BODY FLUID FLOW CONTROL DEVICE
 This is a continuing application of U.S. patent application Ser. No. 09/397,218, filed Sep. 16, 1999, Which is a continuing application of U.S. patent application Ser. No. 08/931,552, filed Sep. 6, 1997, and issued as U.S. Pat. No. 5,954,766, Which disclosures of the above are incorporated herein by reference.
BACKGROUND OF THE INVENTION
 The field of the present invention is valve mechanisms for use in the human body.
 Valves play an important role in a number of bodily functions. One such physiologic valve is in the urinary tract. Valve failure in this system leads to urinary incontinence, a significant health issue. Urinary incontinence is estimated to affect some ten million Americans. The full extent of this problem is unknoWn because less than half of affected adults are believed to actually seek medical attention.
 Devices are available to assist in the control of urinary incontinence. Such devices include external valves, valves extending throughout the loWer urinary tract and into the bladder, devices extending through long portions of the urethra and implanted protheses as Well as injected bulking agents Which support the urethral sphincter to enhance operation. Such devices are often inconvenient, uncomfortable and/or require surgical insertion. Other devices are considered overly intrusive.
 Native valves are also found in cardiovascular systems. In veins, native venous valves promote one-Way floW toWard the heart from the periphery. Diseases exist such as venous thrombosis and thrombophlebitis Which can render native venous valves incompetent, resulting in edema. Replacement of these artificial valves With artificial ones could provide substantial health benefits.
 The pulmonic valve associated With the heart is yet another native floW control mechanism Which can exhibit incompetence either congenitally, through disease or iatrogenically due to treatment of pulmonary stenosis. Aone-Way valve positioned distal to the native pulmonic valve Within the pulmonary artery could be of substantial benefit in overcoming this problem.
 The present invention is directed to a body fluid floW control device Which includes an ability to seal about the device in the fluid passageWay, a placement and retention format for the device and a valve body capable of either or both a pressure threshold for operation and a one-Way floW restriction. The valve body preferably end bulk resilience and a passage therethrough Which is closed by that bulk resilience. This may be defined by an elastomeric or other polymeric body With a passage therethrough cut Without the removal of material. Asingle slit, a cross or a star shaped cut are included among the possibilities. One-Way floW may be accomplished through a flap or other inhibitor physically impeding floW in one direction or by a configuration of the valve to employ passage pressure to prevent opening.
 In a separate aspect of the present invention, such devices as contemplated above are combined With mechanisms to assist in transforming the state of the device from insertion to anchoring.
 Accordingly, it is a principal object of the present invention to provide a floW control device for the human body such as for urinary, venous or pulmonic placement. Other and further objects and advantages may appear hereinafter.
BRIEF DESCRIPTION OF THE DRAWINGS
 FIG. 1 is a perspective vieW of a first floW control device.  FIG. 2 is a cross-sectional side vieW of the device
 FIG. 3 is a cross-sectional side vieW of a second floW control device.
 FIG. 4 is an end vieW of a third fluid floW control device.  FIG. 5 is a cross-sectional vieW taken along line
 FIG. 6 is an end vieW of yet another fluid floW control device.
 FIG. 7 is a cross-sectional vieW taken along line 7-7 of FIG. 6.
 FIG. 8 is a cross-sectional vieW of yet another fluid floW control device.
 FIG. 9 is a cross-sectional vieW of yet another fluid floW control device.
 FIG. 10 is a cross-sectional vieW of yet another fluid floW control device.
 FIG. 11 is a cross-sectional vieW of the device of FIG. 10 With a balloon expander positioned Within the device.
 FIG. 12 is a cross-sectional side vieW of an insertion tool With a fluid floW control device in place.
 FIG. 13 is a prospective vieW of another frame.
 FIG. 14 is a prospective vieW of yet another frame. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
 FIGS. 1 and 2 illustrate a first fluid floW control device capable of one-Way floW, the sealing of a body passageWay and pressure actuation. The device includes a resilient seal 20 Which, in this first embodiment, includes a cylindrical elastomeric or, more generically, polymeric material capable of sealing Within the interior of a body duct or passageWay. This resilient seal is shoWn in this embodiment to be cylindrical but may be tapered through a portion thereof. In either instance, the seal has a substantially circular cross section to fit Within the body duct or passageWay.
 To one end of the seal 20, a valve support 22 extends inWardly from an attachment to the valve body. This valve support 22 preferably provides a barrier to floW through the resilient seal. The support 22 is conveniently formed as one piece With the seal 20.
 Avalve body 24 is attached to the valve support 22 about the outer periphery of the body 24. The valve body 24 is also of polymeric material and may be most conveniently
formed as one piece With the seal 20 and the valve support 22. The body 24 is shoWn in this first embodiment to define a passage 26 Which is shoWn to be a single slit. The slit 26 extends longitudinally through the valve body. The body of the valve being polymeric and resilient is able to provide bulk resilience to maintain its natural state. As the slit 26 is preferably manufactured Without removal of material from the valve body 24, the resilience of the body closes the slit 26 so that no floW can occur. Through empirical testing, an appropriate size of the slit 26 and overall body size and shape of the valve body 24 Will define a threshold pressure Which may be applied to one end of the valve to cause the slit 26 to open. For purposes of urinary tract control, this opening pressure should be in the range of about 0.2 psi to 3.0 psi. For intervascular placement, the threshold should be from about 0.005 psi to 1.0 psi.
 The valve body 24 acts in this embodiment as a one-Way valve because of the substantially parallel sides to either side of the slit 26. In the event that floW builds up on the side of the valve With the extending substantially parallel sides 28, the pressure Will not only build up at the slit 26, it Will also build up on the parallel sides 28 as Well. The pressure on the sides Will prevent the slit from opening.
 A frame, generally designated 30, is located Within the peripheral resilient seal 20. This frame 30 is contemplated to be a metallic member having an expanded metal cylinder 32 defined by longitudinally extending elements 34. In this instance, the longitudinally extending elements 34 are interconnected as one construction so as to form the expanded metal cylinder.
 The resilient seal forming the peripheral element about the frame 30 to define a seal With the duct or passageWay in Which the device is placed may be affixed to the frame 30 by any number of conventional means. For example, the frame 30 may be bonded to the resilient seal 20. The resilient seal 20 may be formed through injection molding, bloW molding, insertion molding or the like With the frame in place Within the mold such that the frame 30 becomes embedded Within the seal 20. There may be a physical interlocking through the use of an inWardly extending flange on the open end of the resilient seal 20 to physically retain the frame 30.
 The frame 30, being of expanded metal, is capable of being easily stretched to expand from a stable first state to a stable expanded state. The first state, referred to as the insertion state, is contemplated With the overall diameter of the frame 30 and the surrounding resilient seal 20 exhibiting a first diameter. With the frame 30 expanded to What may be termed an anchor state, the resilient seal 20 also expands. In the expanded state, the overall device is intended to fit With interference in the duct or passage. Before expansion, easy insertion is contemplated With clearance.
 The construction of this first embodiment provides for the valve support 22 to extend longitudinally in a cylindrical element 36 from an inWardly extending disk element 38. A further inWardly extending disk element 40 extends to the valve body 24. The employment of the cylindrical element 36 betWeen these disk elements 38 and 40 is intended to isolate the valve body 24 from the displacement of the resilient seal 20 as the frame is expanded from an insertion state to an anchor state. Distortion of the valve Which may result in a change in the threshold pressure to open the valve may be avoided.
 Looking to FIG. 3, a similar vieW to that of FIG. 2 illustrates a second embodiment. This embodiment differs from the prior embodiment in the redirection of the valve body 24 at the disk 40. With that redirection, the valve body 24 is positioned to face in the opposite direction. In this Way, the one-Way feature operates to provide floW in the opposite direction relative to the frame 30 and resilient seal 20.
 Turning to FIGS. 4 and 5, another embodiment is illustrated. Identical reference numbers are applied to those of the first embodiment to similar structures and functional elements. Presenting a more quantitative description, the Wall thickness of the elastomeric polymer defining the resilient seal 20, valve support 22 and valve body 24 is contemplated to be betWeen approximately 0.005“ and 0.050“. The Width of the slit is approximately 0.024“ While the outside diameter of the resilient seal 20 is approximately 0.349“. The length of this element is contemplated to be approximately 0.60“. The frame is cylindrical With an OD in the insertion state of approximately 0.329“, a length of approximately 0.304“ and a thickness of approximately 0.005“ to 0.015“. This member is preferably of stainless steel or nitinol. The metallic member in this and each other embodiment is contemplated to be substantially nonreactive With body fluids and the body itself or coated With such a nonreactive material. Other dimensions can also be manufactured depending on the size of the placement.
 Turning to the embodiment of FIGS. 6 and 7, substantially the same device is illustrated as in the prior embodiment. Again, the correspondence of reference numerals reflect similar structures and functional features. This device has an added flap 42 overlying the passage 26. The flap 42 is attached by adhesive, bonding or other conventional procedure. The passage 26 may again be a slit as previously described so as to provide a threshold pressure level before opening. If a passageWay is presented instead, the device Will simply act as a one-Way valve.
 Turning to FIG. 8, a different overall exterior configuration is presented as Well as a different frame. A polymeric resilient seal 44 is shoWn to extend over a frame, generally designated 46. The frame 46 includes longitudinally extending elements 48. The elements 48 extend from a conically shaped portion 50 of the frame 46. This conically shaped portion 50 is truncated to provide a Wide passageWay 52 for operation of the valving mechanism. The resilient seal 44 forms a skirt Which extends inWardly to a valve support 54 Which is located about the truncated conical portion 50. The valve support 54 and the resilient seal 44 are preferably of the same piece of material. A valve body 56 extends across the passageWay 52 in an appropriate thickness to provide the appropriate bulk resilience to accommodate a threshold opening pressure. Apassage 58, shoWn here to be a slit extends through the valve body 56.
 Turning to FIG. 9, a device similar to that of FIG .8 is disclosed. Common reference numerals indicate similar elements and functional features. The resilient seal 44 extends over the longitudinally extending elements as a skirt With the ends of the elements 48 extending outWardly therefrom. Atruncated someWhat conical portion 50 actually forming a dome shape extends to a passageWay 52. The valve support 54 covers this portion 50. A truncated cone shaped element 60 forms a further part of the valve. It may be part of the same piece of material as the resilient seal 44