Patent Document

TECHNICAL FIELD 
     The present disclosure relates generally to methods and systems for sealing tissue punctures, and more particularly, to methods and systems for sealing large bore openings in vessels using multiple closure mechanisms. 
     BACKGROUND 
     Various surgical procedures are routinely carried out intravascularly or intraluminally. For example, in the treatment of vascular disease, such as arteriosclerosis, it is a common practice to access the artery and insert an instrument (e.g., a balloon or other type of catheter) to carry out a procedure within the artery. Such procedures usually involve the percutaneous puncture of the artery so that an insertion sheath may be placed in the artery and thereafter instruments (e.g., catheters) may pass through the sheath to an operative position within the artery. Intravascular and intraluminal procedures unavoidably present the problem of stopping the bleeding at the percutaneous puncture after the procedure has been completed and after the instruments (and any insertion sheaths used therewith) have been removed. Bleeding from puncture sites, particularly in the case of femoral arterial punctures, is typically stopped by utilizing vascular closure devices. 
     While there are a variety of prior art devices and techniques for closing such punctures, one method includes temporarily sealing the tissue puncture intravascularly using an inflation balloon. A sealing material may be delivered to an outer surface of the tissue to seal the tissue puncture. 
     Closing large bore openings in a vessel may be particularly difficult using a pre-formed or flowable sealing material on an exterior surface of the vessel. Challenges exist related to holding closed a large bore opening using only a sealing material because of the large size of the opening and the natural forces tending to bias the opening away from a closed position. Opportunities exist for improvement in closing large bore openings to improve hemostasis. 
     SUMMARY 
     One aspect of the present disclosure relates to a vascular closure assembly configured to seal an opening or puncture in a vessel. The vascular closure assembly includes a suture placement device and a sealant delivery device. The suture placement device is operable to position at least one suture across the puncture to form a primary seal of the puncture. The sealant delivery device includes a sealant delivery tube having a first lumen sized to receive the at least one suture, and a second lumen configured to deliver a volume of sealant to the puncture after forming the primary seal to create a secondary seal of the puncture. The sealant delivery device is slidable along the at least one suture to the puncture. 
     The sealant delivery tube may include a suture insertion slot at a distal end of the sealant delivery tube. The sealant delivery tube may include a helical shaped suture insertion slot at a distal end thereof, and a longitudinal guide slot open to the helical shaped suture insertion slot. The sealant delivery tube may include a helical shaped suture insertion slot at a distal end thereof, wherein the insertion slot forms an acute angle along its length. The sealant delivery device may include a suture retaining member positioned at a distal end thereof, wherein the suture retaining member permits one-way insertion of the at least one suture into the first lumen. The suture placement device may position the at least one suture on opposite sides of the puncture, and tension may be retained in the at least one suture with one of a knot and a suture locking device to at least partially seal the puncture prior to delivering the volume of sealant. 
     Another aspect of the present disclosure relates to a method of closing a puncture in a vessel. The method includes providing a suture placement device and a sealant delivery device, positioning at least one suture across the puncture with the suture placement device, sealing the puncture with the at least one suture, advancing the sealant delivery device along the at least one suture to the puncture, and delivering a volume of sealant through the sealant delivery device to the puncture to further seal the puncture. 
     The method may also include providing a releasable connection between the sealant delivery device and the at least one suture. Delivering a volume of sealant may include mixing the volume of sealant in the sealant delivery device during delivery. The sealant delivery device may include a first lumen configured to receive the at least one suture and a second lumen configured to deliver the volume of sealant. Sealing the puncture may include advancing a knot along the at least one suture to the puncture. The at least one suture may include two suture portions and the sealant delivery device may be advanced along both suture portions to the puncture. 
     The sealant delivery device may include a sealant shaft and an insertion slot extending proximally from an open distal end of the sealant shaft, and the method may include inserting the at least one suture into the insertion slot prior to advancing the sealant delivery device. The sealant delivery device may include a guide slot spaced proximal of the open distal end and intersecting with the insertion slot, and the method may include inserting the at least one suture through the insertion slot and into the guide slot prior to advancing the sealant delivery device. The method may include inserting the at least one suture into a portion of the sealant delivery device before advancing the sealant delivery device. 
     Another example method in accordance with the present disclosure relates to sealing a puncture in a vessel accessible through a percutaneous incision. The method includes providing a sealant delivery device having first and second lumens, and a suture placement device, positioning at least one suture across the puncture with the suture placement device, advancing a knot along the at least one suture to seal the puncture, positioning the at least one suture in the first lumen, advancing the sealant delivery device along the at least one suture to the puncture, and delivering a volume of sealant through the second lumen to the puncture to seal the puncture. 
     The sealant delivery device may include a helical shaped insertion slot providing lateral access into the first lumen, and positioning the at least one suture in the first lumen includes laterally inserting the at least one suture through the insertion slot. The sealant delivery device may include a guide slot intersecting the insertion slot and extending longitudinally, and positioning the at least one suture in the first lumen includes positioning the at least one suture in the guide slot. The sealant may include a resorbable bioadhesive. Positioning at least one suture across the puncture with the suture placement device may include inserting the suture placement device in the puncture, advancing at least one needle through a wall of the vessel adjacent to the puncture, drawing the at least one suture through the wall of the vessel, and removing the suture placement device from the puncture. 
     The foregoing and other features, utilities, and advantages of the invention will be apparent from the following detailed description of the invention with reference to the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings illustrate various embodiments of the present disclosure and are a part of the specification. The illustrated embodiments are merely examples of the present disclosure and do not limit the scope of the invention. 
         FIG. 1  shows components of an example vascular closure system in accordance with the present disclosure. 
         FIG. 1A  is a cross-sectional view of a sealant delivery device of the vascular closure system shown in  FIG. 1  taken along cross-sectional indicators  1 A- 1 A. 
         FIG. 1B  is a close-up view of a distal end portion of the sealant delivery device of the vascular closure system of  FIG. 1 . 
         FIG. 2A  is a close-up view of a distal end portion of another example sealant delivery device. 
         FIG. 2B  is an end view of the sealant delivery device of  FIG. 2A . 
         FIG. 3A  is a close-up view of a distal end portion of another example sealant delivery device. 
         FIG. 3B  is an end view of the sealant delivery device of  FIG. 3A  in a closed position. 
         FIG. 3C  is an end view of the sealant delivery device of  FIG. 3A  in an open position. 
         FIGS. 4-10  show steps of an example method of sealing a vessel puncture using the vascular closure system of  FIG. 1 . 
     
    
    
     Throughout the drawings, identical reference numbers designate similar, but not necessarily identical, elements. 
     DETAILED DESCRIPTION 
     The systems disclosed herein may be used to close or seal percutaneous punctures made through the body tissue of a patient to gain access to a body cavity of a patient. Access through these percutaneous punctures allows a physician to carry out various procedures in or through the body cavity for examination, surgery, treatment and the like. While not meant to be limiting, the systems are illustrated being used to seal percutaneous punctures that provide access to blood vessels in patients for various procedures. It will be appreciated that the systems are applicable to other procedures requiring sealing of a puncture through body tissue into a cavity including, for example, laparoscopic surgery and other microscopic surgery techniques using a relatively small incision. 
     As used in this specification and the appended claims, the terms “engage” and “engagable” are used broadly to mean interlock, mesh, or contact between two structures or devices. Likewise “disengage” or “disengagable” means to remove or capable of being removed from interlock, mesh, or contact. A “tube” is an elongated device with a passageway. The passageway may be enclosed or open (e.g., a trough). A “lumen” refers to any open space or cavity in a bodily organ, especially in a blood vessel. The words “including” and “having,” as well as their derivatives, as used in the specification, including the claims, have the same meaning as the word “comprising.” 
     The general structure and function of tissue closure devices used for sealing a tissue puncture in an internal tissue wall accessible through an incision in the skin are known in the art. Applications of closure devices including those implementing principles described herein include closure of a percutaneous puncture or incision in tissue separating two internal portions of a living body, such as punctures or incisions in blood vessels, ducts or lumens, gall bladders, livers, hearts, etc. 
     An exemplary embodiment of the present disclosure includes a vascular closure system used to provide hemostatis of a vessel puncture. One aspect of the present disclosure relates to systems and methods for achieving secondary hemostatis of a vessel puncture that has been closed using at least one suture. The vascular closure system may include a bioadhesive delivery device configured to apply bioadhesive to a previously sutured vessel puncture (e.g., arteriotomy). The bioadhesive may work in conjunction with the suture to maintain hemostatis. The use of a bioadhesive to achieve hemostatis in combination with a suture closure of the vessel puncture may be particularly useful when dealing with large arteriotomies (e.g., 18 French (F) to 24 F). 
     The bioadhesive delivery device may include a syringe loaded with a bioadhesive, and a delivery sheath coupled in flow communication with the syringe for delivery of the bioadhesive to the vessel puncture. For the procedure, the vessel puncture may have been pre-sutured using a separate large bore closure device or other suture placement device. The sutures may be secured using, for example, knots or a suture locking device such as a clip. A distal tip of the delivery sheath may be designed to communicate with the protruding suture to help advance the bioadhesive delivery device down a percutaneous tissue tract to the vessel. The bioadhesive may be applied to help secure the suture and further seal the vessel puncture to provide improved hemostasis. 
     As mentioned above, the vascular closure system may be particularly useful as part of closing a large bore tissue puncture. Large bore tissue punctures are typically in the range from about 5 F to about 30 F, and more particularly from 10 F to about 25 F. A suture placement device may be used to place at least one suture through tissue adjacent to the tissue puncture. In one example, the suture placement device places two sutures in a wall of the vessel adjacent to the vessel puncture. A suture placement device may be operable percutaneously through a layer of tissue (e.g., skin or fat) that provides access via a tissue tract to the vessel puncture. 
     Suture locking devices or knots may be used to apply and maintain tension in the sutures to at least partially seal the vessel puncture. The free ends of the suture may extend out of the layer of tissue for use in guiding the bioadhesive delivery device to the vessel. The free ends of the suture may be captured by or extend through a portion of the bioadhesive delivery device to provide improved guiding to the vessel puncture. The sealant delivery device may be configured with rapid exchange features that permit mounting the sealant delivery device to the sutures at a location outside of the tissue tract and distal of the proximal ends of the sutures. The free ends of the suture may be cut within the tissue tract after delivery of the bioadhesive and removal of the sealant delivery device. 
     Referring now to  FIG. 1 , an example vascular closure system  10  (also referred to as a vascular closure assembly) is shown and described. The vascular closure system  10  includes a sealant delivery device  12  and an optional suture placement device  14 . The suture placement device  14  may be used to position at least one suture cross a vessel puncture. The suture placement device  14  is removed and the sealant delivery device  12  is advanced along the suture to the vessel puncture. The sealant delivery device  12  deposits a volume of bioadhesive at the vessel puncture. The suture and bioadhesive may be used to seal the vessel puncture and provide hemostatis. A knot or suture locking device may be advanced along the suture to at least partially seal the vessel puncture prior to delivery of the bioadhesive. 
     Referring now to  FIGS. 1-1B , the sealant delivery device  12  includes a sealant shaft  20  (also referred to as a delivery sheath), a sealant manifold  22 , and a sealant mixing device  24 . The sealant shaft  20  includes a sealant lumen  26  (see  FIG. 1A ) and an exchange lumen  28 . The sealant lumen  26  is coupled in flow communication with the sealant mixing device  24  via the sealant manifold  22 . The sealant mixing device  24  includes a housing  25  and a plunger  27 . Operating the plunger  27  in an axial direction relative to the housing  25  advances the bioadhesive through the sealant manifold  22  and the sealant lumen  26 , and out at the vessel puncture. 
     The exchange lumen  28  includes a distal end opening  32 , insertion slot  34 , a longitudinal guide slot  36 , and a tip  44  (see  FIG. 1B ). The tip  44  may define at least in part the distal end opening  32  and the insertion slot  34 . The insertion slot  34  may have a contoured shape such as a helical shape. The insertion slot  34  may be referred to as a helical insertion slot. Many other shapes and constructions are possible for the insertion slot  34 . The insertion slot  34  permits a suture to be threaded into the longitudinal guide slot  36  at any point along a length of the suture. The insertion slot  34  may extend through approximately 90° as shown in  FIG. 1B , although the insertion slot  34  may also traverse smaller or larger angles such as 180°. The insertion slot  34  is open to the distal end opening  32  and intersects with the longitudinal guide slot  36 . 
     The longitudinal guide slot  36  may be shaped generally like a capsule with the insertion slot  34  intersecting the longitudinal guide slot  36  at a location spaced between its distal and proximal ends  38 ,  40 . The longitudinal guide slot  36  may have a shape and orientation that limits an inserted suture from falling out of the longitudinal guide slot  36 . As a suture, such as the suture  62  shown in  FIG. 2A  and  FIGS. 4-10 , is threaded into the insertion slot  34  and longitudinal guide slot  36 , the suture tends to fall towards the proximal end  40  of the longitudinal guide slot  36 , which prevents the suture  62  from slipping back out of the insertion slot  34 . In at least one example, the longitudinal guide slot  36  is aligned parallel with the longitudinal axis of the sealant shaft  20 . 
     The tip  44  may include various features which assist in advancing the suture  62  into the insertion slot  34 . The tip  44  may include tapered features such as a tapered opening at a distal surface thereof or along side surfaces thereof in alignment with the insertion slot  34  to enhance insertion of the suture  62 . In one example, the tip  44  includes a cantilever arm  42  (see  FIGS. 2A-2B ). The cantilever arm may act as a one-way opening or door. The suture  62  may deflect the cantilever arm  42  while moving into the insertion slot  34 . The cantilever arm  42  may automatically move back into the position of  FIGS. 2A-2B  to capture the suture  62  within the exchange lumen  28 . The cantilever arm  42  may limit movement of the suture  62  out of the exchange lumen  28  while advancing the sealant delivery device  12  along the suture  62  to the vessel puncture. In one example, the suture  62  may be removed from the exchange lumen  28  only by retracting the sealant delivery device  12  proximately off a distal end of the suture  62  when the cantilever arm  42  or a similar feature is used to capture the suture  62 . 
     The distal end opening  32  into the exchange lumen  28  may have a diameter D (see  FIG. 2B ), which is large enough to allow a suture to slide freely therethrough. The diameter D may be small enough to prevent any knots tied into the suture (e.g., knot  64  shown in  FIG. 2A ) or a suture locking device attached to the suture from entering through the tip  44 . Consequently, knots such as knot  64  used to hold closed the vessel puncture cannot enter the exchange lumen  28 . In some examples, the diameter D may be no more than approximately two to three times the diameter of the suture  62 . In one example, the suture has a diameter of about 0.12 mm and the internal diameter D is no more than about 0.35 mm. 
     An alternative tip  144  is shown with reference to  FIGS. 3A-3C . The tip  144  is mounted to a sealant shaft  120 , which includes a sealant lumen  126  and an exchange lumen  128 . The tip  144  includes a one-way door  142 , which provides access into the exchange lumen  128 . The tip  144  may include a taper  146  leading to the one-way door  142 . The one-way door  142  may move from a closed position shown in  FIG. 3B  to an open position shown in  FIG. 3C  to permit passage of a suture into the exchange lumen  128 . The one-way door  142  may automatically return back to the closed position shown in  FIG. 3B  upon removing the radially directed force applied to the one-way door  142  by the suture when inserting the suture into the exchange lumen  128 . 
     The cantilever arm  42  and one-way door  142  described with reference to  FIGS. 2A-3C  are included as features of the tips  44 ,  144 , respectively. In other examples, similar suture capturing or locking features may be integrated directly into the sealant shaft  20 ,  120 , rather than being formed in a separate tip, which is inserted into an open distal end of the sealant shaft. In alternative configurations, additional features may be mounted on an exterior circumferential surface of the sealant shaft to assist in capturing the suture within the exchange lumen  128 . In still further embodiments, the sealant shaft  20  includes the sealant lumen  26 , but does not include a separate exchange lumen  28 . The sealant shaft  20  may include a feature positioned on an outer surface thereof or at the distal tip thereof, which provides a slideable connection with the suture  62  for purposes of tracking the sealant delivery device along the suture  62  to the vessel puncture. 
     In other arrangements, the sealant shaft  20  does not include a side or lateral opening into the exchange lumen  28 . The sealant shaft  20  may include a different rapid exchange feature for mounting the sealant delivery device  12  to the suture  62 . The rapid exchange feature may make it possible to mount the sealant delivery device  12  to the suture  62  at a location spaced between the proximal and distal ends of the suture  62 . The rapid exchange capability may be particularly useful when the suture is relatively long and flexible, making it difficult to thread the suture through the exchange lumen  28  and out of a proximal open end of the sealing shaft (e.g., along an entire length of the sealing shaft  20 ). In some arrangements, the rapid exchange feature includes an exchange lumen  28  open at its distal end  32  and then closed along at least a portion of its length to a location spaced proximal of the distal end opening  32  wherein a lateral opening is formed in the exchange lumen  28 . The proximal end of the suture  62  may be threaded through the distal end opening  32  and out of the lateral opening at a location distal of the sealant manifold  22 . 
     The sealant mixing device  24  may carry at least one sealant material. In one example, the sealant material carried by the sealant mixing device  24  includes at least two components that remain separated until just prior to delivering the sealant material to the vessel puncture. The sealant mixing device  24  is shown having a plunger  27  used to expel the sealant material from the sealant delivery device  12 . Other structures and mechanisms may be used to mix, store, and eject the sealant material through the sealant shaft  20  to a tissue puncture. Example sealant mixing devices and related sealant materials are disclosed in U.S. patent application No. 61/692,859 filed on 24 Aug. 2012, and entitled “Sealant Storage, Preparation and Delivery Systems and Related Methods,” and U.S. patent application No. 61/693,052, filed on 24 Aug. 2012, and entitled “Bioadhesive Mixing and Delivery Device and Methods”, which patent applications are incorporated herein in their entireties by this reference. 
     The suture placement device  14  shown in  FIG. 1  includes a handle  50 , and insertion shaft  52 , an anchor  54 , a suture carrying portion  56 , a needle  58 , and a distal locator tip  60 . The handle  50  may include first and second actuators  66 ,  68 . The suture carrying portion  56  may include a plurality of sutures  62 . The suture placement device  14  may be operated to place at least one of the sutures  62  across a vessel puncture  96  as described below with reference to  FIGS. 4-10 . The first actuator  66  may be operated to move the anchor  54  into an expanded position to capture a vessel wall as shown in  FIG. 4 . The second actuator  68  may be operated to advance the needles  58  through the vessel wall and into contact with the suture carrying portion  56  to capture the suture  62 . The second actuator may be operated in a reverse direction to retract the needles  58  to pull the suture  62  through the vessel wall. The first actuator  66  may be operated in a reverse direction to retract the anchor  54 , followed by withdrawal of the suture placement device  14  from the vessel puncture. The suture  62  remains positioned extending through the vessel wall as shown in  FIG. 6 . 
     Details concerning operation of an example suture placement device are shown and described in U.S. patent application Ser. No. 13/490,816, filed on 7 Jun. 2012, and entitled “Large Bore Puncture Closure Device and Methods”, which is incorporated herein in its entirety by this reference. Many types of suture placement devices may be used to position at least one suture across the vessel puncture. Typically, the suture placement device  14  is used to place at least one suture across the vessel puncture prior to other treatment and operational steps related to closing the vessel puncture. For example, the suture placement device  14  may be operated at shown in  FIGS. 4-5  to place the sutures  62  across the vessel puncture prior to advancing the sealant delivery device  12  along the suture  62  to the vessel puncture. 
     Referring now to  FIGS. 4-10 , an example method of sealing a vessel puncture using the vascular closure system  10  is described in detail. Referring first to  FIG. 4 , at least one suture  62  is positioned across a vessel puncture  96  using suture placement device  14 . The vessel puncture  96  is formed in vessel  94  and is accessible through a tissue tract  92  of a tissue layer  90 . 
     The suture placement device  14  is advanced through the tissue layer  92  and the vessel puncture  96  to position the anchor  54 , suture carrying portion  56 , and distal locator tip  60  within the vessel lumen  98 . The suture placement device  14  is then operated by actuating first actuator  66  to capture a wall of vessel  94  between a distal end surface of the insertion shaft  52  and proximal surfaces of the anchor  54 . The second actuator  68  is then actuated to advance needles  58  through the wall of the vessel  94  and into contact with the sutures  62  carried by the suture carrying portion  56 . The second actuator  68  is operated in a reverse direction to withdraw the needles  58  and sutures  62  through the vessel wall as shown in  FIG. 5 . The first actuator  66  is operated in a reverse direction to retract the anchor  54 . The suture placement device  14  is then withdrawn from the vessel puncture  96  and tissue tract  92 . The suture  62  remains extending across the vessel puncture  96  as shown in  FIG. 6 . Free ends of the suture  62  may extend out of the tissue layer  90  for handling by the operator. 
     The operator may tie a knot in at least one of the sutures  62  and advance the knot through the tissue tract  92  to the vessel puncture  96 . The knot may be used to cinch at least one of the sutures  62  to maintain tension in the suture  62  to close the vessel puncture  96 . At least one suture locking device may be used in combination with or in place of the knot  64  for maintaining tension in the suture  62  to hold closed the vessel puncture  96 . The suture locking device (not shown) may be advanced along the suture  62  and into the tissue tract  92  to a position adjacent to the vessel puncture  96 . 
     As discussed above, closing the vessel puncture  96  using only the sutures  62  and any knots or suture locking devices used therewith may provide an initial closure of the vessel puncture  96  (e.g., preliminary hemostasis). However, when closing relatively large vessel punctures such as vessel punctures in the range of about 10 F to 30 F (e.g., about 18 F to about 24 F), which are referred to as large bore vessel punctures, using sutures alone to close the vessel puncture may be inadequate to provide complete hemostatis. The sealant delivery device  12  may be used in combination with the suture closure shown in  FIGS. 4-7  to further seal and maintain closure (e.g., hemostasis) of the vessel puncture  96 . 
     Referring to  FIG. 8 , the sealant delivery device  12  may be mounted to at least one of the sutures  62 . In one example, the sutures  62  are positioned within the exchange lumen  28  and oriented within the longitudinal guide slot  36  as shown in  FIG. 8 . The sealant delivery device  12  is then advanced along the suture  62  to the vessel puncture  96 . As mentioned above, there may be numerous ways to provide a connection between the sealant delivery device  12  and the suture  62  to assist in tracking or guiding the sealant delivery device  12  to the vessel puncture. The exchange lumen  28  shown in  FIGS. 8 and 9  and described above is merely one example of a sealant shaft and associated tip construction that provides a positive connection between the sealant delivery device  12  and the sutures  62  while permitting relative sliding motion therebetween for guiding the sealant delivery device  12  along the sutures  62  to the vessel puncture. In one example, the sutures  62  maintain connection to the sealant shaft using a one-way door (e.g., via doors  42 ,  142  described above). In other examples, the sutures  62  are held in the sealant shaft by applying a rotation force to the sealant delivery device  12 . 
     Referring to  FIG. 9 , the sealant delivery device  12  is operated to advance a volume of sealant through the sealant lumen  26  and into the area surrounding the vessel puncture  96  along an exterior of the vessel  94 . The volume of sealant may form a sealant plug  48  that fills at least a portion of the tissue tract  92  and encapsulates at least a portion of the suture  62  and the knot  64 . The plug  48  may provide further sealing of the vessel puncture  96 . The plug  48  may bond with an outer surface of the vessel  94  adjacent to the vessel puncture  96 . The plug  48  may also bond with the tissue layer  90  within the tissue tract  92 . The plug  48  may bond directly to the suture  62  to provide a connection therebetween. The plug  48  may provide a secondary seal for the vessel puncture  96  and provide further hemostatis. 
     The sealant delivery device may then be withdrawn along the suture  62  and out of the tissue tract as shown in  FIG. 10 . The suture  62  may be trimmed to a shorter length. In at least one example, the suture  62  may be cut within the tissue tract  92  at a location below an outer surface of the tissue layer  90 . The tissue tract  92  may close around the plug  48 . 
     In other arrangements, a sealant shaft includes a sealant lumen and an exchange lumen that does not include a side opening. The exchange port may provide a rapid exchange mounting of the sealant delivery device to the sutures. The rapid exchange features may make it possible to mount the sealant delivery device to the sutures at a location spaced between proximal and distal ends of the sutures. 
     The sealant delivered by the vascular closure system  10  may be used in combination with or independent of at least partially sealing vessel puncture  96  with sutures  62  and corresponding suture knots  64  or a suture locking device. Using a combination of sutures and sealing material may be particularly effective in maintaining a sealed closure of a large bore vessel puncture, wherein sutures or sealing material independently may be less effective in maintaining closure of the vessel puncture. 
     The sealants discussed herein may comprise a single component, or may comprise multiple sealant components that are mixed together. The multiple sealant components may further react together to form a crosslinked network. The sealant components may be naturally derived or synthetic. Some example synthetic components include polyethers such as polyethylene glycol, polypropylene glycol and polytetrahydrofuran. Other examples of synthetic components may include polyamine compositions such as polyvinylpyrrolidones, polyethylene imines and hydrogenated polyacrylonitriles. Other example sealant components include polyacrylic and methacrylic compounds such as polyacrylic acid. Example naturally derived components include protienaceous compositions such as albumin, collagen and polylysine. Other examples include carbohydrate compositions such polyhyaluronic acid. The sealant components may also contain reactive functional groups to promote chemical crosslinking. The sealant components may be cross-linked by any known method including, for example, condensation reactions, Michael addition, and free radical. Functional groups used for crosslinking may include, for example, thiols, acrylates, amines, succinimydyls and aldehydes, to name a few. A particularly preferred bioadhesive comprises a two-part aldhehyde plus albumin composition. This composition may have the practical advance of not requiring pre-mixing, is gamma sterilizable, and provides high tissue adhesion. 
     In one example, the sealing material includes two separate components that remain separated from each other within the sealant mixing device  24  until delivery. In one example, the sealing material includes 20% solids in a 1:1 10 mL batch formulation. The first component includes 1.4 g of bovine serum albumin (BSA) and 3.6 mL of polyphenylene sulfide (PPS). The second component includes 25% glutaraldenhyde in the amount of 2.6 mL and an additional 2.5 mL of deionized water. The amount of seeping material ejected at the vessel puncture may vary depending on, for example, the size of the vessel puncture. In one example, the total amount of bioadhesive material ejected is in the range of about 0.2 mL to about 1.0 mL, more preferably about 0.4 mL to about 0.6 mL. 
     The preceding description has been presented only to illustrate and describe exemplary embodiments of the invention. It is not intended to be exhaustive or to limit the invention to any precise form disclosed. Many modifications and variations are possible in light of the above teaching. It is intended that the scope of the invention be defined by the following claims.

Technology Category: 1