Patent Publication Number: US-2003225379-A1

Title: Composite stasis valve

Description:
CLAIM OF PRIORITY  
     [0001] This application claims priority under 35 U.S.C. 119(e) from U.S. Provisional Application Serial No. 60/357,937 filed Feb. 19, 2002, which application is incorporated herein by reference.  
     TECHNICAL FIELD AND RELATED APPLICATION  
     [0002] This application relates to catheters, in particular to a composite fluid-stasis valve for use with catheters. This application is related to U.S. Pat. No. 5,429,616, which is incorporated by reference herein. 
    
    
     
       BACKGROUND  
       [0003] Fluid stasis mechanisms are commonly used to prevent loss of fluids from the insertion site of a catheter or interventional system. The may range, in complexity, from a simple clamp on a length of tubing to complex valve systems with several moving parts. The most common valves consist of a resilient material in compression within a housing or clamping member. An example of such a valve is patentee&#39;s prior U.S. Pat. No. 5,429,616 wherein a length of tubular resilient foam has an occludible lumen.  
       [0004] An example of the simplest form is U.S. Pat. No. 6,088,889 where a wire clamp is used to occlude a portion of tubing. The resilient material may have a lumen or slit that allows for the passage of an instrument such as a guide wire or catheter.  
       [0005] Most of the existing devices require the user to manually open or close the valve by adjusting the compression on the resilient material and subsequently opening or closing the lumen. An example of this configuration is commonly referred to as a Touey-Borst valve. The manual operation of existing valves most often requires a twisting motion or a squeezing motion. In many cases the action requires the use of both hands. In addition, the existing valves often do not prevent the immediate backflow from within the fluid path as an instrument is inserted or removed.  
       [0006] The existing devices do not perform a complete seal against leakage in the presence of a wide range of instruments or in the presence of multiple instruments. For instance, a single valve element with no instrument in place is generally not optimized for sealing in the presence of an instrument. Often a combination of seals is employed to address these issues, for instance: U.S. Pat. Nos. 6,083,207 and 6,024,729 employ primary seal portions in combination with “duckbill-valves” or “0” closure valves.  
       [0007] Thus, the problems are complex and involve a balance between closing force, opening force, friction, compression and durability. If a valve is inordinately tight, having a closed lumen, it may not allow the insertion of soft, flexible instrumentation such as a “floppy-tip” guidewire, a delicate laser fiber or a soft-tipped catheter. Some catheters, optical fibers and fluid transmission tubes are very delicate and can be damaged by excessive compression or insertion force.  
       [0008] Accordingly, what is needed is a durable stasis valve that blocks the flow of gas or fluid completely and immediately with or without an instrument in place within the gas/fluid path. 
     
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
     [0009]FIG. 1 illustrates a perspective view of a stasis valve as constructed in accordance with one embodiment.  
     [0010]FIG. 2 illustrates a perspective view of a stasis valve as constructed in accordance with one embodiment.  
     [0011]FIG. 3 illustrates an enlarged cut away view of a stasis valve as constructed in accordance with one embodiment.  
     [0012]FIG. 4 illustrates an enlarged cut away view of a stasis valve as constructed in accordance with one embodiment.  
     [0013]FIG. 5 illustrates a side cross-sectional view of a seal module as constructed in accordance with one embodiment.  
     [0014]FIG. 6 illustrates an end, cross-sectional view of a seal module chamber as constructed in accordance with one embodiment.  
     [0015]FIG. 7 illustrates a side cross-sectional view of a seal module as constructed in accordance with one embodiment.  
     [0016]FIG. 8 illustrates an end, cross-sectional view of a seal module chamber as constructed in accordance with one embodiment.  
     [0017]FIG. 9A illustrates a schematic diagram of a stasis valve as constructed in accordance with one embodiment.  
     [0018]FIG. 9B illustrates an enlarged schematic diagram of a stasis valve as constructed in accordance with one embodiment.  
     [0019]FIG. 10A illustrates a schematic diagram of a stasis valve as constructed in accordance with one embodiment.  
     [0020]FIG. 10B illustrates an enlarged schematic diagram of a stasis valve as constructed in accordance with one embodiment.  
     [0021]FIG. 11 illustrates a partial cut away view of a detent arrangement inside a housing as constructed in accordance with one embodiment.  
     [0022]FIG. 12 illustrates a side cross-sectional view of seal module with an instrument as constructed in accordance with one embodiment.  
     [0023]FIG. 13 illustrates a side cross-sectional view of seal module as constructed in accordance with one embodiment.  
     [0024]FIG. 14 illustrates a side cross-sectional view of seal module as constructed in accordance with one embodiment.  
     [0025]FIG. 15 illustrates a side cross-sectional view of seal module as constructed in accordance with one embodiment.  
     [0026]FIG. 16 illustrates an end, cross-sectional view of a seal module chamber as constructed in accordance with one embodiment.  
     [0027]FIG. 17 illustrates an end, cross-sectional view of a seal module chamber as constructed in accordance with one embodiment.  
     [0028]FIG. 18 illustrates an end, cross-sectional view of a seal module chamber as constructed in accordance with one embodiment.  
     [0029]FIG. 19 illustrates an end, cross-sectional view of a seal module chamber as constructed in accordance with one embodiment.  
     [0030]FIG. 20 illustrates a perspective view of a seal module as constructed in accordance with one embodiment.  
     [0031]FIG. 21 illustrates a perspective view of a seal module as constructed in accordance with one embodiment.  
     [0032]FIG. 22 illustrates a perspective view of a seal module as constructed in accordance with one embodiment.  
     [0033]FIG. 23 illustrates a cross-sectional view of a seal module as constructed in accordance with one embodiment.  
     [0034]FIG. 24 illustrates a cross-sectional view of a seal module as constructed in accordance with one embodiment.  
     [0035]FIG. 25 illustrates a cross-sectional view of a seal module as constructed in accordance with one embodiment.  
     [0036]FIG. 26 illustrates a cross-sectional view of a seal module as constructed in accordance with one embodiment.  
     [0037]FIG. 27 illustrates a perspective view of a stasis valve and external mechanism assembly in accordance with one embodiment.  
     [0038]FIG. 28 illustrates a sectional view of a seal module in accordance with one embodiment.  
     [0039]FIG. 29 illustrates a sectional view of a seal module in accordance with one embodiment.  
     [0040]FIG. 30 illustrates a perspective view of a seal valve as constructed in accordance with one embodiment.  
     [0041]FIG. 31 illustrates a transparent perspective view of a housing and a seal valve as constructed in accordance with one embodiment.  
     [0042]FIG. 32 illustrates a cross-sectional view of a seal valve as constructed in accordance with one embodiment.  
     [0043]FIG. 33 illustrates a transparent perspective view of a housing and a seal valve as constructed in accordance with one embodiment.  
     [0044]FIG. 34 illustrates a cross-sectional view of a seal valve as constructed in accordance with one embodiment. 
    
    
     DETAILED DESCRIPTION  
     [0045] In the following detailed description, reference is made to the accompanying drawings which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it is to be understood that other embodiments may be utilized and that structural changes may be made without departing from the scope of the invention. Therefore, the following detailed description is not to be taken in a limiting sense, and the scope of the invention is defined by the appended claims and their equivalents.  
     [0046] With reference to the drawings, FIGS.  1 - 4  illustrate a composite fluid stasis valve  10  with a housing  20 , a proximal end  30 , and a distal end  40 . In one embodiment, the housing  20  comprises a hollow rectangular structure having a first end-wall  21 , a second end-wall  22 , a first side-wall  23 , a second side-wall  24 , a bottom or floor  25 , and a top or lid  26 . A hollow interior wall  11  of the housing  20  is sized and configured to hold and control a composite seal module  100 , a portion of an actuator  50 , and an actuating member  55 .  
     [0047] The first end-wall  21  of the housing  20  is fitted with a connecting member  35  sized and configured to attach in fluid communication to a fluid delivery supply or a body passage such as a blood vessel. The connecting member  35  is a common male thread “Luer” type fitting or a common “slit-fit” tube connector or the like. The second end-wall  22  of the housing  20  is sized and configured to receive an inserted instrument, catheter or guide wire through a receiving member  45 .  
     [0048] The actuator  50 , in one option, includes an actuator flange  57  exterior to the interior wall  11  about the second side wall  24  of the housing  20 . In one option, a second stationary member  65  is positioned in the interior wall  11  of the first side wall  23  of the housing  20  distal to the actuating member  55 . In one example, the second stationary member  65  is part of the interior wall  11  of the first side wall  23  of the housing  20  or in another example, the second stationary member  65  is inserted into the bottom  25  of the housing  20  as a separate piece.  
     [0049] The stasis valve  10  includes the seal module  100  enclosed in the housing  20  such that the seal module  100  is proximally connected to the connecting member  35  and distally connected to the receiving member  45 . The receiving member  45  is, in one option, configured to connect to a fluid or gas delivery system or device such as a syringe, intravenous system or the like. The top edge  18  of the second side wall  24  of the housing  20  forms a guide support for moving the actuating member  55  which, in one option, includes an extension  52 . The top  26  of the housing  20  provides an opposing support member for the moving actuator  50 . As the actuator flange  57  is depressed, the actuator  50  moves across along the top edge  18  of the second side wall  24  toward the interior wall  11  of the first side wall  23  of the housing  20 . The actuating member  55  of the actuator  50  depresses and at least partially collapses, a portion of the seal module  100 . The collapsed portion of the seal module  100  forms a seal  200  preventing fluid and/or gasses communication between the connecting member  35  and the receiving member  45 .  
     [0050] The actuator  50  is adapted to slide from a first position to a second position. In the first position the actuator  50  is, in one option, disposed and held against a portion of the seal module  100  which depresses and at least partially collapses, for example, the central portion  110  of the containment structure  160  by a compressive force  67  from a resilient member (e.g., by a spring  210 ). In one position, the containment structure  160  has a normally closed position (i.e., the lumen remains sealed until a user depresses the actuator  50 ). In the second position, the actuator  50  is disposed away from a portion of the seal module  100  by a compressive force  67  (e.g. by depressing the actuator flange  57 ) thus allowing, for example, the central portion  110  of the containment structure  160  to retract to an unsealed configuration.  
     [0051] A seal module  100 , in one option, extends between the first end-wall  21  of the housing  20  and the second end-wall  22  of the housing  20  and is in fluid communication with the connecting member  35  and the receiving member  45 . The seal module  100  comprises an elongate tubular structure  101  having a central portion  110 , a first end portion  120 , and a second end portion  140 . The central portion  110  is sized and configured to hold a plurality of sealing members including a first seal member  170 , a second seal member  180 , and a third central seal member  165 . It should be noted that one or more of the first seal member  170 , the second seal member  180 , and the third central seal member  165  can be formed of the various materials, and/or having the various properties, discussed throughout this application. In one option, the seal module  100  includes the first seal member  170  fixed at a proximal end  115  of the seal module  100 , a second seal member  180  fixed at a distal end  117  of the seal module  100 , and a third central seal member  165  extending between the first and the second seal members  170 ,  180 . The plurality of seal members  165 ,  170  and  180  have an internal diameter sized to allow the passage of fluids or gases therethrough.  
     [0052] In one embodiment, the first end portion  120  includes a distal end  121  that axially communicates with the central portion  110  of the containment structure  160  within the hollow interior wall  11  of the housing  20  and axially communicates with the connecting member  35  exterior to the housing  20 . The first end portion  120  includes, in one option, a first diameter substantially smaller than the diameter of the central portion  110 . The second end portion  140 , in one option, includes a distal end  141  that axially communicates with the central portion  110  of the containment structure  160  within the hollow interior wall  11  of the housing  20  and axially communicates with the receiving member  45  exterior to the housing  20 . The second end portion  140  includes a second diameter that is substantially smaller than the diameter of the central portion  110 . An amount of compressive force  67  is applied to the actuator flange  57  of the actuator  50  by the user causing the actuator  50  to slide across along the top edge  18  of the second side wall  24 . As the actuator  50  slides across along the top edge  18  of the second side wall  24 , the actuating member  55  is forced against the outer wall  27  of the seal module  100 .  
     [0053] In another embodiment, the actuator  50  is adapted to slide from a first position to a second position. In the first position the actuator  50  is disposed and held against a portion of the seal module  100  which depresses and at least partially collapses, for example, the central portion  110  of the containment structure  160  by a compressive force  67  (e.g. by a spring  210 ) creating a seal  200  preventing gas and/or fluid from passing therethrough. In the second position, the actuator  50  is disposed away from a portion of the seal module  100  by a compressive force  67  (e.g. by depressing the actuator flange  57 ) thus allowing, for example, the central portion  110  of the containment structure  160  to retract to an uncollapsed configuration. When there is no longer a compressive force  67  (e.g. by releasing the actuator flange  57 ), the actuator  50  reengages the portion of the seal module  100  and at least partially collapses, for example, the central portion  110  of the containment structure  160 .  
     [0054] With reference to FIGS.  5 - 22 , the seal module  100 , in one embodiment, includes a flexible, elongate tubular structure  101  having an outer wall  27  which includes a material  166  that is highly elastic, deformable, compliant and yet virtually non-compressible. The outer wall  27  is formed so as to have a large diameter in the central portion  110  and a reduced diameter at the first end portion  120  and the second end portion  140  of the seal module  100 . A first abutment  111  and a second abutment  112  are formed by the diameter reduction of the elongate tubular structure  101 . The first abutment  111  forms a stop or seat for a first seal member  170  and the second abutment  112  forms a stop or seat for a second seal member  180 . A third central seal member  165  is placed between the first seal member  170  and the second seal member  180  and in fluid communication therewith. The third central seal member  165  includes a highly deformable, non-compressible material  166  (e.g., plastic). The third central seal member  165  is sized and configured to maintain an open lumen  193  when no compressive force  67  is applied.  
     [0055] When the actuating member  55  is, in one option, forcibly pushed against the central portion of the seal module  100 , the compressive force  67  of the actuating member  55  against the outer wall  27  of the containment structure  160  inwardly depresses or collapses the third central seal member  165  of the containment structure  160  as the actuator  50  progresses toward the first side wall  23  of the housing  20 . The third central seal member  165  is, in one option, depressed to the point where the containment structure  160  of the seal module  100  slows or stops the flow of fluid (e.g., blood) from communicating between the connecting member  35  and the receiving member  45  of the stasis valve  10 . This creates a seal  200  between the orifices  171 ,  181  of the lumen  191 ,  190 . The stationary member  65  (see FIG. 4) further assists the depression of the outer wall  27  of the containment structure  160  on an opposing side as the actuating member  55  progresses toward the first side wall  23  of the housing  20 .  
     [0056] In one embodiment, the first seal member  170  has an orifice  171  of a selected diameter  194  that corresponds, for example, to a range of instruments used within the seal module  100 . The second seal member  180  includes the orifice  181  that corresponds to a range of inserted instruments. The first seal member  170  provides a fluid/gas tight seal around and upon an instrument within a selected range of diameters  194 , such as a catheter, guidewire, needle or fiber, inserted within the orifice  171  of the first seal member  170 . The second seal member  180  is sized and configured to provide containment for the third central seal member  165 . The orifice  181  of the second seal member  180  is, in one option, substantially the same as the orifice  171  of the first seal member  170  and provides a backup or secondary seal in the event that the first seal member  170  becomes damaged.  
     [0057] The first and second seal members  170  and  180  include elastomeric materials, such as rubber or silicone, and are essentially septums sized and configured to seal against gas or fluid pressure around an instrument. The first and second septum seal members  170  and  180 , allow smooth and accurate movement of instruments since there is no additional compressive force or load required to complete the seal. In one option, a relatively high durometer material is used as the septum material for the first and second seal members  170  and  180  because it provides a low frictional coefficient against most inserted instruments while providing a competent seal. In another embodiment, one or more of the first, second, and third seal members  170 ,  180 , and  165  includes self-lubricating, lubricious or coated septum materials. Such materials include specialty silicones, natural latex, various synthetic rubbers or elastomeric compounds of polyurethane, vinyl or the like. The low friction nature of the first and second seal members  170 ,  180  is in contrast to the highly deformable and compliant nature of the third central seal member  165 .  
     [0058] The third central seal member  165  includes an elongated tubular structure  101  sized and configured to fit into the tubular containment structure  160  between the first seal member  170  and the second seal member  180 . The lumen  193  of the third central seal member  165  is, in one option, slightly larger than the orifice  171  of the second seal member  180  so that an inserted instrument  260  need not contact the luminal surface.  
     [0059] In one embodiment, the third central seal member  165  includes material  166  that is highly elastic, deformable, compliant and yet virtually non-compressible. Materials  166  include modified vinyl, silicone, polyurethane or a combination thereof. The basic materials are, in one option, modified by compounding them with waxes and/or oils or un-cross-linked modifiers. Such materials are commonly available as “C-Flex” or “Kraton” in the range of 5 to 15 (shore A), as examples. The shore hardness of the material  166  is, in another option, in the range of between 15-20 shore on the “00” scale. This provides a material  166  that is extremely soft and compliant and intrinsically “sticky”. An extremely low shore hardness of the third central seal member  165  material  166  allows the third central seal member  165  to be easily compressed upon itself or upon an inserted instrument. For illustrative purposes only, the nature of the material  166  of the third central seal member  165  can be compared to a gelatinous substance. The material  166  exhibits a “selfclosing” nature in that it sticks occlusively to itself forming a nearly fluid/gas tight seal under very light compression.  
     [0060] With particular reference to FIGS. 10A, 10B,  16 - 19 , the highly compliant third central seal member  165  seals around a variety of profile shapes  192  and diameters  194  of the lumen  193  when at least one side of compressive force  67  is exerted upon the central region  195  with respect to the central portion  110  of the containment structure  160 . The compressive load may be supplied by a movable, sliding or hinged, actuator  50  that maintains a compressive load upon the third central seal member  165  under the influence of a spring  210  or other resilient material. The spring  210  provides a compressive load between the actuating member  55  of the actuator  50  and the stationary member  65  positioned in the interior wall  11  of the housing  20 .  
     [0061] With reference to FIGS. 9A, 9B,  10 A,  10 B,  11 , the compressive load upon the third central seal member  165  is, in one option, selectively relieved by moving the movable actuator  50  so as to compress the spring  210  and subsequently enlarge the distance between the actuating member  55  of the actuator  50  and the stationary member  65  positioned in the interior wall  11  of the housing  20 . A “hold-open” or “hold-closed” feature is, in one option, a latching or detent arrangement  250 . An operator can choose to have the lumen of the composite seal remain substantially open, allowing gas or fluid flow in either direction. The operator can subsequently “squeeze” or otherwise operate the actuator  50  to the following sequential position of the detent arrangement  250  thereby allowing the spring  210  to fully compress the third central seal member  165 . For example, the action of “hold and release” is repeated as the actuator  50  is urged from one extreme position to another extreme position within the detent arrangement  250 . The detent arrangement  250  includes, but is not limited to, a series of ramps and slides that move the sliding actuator  50  through a path.  
     [0062] In another embodiment, the actuator  50  includes an extension configured to be urged up an incline ramp  251  and into a depression  252  where it finds a neutral resting place under the return force of the compression spring  210 . Upon further urging forward, the extension  52  of the actuator  50  is forced against an angular wall  253  that forces the extension of the actuator  50  to one side, over a ledge  255 , and into a return incline ramp  256 . The neutral bias of the actuator  50  is to position the extension so as to move up the first incline ramp  251  upon subsequent or further actuation of the actuator  50 .  
     [0063] FIGS.  12 - 15  illustrate the use of a seal module  100  that requires no compressive load for use in sealing the stasis valve  10  closed. The non-compressive embodiment may include a second seal member  180  in a fixed position within the containment structure  160  toward the distal end  117  of the containment structure  160 , a first seal member  170  in a sliding relationship within the containment structure  160 , and a third central seal member  165  comprised of a highly deformable material  166 . The first seal member  170  includes an elastomeric seal that is movable within the containment structure  160  in response to a retrograde flow  270 . The first seal member  170  includes a length that maintains axial alignment within the containment structure  160  which, in one option, includes an orifice  181  that is significantly smaller than the lumen  193 ,  191  size of the other seal members  165 ,  180 . The region adjacent to the small orifice  181  includes a thin cross-section to reduce entry force, friction and restriction. In another option, the seal module  100  includes a first seal member  170  with a first diameter, a second seal member  180  with a second diameter, and a third seal member  165  with a third diameter, the third diameter of the third seal member  165  being greater than at least one of the first diameter and the second diameter.  
     [0064] The seal module  100  includes, in one option, the first seal member  170  having a first material, the second seal member  180  having a second material, and the third seal member  165  having a third material, wherein at least one of the first material of the first seal member  170  and the second material of the second seal member  180  is different than the third material of the third seal member  165 . The first material of the first seal member  170  and the second material of the second seal member  180  can have a lower friction that the third material of the third seal member  165 . The second seal member  180  includes an elastomeric seal that is fixed within the containment structure  160  so that it does not move within the seal module  100 . The second seal member  180  has a length that keeps it axially stable within the containment structure  160  and an orifice  171  that represents the designated lumen  191  size of the instrument  260 .  
     [0065] The back pressure from the retrograde flow  270  forces the first seal member  170  toward the third central seal member  165  in the containment structure  160 . As the first seal member  170  moves distally, or toward the second seal member  180  under the influence of the pressure from the gas or fluid, the third central seal member  165  is compressed. However, since the material  166  of the third central seal member  165  is essentially non-compressible, the lumen  193  of the third central seal member  165  collapses upon itself circumferencially. The material  166  of the third central seal member  165  is sufficiently soft and compliant to deform under the movement of the first seal member  170 . In one option, at least one of the first and the second materials have a higher durometer than the third material. As long as there is backpressure against the first seal member  170 , a gas or fluid tight seal is maintained.  
     [0066] In one embodiment, instrument  260 , for example, a catheter or guidewire is inserted into the valve antegrade, for example, in the distal end  117  of the containment structure  160  while the lumen  193 ,  190 , and  191  of the seal members  165 ,  170 , and  180 , are in an open configuration. The instrument  260  frictionally engages the lumen  190  of the first seal member  170  and forces it distally away from the second seal member  180  and the third central seal member  165 . The first seal member  170  forms a seal against the instrument  260 . The back pressure from the retrograde flow  270  against the first seal member  170  forces the first seal member  170  toward the distal end  117  of the containment structure  160  compressing the third central seal member  165  and collapsing it circumferencially against the instrument  260  forming a second, complete seal.  
     [0067] In another embodiment, instrument  260 , for example, a catheter or guidewire is inserted into the valve antegrade, for example, in the distal end  117  of the containment structure  160  while the lumen  193  of the third central seal member  165  is in a closed configuration. The instrument  260  frictionally engages the lumen  190  of the first seal member  170  and forces it distally away from the second seal member  180  and the closed third central seal member  165 . The first seal member  170  forms a seal against the instrument  260 . The back pressure from the retrograde flow  270  against the first seal member  170  forces the first seal member  170  toward the distal end  117  of the containment structure  160  compressing the third central seal member  165  and collapsing it circumferencially against the instrument  260  forming a second, complete seal.  
     [0068] In yet another embodiment, two or more instruments  260  are inserted into the valve antegrade, for example, in the distal end  117  of the containment structure  160  while the lumen  193 ,  190 , and  191  of the seal members  165 ,  170 , and  180 , are in an open configuration, or in another option, while the lumen  193  of the third central seal member  165  in a closed configuration. The instruments  260  frictionally engage the lumen  190  of the first seal member  170  and forces it distally away from the second seal member  180  and the third central seal member  165 . The first seal member  170  forms a seal against the instruments  260 . The back pressure from the retrograde flow  270  against the first seal member  170  forces the first seal member  170  toward the distal end  117  of the containment structure  160  compressing the third central seal member  165  and collapsing it circumferencially against the instruments  260  forming a second, complete seal. The material  166  of the third central seal member  165  is so compliant that it forms a seal around the instruments  260  even if the instruments  260  are irregularly shaped.  
     [0069] An pressure from the antegrade flow  272  repositions the first seal member  170  toward the proximal end  115  of the containment structure  160  and subsequently opens the stasis valve  10  while preventing back-flow or leakage. While this arrangement may not be as friction-less as the other embodiments using an actuator  50 , it may offer the advantages of “hands-free” operation.  
     [0070] With reference to FIGS.  23 - 29 , the stasis valve  10  includes the seal module  100  enclosed in the housing  20  where, in one option, the seal module  100  includes the first seal member  170  at the proximal end  115  of the containment structure  160 , a second seal member  180  at the distal end  117  of the containment structure  160 , and a third central seal member  165  extending between the first and the second seal members  170 ,  180 . The plurality of seal members  165 ,  170  and  180  have an internal diameter sized to allow the passage of fluids or gases. A support member  168  includes a woven or braided material  166  configured to fit over the first seal member  170  and over the third central seal member  165 . The support member  168  is capable of retractionably collapsing with a compressive side-load by opposing protrusions, for example, the actuating member  55  and the stationary member  65 . In one option, the support member  168  is compressible under a side-load but not elongatable. In one example, this is accomplished by a biased weaving or tubular braiding of rigid material. An example of such a construction is the shielding found on certain electronic wire components. A tubular braided or woven rigid material exhibits the characteristics of an elasometric material and yet is not, itself, elastic.  
     [0071] The actuator  50  is adapted to move from a first position to a second position. In the first position the actuator is, in one option, disposed and held against a portion of the seal module  100  depressing or collapsing, for example, an off-center portion  109  of the containment structure  160  by a compressive force  67  (e.g. by a spring  210 ). In the second position, the actuator  50  is disposed away from a portion of the seal module by a compressive force  67  (e.g. by depressing the actuator flange  57 ) thus allowing, for example, the off-center portion  109  of the containment structure  160  to retract to an uncollapsed configuration.  
     [0072] In the first position, the actuator  50  is, in another option, disposed and held against a portion of the seal module  100  which depresses and at least partially collapses, for example, the central portion  110  of the containment structure  160  by a compressive force  67  (e.g. by a spring  210 ). In the second position, the actuator  50  is disposed away from a portion of the seal module  100  by a compressive force  67  (e.g. by depressing the actuator flange  57 ) thus allowing, for example, the central portion  110  of the containment structure  160  to retract to an uncollapsed configuration.  
     [0073] In one embodiment, the first seal member  170  is fixed in a position at the proximal end  115  of the central portion  110  of the seal module  100 . The first abutment  111  forms a stop or seat for a first seal member  170 . The braided or woven support member  168  is connected to the first seal member  170  and attached to or formed into the wall of the third central seal member  165 . The third central seal member  165  is thus not permitted to migrate under a backpressure load into the distal orifice  181  of the second seal member  180  and occlude said orifice  171 . In one example, a compressive side-load is applied to the third central seal member  165 . In another example, a compressive side-load is applied by opposing protrusions, for example, actuator  50  and stationary member  65 , under a spring  210  load. Under this influence, the material  166  of the third central seal member  165  is not allowed to extrude longitudinally to an area  182  due to the linear limit of the braided or woven support member  168 .  
     [0074] Now referring to FIG. 27, the seal module  100  is, in one option, used without the housing  20  or the containment structure  160 . The seal module  100  includes an elongate tubular structure  101  having a central portion  110  with a proximal end  30  and a distal end  40 . In one option, a compressive or occlusive side load or “squeezing” is supplied by a separate tool or device, such as a clamp  300 , forceps, hemostat or a combination thereof, or additionally occluded by bending or finger pressure. The third central seal  165  is, in one option, closed off from the central lumen  193  of the seal module  100  in the instance where a plurality of instruments  260  are within said lumen  193 . The highly occlusive nature of the material  166  of the third central seal member  165  allows it to conform to the interstices adjacent to the instruments. For instance, a guidewire and catheter may be placed into the same lumen  193  for extension into a body passage rather than have two or more separate insertion sites into the same vessel or passage.  
     [0075] FIGS.  30 - 34  illustrate one embodiment of the stasis valve  10  including a seal module  100  having a lumen sized to allow the passage of fluids or gases. The seal module  100  includes a containment structure  160  with a proximal end  115  and a distal end  117 . The seal module  100  is formed of one or more seal members, as discussed above. In another option, the seal module  100  and/or any of its respective seal members can be formed of one or more materials, including their relative properties, as discussed above.  
     [0076] In one option, two circular actuators  50  are at least partially circumferencially disposed about a portion of the seal module  100  movable from a first position to a second position on opposing sides of the housing  20 . The actuators  50  each include an actuating member  55  which, in one option, is U-shaped. The outer wall  262  of the housing  20  and the inner flange wall  265  of the housing  20  provides opposing support for two resilient members  267  (e.g. spring  210 ) disposed within the actuating member  55 . The resilient members  267  include a proximal end  269  and a distal end  271  where the proximal end  269  of the resilient members  267  abut the inner flange wall  265  of the housing  20  and the distal end  271  of the resilient members  267  each abut the proximal end  273  of an actuator button  261 . In one option, the actuators  50  are configured cylindrically to slide along the cylindrical interior wall  11  of the housing  20  from a first position to a second position.  
     [0077] In the first position the actuating members  55  of the actuators  50  are, in one option, disposed and at least partially circumferencially disposed about the portion  108  of the seal module  100  depressing and at least partially collapsing a portion  108  of the containment structure  160  by a compressive force  67  (e.g. by a spring  210 ). The lumen  193  of the third seal member  165  is at least partially collapsed by the compressive force  67 . In the second position, the actuators  50  are disposed away from the portion  108  of the seal module  100  by a compressive force  67  (e.g. by depressing the distal end  275  of the actuator button  261 ). As each actuator button  261  is depressed, each actuator  50  slides along the cylindrical interior wall  11  of the housing  20 . The proximal end  273  of each actuator button  261  compresses the distal end  271  of each resilient member  267  which in turn, the proximal end  269  of each resilient member  267  compresses against the inner flange wall  265  of the housing  20 . Such movement allows each engaged actuating member  55  to forcibly disengage opposing outer walls  27  of the seal module  100  allowing the portion  108  of the containment structure  160  to retract to an uncollapsed configuration where gases and fluids can pass therethrough. As the actuator  50  is disposed away from the portion  108  of the seal module  100 , the lumen  193  of the third seal member  165  is able to retract in an unsealed configuration.  
     [0078] In another embodiment, the stasis valve  10  includes a containment structure  160  with a proximal end  115  and a distal end  117  with only one actuators  50  disposed against a portion of the seal module  100  movable from a first position to a second position. The actuator  50  includes an actuating member  55  which, in one option, is U-shaped. The outer wall  262  of the housing  20  and the inner flange wall  265  of the housing  20  provide an opposing support for the resilient member  267  (e.g. spring  210 ) disposed within the actuating member  55 . The resilient member  267  includes a proximal end  269  and a distal end  271  where the proximal end  269  of the resilient member  267  abuts the inner flange wall  265  of the housing  20  and the distal end  271  of the resilient member  267  is disposed against the proximal end  273  of an actuator button  261 .  
     [0079] In one option, the actuator  50  is configured cylindrically to slide along the cylindrical interior wall  11  of the housing  20  from a first position to a second position. In the first position the actuating member  55  of the actuator  50  is, in one option, disposed and held against the portion  108  of the seal module  100  depressing and at least partially collapsing a portion  108  of the containment structure  160  by a compressive force  67  (e.g. by a spring  210 ). In the second position, the actuator  50  is disposed away from the portion  108  of the seal module  100  by a compressive force  67  (e.g. by depressing the distal end  275  of the actuator button  261 ).  
     [0080] As the actuator button  261  is depressed, the actuator  50  slides along the cylindrical interior wall  11  of the housing  20 . The proximal end  273  of the actuator button  261  compresses the distal end  271  of the resilient member  267  which in turn, the proximal end  269  of the resilient member  267  compresses against the inner flange wall  265  of the housing  20 . Such movement allows the engaged actuating member  55  to forcibly disengage the outer wall  27  of the seal module  100  allowing the portion  108  of the containment structure  160  to retract to an uncollapsed configuration where gases and fluids can pass therethrough.  
     [0081] The actuating member  55  and/or the actuating button  261  in one option includes aluminum. In another option, the actuating member  55  and the actuating button  261  include plastic. The housing  20 , in one option, is made of ABS plastic. In one option, the third central seal member  165  includes material  166  that is highly elastic, deformable, compliant and yet virtually non-compressible. Materials  166  include modified vinyl, silicone, polyurethane or a combination thereof. The basic materials are, in one option, modified by compounding them with waxes and/or oils or un-cross-linked modifiers. Such materials are commonly available as “C-Flex” or “Kraton” in the range of 5 to 15 (shore A), as examples. The shore hardness of the material  166  is, in another option, in the range of between 15-20 shore on the “00” scale.  
     [0082] The stasis valve  10 , in one option, is made from machining pre-existing amounts of metals and/or plastics. For example, The actuating member  55  and the actuating button  261  is machined from aluminum. In another example, the actuating member  55  and the actuating button  261  are machined from plastic where the housing  20 , in one option, is machined from ABS plastic. In another example, the housing  20 , actuator button  261 , the connecting member  35  and a cap  276  are injection molded utilizing the various material outlined above.  
     [0083] In an example where the stasis valve  10  includes two actuators  50 , the stasis valve  10  is assembled by inserting the actuator button  261  and resilient member  267  (e.g., spring  210 ) into one side of the housing  20 . The actuator button  261  and resilient member  267  (e.g., spring  210 ) are inserted into an opposing side of the housing  20 . Each actuator button  261  is completely compressed and held while the seal module  100  is inserted through the housing  20  and between each actuator  50 . Each actuator button is released and the cap  276  secured to the housing  20 , for example, with an adhesive. Further, the connecting member  35  is snapped onto the housing. The materials used and the assembly thereof of the stasis valve  10  as described herein can include any of the earlier disclosed embodiments or a combination thereof.  
     [0084] It is to be understood that the above description is intended to be illustrative, and not restrictive. Many other embodiments will be apparent to those of skill in the art upon reading and understanding the above description. It should be noted that embodiments or portions thereof discussed in different portions of the description or referred to in different drawings can be combined to form additional embodiments of the invention. The scope of the invention should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.