US 20090287042 A1
A pump and valve assembly for an implantable prosthesis 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 valve assembly further comprising an actuating bar which has ribs to enhance the spring force applied to a flow valve, a support structure to support and appropriately position the actuating bar, and a check valve made of metal with a segment covered with a plastic material.
1. A pump assembly for an implantable prosthesis, comprising:
a housing having an outer wall with at least a portion of the outer wall being compressible;
a first flow valve positioned within the housing and having a seated and an unseated position; and
a bar, having a flexible angularly extending arm, positioned within the housing and wherein said flexible angularly extending arm of said bar is moveable between a first and a second position so that when the flexible angularly extending arm of said bar is moved from the first position to the second position the flexible angularly extending arm of said bar causes the first flow valve to move from the seated to the unseated position.
2. The pump assembly of
a first compressible side wall positioned to intersect an axis defined by a path of travel of the first flow valve from the seated to the unseated position;
a second compressible side wall adjacent to the first compressible side wall, located such that a first portion, the flexible angularly extending arm, of the bar is adjacent to the first compressible side wall and a second portion of the bar is adjacent to the second compressible side wall so that if either the first or the second compressible side wall is compressed, the bar is caused to engage the first flow valve and move the first flow valve from the seated to the unseated position.
3. The pump assembly of
4. The pump assembly of
5. The pump assembly of
6. The pump assembly of
7. The pump assembly of
8. The pump assembly of
9. The pump assembly of
10. The pump assembly of
a pump bulb coupled to the housing, wherein the pump bulb has a first exterior texture and the housing has a second exterior texture that is different than the first exterior texture.
11. The pump of
12. The pump of
13. The pump assembly of
14. A pump and valve assembly for an inflatable prosthesis, comprising:
a valve block having a flow valve; and
a shell attached to the valve block wherein the shell includes a pump bulb and wherein said valve block includes a periphery with pairs of opposing surfaces, and wherein upon any pair of said opposing surfaces of said valve block being compressed said inflatable prosthesis is deflated.
15. A pump assembly for an implantable prosthesis, comprising:
a housing having an outer wall with at least a portion of the outer wall being compressible;
a first flow valve positioned within the housing and having a seated and an unseated position; and
a bar, having a flexible angularly extending arm, positioned within the housing, the bar comprising a spring, wherein the movement of the flexible angularly extending arm provides the moving action of the spring, and being moveable between a first and a second position so that when the bar is moved from the first position to the second position the bar causes the first flow valve to move from the seated to the unseated position.
16. The assembly of
a first compressible side wall positioned to intersect an axis defined by a path of travel of the first flow valve from the seated to the unseated position; and
a second compressible side wall adjacent to the first compressible side wall, located such that the first portion of the bar is adjacent to the first compressible side wall and the second portion of the bar is adjacent to the second compressible side wall so that if either the first or the second compressible side wall is compressed, the bar causes the first flow valve to move from the seated to the unseated position.
17. The assembly of
18. The assembly of
19. The assembly of
20. The assembly of
21. The assembly of
22. The assembly of
23. The assembly of
24. The assembly of
25. The pump assembly of
This application is a continuation application of Ser. No. 10/820,660, filed Apr. 8, 2004, which is a divisional application of Ser. No. 10/006,335, filed on Dec. 3, 2001 (Now U.S. Pat. No. 6,723,042), entitled “PENILE PUMP WITH SIDE RELEASE MECHANISM,” which is a continuation-in-part of related patent application Ser. No. 09/749,075 entitled “PENILE PUMP WITH SIDE RELEASE MECHANISM” which was filed on Dec. 27, 2000, and claims the priority of provisional application Ser. No. 60/295,326 entitled “PENILE PUMP IMPROVEMENTS” which was filed Jun. 1, 2001 (the entire contents of each of which are herein incorporated by reference).
This invention generally relates to a pump and valve assembly for inflating a prosthesis. More particularly, the invention relates to pressure-based mechanisms that inhibit spontaneous inflation of the prosthesis, including stiffening and support mechanisms that also improve the function of the valve.
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's abdomen. The pump assembly is implanted in the scrotum.
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.
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.
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's tissue), causing the various check valves to unseat and allow fluid to flow back to the reservoir.
Since the pump and valve assembly is positioned within the patient'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.
Notably, 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 side walls of the assembly and compress 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.
Although the 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. One such prosthesis pump is disclosed in co-pending U.S. patent application Ser. No. 09/749,075, entitled “Penile Pump With Side Release Mechanism,” which is assigned to the Assignee of the present invention and is incorporated herein by reference. However, the operational efficiency of the prosthesis pump could be further improved by optimizing the function of the check valves.
Metal on metal contact can cause undesired wear of components over time. This can affect the performance of any product. In the pump and valve assembly, the check valve and spring engage one another at an end of the check valve to inhibit movement. Typically, at least a portion of the check valve and spring are made of a metal material such as stainless steel. The repeated application of a spring force by the spring onto the end of the check valve tends to wear or degrade the contact portions of the check valve and spring. This metal on metal contact over time negatively impacts the performance of the valve assembly.
The orientation of the pump and valve assembly creates a condition where the spring applies a force in both the axial and sideways directions onto the check valve, during actuation of the prosthesis pump. The axial force acts to move the check valve poppet into the valve assembly, while the side force has the unintended consequence of pushing the check valve sideways causing the valve to tip sideways. When the check valve is pushed sideways into the valve housing, the valve housing deforms which causes the check valve to be misaligned. This results in the check valve being restrained from moving axially into the valve housing to reach its open position.
Finally, the repeated exertion of axial and side forces of the spring on the end of the check valve tends to cause a reduction in the stiffness of the of the spring. Specifically, the spring is a thin elongate member having a bent portion. As a patient grasps the narrower, shorter side walls of the assembly and compresses them together, the spring flexes inwardly to force, via axial and side forces, the check valve to move to an open position. When the patient releases the side walls of the assembly the spring returns to its original position, permitting the check valve to return to a closed position. The repeated flexing of the spring may cause a reduction in stiffness of the spring, particularly at the bend. This reduction in stiffness may lead to the spring deflecting during actuation in an unintended manner, which can permanently deform the spring. Permanent deformation of the spring has the undesired effect of inhibiting the full axial travel of the check valve between the open and closed positions.
There exists a need to provide a prosthetic penile implant that reduces the wear of the contact point of the check valve and the spring. There is a desire to improve the function of the valve assembly by prevention of deformation of the valve housing and misalignment of the check valve. There is a need to provide a barrier to sideways movement of the check valve when moving between the open and closed positions. Additionally, there is a desire to increase the strength and stiffness of the spring to prevent the spring from deflecting during actuation and prevent permanent deformation of the spring.
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.
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.
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.
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's fingers and appropriately positioning the actuating bar, less force need be exerted by the patient to achieve the desired result.
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 which 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.
To further improve the operational efficiency of the pump and valve assembly, the check valve is made of a metal material with a plastic member disposed over a segment of the metal material. The plastic segment of the check valve prevents undesired frictional metal on metal contact with the actuating bar, and prevents premature wearing of the contact point of the two components.
To further improve the life of the valve assembly, ribs, that extend across a bend, are added to the actuating bar. This modification increases the strength and stiffness of the spring and prevents the actuating arm from deflecting during actuation. In turn, full axial travel of the check valve is ensured. Increasing the strength of the bend also prevents permanent deformation of the spring when normal deflection occurs during actuation of the valve assembly. Another rib is disposed along the actuation face of the actuating bar to limit deformation of the actuation face during actuation of the valve assembly.
To improve the ease of deflation, a stiff poppet support wraps around the valve body and rests against a portion of the check valve. The poppet support has a shelf that provides smooth surface for a portion of the check valve to slide along. The poppet support contacts the check valve and prevents undesirable sideways movement of the check valve against the valve body. The positioning and configuration of the poppet support thus allows the check valve to easily move axially into the valve body to an open position. This results in improved operational efficiency of the check valve and an extended operating life.
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.
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.
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.
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 spring-actuated 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 an uncomplicated, ball-shaped or 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 Ser. No. 09/749,292, filed on Dec. 27, 2000, and entitled “Pressure Based Spontaneous Inflation Inhibitor,” and Ser. No. ______, (Attorney-Docket No. AMS-039) filed concurrently herewith, and entitled “Pressure Based Spontaneous Inflation Inhibitor With Penile Pump Improvements,” the entire disclosures of which are herein incorporated by reference.
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's satisfaction.
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.
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'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
Referring once again to
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.
The configurations illustrated in
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's overall satisfaction with the device.
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.
As illustrated in
As shown in
As illustrated in
Connecting end 338 includes two forked portions 666, one of which is shown in
Angle portion 326 provides actuating bar 310 with a spring force that is applied to an end of reservoir poppet 318 in the same manner as described in the embodiments of above. Angle portion 326 permits actuating face 322 of actuating bar 310 to extend along a side of the length of valve block 317, while actuating arm 324 extends along a side of the width of valve block 317. The configuration of actuating bar 310 enables it to engage an end 266, e.g., the tip, of reservoir poppet 318. Actuating arm 324 includes, opposite angle portion 326, a curved portion 325 for complementary engagement with reservoir poppet end 266. See
As discussed in the embodiments above, when the patient grasps valve assembly 300 in virtually any orientation and applies pressure, actuating bar 310 acts either directly or indirectly to open the appropriate check valves (
When the patient ceases compression of the valve assembly 300, actuating face 322 returns to its original position. Actuating arm 324 moves in a direction indicated by arrow B in
As disclosed in the embodiments above, angle portion 326 in actuating bar 310, and its resistance to flexing outwardly, creates a desirable stiffness, bias or spring force. Actuating bar 310 is capable of forcing reservoir poppet 318 into a position (see
To prevent improper deflection, stiffening ribs 328 are formed on actuating bar 310, as shown by
As discussed above, when a patient compresses valve assembly 300 to deflate the prosthesis, actuating face 322 flexes or pivots inwardly about U-shaped portion 332. This causes actuating face 324 to move into engagement with poppet end 266 (
The relatively thin composition of actuating bar 310 is beneficial for several reasons. During actuation, U-portion 332 bends to flex actuating face 322 inwardly and actuating face 322 moves actuating arm 324 into engagement with reservoir poppet 318. After actuation, U-portion 332, actuating face 322 and actuating arm 324 return to their original position. With an actuating bar formed with a thick material, U-portion 332 does not properly bend during actuation. In operation with a thick actuating bar 310, U-portion 332 does not bend, and connecting end 338 is pushed into valve block 317 causing its inner cavities to distort, such that annular ring 500 (
Since the engagement of actuating arm 324 to poppet end 266 is applied from essentially one side of reservoir poppet 318, the applied spring force is not completely along a longitudinal axis of reservoir poppet 318. The spring force is applied to poppet end 266 in both the axial and transverse/sideways directions. The sideways force has the unintended consequence of tipping reservoir poppet 318 sideways into valve block 317. In response, valve block 317 deforms to cause reservoir poppet 318 to be misaligned. This misalignment results in reservoir poppet 318 being restrained from moving axially into valve block 317 to reach an activated/open position. As shown in
As shown in
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 which 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.