Abstract:
A device for sealing an opening or puncture in the wall of a blood vessel or other percutaneous openings. The device includes a shaft section member of a small diameter, with an expandable balloon and atraumatic tip at its distal end. The proximal end of the device has an inflation/deflation port which is utilized to inflate the balloon once it is in place within the blood vessel or other body cavity. The entire device is placed through a hemostasis vascular introducer or sheath, which is used during invasive percutaneous vascular procedures. The balloon is inflated and withdrawn until it engages the inner surface of the blood vessel. A procoagulant is injected via the introducer to the puncture. After a predetermined time period, the balloon is deflated and the device is withdrawn.

Description:
CROSS-REFERENCES TO RELATED APPLICATIONS 
     This is a Continuation Division of application Ser. No. 08/877,255, filed Jun. 17, 1997, now U.S. Pat. No. 6,017,359, issued Jan. 25, 2000, which in turn is a continuation of application Ser. No. 08/549,430, filed Oct. 27, 1995 now abandoned, which in turn is a continuation-in-part of application Ser. No. 08/303,088, filed Sep. 8, 1994 now abandoned, which is a continuation of application Ser. No. 08/067,213, filed May 25, 1993, now U.S. Pat. No. 5,383,896, issued Jan. 24, 1995. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     This invention relates to medical devices in general and, more particularly, to hemostatic devices. The device is particularly useful for arresting the flow of blood or hemorrhage from punctures of the vascular system. 
     2. Background Art 
     Various surgical procedures are performed by medical specialists such as cardiologists, utilizing percutaneous entry into a blood vessel or body cavity. Examples of such procedures include different techniques to recanalize atherosclerotic blood vessels, such as balloon angioplasty or atherectomy. Recently, both the types and number of procedures performed utilizing the above mentioned percutaneous access to blood vessels have increased greatly. 
     These procedures generally involve the percutaneous puncture with a thin walled needle into a blood vessel. Following this, a guidewire is placed through the needle into the blood vessel and the needle is withdrawn. An intravascular sheath of variable size is then advanced over the guidewire, percutaneously, into the lumen of the blood vessel. The introducer sheath is then used as an ingress/egress means during the procedure. Following completion of the procedure, the introducer sheath may be removed, but this requires the application of prolonged manual pressure over the puncture site by a physician or other suitably trained medical personnel The time involved here is frequently extensive since patients are often treated with a variety of anticoagulant and thrombolytic agents, particularly in the setting of a heart attack. Alternatively, the sheath may be left in the puncture site for a prolonged period of time until the patient&#39;s coagulation status has returned to normal Depending on the size of the vascular sheath, there may be an increased risk of bleeding to the patient, which may require blood transfusion. In addition, there is a significant risk for injury to the blood vessel upon removal of the sheath, particularly if the sheath has been in place for a prolonged period of time. This includes the possible development of an pseudo-aneurysm or severe hematoma. The current technique for removal of introducer sheaths is also painful to the patient and requires prolonged bed rest after removal This adds to the discomfort for the patient, as well as prolonging hospitalization and costs. 
     Many of the intra-vascular procedures are performed in patients who are clinically unstable or who have the potential to become so, following completion of the procedure. Following removal of the vascular access sheath, it could be cumbersome and sometimes difficult to re-enter the blood vessel if necessary. Thus, with the current technique for removal of the sheath following the procedure, no easy, reliable method is available to allow reaccess to the lumen of the blood vessel, if necessary. 
     In the past, various devices and methods have been used and proposed in an attempt to seal punctures in blood vessels by injection of a resorbable hemostatic plug into the puncture site, including U.S. Pat. Nos. 4744364 (Kensey), 4,852,568 (Kensey), and 4,890,612 (Kensey). 
     Despite the need for a device and method which overcome the imitations and problems of the prior art, none insofar as is known, has been proposed or developed. 
     SUMMARY OF THE INVENTION 
     This invention provides a device for sealing an opening or puncture in the wall of a blood vessel. The device includes a shaft section of small diameter, with an expandable balloon and guidewire tip at its distal end. The proximal end of the device has a low profile port which is utilized to inflate and deflate the distal balloon once it is in place within the blood vessel, and which permits removal of a standard hemostasis introducer which is preexisting in the puncture. The introducer is used to inject a procoagulant to the puncture site, proximally with respect to the balloon for sealing. 
     Unique aspects of this invention include: (1) the creation of immediate hemostasis at the puncture site for procoagulant delivery; (2) the device balloon acts as a marker for delivery of procoagulant; (3) balloon approach prevents injection of procoagulant into the bloodstream; and (4) the apparatus and method allow reaccess to the patient&#39;s vasculature. Other features, benefits and objects of this invention will become clear from the following description by reference to the drawings. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a perspective view of a vascular sealing device of the present invention, with segments enlarged to show details of the distal and proximal ends thereof 
     FIG. 2 is a view of the vascular sealing device inserted through an introducer sheath and into a patient&#39;s vascular system, which is shown enlarged and in section. 
     FIG. 3 is a view of the vascular sealing device inserted through a vascular sheath, and being inflated. 
     FIG. 4 is a view of the vascular sealing device with its balloon portion inflated, and further showing removal of the vascular sheath. 
     FIG. 5 is a view of the vascular sealing device with the balloon inflated and being pulled firmly up against the inner surface of a vascular puncture. 
     FIG. 6 is a crossectional view of the apparatus taken along line  6 — 6  of FIG. 1 a.   
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Referring to FIGS. 1 and 6, a preferred form is shown of the vascular sealing device  10  for effecting closure of a puncture in a blood vessel which has been entered through percutaneous techniques. The device  10  is useable with a procoagulant which is injected through a standard percutaneous vascular sheath or introducer. The vascular sealing device  10  is shown to have an elongated thin, generally tubular body or conduit  15  with proximal and distal ends  11  and  12 , respectively. Basically, the proximal end  11  of the device  10  is for physician manipulation and connection to associated medical apparatus described further below, while the distal end  12  is for insertion into the patient&#39;s body. Located at the proximal end  11  of device  10  is an inflation/deflation port  14 . 
     The body member  15  has a tubular structure constructed of hypotubing or a similar material This structure also has a cylindrical and thin outer body wall with a central, continuous, and longitudinally extending lumen  28 . The body member  15  has an outside diameter preferably not greater than 0.038 inches (0.965 mm.). The body  15  is semi-flexible and, importantly, has a predetermined rigidity such that central lumen  28  integrity is maintained. This is particularly important during longitudinal translational manipulation by the physician, through vascular introducer means (described below), into a percutaneous puncture in the patient&#39;s skin. The hypotubing of the body  15  is preferably constructed of a metallic material such as stainless steel, for example. Alternatively, the body  15  may be constructed of a polymeric material The body member  15  is shown to have a length preferably of at least 11.79 inches (30 cm). 
     The proximal end  11  of the lumen or hollow interior  28  is sealed with elastomeric material, preferably silicone, to form an inflation/deflation port  14 . The seal forms the inflation/deflation port  14  by adhering to the internal wall surfaces of the proximal end  11  of body  15 . The seal is of sufficient strength to maintain a pressure difference between the internal lumen  28  and the proximally disposed exterior of the seal This pressure difference is of a magnitude sufficient to maintain inflation of the balloon  34 , which is in continuity with the lumen  28 . The inflation/deflation port  14  is utilized by piercing its proximal face, preferably with a syringe needle, to a depth which allows the needle lumen to be in continuity with the lumen  28 . An external syringe, attached to the proximal end of the needle, provides a piston means by which a gas or liquid is pumped into the balloon  34  for inflation, or out of the balloon  34  for deflation. Removal of the needle from the inflation/deflation port  14  causes the seal to re-establish the pressure differential barrier. 
     The structure of the proximal end  11  also allows the user to later slide a standard vascular sheath over the device body  15  and then to advance it to the puncture site for positioning within the blood vessel lumen. This allows reentry into the blood vessel, if necessary, for a further interventional procedure. 
     The bottom or distal end  12  of the device body  15  is shown to have a distal tip  29 . The distal tip  29  further has an inset segment  32 . The inset segment  32  has a tubular configuration and is oriented coaxially with respect to the distal tip  29 . The inset segment  32  preferably has a diameter which is less than that of the distal tip  29  and a length equivalent to that of the wall of the balloon  34  when deflated. Thus, an inset with respect to the distal tip  29  is formed by this structure. The lumen  28  extends into the inset segment  32  and is communicatively connected to an orifice  33 , which is disposed in the side wall of the inset segment  32 . The orifice  33  is shown to have a circular configuration. 
     Referring to FIGS. 1A and B, the balloon  34  is disposed about the inset segment  32 . In an uninflated state, the balloon  34  has a tubular configuration and is sealingly secured at each of its ends to respective ends  30  and  31  of the inset segment  32 . Sealing securement may be made by various methods, including adhesives, ultrasonic welding, and compression fitting. The uninflated diameter of the balloon  34  is such that it is disposed substantially within the recess space formed by the difference in diameter of the inset segment  32  and the distal tip  29 . This provides a low profile device diameter which reduces vascular trauma and puncture site diameter upon removal. In an inflated state the balloon  34  preferably assumes a rounded configuration, for example elliptical with a minimum inflated diameter of two times the french size of the introducer sheath puncture hole being sealed. In addition, the height or thickness of the inflated balloon  34  is preferably less than one half the diameter of a typical blood vessel being sealed, so as to minimize obstruction of flow through the blood vessel The balloon  34  is preferably constructed of an expandable material such as natural latex. 
     A flexible atraumatic extension  37  is shown disposed at the distal end  12  of the vascular sealing device  10 , extending from the inset segment  32 . The extension  37  preferably has a tubular structure with a diameter equivalent to that of the distal tip  29 . Importantly, the extension  37  is formed of a flexible material such as guidewire as known in the art. The extension  37  is shown to have an end portion which is preferably curved in its inoperative state. This structure decreases the level of trauma to the vessel wall during insertion and manipulation of the device  10 . 
     Referring to FIG. 1,  81  refers to a distance marker upon body  15  for the purpose of indicating to the user that the balloon  34  is distal to the sheath taper end  48  shown in FIGS. 2 and 3. By alignment of marker  81  at the top of the hemostatic valve opening at cap  45 , proper location of the balloon  34  with respect to sheath tapered end  48  is assured. 
     Referring generally to FIGS. 2-5, in use, the vascular sealing device  10  is inserted into the input end  45  of an introducer or vascular sheath device  43  which has been previously positioned within the lumen  58  of a blood vessel  56 . The typical introducer  43 , as is well known, comprises a body structure  46 , an elongated sheath  47  with a tapered end  48 , a hemostatic ingress/egress valve  80  within a cap  45 , an auxiliary tube  44  and a suture connector  49  which may be used to maintain the introducer  43  in an operative position on the patient&#39;s skin surface  55  for prolonged periods of time and to thereby permit reaccess to the patients vascular system  56 . The body  46  of the introducer  43  remains on the exterior of the patient&#39;s body at all times, while the sheath  47  extends through puncture  60  in the skin surface  55 , tissue  59 , and vessel wall  57 . 
     The vascular sealing device  10  is first inserted through the valve or gasket  80  of the introducer  43 , distal end  12  first, and is advanced by physician manipulation of the body member  15 , primarily, until the distal end  12  extends just beyond the distal tapered tip  48  of the sheath  47 . Next, an inflator such as a syringe (not shown) pierces the inflation/deflation port  14  of device  10 . Fluid or gas is advanced into the device  10  until a predetermined amount of balloon  34  inflation is attained. Then, the inflating means is removed. Next, the inflated balloon section  34  is pulled up against the vessel wall  56  at the puncture site  60 , by manipulating the body member  15 . At this point in the procedure, a hemostatic seal is effected at the puncture site  60 . Next, and importantly, a procoagulant is injected through a fluid access port  44  of the introducer  43  and is released out its distal end  48  at the puncture site  60 . Next, the introducer sheath  47  is withdrawn by manipulation of the introducer body  46  and sheath  47  proximal end. The balloon section  34  remains abutted against the inner intraluminal surface  56  of the puncture site  60 . After a predetermined time period, on the order of 1-3 minutes, the balloon  34  is deflated and the device  10  is pulled proximally out of the puncture site  60 . 
     The procoagulant may include one of the following substances or combinations of substances: (1) thrombin, (2) collagen, (3) fibrin/fibrinogen, (4) cyanoacrylate, (5) thrombin and collagen, (6) fibrin/fibrinogen and collagen, (7) cyanoacrylate and collagen, and (8) thrombin and fibrin/fibrinogen. 
     The advantages of the device  10  and method of the present invention include, but are not limited to, both individually and cooperatively, (1) that the inflated balloon  34  blocks egress of blood immediately upon being properly positioned in blood vessel at the puncture site to provide fast hemostasis; (2).that the inflated balloon  34  acts as an internal marker to permit the user to accurately gauge the depth of the puncture and the thickness of the tissues surrounding the puncture; and (3) that the inflated balloon  34  acts as a backstop at the inner wall of the blood vessel to (i) precisely position the sealing clot in the puncture and (ii) to prevent procoagulant from entering the patient&#39;s circulatory system. 
     The descriptions above and the accompanying drawings should be interpreted in the illustrative and not the limited sense. While the invention has been disclosed in connection with the preferred embodiment or embodiments thereof, it should be understood that there may be other embodiments which fall within the scope of the invention as defined by the following claims. Where a claim is expressed as a means or step for performing a specified function it is intended that such claim be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof, including both structural equivalents and equivalent structures.