Abstract:
A hemostatic valve assembly is disclosed. The assembly comprises a housing having a sidewall that tapers radially inwardly towards the housing distal end. A valve member having an open proximal end and a tapered distal end with an orifice formed therein is disposed within the housing chamber. The valve member is deformable between a closed configuration in which the orifice is substantially closed and an open configuration in which the orifice is open. A biasing member disposed proximal to the valve member is moveable between a longitudinally compressed condition and a longitudinally expanded condition. When in an expanded condition, the biasing member pushes the valve member longitudinally and against the tapered sidewall of the housing. The tapered sidewall of the housing urges the distal end of the valve member radially inwardly, thus urging the orifice to the substantially closed configuration.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Application No. 62/095,272 filed on Dec. 22, 2014, the entire contents of which are hereby incorporated by reference. 
     
    
     TECHNICAL FIELD 
       [0002]    This disclosure relates to medical devices. More particularly, it relates to hemostatic valve systems. 
       BACKGROUND 
       [0003]    Numerous procedures have been developed that involve the percutaneous insertion of a medical device into a body vessel of a patient&#39;s body. Such a device may be introduced into the vessel by a variety of known techniques. For example, a wire guide may be introduced into a vessel using the Seldinger technique. This technique involves creating a minimally invasive opening in a vessel with a needle and inserting a wire guide into the vessel through a bore of the needle. The needle is withdrawn, leaving the wire guide in place. An introducer device is then inserted over the wire guide and into the vessel. The introducer device may be used in a conventional manner to insert into the body vessel a variety of medical devices such as catheters, guiding catheters, balloons, stents, stent grafts, and the like. 
         [0004]    For example, an introducer device may be used to deliver and deploy an endoluminal prosthesis, such as a stent or stent graft, to treat a damaged or diseased body lumen such as a stenosis in a blood vessel. The introducer device may include a prosthesis that is radially compressed onto a delivery catheter and is covered by an outer sheath. To deploy the prosthesis, the operator withdraws the outer sheath distally over the delivery catheter, thereby exposing the prosthesis for outward expansion thereof. 
         [0005]    One of the challenges associated with endoluminal procedures is controlling the flow of bodily fluids within the introducer device during the procedure. One or more mechanisms, such as valves may be provided when it is necessary or desired to control the flow of bodily fluids within the introducer device. For example, the introducer device may include a hemostatic valve to limit or prevent blood loss through the introducer device during a procedure. 
         [0006]    Often, a single introducer device may be used to insert and/or deploy multiple medical devices during a procedure. For example, a single introducer device with a hemostatic valve may be used for introducing a delivery catheter for deployment of an endoluminal prosthesis within a vessel. Once the prosthesis is placed within the vessel, the introducer device with the hemostatic valve may also be used to deliver an interventional device or catheter, such as a balloon catheter, to the vessel to facilitate expansion of the deployed prosthesis. In this example, the hemostatic valve is able to provide a hemostatic seal under several conditions: (1) to seal against the delivery catheter carrying the endoluminal prosthesis when the delivery catheter is inserted into the introducer and through the valve; (2) to seal against the interventional catheter when the interventional catheter is inserted in the introducer and through the valve, and (3) to re-seal when the delivery catheter and/or the interventional catheter are removed from the introducer and valve. 
       SUMMARY 
       [0007]    The present embodiments provide a hemostatic valve. In one example, the hemostatic valve assembly comprises a housing comprising a proximal end, a distal end, and a sidewall defining a housing chamber between the proximal and distal ends. At least a portion of the housing sidewall tapers radially inwardly in a proximal to distal direction. A valve member is disposed at least partially within the housing chamber, the valve member comprising an open proximal end and a distal end having an orifice formed therein and a sidewall extending between the proximal and distal ends of the valve member to form a valve cavity. The valve member is deformable between a closed configuration in which the orifice is substantially closed and an open configuration in which the orifice is open. A biasing member is disposed proximal to the valve member and is moveable between a longitudinally compressed condition and a longitudinally expanded condition. When the biasing member is in the expanded condition, it pushes the valve member longitudinally and against the tapered sidewall of the housing. The tapered sidewall of the housing thereby urges at least the distal end of the valve member radially inwardly, thus urging the orifice to the substantially closed configuration. 
     
    
     
       BRIEF DESCRIPTIONS OF THE DRAWINGS 
         [0008]      FIG. 1  shows one example of a hemostatic valve system attached to a sheath. 
           [0009]      FIG. 2  shows an exploded view of the hemostatic valve system of  FIG. 1 . 
           [0010]      FIG. 3  shows a longitudinal cross sectional view of the hemostatic valve system of  FIG. 1  with a side port. 
           [0011]      FIG. 4  shows a longitudinal cross sectional view of a support member of the hemostatic valve system of  FIG. 1 . 
           [0012]      FIG. 5  shows a perspective view of a valve member of the hemostatic valve system of  FIG. 1 . 
           [0013]      FIG. 6  shows a side elevation view of the valve member of the hemostatic valve system of  FIG. 1 . 
           [0014]      FIG. 7  shows a longitudinal cross sectional view of the valve member of the hemostatic valve system of  FIG. 1 . 
           [0015]      FIG. 8  shows a longitudinal cross sectional view of the hemostatic valve system of  FIG. 1  with one example of an interventional device disposed therethrough. 
           [0016]      FIG. 9  shows a longitudinal cross sectional view of the hemostatic valve system of  FIG. 1  with another example of an interventional device disposed therethrough. 
           [0017]      FIG. 10  shows an exploded view of another example of a hemostatic valve system. 
       
    
    
     DETAILED DESCRIPTION 
       [0018]    The present disclosure relates to a hemostatic valve system. In the present disclosure, the term “proximal” refers to a direction that is away from a physician during a medical procedure, while the term “distal” refers to a direction that is closest to the physician during the procedure. In addition, like reference numbers throughout the various drawings designate similar structure. 
         [0019]      FIG. 1  shows one example of a hemostatic valve system  100  attached to a sheath  10 . Sheath  10  may be positioned within a body vessel to provide access to the body vessel for a medical procedure. The hemostatic valve system  100  may aid in sealing a distal end of the sheath  10  to prevent a body fluid from exiting the body vessel via the sheath during the medical procedure. The hemostatic valve system  100  may enable access to the sheath  10  for delivery of an interventional device into the body vessel as further described below. 
         [0020]    The hemostatic valve system  100  may include a tubular body  150 , a supporting member  130 , a biasing member  180 , an engaging member  190 , a valve member  170 , and a housing  110 . 
         [0021]    Tubular body  150  may extend from the distal end of sheath  10 . Support member  130  may be attached at the distal end of tubular body  150 . Biasing member  180  may be attached at the distal end of support member  130 . Engaging member  190  may be attached at the distal end of biasing member  180 . Valve member  170  may be attached at the distal end of engaging member  190 . Housing  110  is positioned at a distal end of hemostatic valve system  100 . As described more fully below, the housing  110  may include an aperture  122 . Biasing member  180 , engaging member  190 , and valve member  170  are at least partially received within a chamber  118  of the housing  110 . 
         [0022]      FIG. 2  shows an exploded view of the hemostatic valve system of  FIG. 1 . As shown in  FIG. 2 , tubular body  150  may include a distal portion  162  and a proximal portion  164 . The outer surface of the proximal portion  164  may include engaging members  166  (e.g., ribs, threads, splines, projections or the like). The engaging members  166  may be configured to engage the distal end of the sheath (not shown) to aid in maintaining the connection between the hemostatic valve system  100  and the sheath  10  (not shown). Tubular body  150  may be engaged with support member  130 . 
         [0023]    As shown in  FIG. 2 , support member  130  may be configured as a tubular member having a distal end  132 , a proximal end  134 , a sidewall  136 , and a lumen  138  extending longitudinally within the sidewall. The distal end  132  may include a distal end opening. The proximal end  134  may include a proximal end opening (not shown). In this manner, lumen  138  may include a substantially continuous pathway through the support member  130  from the distal end  132  to the proximal end  134 . 
         [0024]    The support member  130  may have a support flange  140 . A support flange  140  may be positioned at the proximal end  134  of the support member  130 . The support flange  140  may be formed integrally with the sidewall  136  of the support member  130  or formed separately and coupled to the sidewall  136  of the support member. The support flange  140  may extend radially outward away from the sidewall  136 . The support flange  140  may at least partially encircle the sidewall  136  of the support member  130 . For example, the support flange  140  may be substantially disc-shaped as shown in  FIG. 2 . An opening (not shown) may extend through the support flange  140 . The sidewall  136  may extend distally from the support flange  140  such that the lumen  138  is in communication with the opening in the support flange. The support flange  140  may include a support surface  142 , which may face in a distal direction. The opening (not shown) in the support flange  140  may be positioned approximately at the center of the support surface  142 . The biasing member  180  may be in contact with the support surface  142  as further described below. 
         [0025]    The sidewall  136  of the support member  130  may be disposed about the longitudinal axis of the hemostatic valve system  100 . At least a portion of the sidewall  136  may be tapered such that an outer diameter of the support member  130  increases in a distal to proximal longitudinal direction along the portion thereof. For example, the sidewall  136  may include a tapered portion  144 , which may be positioned at the distal end  132  as shown in  FIG. 2 . The outer diameter of the support member  130  may increase in the distal to proximal longitudinal direction along the tapered portion  144 . In this manner, the distal end  132  may be configured as a beveled end  129  of the support member  130 . The tapered portion  144  of the support member  130  may be configured as a straight taper or a curved taper. 
         [0026]    The sidewall  136  of the support member may include a shaft portion  146  extending longitudinally between the tapered portion  144  and the support flange  140 . The outer diameter of the support member  130  may be substantially constant along the shaft portion  146 . In this manner, the outer surface of the shaft portion  146  may have a substantially cylindrical shape. The inner diameter of the support member  130  may be substantially constant between the distal end  132  and the proximal end  134 . Alternatively, the inner diameter of the support member may vary longitudinally along the length thereof. 
         [0027]    As shown in  FIG. 2 , biasing member  180  may be configured as a tubular member having a distal end  181 , a proximal end  182 , and a lumen  183  extending longitudinally within the biasing member. 
         [0028]    The biasing member  180  may have any suitable configuration capable of longitudinal compression. For example, the biasing member may be configured as a coiled spring, flat wire spring, or in another example, the biasing member  180  may be configured as a feather spring as shown in  FIG. 2 . More specifically, the biasing member  180  having a feather spring configuration may include a base portion  184  and one or more spring members  185  extending distally from the base portion. The base portion  184  may be configured as an annular member (e.g., an annular ring) at least partially encircling the longitudinal axis of the hemostatic valve system  100 . The spring members  185  may be configured as substantially flat blade-shaped or vane-shaped members extending distally from the base portion  184  as shown in  FIG. 2 . Each spring member  185  may be angled relative to the distal surface of the base portion  184 . For example, each spring member  185  may form an acute angle with the distal surface of the base portion  184  such that each spring member  185  extends distally and circumferentially relative to the longitudinal axis of the valve system  100 . Additionally, or alternatively, each spring member  185  may be angled or turned in a fan blade like configuration relative to the base portion  184 . 
         [0029]    The biasing member  180  may include any suitable number of spring members  185 . The number of spring members  185  may be selected to provide the desired expansion force. The spring members  185  may be spaced circumferentially about the base portion  184 . For example, the spring members  185  may be distributed about the base portion  184  to provide a substantially balanced force against the valve member  170  circumferentially about the rim at the proximal end  172  thereof. 
         [0030]    As shown in  FIG. 2 , engaging member  190  may be configured as a tubular member having a distal end  191 , a proximal end  192 , and a lumen  193  extending longitudinally within the engaging member  190 . The engaging ember  190  may include a base portion  194  and one or more extensions  195  extending distally from the base portion  194 . The base portion  194  may be configured as an annular member (e.g., an annular ring) at least partially encircling the longitudinal axis of the hemostatic valve system  100 . The extensions  195  may extend distally from the distal end of the base portion  194  as shown in  FIG. 2 . The extensions  195  may be distributed circumferentially about the base portion  194  and spaced from one another. In this manner, a recess  196  may be formed between each pair of adjacent extensions  195 . The extensions  195  and recesses  196  may collectively form a serrated distal end  191  of the engaging member  190 . The serrated distal end  191  may aid in engaging the valve member  170  as further described below. 
         [0031]    As shown in  FIG. 2 , valve member  170  may be configured as a dome or bowl-shaped member having a distal end  171  and a proximal end  172 . As shown, the valve member has a hemispherical configuration. A cavity  173  may be formed within the valve member  170  between the distal end  171  and the proximal end  172 . 
         [0032]    As shown in  FIG. 2 , housing  110  may include a distal end  112  and a proximal end  114 . An outer wall  116  of the housing  110  may surround a chamber  118  disposed within the outer wall. The outer wall  116  may be disposed about a longitudinal axis of the hemostatic valve system  100 , which axis may be coextensive with a longitudinal axis of the sheath  10  (shown in  FIGS. 8 and 9 ). 
         [0033]    At least a portion of the outer wall  116  may be tapered such that an inner diameter of the housing  110  increases in a distal to proximal longitudinal direction along the portion thereof. The taper may be configured as a straight taper, such that an inner surface of the outer wall  116  may have a substantially frustoconical shape along the tapered portion. Alternatively, the taper may be configured as a rounded taper as shown in  FIG. 2 . In other words, the inner surface of the outer wall  116  may have a curved or dome shape along the tapered portion. In this manner, the outer wall  116  of the housing  110  may be configured as a dome substantially surrounding the chamber  118  formed by the outer wall. For example, the inner surface of the outer wall  116  may have a shape similar to a spherical dome (e.g., a hemisphere) or a spheroidal dome along the tapered portion. An outer surface of the outer wall  116  may have a shape similar to the inner surface as shown in  FIG. 2 . For example, the outer surface of the distal portion  120  of the outer wall  116  may be dome-shaped. Alternatively, the thickness of the outer wall may vary longitudinally such that the outer surface of the outer wall  116  has a different shape than the inner surface. For example, an outer diameter of the outer wall may be substantially constant along the tapered portion of the outer wall. In this manner, the outer surface of the outer wall may be substantially cylindrical. 
         [0034]    A cross sectional area of the chamber  118  may be defined by the inner surface of the outer wall  116 . At least a portion of the chamber  118  may be tapered such that the chamber has an increasingly larger cross sectional area in the distal to proximal longitudinal direction, as shown in  FIG. 2 . The distal portion of the chamber  118  may be disposed within the distal portion  120  of the outer wall  116 . The taper of the chamber  118  may be configured as a straight taper or a rounded taper as described above with reference to the taper of the outer wall  116 . 
         [0035]    The housing  110  may include an aperture  122  formed in the outer wall  116 . The aperture  122  may be positioned at the distal end  112  of the housing  110  and disposed about the longitudinal axis of the hemostatic valve system  100 . For example, the aperture  122  may be positioned at or aligned with an apex of the domed housing  110  as shown in  FIG. 2 . The aperture  122  may have any suitable cross sectional shape including, for example, circular, elliptical, rectangular, or triangular. The aperture  122  may include a beveled entrance  129  at the distal end thereof as shown in  FIG. 1  and  FIG. 5 . This may aid in guiding an interventional device into the aperture for advancement through the hemostatic valve system  100  as further described below. 
         [0036]    The outer wall  116  of housing  110  may include a proximal portion  124  extending distally from the distal portion  120  as shown in  FIGS. 1-3 . The housing  110  may have a substantially constant inner diameter and/or outer diameter along the proximal portion  124 . For example, the inner surface and the outer surface of the proximal portion  124  may be substantially cylindrical about the longitudinal axis of the hemostatic valve system  100  as shown in  FIGS. 1-3 . 
         [0037]    The proximal end  114  of the housing  110  may be configured as an open end. In this manner, the chamber  118  may include a continuous pathway through the housing  110  from the aperture  122  at the distal end  112  to the open proximal end  114 . A medical device such as an interventional device (not shown) may be advanced into the housing  110  through the aperture  122 , distally through the chamber  118 , and out of the housing  110  through the open proximal end  114  to introduce the medical device (not shown) into the sheath  10  as further described below. 
         [0038]      FIG. 3  shows a longitudinal cross sectional view of the hemostatic valve system  100  of  FIG. 1  with a side port  160 . The tubular body  150  may be engaged with the support member  130  as shown in  FIG. 3 . The tubular body  150  may include a distal end  152 , a proximal end  154 , a sidewall  156 , and a lumen  158  extending longitudinally within the sidewall. The tubular body  150  may be disposed about the longitudinal axis of the hemostatic valve system  100 . The distal end  152  may include a distal end opening. The proximal end  154  may include a proximal end opening. In this manner, the lumen  158  may include a substantially continuous pathway through the tubular body  150  from the distal end  152  to the proximal end  154 . 
         [0039]    As shown in  FIG. 3 , the tubular body  150  may include a side port  160 , which may extend outward from the sidewall  156 . The side port  160  may be in fluid communication with the lumen  158 . The side port  160  may include a coupling (e.g., a Luer lock coupling), which may enable attachment of a syringe, tubing, or other apparatus to the side port. The side port  160  may enable introduction of a fluid (e.g., medication, contrast medium, saline, or other suitable fluid) into the lumen  158  of the tubular body  150  and distally into the sheath  10 . 
         [0040]    As shown in  FIG. 3 , the distal end  152  of the tubular body  150  may be engaged with the support member  130 . For example, the distal end  152  of the tubular body  150  may be coupled to the flange  140  of the support member  130  as shown in  FIGS. 1 and 3 . The tubular body  150  may be coupled to the support member  130  using any suitable type of connection including, for example, an adhesive connection, a snap fit connection, a threaded connection, or a fastener (e.g., a screw, a bolt, or a rivet). In one example, the tubular body  150  may be formed integrally with the support member  130 . In one example, a secondary sealing member (e.g., a conventional valve O-ring or disc (not shown) may be disposed between the tubular body  150  and the support member  130  The secondary sealing member may supplement the valve member  170  in sealing the distal end of the sheath. In one example, the support member  130  is at least partially received within the lumen  158  of the tubular body  150  as further described below with reference to  FIG. 10 . 
         [0041]    The sidewall  156  of the tubular body  150  may include a distal portion  162  and a proximal portion  164 . The distal portion  162  may have a larger outer diameter than the proximal portion  164  as further described below. The outer diameter and/or the inner diameter of the sidewall  156  may be substantially constant along the distal portion  162  of the tubular body  150 . In this manner, the outer surface and/or the inner surface of the distal portion  162  of the tubular body  150  may be substantially cylindrical about the longitudinal axis. Alternatively, the outer diameter and/or the inner diameter may taper along the distal portion of the tubular body  150 . For example, the outer diameter and the inner diameter may decrease in the distal to proximal longitudinal direction along the distal portion  162  of the tubular body  150  as shown in  FIGS. 1-3 . In this manner, the outer surface and the inner surface of the distal portion  162  may have a frustoconical shape about the longitudinal axis. 
         [0042]    The sidewall  156  of the tubular body  150  may taper from the larger diameter of the distal portion  162  to the smaller diameter of the proximal portion  164 . The proximal portion  164  may be configured to be received in the distal end of the sheath  10  to couple the hemostatic valve system  100  to the sheath  10 . As shown in  FIG. 2 , the outer surface of the proximal portion  164  may include engaging members  166  (e.g., ribs). The engaging members  166  may be configured to engage the distal end of the sheath  10  to aid in maintaining the connection between the hemostatic valve system  100  and the sheath  10 . The sheath  10  may include a flared distal end configured to fit over the proximal portion  164  of the tubular body  150  as shown in  FIG. 3 . 
         [0043]    As shown in  FIG. 3 , the support member  130  may be disposed at least partially within the chamber  118  of the housing  110 . A space may be defined between the inner surface of the outer wall  116  of the housing  110  and the outer surface of the sidewall  136  of the support member  130 . The valve member  170 , the biasing member  180 , and/or the engaging member  190  may be received within the space as further described below. The valve member  170 , the biasing member  180 , and/or the engaging member  190  may be capable of moving longitudinally within the space relative to the housing  110  and the support member  130 . 
         [0044]    The outer surface of the sidewall  136  of the support member  130  may be shaped to correspond to the inner surface of the outer wall  116  of the housing  110 . In other words, the outer surface of the sidewall  136  of the support member  130  may have a shape similar to the inner surface of the outer wall  116  of the housing  110 . For example, the shape of the inner surface of the outer wall  116  of the housing  110  along the distal portion  120  thereof and the shape of the outer surface of the sidewall  136  of the support member  130  along the tapered portion  144  thereof may substantially correspond to one another. Additionally, or alternatively, the shape of the inner surface of the outer wall  116  of the housing  110  along the proximal portion  124  thereof and the shape of the outer surface of the sidewall  136  of the support member  130  along the shaft portion  146  thereof may substantially correspond to one another. In this manner, a distance between the inner surface of the outer wall  116  of the housing  110  and the outer surface of the sidewall  136  of the support member  130  may be substantially constant along at least a portion of the lengths thereof. For example, the distance between the inner surface of the outer wall  116  of the housing  110  and the outer surface of the sidewall  136  of the support member  130  may be substantially constant along the length of the tapered portion  144  of the sidewall  136  and/or along the length of the shaft portion  146  of the sidewall  136 . Such uniform spacing may aid in supporting the valve member  170  between the inner surface of the outer wall  116  of the housing  110  and the outer surface of the sidewall  136  of the support member  130  as further described below. 
         [0045]    As seen in  FIG. 3 , the housing  110  may be coupled to the support member  130 . For example, an engaging portion  126  of the housing  110  may include a Groove in an inner surface thereof. The groove may extend circumferentially about the inner surface of the engaging portion  126 . An outer edge of the flange  140  of the support member  130  may be received in the groove of the housing  110 . The housing  110  may be pressed onto the support member  130  until the flange  140  snaps into the groove. In this manner, the housing  110  may be coupled to the support member  130  using a snap fit connection and/or using any other suitable type of connection. For example, the engaging portion  126  of the housing  110  may include internal threads configured to engage with external threads on the outer edge of the flange  140  of the support member  130 . In other examples, the engaging portion  126  of the housing  110  may be coupled to the support member  130  using an adhesive or a fastener (e.g., a screw, a bolt, or a rivet). 
         [0046]    The support member  130  may be at least partially disposed within the cavity  173  of the valve member  170 . For example, the tapered portion  144  of the support member  130  may be disposed within the cavity  173  as shown in  FIG. 3 . 
         [0047]    The valve member  170  may be disposed within the chamber  118  of the housing  110  in the space between the housing  110  and the support member  130  as shown in  FIG. 3 . The valve member  170  may be disposed at least partially within the distal portion of the chamber  118 . In this manner, at least a portion of the valve member  170  may be disposed between the distal portion  120  of the housing  110  and the tapered portion  144  of the support member  130 . This may aid in biasing the valve member  170  toward a closed configuration and/or providing support to the valve member as further described below. 
         [0048]    The wall of the valve member  170  may have a thickness corresponding to the width of the space between the housing  110  and the support member  130 . The valve member  170  may substantially fill the space along at least a portion of the length of the space. The outer surface and the inner surface of the bowl-shaped valve member  170  may be tapered. For example, the outer surface of the valve member  170  may have a shape similar to the shape of the inner surface of the distal portion  120  of the housing  110 . Additionally, or alternatively, the inner surface of the valve member  170  may have a shape similar to the shape of the outer surface of the tapered portion  144  of the support member  130 . In one example, the inner surface and the outer surface of the valve member  170  may have a shape similar to a spherical dome (e.g., a hemisphere) or a spheroidal dome. The outer surface of the valve member  170  may be engaged by the inner surface of the housing  110 . The inner surface of the valve member  170  may be engaged by the support member  130 . 
         [0049]    The valve member  170  may include an orifice  174  at the distal end  171 . The proximal end  172  of the valve member  170  may be configured as an open end. In this manner, the cavity  173  may include a substantially continuous pathway through the valve member  170  from the distal end  171  to the proximal end  172 . 
         [0050]      FIG. 4  shows a longitudinal cross sectional view of a support member  130 . The support member  130  may include an engaging rim  141  positioned at the distal end  132 . The engaging rim  141  may be configured to engage the valve member  170  to aid in urging the valve member toward a closed configuration as further described below. The engaging rim  141  may include a notch  143  in an inner surface of the support member  130  at the distal end  132 . The notch  143  may extend circumferentially around the sidewall  136  of the support member  130 . An outer ridge  145  and an inner ridge  147  may be positioned on opposing sides of the notch  143 . The notch  143  may include angled walls. In this manner, the notch  143  may be configured as a substantially V-shaped trough positioned between the outer ridge  145  and the inner ridge  147 . 
         [0051]    In response to movement of the valve member  170  toward an open configuration as further described below, the material of the valve member may be urged against and/or flow into the notch  143  between the outer ridge  145  and the inner ridge  147 . This may cause deformation of the surface of the valve member  170  in contact with the engaging rim  141 . Such deformation may urge the valve member  170  toward the closed configuration. For example, the angled walls of the notch  143  may aid in urging the material of the valve member  170  out of the notch. In other words, the shape of the engaging rim  141  may cause the material of the valve member  170  to be urged out of the notch  143 , which may cause the valve member  170  to be urged toward the closed configuration. 
         [0052]      FIGS. 5-7  show a perspective view, a side elevation view, and a longitudinal cross sectional view, respectively, of the valve member  170 . The valve member  170  may include a dimple  176  positioned at the distal end  171 . The dimple  176  may be configured as a depression in the outer surface of the valve member  170 . The orifice  174  of the valve member  170  may be positioned within the dimple  176  (e.g., approximately at the center of the dimple). The dimple  176  may aid in guiding an interventional device (not shown) toward the orifice  174  to advance the interventional device through the valve system as further described below. 
         [0053]    As shown in  FIGS. 5-7 , a ridge  177  may be formed in the outer surface of the valve member  170 . The ridge  177  may be positioned near the distal end  171  of the valve member. The ridge  177  may be configured as a raised portion of the outer surface of the valve member  170 . The ridge  177  may extend circumferentially around the valve member  170 . For example, the ridge  177  may circumscribe substantially the entire outer surface of the valve member  170  as shown in  FIG. 5 . In this manner, the ridge  177  may be substantially ring-shaped. In use, the ridge  177  may engage the inner surface of the housing  110 . In this manner, the ridge  177  may aid in forming a seal between the valve member  170  and the housing  110 . 
         [0054]    As shown in  FIG. 7 , the inner surface of the valve member  170  may include a flattened portion  178  positioned near the distal end  171 . The flattened portion  178  may be configured as a substantially planar surface positioned at a distal end of the chamber  118 . A channel  179  may be formed in the inner surface of the valve member  170 . The channel  179  may extend circumferentially along the inner surface of the valve member  170 . For example, the channel  179  may extend circumferentially around substantially the entire inner surface of the valve member  170 , in this manner, the channel  179  may be substantially ring-shaped. The channel  179  may at least partially circumscribe the flattened portion  178  of the valve member  170 . For example, the flattened portion  178  may be positioned within an open center of the ring-shaped channel  179 . The channel  179  aids in enabling the valve member  170  to flex (e.g., upon moving between the closed configuration and the open configuration). For example, the thickness of the valve member  170  at the channel  179  may be reduced relative to the remainder of the valve member  170 . The portion of the valve member  170  with the reduced thickness may act as a flexible hinge to enhance the flexibility of the valve member  170 . 
         [0055]    The orifice  174  may include an opening extending partially or entirely through the valve member  170 . The orifice  174  may provide a pathway through the valve member  170  from the exterior of the valve member into the cavity  173 . In one example, the orifice  174  includes a hole (not shown) through the valve member  170 , in another example, the orifice  174  includes a slit  199  formed in the valve member  170 . The slit  199  may extend partially or entirely through the valve member  170  to form the orifice  174 . For example, the slit  199  may extend entirely through the valve member  170  as shown in  FIG. 5 . In one example (not shown), the orifice  174  may include a first slit formed in the outer surface of the valve member  170  and a second slit formed in the inner surface of the valve member opposite the first slit. The first slit and the second slit may be angled relative to one another. For example, the first slit and the second slit may be oriented perpendicular to one another. In other examples, the first slit and the second slit may be oriented at any other angle relative to one another. Each of the first slit and the second slit may extend partially (e.g., approximately half way) through the valve member  170 . In this manner, the first slit and the second slit may intersect one another to form the orifice  174  extending through the valve member  170 . 
         [0056]    The orifice  174  may be positioned approximately at the apex  197  of the bowl-shaped valve member  170  and aligned with the dimple  176  of the valve member  170  at a point along the longitudinal axis of the valve system  100 . The orifice  174  may be substantially aligned with the aperture  122  of the housing  110  and the distal end opening of the support member  130 . In this manner, an interventional device may be advanced through the aperture  122  and the orifice  174  and into the support member  130  as further described below. 
         [0057]    The valve member  170  may be deformable between a closed configuration (see  FIG. 3 ) and an open configuration (see  FIG. 8 ).  FIG. 3  shows the hemostatic valve system  100  with the valve member  170  in the closed configuration. In the closed configuration, the orifice  174  may be substantially closed or sealed. To that end, one or more edges  189  of the valve member  170  adjacent to the orifice  174  may be in abutting contact with one another. For example, edges  189  of the valve member  170  opposite the slit that defines the orifice  174  may be in abutting contact with one another. Body fluid may be substantially prevented from flowing through the orifice  174  in the closed configuration. In this manner, the distal end  11  of the sheath  10  may be substantially sealed by the hemostatic valve system  100  with the valve member  170  in the closed configuration, and as a result, any fluid flowing distally through the sheath  10  is prevented from flowing through the valve system  100  with the valve member  170  in the closed configuration. 
         [0058]      FIG. 8  shows a longitudinal cross sectional view of the hemostatic valve system  100  of  FIG. 1  in the open configuration with one example of an interventional device  20  disposed therethrough. The interventional device  20  may include any device, object, or structure that supports, repairs, or replaces, or that may be used alone or in combination with other devices, objects, or structures, to support, repair, or replace a body part or a function of that body part. Examples of interventional devices include sheaths, catheters, wire guides, cardiac leads, vessel occlusion devices, filters, stents, stent grafts, and delivery and deployment devices. 
         [0059]    A proximal end of the interventional device  20  may be introduced through the aperture  122  in the housing  110  and brought into contact with the valve member  170 . The interventional device  20  may be advanced proximally through the orifice  174  of the valve member  170 . This may cause the edges  189  of the valve member  170  adjacent to the orifice  174  to be pushed outward to accommodate the interventional device  20 . The valve member  170  may begin to deform as the orifice  174  is pushed open. To that end, the valve member  170  may be formed from a substantially compliant material such that as the orifice  174  is pushed open, the material of the valve member  170  is capable of flowing into the recesses  196  of the engaging member. In this manner, as the valve member  170  deforms, the material at the proximal end  172  of the valve member  170  may flow into the recesses  196  of the engaging member  190  such that the proximal rim  175  of the valve member takes on a shape corresponding to the serrated distal end  191  of the engaging member. This may increase the contact area between the engaging member  190  and the valve member  170 , which may aid in supporting the valve member. 
         [0060]    The material of the valve member  170  may be sufficiently elastic so that the valve member is biased toward its initial, non-deformed closed configuration as illustrated in  FIG. 1 . Additionally, the distal force exerted by the biasing member  180  may urge the valve member  170  distally within the housing  110  as described above, which may cause the valve member to squeeze the interventional device  20  to form a seal around the outer surface of the interventional device  20 . The recesses  196  of the engaging member  190  may receive a sufficient amount of the material of the valve member  170  that further compression of the biasing member  180  is unnecessary to accommodate the interventional device  20 . The interventional device  20  may have a sufficiently small outer diameter, that the volume of material of the valve member  170  that is displaced upon passage of the interventional device through the orifice  174  is able to fit within the available volume provided by the recesses  196  of the engaging member  190 . In this manner, the engaging member  190  may remain substantially stationary relative to the support member  130  and the housing  110 . 
         [0061]    The interventional device  20  may be advanced further proximally through the support member  130  and the tubular body  150  of the hemostatic valve system  100  and into the sheath  10 . The interventional device  20  may be advanced further proximally through the sheath  10  to a target location within the patient&#39;s body. The interventional device  20  may be retracted distally and removed from the hemostatic valve system  100 . The material of the valve member  170  may be sufficiently elastic and compliant that, upon removal of the interventional device  20 , the valve member may return to the closed configuration shown in  FIG. 3 . The force applied by the biasing member  180  and the shapes of the valve member  170 , the housing  110 , and/or the engaging member  190  may aid in biasing the valve member  170  toward the closed configuration as described above. In this manner, the hemostatic valve system  100  may be configured as a dynamic sealing system that actively closes to seal around the interventional device  20  and also seal upon removal of the interventional device  20  therefrom. 
         [0062]      FIG. 9  shows a longitudinal cross sectional view of the hemostatic valve system of  FIG. 1  with another example of an interventional device  30  disposed therethrough. The interventional device  30  may be any suitable interventional device as described above with reference to the interventional device  20 . The interventional device  30  may have a larger outer diameter than the interventional device  20 . 
         [0063]    A proximal end of the interventional device  30  may be introduced through the aperture  122  in the housing  110  and through the orifice  174  of the valve member  170 . This may cause deformation of the valve member  170  as described above with reference to  FIG. 8 . As the valve member  170  deforms, the material of the valve member may flow into the recesses  196  of the engaging member  190  such that the proximal rim  175  of the valve member takes on a shape corresponding to the serrated distal end  191  of the engaging member. The interventional device  30  may have a sufficiently large outer diameter that the orifice  174  may be further expanded after filling the recesses  196  of the engaging member  190  with the material of the valve member  170  as described above. This may cause the material of the valve member to be pushed proximally in the space between the outer wall  116  of the housing  110  and the sidewall  136  of the support member  130  as shown in  FIG. 9 . This may cause the engaging member  190  to move proximally relative to the support member  130  and the housing  110 , which may cause further compression of the biasing member  180  to accommodate the interventional device  30 . 
         [0064]    The interventional device  30  may be advanced further proximally through the support member  130  and the tubular body  150  of the hemostatic valve system  100  and into the sheath  10 . The interventional device  30  may be advanced further proximally through the sheath  10  to a target location within the patient&#39;s body. The interventional device  30  may be retracted distally and removed from the hemostatic valve system  100 . The material of the valve member  170  may be sufficiently elastic and compliant that, upon removal of the interventional device  30 , the valve member may return to the closed configuration. The engaging member  190  may move distally relative to the support member  130  and the housing  110  to return to its initial position within the housing  110 , and the biasing member  180  may expand longitudinally. The force applied by the biasing member  180  and the shapes of the valve member  170 , the housing  110 , and/or the engaging member  190  may aid in biasing the valve member toward the closed configuration as described above. 
         [0065]      FIGS. 8-9  illustrate the hemostatic valve system  100  with the valve member  170  in the open configuration. One or more edges  189  of the valve member  170  adjacent to the orifice  174  may be spaced from one another such that they are not in abutting contact. For example, edges  189  of the valve member  170  opposite the slit  199  that defines the orifice  174  may be spaced from one another and thus the orifice  174  is open. In this manner, an interventional device may be capable of passing through the valve member  170  to introduce the interventional device through the hemostatic valve system  100  and into the sheath  10  as shown in  FIGS. 8-9 . The edges  189  of the valve member  170  adjacent to the orifice  174  may be in contact with an interventional device to provide a seal around the interventional device. In this manner, body fluid may be substantially prevented from flowing through the orifice  174  and around the interventional device, and the distal end of the sheath  10  may be substantially sealed by the hemostatic valve system  100 . 
         [0066]    The shapes of the housing  110 , the support member  130 , and/or the valve member  170  may aid in biasing the valve member toward the closed configuration. More specifically, the valve member  170  may be urged distally within the chamber  118  of the housing  110  by the biasing member  180  and/or the engaging member  190 . As the valve member  170  is urged distally, the inner surface of the outer wall  116  of the housing  110  may engage the outer surface of the valve member  170 . For example, the inner surface of the distal portion  120  of the housing  110  (e.g., the tapered inner surface) may engage the outer surface of the valve member  170  (e.g., the tapered outer surface). Urging the valve member  170  distally into the tapered distal portion  120  of the inner surface of the housing  110  may cause the distal end  171  of the valve member to be squeezed inward or radially compressed by the inner surface of the housing. This may cause the edges  189  of the valve member  170  adjacent to the orifice  174  to be urged toward one another. In this manner, the orifice  174  may be urged toward the closed configuration. The position of the support member  130  within the cavity  173  of the valve member  170  may aid in preventing the valve member  170  from collapsing inward as the valve member  170  is urged toward the closed configuration. In this manner, the support member  130  may provide support to the valve member  170  from within valve chamber  118 . 
         [0067]    The biasing member  180  may be longitudinally compressible. Upon compression of the biasing member  180 , which may occur upon insertion of an interventional device into the valve system  100 , for example, the proximal end  182  of the biasing member  180  may press against the support flange  140  and exert a longitudinal force in the distal direction. The distal end  181  of the biasing member  180  may be in contact with the valve member  170  and/or the engaging member  190 . In this manner, the longitudinal force exerted by the biasing member  180  may urge the valve member  170  distally within the chamber  118 . This may aid in biasing the valve member  170  toward the closed configuration as described above. 
         [0068]    Upon longitudinal compression of the biasing member  180 , the spring member(s)  185  may be flexed, compressed, or bent toward the distal surface of the base member  184 . The angle between the biasing member(s)  185  and the distal surface of the base member  184  may be reduced upon compression of the biasing member  180 . Each spring member  185  may have a contoured outer edge. For example, the outer edge of each spring member  185  may be curved such that, as the spring member  185  is flexed toward the base member  184 , the outer edge of each spring member  185  remains within the outer diameter of the base member. In this manner, the outer diameter of the biasing member  180  may remain constant during longitudinal compression of the biasing member. In other words, the outer diameter of the biasing member  180  may not expand during longitudinal compression of the biasing member. 
         [0069]    The engaging member  190  may be disposed within the chamber  118  of the housing and proximal of the valve member  170 . For example, the engaging member  190  may be disposed between the valve member  170  and the biasing member  180  as shown in  FIGS. 1-3 . The support member  130  may be at least partially disposed within the lumen  193  of the engaging member  190 , with the engaging member  190  being longitudinally moveable relative to the support member  130  and the housing  110 . The proximal end  192  of the engaging member  190  may be in contact with the biasing member  180 . The distal end  191  of the engaging member  190  may be in contact with the valve member  170 . In this manner, the biasing member  180  may urge the engaging member  190  distally within the chamber  118  and, in turn, urge the valve member  170  distally within the chamber  118 . As mentioned previously, as the valve member  170  is urged distally, the tapered inner surface of the outer wall  116  of the housing causes the valve member  170  to be urged radially inwardly into a closed or sealing configuration. 
         [0070]      FIG. 10  shows an exploded view of another example of a hemostatic valve system  200 . The valve system  200  may be similar to the hemostatic valve system  100  described above. For example, the valve system  200  may include a housing  210 , a tubular body  250 , a valve member  270 , a biasing member  280 , and an engaging member  290 , which may be configured substantially as described above with reference to the hemostatic valve system  100 . The valve system  200  may include a support member  230 , which may have a somewhat different configuration than the support member  130  described above. The support member  230  may be configured as a tubular member having a distal end  232  with a distal end opening, a proximal end  234  with a proximal end opening, a sidewall  236 , and a lumen  238  extending longitudinally within the sidewall. A support flange  240  may be positioned at or near the proximal end  234  of the support member  230 . The support flange  240  may extend radially outward away from the sidewall  236 . The support flange  240  may include a support surface  242 , which may face in a distal direction. The biasing member  280  may be in contact with the support surface  242  as described above with reference to the hemostatic valve system  100 . The sidewall  236  may include a tapered portion  244 , which may be positioned at the distal end  232 . The support member  230  may include an engaging rim (not shown in detail) as described above with reference to the engaging rim  141  of the support member  130 . The sidewall  236  may include a shaft portion  246  extending longitudinally between the tapered portion  244  and the support flange  240 . 
         [0071]    The support member  230  may further include a plug member  248  extending proximally from the support flange  240 . The plug member  248  may be formed integrally with the support flange  240  or formed separately and then attached to the support flange. An outer surface of the plug member  248  may be tapered. For example, an outer diameter of the plug member  248  may decrease in a distal to proximal longitudinal direction. The plug member  248  may be engaged by the distal end of the tubular body  250 . To that end, the outer surface of the plug member  248  may be sized and shaped to correspond to the inner surface of the distal end of the tubular body  250 . In this manner, the plug member  248  may be configured to be disposed at least partially within the lumen of the tubular body  250 . With the plug member  248  in place within the body  250 , the side port of the body may be positioned proximal of the proximal end  234  of the support member  230 . The housing  210  may be coupled to the tubular body  250  using any suitable type of connection as described above with reference to the hemostatic valve system  100 . In this manner, the support member  230  may be maintained in position between the housing  210  and the body  250 . 
         [0072]    The hemostatic valve systems  100 ,  200  described herein may be capable of sealing around interventional devices having a wide range of sizes. The valve systems  100 ,  200  may be capable of sealing around relatively large interventional devices and recovering to seal around relatively small interventional devices or to return to the closed and sealed position (e.g., after removal of all interventional devices). In one non-limiting example, the hemostatic valve system  100  may be capable of sealing around a relatively large dilator (e.g., about 24 Fr) and then recovering to seal around a relatively fine guide wire (e.g., having an outer diameter of about 0.018 in) while further recovering to completely seal when all interventional devices and/or wires have been removed. The valve systems described herein may be capable of achieving a balance between being tight enough to seal with nothing extending across and through the valve and conformable enough to allow easy passage of interventional devices therethrough. 
         [0073]    The hemostatic valve systems described herein may also be capable of sealing around one or more devices having a wide range of sizes at the same time. For example, the hemostatic valve system  100 ,  200  may be capable of sealing around two interventional devices at the same time. 
         [0074]    The hemostatic valve systems  100 ,  200  described herein, or various components thereof, may be formed from any suitable materials. Suitable polymeric materials may include, for example, silicone, polyamide (nylon), polyurethane, polyether ether ketone (PEEK), polyester (e.g., polyethylene terephthalate (PET)), polyethylene, polyethylene oxide (PEO), polystyrene, polypropylene, or blends or copolymers thereof. The valve member may be formed from any suitable elastomeric material including, for example, silicone; urethane; rubber; polytetrafluoroethylene (PTFE); a polyamide (e.g., nylon 12); a polyamide block copolymer (e.g., PEBA); a polyolefin; a polyester (e.g., PET); a polyurethane copolymer with MDI, HMD or TDI hard segment and aliphatic polyester, polyether, or polycarbonate soft segment (e.g., Pellethane, Estane or Bionate); polyester copolymers with 4GT (PBT) hard segments and aliphatic polyester or polyether soft segments (e.g., Hytrel, Pelprene or Arnitel)); or blends or copolymers thereof. In one example, the valve member  170 ,  270  may be formed from a substantially compliant material such as, for example, a high consistency rubber (HCR) including silicone or LSR Silicone Rubber. The material may have a high tear strength and/or a high elongation. 
         [0075]    While various embodiments of the invention have been described, the invention is not to be restricted except in light of the attached claims and their equivalents.