Abstract:
A pump and valve assembly for an implantable prothsesis is provided with an internal actuating bar positioned such that when any portion of the housing is compressed, the check valves within are opened allowing for deflation of the cylinders. The pump and valve assembly also includes a textured surface over a portion of the housing to allow for quick identification of the component, as well as to make it easier for the patient to grasp it. The pump bulb has a different size than than the valve assembly, further facilating the differention between the two based on tactile perception.

Description:
BACKGROUND OF THE INVENTION  
         [0001]    The present invention relates to a pump and valve assembly for an implantable prosthesis. More specifically, the present invention relates to a pump and valve assembly configured to facilitate the manipulation and actuation of an implantable prosthesis.  
           [0002]    One common treatment for male erectile dysfunction is the implantation of a penile prosthesis. Such a prosthesis typically includes a pair of inflatable cylinders, which are fluidly connected to a reservoir (typically liquid filled) via a pump and valve assembly. The two cylinders are normally implanted into the corpus cavernosae of the patient and the reservoir is typically implanted into the patient&#39;s abdomen. The pump assembly is implanted in the scrotum.  
           [0003]    During use, the patient actuates the pump and fluid is transferred from the reservoir through the pump and into the cylinders. This results in the inflation of the cylinders and thereby produces the desired penis rigidity for a normal erection. Then, when the patient desires to deflate the cylinders, a valve assembly within the pump is actuated in a manner such that the fluid in the cylinders is released back into the reservoir. This deflation then returns the penis to a flaccid state.  
           [0004]    Presently, the pump and valve assembly used in such implantable prostheses share certain similar characteristics. For example, they include fluid pathways allowing the flow of fluid to and from the reservoir, as well as to and from the cylinders. This fluid flow is controlled by one or more check valves positioned in the fluid pathways within the housing of the assembly.  
           [0005]    A compressible pump bulb is also attached to the housing and is in fluid communication with the various fluid pathways therethrough. In order to inflate the cylinders, the compressible pump bulb is actuated by the patient thereby urging fluid past the check valves into the cylinders. In order to deflate the cylinders, the valve housing is grasped and squeezed (through the patient&#39;s tissue), causing the various check valves to unseat and allow fluid to flow back to the reservoir.  
           [0006]    Since the pump and valve assembly is positioned within the patient&#39;s scrotum, the various components of the assembly must be small. As a result, manipulation of the pump and valve assembly is sometimes difficult. For example, patients requiring the use of penile prosthesis discussed herein are oftentimes elderly and have a reduced dexterity as a result of aging. Thus, in some instances, even locating the device within the tissue can be a challenge, let alone identifying the correct portion of the assembly to actuate. More specifically, with some patients, it may be difficult to determine whether the housing portion of the assembly that leads to release or deflation of the cylinders is being grasped or whether the bulb portion, which would be used to inflate the cylinders, is being grasped.  
           [0007]    In this connection, it should be noted that the length of the valve assembly is determined (at least in one direction) by the size of the various check valves and the distance such valves must move in order to open and close the various fluid passageways. As a result, such a pump and valve assembly typically is longer in a direction parallel with the check valves. Moreover, in order to release the check valves in an assembly configured in this manner, the patient must grasp the narrower, shorter sidewalls of the assembly and compresses them together. Since such a configuration can present challenges insofar as the spring tension of the check valves at the time of desired deflation is typically at a maximum while the surface area of the assembly which must be compressed in order to cause such deflation is at a minimum. This condition can lead to a situation where the patient has difficulty actually compressing the assembly, or in extreme circumstances, actually loses grip of the assembly during such attempts at deflation.  
           [0008]    Thus, although existing devices function with extreme efficiency and reliability, for some patients it appears there is a desire for a pump and valve assembly in an implantable prosthesis that improves operative manipulation of the assembly.  
         BRIEF SUMMARY OF THE INVENTION  
         [0009]    The present invention provides various features which taken alone or in combination with one another provide for an improved pump and valve assembly for an implantable prosthesis. The present pump and valve assembly includes a pump bulb that must be differentiated from the valve housing when inflation of the cylinders is desired. The pump bulb itself has dimensions that are somewhat different than the remainder of the housing. However, to supplement differentiation between the bulb and the valve housing, the valve housing is provided with a textured surface so that even through tissue the patient is able to readily discern which area comprises the pump bulb and which area comprises the valve housing. This is important in that the pump bulb is compressed for inflation while the valve housing is compressed for deflation.  
           [0010]    The pump assembly of the present invention is also configured such that it has a length longer than its width, with its internal check valves running parallel with the length. To release fluid from the inflated cylinders, the internal check valves are actuated so that they move in a direction parallel to the length, until they open. To achieve this action directly, the opposing sides of the width of the valve housing are compressed. This compression causes actuation of the internal check valves.  
           [0011]    In addition, an actuating bar is positioned within the valve housing parallel with and extending along at least one of the sides of the length. An arm attached to the actuating bar extends along a portion of one of the sides of the width in close proximity to the tip of one of the check valves. Thus, the configuration of the actuating bar causes it to engage and open the check valve allowing fluid to flow from the cylinder to the reservoir. Furthermore, the patient can grasp the valve housing in virtually any orientation and when pressure is applied, the actuating bar will act either directly or indirectly to open the appropriate check valves. Thus, so long as the patient grasps any portion of the pump and valve assembly other than the pump bulb, compression will result in the desired opening of the check valves, which will allow the cylinders to deflate.  
           [0012]    Furthermore, since the patient can grasp the valve housing along the sides of the length, i.e., surfaces with larger surface area, less pressure need be applied to achieve the successful opening of the check valves. In other words, by increasing the surface area that is engaged by the patient&#39;s fingers and appropriately positioning the actuating bar, less force need be exerted by the patient to achieve the desired result.  
           [0013]    The textured surface of the valve housing not only helps the patient identify the correct portion of the pump and valve assembly to actuate, it also serves to prevent slippage once the patient begins to compress the housing. Thus, what is achieved is an efficient and ergonomic pump and valve assembly for an implantable prosthesis. The pump and valve assembly can advantageously be formed from a minimal number of components. That is, all that need be molded are a valve block and a corresponding pump bulb that surrounds the valve block. The various check valves can be inserted into the valve block and then placed within the interior of the pump bulb, thus forming a completed assembly. This results in certain manufacturing efficiencies, thus reducing both cost and time of production. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0014]    [0014]FIG. 1 is a perspective view of a pump and valve assembly according to the present invention.  
         [0015]    [0015]FIG. 2 is a front sectional view of the pump and valve assembly illustrated in FIG. 1.  
         [0016]    [0016]FIG. 3 is a top sectional view of the pump and valve assembly illustrated in FIG. 1, shown in a state where the cylinders are being deflated.  
         [0017]    [0017]FIG. 4 is a top sectional view of the pump and valve assembly illustrated in FIG. 1, shown in a state where the check valves are in a deactivated position.  
         [0018]    [0018]FIG. 5 is a top sectional view of the pump and valve assembly illustrated in FIG. 1, shown in a state where the check valves are in a pumping position.  
         [0019]    [0019]FIG. 6 is a side sectional view of the pump and valve assembly illustrated in FIG. 1. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0020]    Referring to FIG. 1, a pump and valve assembly is illustrated and generally referred to as  10 . Pump and valve assembly  10  includes two different sections: valve housing  12  and pump bulb  15 . Pump bulb  15  is a compressible member, defining a chamber more clearly shown in FIG. 2. Valve housing  12  is fluidly coupled to pump bulb  15  and contains the various other working components of pump and valve assembly  10 . Pump and valve assembly  10  will be fluidly coupled to a reservoir and a pair of cylinders (not shown). This is accomplished through tubing connected to reservoir coupling  25  and cylinder couplings  30 , which are integral with valve housing  12 . Pump and valve assembly  10  is configured such that pump bulb  15  extends from one end of valve housing  12 , while reservoir coupling  25  and cylinder couplings  30  extend from the other. Thus, when implanted in the patient, reservoir coupling  25  and cylinder couplings  30  and the fluid tubing they are coupled to are oriented toward the patient&#39;s abdomen, while the pump bulb  15  is disposed in the opposite direction. Therefore, when pump bulb  15  is grasped by a patient, there is no interference from or contact with the tubing coupled to reservoir coupling  25  and cylinder couplings  30 .  
         [0021]    Valve housing  12  is illustrated as being generally rectangular, having a first major panel  35  that is longer than first minor panel  45 . The length of first major panel  35  is determined by the distance required to incorporate the various check valves described below and allow their proper functioning. Likewise, first minor panel  45  need only be long enough to incorporate the width of these check valves and once again allow their proper functioning. Of course, some consideration can be given to the optimal diameter of the fluid tubing and couplings connecting pump and valve assembly  10  to the reservoir and cylinders. Though shown as being generally rectangular, valve housing  12  can take on any configuration (and dimension) so long as the check valves contained therein operate correctly. The illustrated configuration generally minimizes the volume required for valve housing  12  to operate effectively. Thus, the net result is that first major panel  35  is generally longer than first minor panel  45 .  
         [0022]    Referring to FIGS. 1 and 2, the internal configuration of pump and valve assembly  10  will be described. Two separate molded components are utilized to form pump and valve assembly  10 . That is, valve block  20  is combined with shell  17  to form the completed unit. Pump bulb  15  and valve housing  12  are a single, integral unit referred to as shell  17  that substantially surrounds valve block  20 . As illustrated, shell  17  includes valve housing  12 , which surrounds valve block  20 . Alternatively, shell  17  could be a smaller component that does not surround valve block  20 , but is simply coupled to it. In either case, only two molded components need be provided to complete the device. These components can be formed from silicone or any other appropriate material.  
         [0023]    The use of only two molded components to form pump and valve assembly  10  is advantageous. Previous devices generally have four or more molded components which must be individually put together. Only two components can be bonded in a single step. Bonding includes heating, using adhesive, or various other joining techniques. The two bonded components then take time to set up before the next component can be added. Thus, a four component device results in a fairly long manufacturing process having increased costs associated therewith.  
         [0024]    With the present device, valve block  20  is molded and the various valve components are inserted into place. Shell  17  is then attached and bonded. Thus, only a single bonding or adhering step is required to complete the product. This greatly increases throughput, decreases costs, and decreases manufacturing time without sacrificing quality or durability.  
         [0025]    Located within valve block  20  are a plurality of fluid passageways coupling reservoir coupling  25  and cylinder couplings  30  to pump bulb  15  through bulb passageway  95  via medial passageway  60 . Disposed within medial passageway  60  are two springactuated poppets: a reservoir poppet  65  and a cylinder poppet  75 , which respectively and selectively abut reservoir poppet valve seat  85  and cylinder poppet valve seat  90 . Cylinder poppet  75  is a relatively simple conical-shaped check valve. Reservoir poppet  65  is an elongated member having a somewhat more complicated shape. The configuration of reservoir poppet  65 , along with the configuration of valve block  20  along medial passageway  60  is designed to allow the proper operation of the poppets while also preventing spontaneous inflation. The functionality and operability of this arrangement is discussed in co-pending application, filed concurrently herewith, entitled Pressure Based Spontaneous Inflation Inhibitor In A Pump For An Inflatable Prosthesis, the entire disclosure of which is herein incorporated by reference.  
         [0026]    During a compression of pump bulb  15 , fluid is forced from the internal chamber of pump bulb  15  through bulb passageway  95 , causing cylinder poppet  75  to open and allow fluid to flow through cylinder couplings  30  into the respective cylinders. When pump bulb  15  is released, cylinder poppet  75  closes under spring pressure. The vacuum generated by pump bulb  15  causes reservoir poppet  65  to unseat itself and allow fluid to flow from the reservoir through reservoir coupling  25  so that fluid once again fills pump bulb  15 . Repeated compressions are performed to entirely inflate the cylinders to the patient&#39;s satisfaction.  
         [0027]    When it is desired to deflate the cylinders, the patient compresses valve housing  12  by squeezing first minor panel  45  towards second minor panel  50 . As this occurs, the outer wall of valve housing  12  engages actuating bar arm  130  which engages reservoir poppet tip  70 , causing reservoir poppet  65  to unseat itself as well as unseating cylinder poppet  75 . Fluid is then able to flow from the cylinders to the reservoir through medial passageway  60 . When satisfactorily deflated, the patient releases valve housing  12 , allowing reservoir poppet  65  and cylinder poppet  75  to reseat themselves and prevent fluid flow.  
         [0028]    To perform the above described deflation process, the patient may compress first minor panel  45  and second minor panel  50 . In some patients, however, it may be difficult to achieve this compression because of the relatively small size of first and second minor panels  45  and  50 . Likewise, it may be difficult for certain patients to grasp valve housing  12  in this manner since valve housing  12  may slip out of position between the patient&#39;s fingers. Thus, the present pump and valve assembly  10  provides an actuating bar  100  that allows the patient to grasp the first major panel  35  and second major panel  120  (as illustrated in FIGS.  3 - 5 ).  
         [0029]    Referring to FIG. 3, the operation of actuating bar  100  is illustrated. Actuating bar  100  is disposed within valve block  20  by frictionally securing one end of actuating bar  100  into valve block interface  125  which securely holds it in place. Actuating bar  100  extends substantially along the length of major panel  120 . Actuating bar arm  130  is integrally coupled with actuating bar  100  and generally extends substantially along the length of first minor panel  45 . Actuating bar  100  is comprised of a suitable material, such as stainless steel or plastic. FIG. 3 illustrates a configuration of actuating bar  100  when a patient is compressing valve housing  12 . The configuration illustrated in FIG. 4 is that of a deactivated state. In this state, the patient does not intend to inflate (nor deflate) the cylinders. The relationship between reservoir poppet  65  and valve block  20  in the area of medial passageway  60  is such that spontaneous inflation is prevented. FIG. 5 illustrates a pumping state. Reservoir poppet  65  is moved to the right (as illustrated) and tip  70  abuts arm  130 . When pump bulb pressure is sufficient, cylinder poppet  75  will be unseated. FIGS.  4  illustrates the position of actuating bar  100  in a deactivated state, that is, when the patient is not compressing valve housing  12 .  
         [0030]    Returning to FIG. 1, major panels  35  and  120  contain a textured surface  40 , containing a plurality of raised sections. These raised sections make it easy for the patient to identify and distinguish valve housing  12  from pump bulb  15  and also allow the patient to grasp it better. Furthermore, because major panels  35  and  120  are relatively large in comparison to minor panels  45  and  50 , it is easier for the patient to grasp and compress these major panels  35  and  120 .  
         [0031]    Referring once again to FIG. 3, when major panels  35  and  120  are compressed towards one another, actuating bar  100  is deflected from the position illustrated in FIG. 4 to the position illustrated in FIG. 3. Thus, by engaging reservoir poppet tip  70 , actuating bar arm  130  forces reservoir poppet  65  to move towards and open cylinder poppet  75 . More specifically, actuating bar  100  is generally parallel with second major panel  120  in the deactivated stage. When engaged, actuating bar  100  is deflected towards first major panel  35 . Because of the angle between actuating bar  100  and actuating bar arm  130 , actuating bar arm  130  is caused to move towards reservoir poppet tip  70 , as well as first major panel  35 . Insofar as this movement is defined by the internal wall of valve housing  12 , actuating bar arm  130  moves to the position illustrated in FIG. 3, engaging and opening reservoir poppet  65 . Of course, this does not preclude the patient from grasping first minor panel  45  and second minor panel  50  and compressing them towards one another. If this is done, reservoir poppet  65  will likewise be effectively unseated. As such, it should be noted that the patient can grasp valve housing  12  in numerous orientations and a compression will effectively either directly engage reservoir poppet  65  or cause actuating bar  100 , and more particularly actuating bar arm  130  to engage and open reservoir poppet  65 . Thus, the patient need not maintain any particular orientation of valve housing  12  while deflating the cylinders. That is, any grip achieved on the valve housing  12  can be utilized to effectively open the poppets.  
         [0032]    The configuration of major panels  35  and  120 , including textured surface  40 , will allow patients to easily identify the portion of valve housing  12  having a larger surface area and to grip it more effectively. When doing so, it may seem to the patient that less force need be applied in order to unseat reservoir poppet  65 . That is, the spring tensions involved are constant for cylinder poppet  75  and reservoir poppet  65 . However, because of the larger surface area of major panels  35  and  120 , as compared to minor panels  45  and  50 , the patient need apply less force in order to successfully actuate the device.  
         [0033]    The configurations illustrated in FIGS. 4 and 5 differ only in that reservoir poppet  65  is in different positions with respect to valve block  20 , depending upon whether the device is in a deactivated state as in FIG. 4 or in a pumping state as in FIG. 5. This is more a characteristic of the spontaneous inflation preventing mechanism as mentioned above, rather than being directly related to the operation of actuating bar  100 . Of note, actuating bar arm  130  is configured to receive reservoir poppet tip  70  during the pumping stage as illustrated in FIG. 5. That is, during the compression of pump bulb  15  fluid pressure will force reservoir poppet  65  to its right most position as illustrated in FIG. 5. Because of the configuration of actuating bar arm  130  in its unbiased position, it will not interfere with this operation.  
         [0034]    [0034]FIG. 6 illustrates a side sectional view of pump and valve assembly  10 . Actuating bar  100  only extends along a portion of valve block  20 . When a patient engages first major panel  120 , actuating bar  100  will be relatively small in comparison to the surface area defined by the patient&#39;s finger. To further facilitate the ease with which the patient can compress actuating bar  100  and effectively unseat reservoir poppet  65 , valve block  20  is enhanced by valve block tabs  115 , which help define valve block recess  110  within which actuating bar  100  is seated. Thus, when the patient engages first major panel  35 , moving it towards second major panel  120 , this movement is enhanced by the flexibility of valve block tabs  115  allowing a larger portion of first major panel  35  to deflect into valve block recess  110 .  
         [0035]    The ease with which the patient can identify, grasp and compress the relevant portion of pump and valve assembly  10 , may ultimately determine the patient&#39;s overall satisfaction with the device. FIG. 6 illustrates yet another factor that serves to facilitate this. The width of pump bulb  15  is defined as A, while the width of valve housing  12  is defined as B. Notably, the width A of valve housing  12  is smaller than the width A of pump bulb  15 . The relevant factor is that pump bulb  15  is sized differently than valve housing  12 . It does not matter which component is larger or smaller.  
         [0036]    Thus, when the patient grasps pump and valve assembly  10 , there are several factors that can be utilized to determine which portion the patient is grasping. First, the orientation of pump bulb  15  towards the bottom is an initial indicator. The textured surface  40  of the major panels  35  and  120  is a secondary indicator and the relative size difference between pump bulb  15  and valve housing  12  is a tertiary indicator. These components also work together along with actuating bar  100  to make it easier for the patient to compress valve housing  12  and open the internal poppets, allowing the cylinders to be deflated. This is accomplished because major panels  35  and  120  are larger and easier to grasp and their compression towards one another actuates actuating bar  100  which in turn actuates and opens reservoir poppet  65 . The textured surface  40  makes it easier for the patient to grip valve housing  12  during this process. Finally, the configuration of actuating bar  100  can be configured to provide positive feedback to the patient that they are successfully opening the valves to allow for deflation. That is, actuating bar  100  can be provided with a bent area configured such that when actuating bar  100  is actuated, it will cause a clicking sensation that is audibly or physically sensed by the patient to let them know that they have sufficiently compressed valve housing  12 . Other identifying devices or configurations could be used as well.  
         [0037]    Those skilled in the art will further appreciate that the present invention may be embodied in other specific forms without departing from the spirit or central attributes thereof. In that the foregoing description of the present invention discloses only exemplary embodiments thereof, it is to be understood that other variations are contemplated as being within the scope of the present invention. Accordingly, the present invention is not limited in the particular embodiments that have been described in detail therein. Rather, reference should be made to the appended claims as indicative of the scope and content of the present invention.