Abstract:
The present invention provides apparatus and methods of closing internal tissue punctures. The apparatus and method provide for an introducer sheath having at least one side port enabling aspiration of an internal tissue puncture site and injection of a sealant.

Description:
FIELD OF THE INVENTION  
       [0001]     The present invention relates to medical devices, and, more particularly, to tissue puncture sealing devices.  
       BACKGROUND OF THE INVENTION  
       [0002]     Various medical procedures, particularly cardiology procedures, involve accessing a corporeal vessel or other lumen through a percutaneous sheath. The sheath necessarily requires the formation of a hole or opening in the vessel wall so that a medical procedure can be performed via the sheath. After the particular medical procedure has been performed, the sheath must eventually be removed from the vessel and the access hole in the vessel wall must be closed.  
         [0003]     Historically, the access hole is closed by the application of prolonged manual pressure over the puncture site by a physician or other trained medical professional. The time involved with this method is extensive and costly. In addition, because patients are often treated with a variety of anticoagulant and thrombolytic agents, the manual pressure required to close the access opening in the vessel wall may be even longer. The discomfort and delay in mobilization for patients resulting from this prolonged manual pressure is significant.  
         [0004]     Therefore, a number of vascular closure devices have been developed to close an access opening in the vessel wall more efficiently. For example, closing an access opening in the vessel wall may involve packing a resorbable sealing plug at the hole or sandwiching the hole between the sealing plug and an anchor. Examples of such vascular closure devices and methods are described in U.S. Pat. Nos. 6,179,863; 6,090,130; and 6,045,569 and related patents that are hereby incorporated by reference.  
         [0005]     Alternatively, closing an access opening in the vessel wall may include the use of a balloon catheter. For example, an access opening in the vessel wall may be closed by inserting a balloon catheter through the opening in the vessel wall, inflating the balloon, pulling the balloon against the inner wall of the vessel, introducing a procoagulant to the incision site external to the puncture in the vessel wall, and withdrawing the balloon catheter. This method relies on a biochemical reaction between the procoagulant and the blood. The reliance on a biochemical reaction, however, can be problematic. For example, the mixing of the procoagulant with the blood is arbitrary. Therefore, in many cases an exaggerated dose of the procoagulant is applied in an attempt to ensure hemostatis. An exaggerated dose, however, can accidentally enter the blood stream and introduce complications. Moreover, reliance on a chemical reaction based on arbitrary mixing between the procoagulant and the blood often results in an inconsistent seal composition, which in turn results in inconsistent hemostatic sealing performance.  
       SUMMARY OF THE INVENTION  
       [0006]     In one of many possible embodiments, the present invention provides an internal tissue puncture sealing apparatus. The internal tissue puncture sealing apparatus comprises a first thin, elongated conduit having a first central lumen and first and second ends. The first end is insertable through the internal tissue puncture and has an inflation segment in fluid communication with the central lumen. The first end includes an expandable member that is selectively inflatable with a fluid via the central lumen. The apparatus also includes a second thin, elongated conduit having a second central lumen receptive of the first thin, elongated conduit. The proximal end of the second conduit has at least one valved side-port in fluid communication with an annulus between the first and second conduits. The valved side-port may include a vacuum communication path and a sealant injection path, which enable aspiration of a tissue puncture site and sealing of the puncture.  
         [0007]     Another aspect of the invention provides a method of closing a hole in a vessel wall. The method may include inserting an inflatable device through an introducer that is disposed in the vessel, inflating the inflatable device, sealing the inflatable device against an inner wall of the vessel, reducing the pressure inside of the introducer, injecting a sealant into the introducer, deflating the inflatable device, and removing the inflatable device through the sealant. Following removal of the inflatable device, manual pressure may be applied to the hole for a short period of time to ensure continued hemostasis. According to some aspects of the invention, a specially designed introducer is swapped with a standard introducer used to facilitate insertion of vascular tools used to perform a vascular procedure prior to inserting the inflatable device.  
         [0008]     The foregoing and other features, utilities and advantages of the invention will be apparent from the following more particular description of preferred embodiments of the invention as illustrated in the accompanying drawings. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0009]     The accompanying drawings illustrate various embodiments of the present invention and are a part of the specification. The illustrated embodiments are merely examples of the present invention and do not limit the scope of the invention.  
         [0010]      FIG. 1  is an exploded assembly view of an introducer sheath and an associated balloon catheter according to one embodiment of the present invention.  
         [0011]      FIG. 2  is a perspective view of the balloon catheter inserted into the introducer sheath.  
         [0012]      FIG. 3  is a sectional side elevation view of a patient with the introducer sheath of  FIG. 1  in place within an arteriotomy and the associated balloon catheter extending through the introducer sheath and into a blood vessel according to one embodiment of the present invention.  
         [0013]      FIG. 4  is a sectional side elevation view of the patient, introducer sheath, and balloon catheter of  FIG. 3  with a balloon of the balloon catheter inflated and sealing the arteriotomy.  
         [0014]      FIG. 5  is a sectional side elevation view of the patient, introducer sheath, and balloon catheter of  FIG. 4  shown with the introducer sheath connected to a vacuum apparatus according to one embodiment of the present invention.  
         [0015]      FIG. 6  is a sectional side elevation view of the patient, introducer sheath, and balloon catheter of  FIG. 5  shown with the introducer sheath connected to a sealant injector according to one embodiment of the present invention.  
         [0016]      FIG. 7 a  sectional side elevation view of the patient, introducer sheath, and balloon catheter of  FIG. 6  with the balloon deflated and being withdrawn through the sealant according to one embodiment of the present invention.  
         [0017]      FIG. 8  is a sectional side elevation view of the patient following retraction of the introducer sheath and balloon catheter from the situs of the arteriotomy.  
     
    
       [0018]     Throughout the drawings, identical reference numbers designate similar, but not necessarily identical, elements.  
       DETAILED DESCRIPTION  
       [0019]     As mentioned above, vascular procedures are commonly performed throughout the world and require access to a blood vessel through a puncture or opening in the vessel. Often an introducer sheath is placed in the opening to facilitate access to the vessel by one or more vascular instruments, including puncture closure devices. Proper location of an artery or other lumen is typically indicated by a flow of blood through the lumen into the introducer sheath or other instrument as the instrument enters the vessel. The present invention describes methods and apparatus for sealing the vessel opening or arteriotomy following completion of a vascular procedure. The methods and apparatus may also be used, however, to close punctures caused by accidents or other injuries, and are not limited to use following a vascular procedure. The principles described herein may be used to close internal tissue punctures of any kind in any live body. Therefore, while the description below is directed primarily to closing arteriotomys, the methods and apparatus may be used according to principles described herein with any bodily lumen to close a hole or puncture.  
         [0020]     As used throughout the claims and specification, the term “sealant” is used broadly to encompass any fluid, foam, or gel that does not require a biochemical reaction with bodily fluids to set or cure for sealing purposes. The term “fluid” refers to molecules of a substance that move freely past one another and have the tendency to assume the shape of its container, including liquids, foams, gels, and gasses. A “lumen” refers to any open space or cavity in a bodily organ, especially in a blood vessel, or a fluid passageway through a vascular device. “Aspirate” or “aspirating” means to remove fluids with a suction device. The term “vacuum” means lower pressure than local atmospheric pressure or a device that creates a lower pressure. The words “having” and “including” have the same meaning as the word “comprising.” 
         [0021]     Referring now to the drawings, and in particular to  FIG. 1 , an internal tissue puncture sealing apparatus  100  according to one embodiment of the present invention is shown. As shown in  FIG. 1 , the internal tissue puncture sealing apparatus  100  includes a first thin, elongated conduit. According to  FIG. 1 , the first thin, elongated conduit is a balloon catheter  102  and includes a first central lumen  104  and first and second ends  106 ,  108 , respectively. The first end  106  includes an inflation segment  112 . According to  FIG. 1 , the inflation segment  112  comprises an expandable member such as a balloon  114  that is in fluid communication with the central lumen  104 . Therefore, the balloon  114  is selectively inflatable with a fluid via the central lumen  104 . The balloon  114  may be inflated by increasing the pressure of the fluid inside the central lumen  104 . For example, the second end  108  of the balloon catheter includes a syringe  116  that may be depressed to inflate the balloon  114  with saline solution. Downstream of the syringe  116  is a valve  118  that selectively isolates the central lumen  104  from the syringe  116 . Accordingly, when the valve  118  is open, the syringe  116  may be depressed, resulting in expansion or inflation of the balloon  114 . Further, following inflation, the valve  118  may be closed, maintaining the expansion of the balloon  114 . When uninflated as shown in  FIG. 1 , the balloon  114  is coaxial and substantially flush with the central lumen  104 .  
         [0022]     The internal tissue puncture sealing apparatus  100  also includes a second thin, elongated conduit. According to  FIG. 1 , the second thin, elongated conduit comprises an introducer assembly or sheath  120 . The introducer sheath  120  has a second central lumen  122  that is receptive of the balloon catheter  102 .  
         [0023]     The introducer sheath  120  also has a distal end  124  and a proximal end  126 . The proximal end  126  includes at least one side-port  128  extending into the second central lumen  122 . According to  FIG. 1 , the side-port  128  is in fluid communication with an external valve  130 . The external valve  130  branches to a vacuum port  132  and a sealant injection port  134 . However, according to some embodiments the vacuum port  132  and sealant injection port  134  are one and the same, and thus there may be no branching.  
         [0024]     As shown in  FIG. 1 , the vacuum port  132  is in fluid communication with a vacuum source or other evacuator, for example a vacuum syringe  136 . Similarly, the sealant injection port  134  is in fluid communication with a sealant supply, such as a sealant-containing syringe  138 . Therefore, the external valve  130  may comprise a translucent three-way valve positionable between a first or closed position isolating both the vacuum port  132  and the sealant injection port  134  from the second central lumen  122 , a second position opening a fluid communication path between the second central lumen  122  and the vacuum port  132 , and a third position opening a fluid communication path between the second central lumen  122  and the sealant injection port  134 . Details of the external valve  130  and the associated vacuum port  132  and sealant injection port  134  are shown in  FIGS. 3-7 .  
         [0025]     The balloon catheter  102  may be inserted into the introducer sheath  120  as shown in  FIG. 2 . When the balloon catheter  102  is inserted into the introducer sheath  120 , an annulus  142  is created between the balloon catheter  102  and the introducer sheath  120 . The side-port  128  is thus in fluid communication with the annulus  142 .  
         [0026]     A stopper sleeve or spacer  140  is shown disposed over the balloon catheter  102  to limit the insertion distance of the balloon catheter into the introducer sheath  120 . The length of the spacer  140  is chosen such that the first end  106  of the balloon catheter  102  extends beyond the distal end  124  of the introducer sheath  120  by a predetermined distance. According to some embodiments, the predetermined distances is approximately 2.5-4.0 cm. The predetermined distance allows for the balloon  114  of the inflation segment  112  to pass into a vessel as discussed in more detail below. The spacer  140  may comprise a split tube that can be easily removed as desired.  
         [0027]     Methods of closing a hole or puncture such as an arteriotomy  144  using the internal tissues puncture sealing apparatus  100  are next discussed with reference to  FIGS. 3-8 . Referring first to  FIG. 3 , the tissue puncture sealing apparatus  100  is shown with the introducer sheath  120  inserted into the arteriotomy  144 . Although  FIG. 3  shows the introducer sheath  120  passing through an incision tract  146  leading to the arteriotomy  144 , according to some methods the introducer sheath  120  may be swapped with a standard introducer that may have been used to perform a vascular procedure. Preferrably, however, the introducer sheath  120  is used both for introducing instruments used to perform a vascular procedure and for closing the arteriotomy  144 .  
         [0028]     With the introducer sheath  120  inserted into the arteriotomy, the balloon catheter  102  is introduced through the second central lumen  122  until the first or distal end  106  of the balloon catheter  102 , including the inflation segment  112 , extends beyond the distal tip  124  of the introducer sheath  120  and into a blood vessel  148 . The balloon  114  is in fluid communication with the first central lumen  104 . Therefore, opening the catheter valve  118  ( FIG. 2 ) and depressing the syringe  116  ( FIG. 2 ) inflates the balloon  114  of the inflation segment  112  as shown in  FIG. 4 . To maintain the balloon  114  in an inflated posture, the catheter valve  118  may be closed. The balloon catheter  102  and the introducer sheath  120  are retracted until the balloon  114  bears against an inner wall  150  of the blood vessel  148  and seals the internal portion of the arteriotomy  144  as shown in  FIG. 4 .  
         [0029]     With the balloon  114  in place internally sealing the arteriotomy  144 , the side-port valve  130  is opened to allow fluid communication between the annulus  142  and the vacuum syringe  136  as shown in  FIG. 5 . A vacuum is created in the annulus  142  by a withdrawing a stem  152  of the vacuum syringe  136  or by some other vacuum device. As the vacuum is created in the annulus  142  and communicated to the incision tract  146 , a situs  154  of the arteriotomy  144  and is aspirated, removing fluids from the incision tract  146  via the annulus  142 .  
         [0030]     As the arteriotomy  144  is aspirated, a surgeon or other medical professional may visually inspect the fluid contents evacuated through the translucent valve  130  to assess blood flow through the arteriotomy and thereby ensure proper positioning of the introducer sheath  120  and/or the balloon  114  within the blood vessel  148 . A flow of blood may indicate that the balloon  114  is not properly sealing the arteriotomy  144 .  
         [0031]     When the surgeon is satisfied with the positioning of the introducer sheath  120  and the balloon  114 , the side-port valve  130  is toggled to create a fluid communication path between the annulus  142  and the sealant contained by the sealant-containing syringe  138  or other sealant supply as shown in  FIG. 6 . The sealant-containing syringe  138  holds a volume of sealant that is injected into the introducer sheath  120  via the side-port  128  as a stem  156  is depressed. The sealant flows through the annulus and into the incision tract  146 . Further, because the incision tract  146  has been evacuated and is in a vacuum condition, the sealant is drawn through the annulus toward the arteriotomy  144 . The vacuum condition of the situs  154  external to the arteriotomy  144 causes the sealant to quickly and efficiently fill all of the voids around the arteriotomy  144  and in the incision tract  146 . Preferably, the sealing-containing syringe  138  holds a volume of sealant sufficient to fill the annulus  142  and therefore the incision tract  146 . As the sealant is injected, the sheath  120  is preferably withdrawn with respect to the balloon  114  to allow the sealant to fill the incision tract  146 . Therefore, in order to facilitate retraction of the sheath  120 , the spacer  140  ( FIG. 2 ) is removed.  
         [0032]     Following injection of the sealant, the sealant may be optionally activated, cured, or set. The sealant may comprise a gel or foam made of materials including, but not limited to: collagen, polyvinyl alcohol, polyethylene glycol, cyanoacrylates, chitosan, poly-n-acetyl glucosamine. Unlike the materials used in previous devices, none of the materials recited herein is dependent on a biochemical reaction with blood or other bodily fluids to create a hemostatic seal. However, the gels or foams used according to some aspects of the present invention may in some cases be activated or cured by, for example, application of a second fluid, UV light, or other activation mechanisms.  
         [0033]     When the sealant is in place adjacent the exterior of the arteriotomy  144 , the balloon  114  is deflated as shown in  FIG. 7 . The balloon  114  is deflated by reopening the catheter valve  118  ( FIG. 2 ). The stem  158  ( FIG. 2 ) of the catheter syringe  116  ( FIG. 2 ) may be retracted to ensure full deflation of the balloon  114 . The balloon catheter  102  and the introduction sheath  120  are retracted, with the balloon  114  sliding through the sealant. According to some embodiments, following removal of the balloon catheter and the instruction sheath  120 , manual pressure may be applied to the arteriotomy site to counteract any sealing action disruption caused by the act of pulling the balloon  114  through the sealant. However, the manual pressure is applied for only a fraction of the time allocated to traditional arteriotomy closures. For example, according the principles described herein, manual pressure may be applied following retraction of the internal tissue puncture sealing apparatus  100  for only ten minutes or less. The sealant remains in the incision tract  146  sealing the arteriotomy  144  as shown in  FIG. 8 .  
         [0034]     While the invention has been particularly shown and described with reference to embodiments thereof, it will be understood by those skilled in the art the various other changes in the form and details may be made without departing from the scope of the invention.