further discussed below, such that when the guidewire  218  is removed from the hole, the expandable hemostatic material may swell and expand to seal the hole.  
         [0048]      FIGS. 10A, 10B , and  10 C illustrate still another embodiment of a releasable mechanism in an attached and detached mode, respectively. The releasable mechanism, generally numbered  300 , has a first connector  302  having a first end  306  and a second end  304  and a second connector  308  having a top  310  and a bottom  312 . The first connector first end  306  may be attached near the center of the plug  126 . The second connector top  310  may extend beyond a patient&#39;s skin to allow a user to release the release mechanism from the plug  126 .  
         [0049]     The first connector second end  304  has a first ring  314  positioned at an angle away from the second end  304 . The second connector  308  has a projection  320  parallel to a second ring  316  near the bottom  312  such that the projection  320  and the second ring  316  form a recess  322  to releasably mate with the first ring  314 . The projection  320  may be shorter in length that the second ring  316 . Both the first ring  314  and the second ring  316  have a lumen  319   a ,  319   b  to receive a guidewire  318 .  
         [0050]     As shown in  FIG. 10B , the location of the first ring  314 , second ring  316 , and projection  320  are not meant to be limiting. For example, the projection  320  may be in front of the second ring  316  as shown in  FIG. 10B  or may be behind the second ring  316  as shown in  FIG. 10C . Additionally, the first ring  314  may be located at the second end  304  as illustrated in  FIG. 10C  or may be located near the second end  304  as illustrated in  FIG. 10B . Thus, it may be appreciated that there are many different placements for the first ring, second ring, and projection.  
         [0051]     In use, the first ring  314  is positioned within the recess  322  and the guidewire  318  is positioned through lumens  319   a ,  319   b . The guidewire  318  will assist in preventing the first connector  302  and the second connector  308  from separating but will allow the releasable mechanism to move axially along the length of the guidewire  318 . Once the plug  126  is positioned at the puncture site, the guidewire  318  is removed and the first ring  314  may be released from the recess  322  with a gentle tug or twist such that the first ring  314  is no longer within the recess  322  as shown in  FIGS. 10B and 10C .  
         [0052]     When the guidewire  318  is removed from the plug  126  a hole will be formed in the plug  126  that will allow blood to flow through. However, the plug  126  may be made of any self-sealing absorbable material as further described below. Thus, the hole may self-seal itself closed to prevent any flow of blood through the hold. Additionally, the guidewire hole may be made of an expandable hemostatic material, such as foam and other materials as further discussed below, such that when the guidewire  318  is removed from the hole, the expandable hemostatic material may swell and expand to seal the hole.  
         [0053]      FIG. 11  illustrates another embodiment of the hemostatic pressure device. The device, generally numbered  400 , comprises a disk  402  attached to a neck  404  which is attached to a body  406 . In use, the device  400  would be compressed radially for placement through the tissue tract with the use of a sheath, pusher, or release mechanism.  
         [0054]     The disk  402  may be similar to the hemostatic pressure plug described above. The disk will circumferentially intervascularly seal and cover the puncture site. The device  400  may have a release mechanism  408  attached near the center of the body  406  opposite from the neck  404 . Since several possible embodiments of the release mechanism are discussed in detail above, it will not be discussed further herein.  
         [0055]     Neck  404  may by attached near the center of disk  402  at one side. In use, neck  404  will be positioned within the blood vessel wall. Thus, neck  402  may have a smaller diameter than the disk  402  and body  406  such that when neck  402  is positioned within the blood vessel puncture wall, it will not tear or rip the blood vessel wall. Body  406  may be attached to neck  402  opposite the side where neck  404  is attached to the disk  402 . Body  406  may be any hemostatic material such as the hemostatic material detailed above. Body  406  may expand to provide additional intravascular sealing of the blood vessel puncture.  
         [0056]     Although disk  402 , neck  404 , and body  406  may be made of the same materials as discussed in detail below, it is preferable that disk  402  has enhanced properties of density, strength, and resilience. The enhanced properties of disk  402  may be achieved through heat setting and pressure to permanently set the disk axially as a more dense, thinner form. By way of example only, heat from about 200° F. to 400° F. and pressure from as little as 15 psi may be used to set the disk. The neck may also be modified, for instance by radial heat setting, to a more dense, smaller diameter all the while maintaining at least some of its ability to expand upon exposure to blood or fluids.  
         [0057]     The device  400  may be selectively coated with known substances to slow their expansion and/or absorption rates. The device  400  may also be coated with absorbable or non-absorbable polymers and dispersions and soaked or wicked with any desired absorbable or non-absorbable polymers and dispersions for delivery to the blood vessel puncture site.  
         [0058]     The various releasable mechanisms described above are illustrated as cylindrical or rod shaped. However, the releasable mechanisms may be any shape such as a rod, square, or other shape. Additionally, the embodiments described above were illustrated with reference to a releasable mechanism and plug used with a guidewire. However, there are other applications the releasable mechanism may be used with such as neurological surgery devices and coils.  
         [0059]     The plug may be made of any semi-rigid, absorbable, biocompatible material such as Collagen, Oxidized Cellulose, PGA, methyl cellulose, carboxymethyl cellulose, carbowaxes, gelatin (particularly pigskin gelatin), urethane foam, and sugar based compounds. Among the other suitable polymers are polylactic glycolic acids, polyvinyl pyrrolidone, polyvinyl alcohol, polyproline, and polyethylene oxide. Alternatively, the plug may be made of a non-absorbable material such as dacron, gortex, felt, suede, urethane foam, and any other cross-linked or fixed xenograft materials. The plug should not be made of a flimsy material that does not retain its shape because it will be difficult to position the plug at the puncture site and the plug will not be able to securely block the entire puncture. The plug requires some memory such that it can substantially retain its original shape after being compressed or folded when delivered through the tissue tract, sheath, or any other delivery device. The plug should not be made of a rigid material or it will not conform to the shape of or be pressure sealed to the puncture thereby resulting in the oozing of blood out of the blood vessel puncture.  
         [0060]     The release mechanisms, guidewire, attachment mechanism, and hemostatic material described above may be made of any type of absorbable, biocompatible material as described above. The hemostatic material may also be made of other materials such as fibrillar collagen, collagen sponge, regenerated oxidized cellulose, gelatin powder, hydrogel particles. Alternatively, the release mechanisms, guidewire, and attachment mechanism may be made of a non-absorbable material such as any biocompatible textile material, non-absorbable plastics, Nitinol, stainless steel, and the like.  
         [0061]      FIG. 12  illustrates a method for promoting hemostasis at a puncture site. After a surgical procedure is complete, the puncture site must be sealed to control bleeding from the punctured artery. The blood vessel puncture is located at  250 . There are various methods to locate the blood vessel puncture site, of which any of the methods may be used with the embodiments described above. By way of example only, and not intended to be limiting, a depth indicator or marker on the sheath, pusher, or introducer may be used to locate the blood vessel puncture. Other methods, such as the use of a bleed back indicator illustrated on the pusher in  FIG. 4B  or on the release mechanism in  FIG. 8C , may be used to locate the puncture site. The various methods which may be used to locate the puncture site will not be described herein so as to not overcomplicate the present disclosure.  
         [0062]     Once the blood vessel puncture site is located, the hemostatic pressure plug is inserted into the tissue tract at  252 . The plug may be inserted into the tissue tract by any means, such as with the use of a sheath and pusher or with any of the release mechanisms described above. The hemostatic pressure plug is pushed into the tissue tract until it is deployed into the blood vessel lumen at  254 . All surgical devices are withdrawn from the tissue tract at  256  and the plug is positioned and confirmed that it is at the puncture site at  258 .  
         [0063]     The plug may be positioned at the puncture site with only a slight pull of the release mechanism in a direction away from the blood vessel or away from the patient&#39;s skin. The pressure within the blood vessel lumen is greater than the pressure within the tissue tract. This pressure difference causes the plug to be sucked into and around the puncture thereby surrounding the puncture and blocking blood flow out of the puncture. It is also this pressure difference which allows the plug to be securely positioned around the puncture. Confirmation that the plug is located at the blood vessel puncture site may be completed through visual indication, such as lack of bleeding out of the tissue tract or out of a bleed back indicator as discussed below, or tactile feel, such as when the user feels an increase in tension when pulling on the release mechanism.  
         [0064]     Once the plug is securely positioned around the puncture, a pledget or hemostasis material may be deployed adjacent the puncture site at  260 . The hemostasis material may be delivered to the puncture through the tissue tract  264  by any means and will not be discussed herein to prevent obfuscation of the present disclosure. However, by way of example only and not intended to be limiting, the pledget may be inserted through the release mechanism or by fluid pressure with the use of a sheath. If a pledget is not utilized, the release mechanism may be released and withdrawn from the tissue tract at  262 .  
         [0065]      FIG. 13  illustrates another method for promoting hemostasis at a puncture site. The blood vessel puncture may be located at  350  through any method described above. Once the puncture site is located, the hemostatic pressure plug is inserted into the tissue tract at  352 . The hemostatic pressure plug may then be pushed into the tissue tract until it is deployed into the blood vessel lumen at  354 . The plug may be positioned and confirmed that it is at the puncture site at  356 .  
         [0066]     The plug may be positioned at the puncture site with only a slight pull of the release mechanism in a direction away from the blood vessel or away from the patient&#39;s skin. The pressure within the blood vessel lumen is greater than the pressure within the tissue tract. This pressure difference causes the plug to be sucked into and around the puncture thereby surrounding the puncture and blocking blood flow out of the puncture. It is also this pressure difference which allows the plug to be securely positioned around the puncture. Confirmation that the plug is located at the blood vessel puncture site may be completed through visual indication, such as lack of bleeding out of the tissue tract or out of a bleed back indicator as discussed below, or tactile feel, such as when the user feels an increase in tension when pulling on the release mechanism.  
         [0067]     Once the plug is securely positioned around the puncture, the release mechanism may be released and withdrawn from the tissue tract at  358 . All surgical devices may then be withdrawn from the tissue tract at  360 .  
         [0068]     While embodiments and applications have been shown and described, it would be apparent to those skilled in the art having the benefit of this disclosure that many more modifications than mentioned above are possible without departing from the inventive concepts herein. The invention, therefore, is not to be restricted except in the spirit of the appended claims.