Patent Publication Number: US-6656207-B2

Title: Expansile device for use in blood vessels and tracts in the body and method

Description:
This is a continuation of application Ser. No. 09/528,574 filed Mar. 20, 2000, now U.S. Pat. No. 6,464,712 which is a continuation-in-part of prior application Ser. No. 09/241,680, filed Feb. 1, 1999 which is a continuation-in-part of application Ser. No. 08/972,383, filed Nov. 18, 1997 which issued as U.S. Pat. No. 5,922,009 on Jul. 13, 1999, which is a continuation-in-part of application Ser. No. 08/798,870, filed Feb. 11, 1997 which issued as U.S. Pat. No. 5,782,860 on Jul. 21, 1998. 
    
    
     This invention relates to an expansile device for use in vascular access tracts and non-vascular tracts in the human body and method and more particularly for percutaneous occlusion of vascular access sites in the human body. 
     Percutaneous access to the blood vessels and organs of the human body for diagnosis and treatment of disease processes has heretofore been accomplished. 
     Percutaneous vascular procedures are performed involving the coronary, peripheral and cerebral vasculature. These procedures include coronary and peripheral angiography, angioplasty, atherectomies, coronary retroperfusion and retroinfusion, cerebral angiograms, treatment of strokes, cerebral aneurysms and the like. Patients undergoing such procedures are often treated with anti-platelet drugs, anticoagulants such as heparin, thrombolytics, or a combination thereof, all of which interfere with coagulation making it more difficult for the body to seal a puncture site. Various devices and methods have heretofore been utilized, however, they all have had deficiencies, including the use of complicated devices and methods. In addition, difficulties are still encountered in obtaining good seals. There is therefore a need for a device and method for percutaneous access and occlusion of vascular access sites and other puncture sites and natural tracts in the human body which overcome the deficiencies of prior art devices and methods. 
     In general, it is an object of the present invention to provide an expansile or closure device and method for percutaneous access and occlusion of vascular access sites, other puncture sites and natural tracts involving various organs having lumens or cavities in the human body which will make possible a positive seal of the puncture site or tract promoting rapid healing of the puncture site or tract. 
     Another object of the invention is to provide a closure device and method of the above character which can be easily and reliably used. 
     Another object of the invention is to provide a closure device and method of the above character which permits easy placement of the device without measuring or sizing of the tract or device. 
     Another object of the invention is to provide a closure device and method of the above character which can be deployed or made operative with one maneuver or movement. 
     Another object of the invention is to provide a closure device and method of the above character which can be deployed and is effective in severely tortuous vessels. 
     Another object of the invention is to provide a closure device and method of the above character which enables continued substantially unobstructed blood flow during deployment and use of the closure device. 
     Another object of the invention is to provide a closure device and method of the above character in which no foreign body remains in the blood vessel. 
     Another object of the invention is to provide a closure device and method of the above character that permits early ambulation of patients and avoids prolonged bed rest. 
     Another object of the invention is to provide a closure device and method of the above character which reduces the risk of bleeding, formation of arteriovenous fistula, formation of pseudoaneurysm, thrombosis with distal embolization and infection. 
     Another object of the invention is to provide a closure device and method of the above character that reduces the risk of causing ischemia of an extremity. 
     Another object of the invention is to provide a closure device and method of the above character that is inexpensive, quick, safe, easy to use and is disposable. 
    
    
     Additional objects and features of the invention will appear from the following description in which the preferred embodiments and the methods using the same are described in conjunction with the accompanying drawings. 
     FIG. 1 is a side-elevational view partially in section of an expansile or closure device for obtaining percutaneous access and occlusion of tracts and punctures in the human body incorporating the present invention without the tip guide and having the expansile member in a deployed or expanded position. 
     FIG. 2 is a side-elevational view partially in section of the device in FIG. 1 with the expansile assembly in a de-deployed or contracted configuration. 
     FIG. 3 is an exploded side-elevational view in section showing the handle assembly and stop mechanism of the device of FIGS. 1-2. 
     FIG. 4 is a cross-sectional view taken along the line  4 — 4  of FIG.  3 . 
     FIG. 5 is a cross-sectional view extending distally for several millimeters taken along the line  5 — 5  of FIG.  3 . 
     FIG. 6 is a side-elevational view partially in section of another embodiment of the device of the present invention without the tip guide and having the expansile member in the expanded configuration. 
     FIG. 7 is a side-elevational view partially in section of the device in FIG. 6 with the expansile assembly in a de-deployed or contracted configuration. 
     FIGS. 8 a  and  8   b  are exploded cross-sectional views of the distal extremity of another embodiment of the device of the present invention showing the expansile assembly in the expanded configuration occluding a puncture in a blood vessel. FIG. 8 a  shows the expansile assembly of the device without proximal tension applied thereto and FIG. 8 b  shows the expansile assembly of the device with proximal tension applied thereto. 
    
    
     In general, the device for expansion within an organ having a wall defining a lumen or cavity in the body of the present invention comprises an elongated tubular member having proximal and distal extremities and having a longitudinal axis. An expansile member is carried by the distal extremity of the elongated tubular member and is movable between contracted and expanded configurations. A deformable membrane at least partially covering the expansile member is sized so as to be capable of expanding as the expansile member moves from the contracted configuration to the expanded configuration. Deployment means are carried by the proximal extremity of the elongated tubular member and coupled to the expansile member. The deployment means are adapted to be capable of moving the expansile member between the contracted and expanded configurations. A handle assembly is carried by the proximal extremity of the elongated tubular member and coupled to the deployment means. 
     More specifically, as shown in FIGS. 1-2, the expansile device  21  of the present invention comprises a first elongate tubular member  22 , preferably a flexible elongate tubular member  22 , formed of a suitable plastic material, preferably a cast thermoset material such as polyimide. The inner and outer surfaces of the polyimide material may be coated with a lubricious material such as Teflon™. Alternatively, the thermoset material may be a polyimide-Teflon™ composite in order to provide the desired lubricious inner and outer surfaces. The first flexible elongate tubular member  22  has proximal and distal extremities  23  and  24  with a longitudinal axis extending from the proximal  23  to the distal extremity  24  and is provided with a first lumen  26  circular in cross-section which, as shown, may be centrally disposed extending from the proximal extremity  23  to the distal extremity  24 . 
     The flexible elongate tubular member  22  is of a suitable size, as for example having an outer diameter ranging from 1-9 French corresponding to an outer diameter ranging from approximately 0.008″ to 0.050″, preferably approximately 0.022″-0.026″, and a suitable length, as for example 10-150 centimeters, preferably 33 centimeters ±1 centimeter. The first lumen  26  in the first flexible elongate tubular member  22  may have an inside diameter of approximately 0.003″ to 0.030″, preferably 0.012″-0.014″. 
     Expansile means in the form of an expansile assembly  31  is carried by the distal extremity  24  of the flexible elongate tubular member  22  and is movable between contracted and expanded positions. A deployment mechanism is carried by the proximal extremity  23  of the flexible elongate tubular member  22  and adapted to be operated by the human hand for movement from a contracted position or configuration to an expanded position or configuration. 
     The expansile assembly  31  includes an expansile member  32  and a membrane  33  which at least partially covers the expansile member  32 . As shown in FIG. 2, the expansile member  32  is in a form having a complex geometrical configuration, preferably a ellipsoidal, helical or bi-conical coil configuration  34 , when in the free, unconstrained state. As hereinafter discussed, the helical coil  34  is formed of a suitable material such as a shape memory or superelastic material which can be elongated, contracted or constrained without permanent deformation but, at body temperature, when freed or unconstrained returns to the memorized helical coil configuration  34  to which it has been annealed. One material found to be particularly suitable for such an application is a nickel/titanium alloy wire, often called Nitinol™ wire. 
     The correctly annealed and configured helical coil  34  has a plurality of generally circular turns, loops or coils creating, preferably, a proximal coil, loop or turn  66 , a middle coil, turn or loop  67  and a distal coil, turn or loop  68  as shown in FIG.  1 . The proximal, middle and distal coils  66 ,  67  and  68  are generally nonplanar with respect to one another. At least a portion of the proximal coil  66  and a portion of the distal coil  68  each lie in a plane that is generally parallel to one another and generally perpendicular to the longitudinal axis of the flexible elongate tubular member  22 . The middle coil  67  is non-planar and helical as it connects the proximal and distal coils  66  and  68  so that the unconstrained or free helical coil  34  assumes a substantially ellipsoidal or bi-conical shape. 
     The middle coil  67 , when freed or unconstrained, has a suitable diameter ranging from 3 to 10 millimeters, preferably, greater than or equal to 5.33 millimeters (16 French). As hereinafter discussed, during deployment the middle coil  67  is partially flattened and constrained by the membrane  33  to maintain a diameter of approximately 16 French in order to overlap a puncture site or other opening to assist in occluding the opening. The proximal and distal coils  66  and  68  are of approximately equal size and diameter ranging from 1 to 5 millimeters, preferably 2 to 3 millimeters. The unconstrained helical coil  34  configuration has a distance from the proximal  66  to the distal  68  coil of approximately 4-8 millimeters. As hereinafter discussed, the helical coil  34  is retracted into the flexible elongate tubular member  22  to obtain the de-deployed configuration wherein the contracted, constrained diameter corresponds to the approximate diameter of the Nitinol wire used to construct the expansile member  32 , ranging from 0.002″ to 0.010″, preferably 0.0055″. As hereinafter discussed, the expansile member  32  is provided with a straight portion  73  of Nitinol wire proximal to the helical coil  34  having a length of approximately 50 millimeters ±2 millimeters. 
     The deployment means or mechanism  80  includes a push-pull element or member  81 , preferably in the form of a wire  81  with proximal and distal extremities  82  and  83 , which is slidably disposed in and extends through the first lumen  26  of the flexible elongate tubular member  22  as hereinafter discussed. The push-pull member  81  is formed of a suitable material such as stainless steel in order optimize torque transmission. The push-pull member  81  has a suitable diameter ranging from approximately 0.005″-0.020″, preferably 0.010″. In order to provide for optimal torque transmission after being bonded to the Nitinol expansile member  32  as hereinafter discussed, the distal extremity  83  of the push-pull wire  81  provided with a tapered portion  84 . The tapered portion  84  has a length ranging from approximately 1.0 centimeters to 6.0 centimeters. 
     A hypotube connector  101  is provided for joining the tapered portion  84  of the push-pull wire  81  to the is proximal straight portion  73  of the Nitinol wire  61 . The hypotube connector  101  has a length ranging from approximately 2.0 centimeters to 4.5 centimeters, an inner diameter ranging from approximately 0.006″-0.008″ and an outer diameter ranging from approximately 0.009″-0.012″. During manufacture, the tapered portion  84  of the push-pull wire  81  is inserted into one end of the hypotube connector  101  and the proximal end of the straight portion  73  of the Nitinol wire is inserted into the opposite, distal end of the connector  101  whereupon all are bonded together within the hypotube connector  101  utilizing a suitable adhesive such as Loctite™ 648. It should be appreciated that, by grinding and shaping a single length of Nitinol wire, one piece can be utilized having a distal thinner segment which can be shaped into the coil. This obviates the requirement of having a stainless steel push-pull wire, hypotube and connection therebetween. 
     The proximal end  23  of the flexible elongate tubular member  22  is provided with an expander tube or strain relief member  113  made of a suitable material, such as polycarbonate, having an inner diameter ranging from 0.024″-0.028″, an outer diameter ranging from 0.030″-0.036″ and a length of approximately 24-26 millimeters. The expander tube  113  is disposed over the proximal end  23  of the tubular member  22  so that the proximal end of the expander tube  113  is positioned approximately 0.5-1.0 millimeters distal to the proximal most end  23  of the tubular member  22  and suitably bonded thereto using an appropriate adhesive such as cyanoacrylite. 
     As shown in FIGS. 1-3, a stop mechanism or means  121  is provided to control the range of movement or travel of the push-pull wire  81  during deployment and de-deployment of the expansile assembly  31 . The stop mechanism  121  comprises first and second, or inner and outer, slidably and rotatably nested, or coaxially carried stop members or handles  122  and  123  which are formed of polycarbonate and mounted as hereinafter discussed. 
     The inner stop member or handle  122  is formed of a polycarbonate extrusion which, initially, has an outer configuration that is square in cross section and has a dimension ranging from approximately 0.015″-0.050″, preferably approximately 0.038″. The inner member  122  has a length of approximately 60 millimeters ±5 millimeters and carries a circular in cross section lumen extending therethrough, the lumen having a diameter ranging from approximately 0.010″-0.016″. During manufacture, the inner stop member  122  is twisted or turned in order to form a threaded outer surface or helical groove  125  therein which carries pitches of varying degrees or distances. As shown in FIG. 3, the thread  125  carries, preferably, a greater pitch on the proximal segment of the inner handle  122  and a lesser pitch on the distal segment of the inner handle  122 . 
     The distal end of the inner handle  122  carries a collar  124  formed of cyanoacrylite and having a length of approximately 3-5 millimeters and an outer diameter ranging from approximately 0.024″-0.040″. The outer collar  124  is coaxially adhesively mounted over the inner handle  122  so that the distal end of the collar  124  is disposed slightly proximal to the distal end of the inner handle tube  122  by several millimeters. 
     As seen in FIG. 3, an inner handle support hypotube  127  is coaxially, adhesively mounted upon the proximal extremity  82  of the push-pull wire  81  using, preferably, cyanoacrylite so that the proximal end thereof is flush with the proximal most tip of the push-pull wire  81 . The support hypotube  127  has an inner diameter ranging from 0.008″ to 0.018″, preferably approximately 0.012″ and an outer diameter ranging from 0.015″ to 0.028″, preferably approximately 0.020″. The inner handle  122  is coaxially, adhesively mounted upon the support hypotube  127 , also using an appropriate adhesive such as cyanoacrylite, so that the proximal end  82  of the push-pull wire  81  and the support hypotube  127  carried thereby extend through and proximal of the inner handle  122  as hereinafter discussed. 
     The outer handle stop member  123  is also constructed of polycarbonate and has a length of approximately 65 millimeters ±5 millimeters, an inner diameter ranging from approximately 0.020″-0.060″, preferably approximately 0.055″, and an outer diameter ranging from approximately 0.035″-0.080″, preferably approximately 0.066″. In addition, the proximal end of the outer stop member  123  is provided with a slotted stop segment or inner nut or bushing  126  which has an outer diameter equal to the outer diameter of the outer stop member  123  and which is formed so that the slot  126  is square in shape and has a dimension which is, preferably, approximately 0.042″ or slightly larger than the square, outer dimension of the inner handle  122 . As shown in FIGS. 1-3, the distal end of the outer handle  123  is secured to the proximal extremity  23  of the elongate tubular member  22  by being adhesively secured to the proximal end of the expander tube  113  using, preferably, an ultra-violet cured adhesive. 
     As shown in FIGS. 1-3, a freely rotatable handle assembly  131  is provided and carried by the segments of the push-pull wire  81  and inner handle support hypotube  127  extending proximal to the inner handle  122 . The rotatable handle assembly  131  comprises a rotatable hypotube casing  132 , a rotatable collar  133 , a back stop member  134  and a handle grip or sleeve  136  as hereinafter discussed. The complete assembly  131  is sized so as to be capable of being passed through a conventional introducer sheath as hereinafter described. As such, it has a maximum diameter that is no greater than, and, preferably less than, approximately two to three times the diameter of the elongate tubular member  22 . 
     The hypotube casing  132  is of appropriate size, having a length of approximately 15 millimeters, an inner diameter of approximately 0.035″ and an outer diameter of approximately 0.042″. The hypotube casing  132  is covered with a handle grip or sleeve  136  made of an approximately 15 millimeters length of RNF heat shrink tubing having a thickness of approximately {fraction (1/16)}″ and which is applied in a conventional manner. 
     The rotatable collar  133  is constructed of hypotube having a length of approximately 8 millimeters, an inner diameter of approximately 0.025″ and an outer diameter of approximately 0.032″. The collar  133  is adhesively, coaxially mounted within the casing  132  using an appropriate adhesive, preferably cyanoacrylite, so that the distal end of the collar  133  is flush with the distal end of the casing  132 . The rotatable collar  133  carried by the casing  132  is coaxially rotatably mounted over the proximal end of the inner handle support hypotube  127  as shown in FIGS. 1-3. 
     A back stop member  134  constructed of stainless steel hypotube and having a length of approximately 4 millimeters, an inner diameter of approximately 0.025″ and an outer diameter of approximately 0.032″ is adhesively, coaxially mounted (also preferably using cyanoacrylite) on the proximal end of the inner handle support tube  127  proximal to the rotatable collar  133  so that the proximal end of the stop member  134  is flush with the tip of the proximal end of the inner handle support tube  127 . 
     As assembled, the push-pull element  81 , with the threaded inner handle member  122  affixed thereto and the collar  124  carried thereby, is movable longitudinally and rotationally within and in relation to the outer handle member  123  which has its distal extremity secured to the expander hypotube  113  carried by the proximal extremity  23  of the polyimide tubular member  22  as hereinbefore discussed. Using the freely rotatable handle assembly  131 , it is movable between a forward or distal most position wherein the distal end of the inner handle  122  is engaged with or abutting against the proximal extremity  23  of the polyimide member  22  and the distal end of the rotatable collar  133  abuts against the proximal end of the stop segment  126  of the outer handle member  123  and a rearward or proximal most position wherein the collar  124  is engaged with the stop segment  126  carried by the proximal extremity of the outer member or handle  123  and the proximal end of the rotatable collar  133  abuts against the distal end of the back stop member  134 . As hereinafter discussed, these positions correspond to deployed and de-deployed positions and configurations of the expansile assembly  31 . 
     The distal extremity  24  of the flexible elongate tubular member  22  is provided with a hypotube tip  105  over which the membrane  33  is disposed and moves as hereinafter discussed. The hypotube tip  105  is constructed of  304  stainless steel hypotube, or other suitable material, having an outer diameter ranging from approximately 0.028″-0.040″ and an inner diameter ranging from 0.024″-0.030″ and which is cut to have a length of approximately 3-5 millimeters. The hypotube tip  105  is coaxially mounted over the distal extremity  24  of the polyimide tubular member  22  using, preferably, Loctite so that the tip of the distal extremity  24  of the tubular member  22  is flush with the distal end of the hypotube tip  105 . 
     A tip guide (not shown) is slidably carried by the polyimide tubular member  22  for use as hereinafter discussed. The tip guide is constructed of {fraction (1/16)}″ RNF 100 Shrink tubing. The tip guide has a longitudinal axis and a length of approximately 32 millimeters. In addition, the distal portion of the tip guide is provided with a larger, non-shrunk end. 
     As hereinbefore discussed, the expansile assembly  31  also carries a deformable flexible membrane  33  which is carried by and secured to the distal extremity  24  of the elongate tubular member  22  as shown in FIGS. 1-2. 
     The membrane  33  is formed of Polyblend™ Extrusion having an internal or inner diameter of 0.020″, an outer diameter of 0.036″ and which is cut to have a length of approximately 1 centimeter ±1. The proximal end of the membrane  151  is secured to the proximal end of the hypotube tip  105 , using an appropriate material such as Loctite 496 adhesive, so that the distal membrane tip  152  extends distal to the tip of the distal extremity  24  of the flexible elongate tubular member  22  and so that distally extending portion of the membrane tip  152  has a length, measured from the distal end of the hypotube tip  105  to the distal end of the membrane tip  152 , of approximately 1.0-1.5 millimeters. The extruded membrane tip  152  is subsequently sealed or closed with an extrusion beading  153  as hereinafter discussed. 
     The beading  153  is made of the same or similar Polyblend material in the form of a solid plug having a diameter of 0.025″ and a length of 5 millimeters. This segment of extrusion beading  153  is inserted into the distal, open end of the membrane tip  152  approximately 0.5-0.75 millimeters and heat bonded to the membrane tip  152  so that the distal tip of the beading  153  is flush with the distal end of the membrane tip  152 . 
     Operation and use of the expansile device  21  of the present invention is similar to that disclosed in U.S. Pat. No. 5,782,860, issued Jul. 21, 1998 and U.S. Pat. No. 5,922,009, issued on Jul. 13, 1999, the relevant portions of which are hereby incorporated by reference in their entirety. 
     Prior to deployment, the expansile member  32  is fully or completely retracted within the distal extremity  24  of the flexible elongate tubular member  22  which causes the expansile member  32  to assume a contracted configuration. Insertion of the device  21  in the contracted configuration into a conventional sheath introducer (not shown) is facilitated by using the tip guide  106  carried by the polyimide tubular member  22  as hereinbefore discussed. Prior to inserting the device  21  into the sheath introducer, the operator slides the tip guide  106  distally, from the middle of the polyimide tubular member  22  to the distal extremity  24  thereof. When the distal end of the tip guide  106  is disposed slightly distal to the distal extremity  24  of the polyimide tubular member  22  and the membrane  33  carried thereby, the distal end of the tip guide  106  is frictionally fit into the conventional one-way valve carried by the sheath introducer, thus urging the valve into a slightly opened position. The distal extremity  24  of the elongate tubular member  22  can then be easily and atraumatically introduced through the valve of the introducer and advanced distally therein until the device is aptly disposed through the tract opening or, in the case of a vascular puncture, in the blood vessel as hereinbefore discussed. By not relying on the tip of the distal extremity  24  of the device  21  to open the valve of the introducer sheath, the integrity of the membrane  33  carried thereby is maintained. 
     Once appropriately disposed in a tract or puncture site, deployment of the device  21  is accomplished by using the freely rotatable handle assembly  131  to operate the deployment means  80  to move the push-pull wire  81  distally to urge the expansile member  32  distally out of the lumen  26  of the flexible elongate tubular member  22 , into the membrane  33 . As soon as the distal part of the expansile member  32  clears the lumen  26 , it begins an attempt to expand into its shape memory, predetermined, or free configuration which corresponds to the ellipsoidal, helical coil configuration  34 . However, as hereinafter discussed, the expansile member  32  is prevented from fully expanding into its free shape configuration as a result of the membrane  33  partially constraining the expansion process. 
     More specifically, the distal coil  71  operates to expand the membrane  33  initially to a small degree. This initial process avoids sudden gross distortion of the membrane  33 . As soon as the expansile member  32  moves further distally out of the lumen  26  and expands into the membrane  33 , the non-adherent portion of the membrane  33 , distal to the portion of membrane  33  fixed to the distal extremity  24  of the elongate tubular member  22 , preferentially begins to move and assume the planar configuration due to the lubricious surface of the hypotube tip  105  and the ease with which the membrane  33  slides thereupon. Expansion proceeds with the middle coil  69  causing the membrane  33  to expand to its desired size. The proximal coil  68  expands last, to centralize and stabilize the configuration so that the push-pull wire  81  is centered with respect to the middle coil  69  and the fully expanded membrane  33 . 
     Throughout the deployment process, as the coil  34  is expanding and seeking its memorized configuration it is rotating in a leftward or counter-clockwise direction. As a result, the push-pull member  81  is being torqued by the slightly rotating coil  34  in the same direction. This torque requires that the push-pull member  81  be permitted to rotate counter-clockwise in order for the coil  34  to operatively rotate and expand within, and without damaging, the membrane  33  as hereinafter discussed. Furthermore, the amount of torque developed by the expanding coil  34  varies so that more torque is developed and, therefore, more rotation of the push-pull member  81  is optimal, during deployment of the distal portion of the coil  34 . In all, the push-pull member  81  rotates approximately 1 to 3, preferably approximately 1.5 to 2, revolutions. As hereinafter discussed, when the operator pushes the freely rotatable handle  131  distally, the variable pitch threaded inner handle  122  effects such a counter-clockwise, controlled, torqued deployment. 
     The counter-clockwise rotation during deployment is provided and controlled by rotation means or mechanism which comprises the threaded  125  portion of the inner handle  122  traveling longitudinally and rotationally through the square shaped inner bushing or nut  126  of the outer handle member  123 . The lesser or tighter pitch of the thread  125  at the distal segment of the inner handle  122  causes greater rotation during deployment of the distal coil  71 . It should be appreciated that the direction of rotation of the expansile member depends upon the orientation in which the coil is manufactured. It is, therefore, only important that the rotation means be manufactured to provide controlled rotation in the same direction as that which the coil seeks during expansion according to its manufactured orientation. 
     Furthermore, the hypotube casing  132  and the rotatable collar  133  enable the operator to ergonomically and stably maintain a hand-hold on the handle  131  of the device  21  during operation thereof without having to remove his or her hand in order to accommodate or permit rotation of the inner handle member  122 . This is effected by the free rotation of the inner handle support tube  127 , the push-pull member  81  and the back stop member  134  within the casing  132  and rotatable collar  133 . That is, the handle assembly  131  accommodates rotation of the deployment means  80  and expansile member  32  without, or independent of, the portions of the handle assembly  131  held by the operator. 
     During expansion of the expansile member  32  the membrane  33  covering the coil  34  simultaneously constrains the coil  34 , thus exerting counteractive or countervailing contractile forces on the expanding coil  34  which is seeking its memorized, ellipsoidal, bi-conical, free or unconstrained configuration. Thus, the membrane  33  does not expand passively. Rather, the expanding coil  34  forcibly expands the membrane  33  to cause the non-planar turns or coils  68 ,  69  and  71  of the coil  34  to assume a substantially planar or disk-like configuration with the membrane  33  being taut and disposed on opposite sides of the expansile member  32  to form an expansile assembly  31  which when expanded is generally perpendicular to the longitudinal axis of the first flexible elongate tubular member  22 . The expansile member  32 , when so deployed into this constrained, partially expanded configuration, is sufficiently rigid and robust so as to provide a supporting framework for the membrane  33  to keep it taut and capable of occluding an opening. In addition, deployment of the expansile assembly  31  is effected without obstructing or impinging on walls of the smallest openings in the body due to the uniquely small profile and expansion mechanics of the helical coil  34  during deployment and de-deployment as hereinbefore discussed. 
     Another embodiment of the expansile device of the present invention is shown in FIGS. 6 and 7. Device  221  is similar to device  21  with the principle difference being in the expanded configuration of device  221 . Thus all parts of closure device  221  that are identical to those of device  21  carry the same numbers as those of the closure device  21 . In addition, device  221  is provided with means for urging the membrane  33  into a partially convex configuration during movement of expansile member  32  between contracted and expanded configurations to seal a puncture. Inner handle  122  of device  221  carries a piston  222  which replaces collar  124  in device  21 . Piston  222  is made of any suitable material, preferably a compressible or deformable silicone O-ring, and is of an appropriate diameter slightly larger than the inner diameter of outer handle  123 . Piston or O-ring  222  is mounted to inner handle  122  in an appropriate manner similar to that hereinbefore described for collar  124  of device  21 . Outer handle  123  is provided with a small transverse hole  223  located at a predetermined, appropriate point along the longitudinal axis of outer handle  123 . Hole  223  has an appropriate diameter ranging from approximately 0.005-0.050 inches, preferably approximately 0.020 inches. 
     Operation and use of device  221  is the same as that of device  21 . 
     The primary difference between device  21  and device  221  is the configuration that membrane  33  assumes during deployment, when expansile assembly  31  is in the fully expanded configuration, occluding or sealing a vascular puncture. During deployment of device  221 , as inner handle  122  rotates and slides distally within outer handle  123 , piston  222  maintains a substantially air-tight seal between inner and outer handles  122  and  123 . Thus, as long as piston  222  is disposed proximal of hole  223 , air naturally contained between inner and outer handles  122  and  123  and within lumen  26  of elongate tubular member  22  is displaced or vented out of outer handle  123  through hole  223  as inner handle  122  moves distally. When piston  222  becomes disposed distal of hole  223 , continued distal movement of inner handle  122  within outer handle  123  forcibly displaces a predetermined volume of air, retained both in between inner and outer handles  122  and  123  and within lumen  26  of elongate tubular member  22 , into membrane  33 . 
     As hereinbefore described in conjunction with device  21 , during expansion of device  221 , the non-adherent portion of membrane  33 , distal to the portion of membrane  33  fixed to distal extremity  24  of elongate tubular member  22 , begins to move preferentially. With the compression and introduction of the small quantity of air from lumen  26 , the deployment of coil  34  into membrane  33  causes the proximal outer surface  224  of membrane  33  to assume a substantially different configuration from the distal outer surface  226  of membrane  33  as seen in FIG.  1 . The taper of proximal outer surface  224  assumes a substantially convex configuration in the expanded configuration instead of the substantially disk-like configuration of the proximal side of membrane  33  in expanded device  21 . Similar to membrane  33  of device  21 , distal outer surface  226  of membrane  33  of device  221  maintains a disk-like configuration when device  221  is in the fully expanded configuration within the vascular puncture. 
     Due to the durometer of the membrane material, the alteration in taper of proximal outer surface  224  of membrane  33  of device  221  occurs at pressures very close to the mean arterial pressure of a human patient. Thus, the disk-like configured distal outer surface  226  of membrane  33  of expansile assembly  31  is naturally urged or forced laterally by arterial blood flow within the vessel, towards the inner wall of the vessel whereby the tapered proximal outer surface  224  is caused to more tightly occlude the puncture in the wall of the vessel without the expansile assembly  31  obstructing ongoing blood flow. 
     Another embodiment of the expansile device of the present invention is shown in FIG.  8 . Device  231  is similar to device  221  with the principle difference being in the expanded configuration of device  231 . Thus all parts of closure device  231  that are identical to those of device  221  carry the same numbers as those of the closure device  221 . In addition, device  231  is provided with means for urging the proximal outer surface  224  of membrane  33  into a convex configuration during movement of expansile assembly  31  between contracted and expanded configurations that is distinct from the urging means of device  221 . Expansile member  32  is provided with an additional proximal coil  232 . Additional proximal coil  232  is of substantially equal size and diameter to proximal coil  66 . In the free or unconstrained configuration of helical coil  34 , proximal coils  66  and  232  lie immediately adjacent to one another like two coils of a tightly wound spring. Thus, the overall unconstrained configuration and size of coil  34  is essentially unchanged from that of device  221 . 
     Operation of device  231  is substantially the same as that of device  21  with the main difference being in the expanded configuration which device  231  assumes. In addition, second proximal coil  232  requires that, in order to be fully deployed, device  231  be provided with a slightly increased stroke length (not shown). During movement of the expansile member  32  from the contracted to the expanded configuration, due to the additional stiffness and bulk provided by tightly apposed proximal coils  66  and  232 , the proximal outer surface  224  of membrane  33  is tented or tapered between the two coils  66  and  232  and assumes a substantially convex configuration as opposed to the substantially disk-like configuration of both sides of membrane  33  assumed by device  21  in the expanded configuration. Double coils  66  and  232  stretch or unwind less when tension is applied to fully deployed device  231 . Thus, proximal outer surface  224  of membrane  33  is more firmly supported when device  231  is under tension. In addition, as shown in FIG. 8 b,  depending on the stiffness provided the proximal coils  66  and  232 , they can be made to separate slightly under tension so that during deployment of device  231 , proximal coil  66  remains inside and up against the inner vessel wall of the puncture while proximal coil  232  is made to pull proximally, through the arteriotomy or puncture in the vessel, and come to rest on the outer wall thereof. In this manner the inner and outer walls of the artery are, essentially, sandwiched or gently compressed between proximal coils  66  and  232  whereupon any additional external proximal tension may be eliminated or discontinued. This is particularly useful for larger arteriotomies or punctures. 
     It is apparent from the foregoing that there has been provided an expansile device for use in blood vessels and tracts in the human body and more particularly for percutaneous occlusion of vascular access sites in the human body and method of using and manufacturing the same. 
     Although the expansile device and method have been described principally in use with the human body it should be appreciated that the expansile device and method also can be utilized with animals in a similar manner. 
     In addition, it should be appreciated that the expansile device can be used within many different natural and iatrogenically created tracts in the body in order to provide for other therapeutic or prophylactic modalities. 
     Thus, it is also apparent from the foregoing that there has been provided a expansile device and method for percutaneous access and occlusion of openings and tracts in the human body that have distinct advantages over those heretofore provided.