Abstract:
An implantable apparatus for controlling fluid flow within a host body includes a constricting member with a plunging member for reducing fluid flow within a body canal when in a closed position. A biasing member biases the constricting member against the body canal. A pulling member counters the force exerted by the biasing member such that when activated, the constricting member is forced away from the closed position so as to allow increased fluid flow within the body canal. An activating member activates the pulling member.

Description:
U.S. PATENT APPLICATION 
     This application for U.S. patent is filed as an application under U.S.C., Title 35 §111(a). 
    
    
     FIELD OF THE INVENTION 
     The invention relates to implantable medical devices for the control of fluid flow through a body host canal or vessel, such as an urethra. 
     BACKGROUND 
     Incontinence is a condition wherein persons lose control over their voluntary, urinary function. The condition can arise from various causes. These causes include a variety of related and unrelated diseases, aging, and deterioration of the voluntary urethra sphincter muscle. The cost and inconvenience to persons suffering from this condition are great. Several remedies exist that are known in the prior art. Among these, the most common are surgical corrections (minor and major), drugs, and devices which serve to capture discharges (i.e., “capture” or diaper systems). Another solution is to place a patch over the urinary orifice to prevent unwanted discharge. Possibly, the most effective solution to date is the use of artificial sphincters. These devices are surgically installed and are hydraulically or pneumatically driven, operating by inflation of ballasts to suppress fluid flow. However, control of these devices is not always easy and is often inconvenient. Accordingly, there is a need for an improved method and apparatus to control the urinary function. 
     SUMMARY OF THE INVENTION 
     The present invention overcomes and alleviates the above-mentioned drawbacks and disadvantages in the art through the discovery of novel implantable body fluid flow control devices for the control of fluid flow through a host body canal or vessels, such as an urethra. 
     Generally speaking, and in accordance with the invention, an implantable apparatus for controlling fluid flow within a host body comprises (1) a constricting member for reducing fluid flow within a body canal when in a closed position, (2) a biasing member for biasing the constricting member against the body canal, (3) a pulling member for countering the force exerted by the biasing member such that when activated the constricting member is forced away from the closed position so as to allow increased fluid flow within the body canal, and (4) an activating member for activating the pulling member. 
     The object and advantages of the implantable fluid flow control devices of the present invention permit implantation and use without severing the canal or vessel to be constricted. Moreover, because trauma is minimized with respect to the canal or vessel, and the devices of the present invention are relatively small, lightweight and made of corrosion-resistant material, such as durable plastics or stainless steel, the devices are suitable for use for extended period of time to control fluid flow through numerous types of vessels to control, for example, urination, ejaculation, nutrition absorption, obesity, etc. 
     These and other objects, features and advantages of the present invention may be better understood and appreciated from the following detailed description of the embodiments thereof, selected for purposes of illustration and shown in the accompany Figs. It should therefore be understood that the particular embodiments illustrating the present invention are exemplary only and not to be regarded as limitations of the present invention. 
    
    
     BRIEF DESCRIPTION OF THE FIGS. 
     The foregoing and, other objects, advantages and features of the present invention, and the manner in which the same are accomplished, will become more readily apparent upon consideration of the following detailed description of the present invention taken in conjunction with the accompany FIGS. which illustrate preferred and exemplary embodiments, and wherein: 
     FIG. 1 is a first partial side explosion view of a body fluid control device according to the invention. 
     FIG. 2 is a second partial side explosion view of the body fluid control device. 
     FIG.  3 ( a ) is a partial side view of the device shown in FIG. I in the closed position. 
     FIG.  3 ( b ) is a partial view of an alternative device depicted in FIG.  3 ( a ). 
     FIG.  4 ( a ) is a partial side view of the device shown in FIG. 2 in the closed. 
     FIG.  4 ( b ) is a partial side view of an alternative device. 
     FIG.  5 ( a ) is a side-sectional view of a manual activating member. 
     FIG.  5 ( b ) is a top view of the manual activating member shown in FIG.  5 ( a ). 
     FIG.  6 ( a ) is a side sectional view of a motorized activating member. 
     FIG.  6 ( b ) is a top view of the motorized activating member shown in FIG.  6 ( a ). 
     FIG.  7 ( a ) is side sectional view of a solenoid activating member. 
     FIG.  7 ( b ) is a side sectional view of the member shown in FIG.  7 ( a ). 
     FIG. 8 is a side sectional view of an alternative embodiment of a body fluid flow control device according to the invention. 
     FIG.  9 ( a ) is a partial side view of another alternative embodiment of the invention in the closed position. 
     FIG.  9 ( b ) is a partial side view of the alternative embodiment shown in FIG.  9 ( a ). 
     FIG.  9 ( c ) is an exploded view of a section of the alternative embodiment depicted in FIG.  9 ( a ). 
     FIG.  10 ( a ) is a partial side view of yet another alternative embodiment of the invention in the closed position. 
     FIG.  10 ( b ) is a partial side view of the alternative embodiment shown in FIG.  10 ( a ). 
     FIG.  11 ( a ) is a partial side view of a manual switch for use with the device of the present invention. 
     FIG.  11 ( b ) is a partial side view of the manual switch depicted in FIG.  11 ( b ) but shown implanted under skin and being activated by a user of a device of the present invention. 
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     By way of illustrating and providing a more complete appreciation of the present invention and many of the attendant advantages thereof, the following detailed description is given concerning the novel implantable body fluid control devices and uses thereof. 
     Referring now in more detail to the FIGS., in which like numerals refer to like parts throughout several views, FIGS. 1 and 2 show partial side explosion views of a body fluid flow control device according to the present invention. In one embodiment, the body fluid flow control device comprises a first engaging element  102  and a second engaging element  104 . When the first engaging element  102  is coupled with the second engaging element  104 , an inner diameter is formed which is well suited for fitting around a host body canal, i.e., any tube or vessel within the human or other animal body, such as the urethra. The body fluid flow control device also comprises a locking mechanism  106  for locking the first and second engaging elements  102  and  104  together. The locking mechanism  106  as shown is in the form of locking pins  108  located on the first engaging element  102  and locking holes  110  located on the second engaging element  104 . It should be understood that any other equivalent locking mechanism can be used for this purpose. Alternative locking mechanisms contemplated by the present invention include, but are not limited to, the use of a strap and snap pins or interconnecting molding on the first and second engaging elements  102  and  104 . The body fluid flow control devices of the present invention further includes a plunging member  112  located within the inner diameter formed by the coupling of the first and second engaging elements  102  and  104  such that the plunging member  112  applies pressure against a body canal or vessel, such as an urethra. 
     A biasing member is utilized by the body fluid flow control device of the present invention so as to force the plunging member  112  to normally apply pressure against the body canal when the body fluid flow control device is in the closed position. The biasing member, in on embodiment, comprises at least one spring  114  situated between the plunging member  112  and the second engaging element  104 . Alternative biasing members include the use of any structural support which, when in the normal position, will force the plunging member  112  away from the second engaging element  104  and towards the body canal and which may be offset by the pulling member described below. 
     A pulling member is utilized to offset the force of the biasing member when the body fluid flow control device of the present invention is activated. The pulling member comprises a cable  115  covered by a protective sleeve  116  with a first end  118  and a second end  120 .The first end  118  of the cable  115  runs slidably through the second engaging element  104  and is attached to the plunging member  112 . FIGS.  3 ( a ) and  3 ( b ) and FIGS.  4 ( a ) and  4 ( b ) show the above described portion of the invention in the closed position. 
     FIGS.  5 ( a ) and  5 ( b ) illustrate an activating member comprising a housing  202 , a thin silicone membrane  204 , and a cup  206  for facilitating the storage of the expanse of cable  115  placed therein during activation of the body fluid flow control device. The second end  120  of the cable  115  runs slidably through a side of the housing  202  and is fixed to the opposite side of the housing  202 . The activating member is placed such that substantially perpendicular pressure against the portion of cable  115  running between the two sides of the housing  202  results in movement of the plunging member  112  away from the body canal allowing at least some fluid flow there through. The placement of substantially perpendicular pressure against the housed cabling results in movement of the first end  118  of the cable  115  offsetting the force exerted by the biasing member  114  against the plunging member  112 . 
     FIGS.  6 ( a ) and  6 ( b ) illustrate an alternative activating member contemplated by the present invention. This alternative activating member comprises a housing  302 , a stepper motor  304 , a cable mounting block  306 , and a threaded shaft  308  attached to the stepper motor. The second end of the cable  120  runs slidably through a first side of the housing  302  and is fixed to the cable mounting block  304 . The stepper motor  304  is mounted on the opposite side of the housing  302 . The block  306  is mounted on the threaded shaft  308  such that activation of the motor  304  turns the shaft  308  and the block  304  is axially pulled towards the motor. The activating member is placed such that movement of the block  306  results in movement of the plunging member  112  away from the body canal allowing at least some fluid flow there through. The movement of the block  306  results in movement of the first end  118  of the cable  115  offsetting the force exerted by the biasing member  114  against the plunging member  112 . 
     FIGS.  7 ( a ) and  7 ( b ) illustrate yet another activating member contemplated by the present invention. The activating member comprises a housing  402  and a piston-like solenoid mechanism  404  having wratchet holes  406  for connection to a manual switch via wire  405 . The second end  120  of the cable  115  runs slidably through a side of the housing  402  and is fixed to the opposite side of the housing  402 . Activation of the solenoid  404  causing a piston to move downwards against the portion of cable  115  running between the two sides of the housing  402 . The activating member is placed such that the application of this substantially perpendicular pressure against the housed cabling results in movement of the first end of the cable  115  offsetting the force exerted by the biasing member  114  against the plunging member  112 . This results in movement of the plunging member  112  away from the body canal allowing at least some fluid flow there through. 
     The body fluid flow control devices of the present invention may utilize a number of triggering mechanism options, such as a touch sensor as shown FIGS.  11 ( a ) and  11 ( b ), infrared, voice or sound activation. Any of the several well-known control devices can be used to control the operation of the body fluid flow control devices of the present invention by a user so long as the objectives of the present invention are not defeated. 
     As discussed above, the body fluid flow control devices of the present invention are surgically implanted into a human or other animal host. In addition to implanting a body fluid flow control device of the present invention, the host will require a control mechanism that can be operated by the host from outside the host. One simple example as depicted in FIGS.  11 ( a ) and  11 ( b ) is a switch  800  implanted just underneath the host&#39;s skin  810  such that the host can activate it by pressing with a finger  811  on the skin above the switch. Any of several known pressure-activated switches will do provided that they are made from a suitable corrosion resistant material. Another control mechanism could be a smart card having a coil or other member for generating electromagnetic signals that control a control device inside the host. 
     FIG. 8 illustrates another alternative embodiment of the present invention. Similar to the embodiment referred to in FIGS. 1 and 2, the body fluid flow control device comprises a first engaging element  502 , a second engaging element  504 , a locking mechanism (not shown) for locking the first and second engaging elements  502  and  504  together, a plunging member  512  located within the inner diameter formed by the coupling of the first and second engaging elements  502  and  504 , and a biasing member  514  so as to force the plunging member  512  to normally apply pressure against the body canal when the device is in the closed position. 
     A pulling member is utilized to offset the force of the biasing member when the body fluid flow control device is activated. The pulling member comprises a triangular shaped pivot member  516  with three corners wherein the first corner opposite the hypotenuse has a fixed pivot point  518  and the second corner has a floating pivot point  520  coupled to the plunging member  512 . The body fluid flow control device further comprises a stepper motor  522 , a threaded shaft  524 , and a bearing wheel assembly  526 . The bearing wheel assembly  526  is mounted on the threaded shaft  524  such that activation of the motor  522  turns the shaft  524  and the bearing wheel  526  moves away from the motor  522  and against the triangular pivot member  516 . The force exerted by the bearing wheel  526  against the triangular pivot member  516  forces the pivot member  516  to move along its fixed pivot  518 . Movement of the pivot member  516  along its fixed pivot point  518  causes the floating pivot point  520  to move in a downward motion offsetting the force exerted by the biasing member  514  against the plunging member  512 . This results in movement of the plunging member  512  away from the body canal allowing at least some fluid flow there through. 
     FIG. 9 illustrates another embodiment of the present invention. Similar to the embodiment referred to in FIGS. 1 and 2, the body fluid flow control device comprises a first engaging element  602 , a second engaging element  604 , a flexible locking mechanism  606  for locking the first and second engaging elements  602  and  604  together, a biasing member  614 , and a cable  615  within a protective sleeve  616  with a first end  618  and a second end  620 . The first engaging element  602  and second engaging element  604  are hinged together on a fixed pivot point  622 . The biasing member  614  is situated behind the pivot point  622  such that it forces the first engaging element  602  and second engaging elements  604  into a closed position. The closure of the engaging elements  602  and  604  constricts the body canal situated between them. A flexible locking mechanism  606 , such as a spring, is utilized to maintain the engaging elements  602  and  604  in a normally closed position. The first end  618  of the cable  615  runs slidably through the second engaging element  604 , running parallel with the biasing member  614 , and is fixed to the first engaging element  604 . 
     The activating member described in reference to FIGS. 5,  6  and  7  are equally applicable with this embodiment of the present invention. Rather than affecting the positioning of a plunging member, activation of the body fluid flow control device in this embodiment results in the first end  618  of the cable  615  moving against the force exerted by the biasing member  614  causing the first engaging element  602  to move along the pivot point  622  therefore opening the inner diameter of the body fluid flow control device allowing at least some fluid flow there through. 
     FIG. 10 illustrates yet another embodiment contemplated by the present invention similar to the embodiment described in reference to FIG. 9 but without the flexible locking mechanism. As with the prior embodiment, this embodiment comprises a first engaging element  702 , a second engaging element  704 , a biasing member  714 , a cable  715  covered with a protective sleeve  716  with a first end  718  and a second end  720 , and a pivot point  722 . This embodiment operates in the same manner as previously described regarding the prior embodiment as described with reference to FIG.  9 . 
     Accordingly, it will be understood that various embodiments of the present invention have been disclosed by way of example and that other modifications and alterations may occur to those skilled in the art without departing from the scope and spirit of the appended claims. Thus, the invention described herein extends to all such modifications and variations as will be apparent to the reader skilled in the art, and also extends to combinations and subcombinations of the features of this description and the accompanying FIGS. Although preferred embodiments of the present invention have been illustrated in the accompanying FIGS. and described in the foregoing detailed description, it will be understood that the present invention is not limited the embodiments disclosed, but is capable of numerous rearrangements, modifications and substitutions without departing from the spirit of the present invention as set forth and defined by the following claims, such as for example those embodiments described in non-provisional U.S. patent application, Ser. No. 09/048,823, filed Mar. 26, 1998, which is incorporated hereinto in its entirety by reference.