The present invention relates to implantable prostheses. In particular, but not by way of limitation, the present invention relates to implantable malleable (non-inflatable) penile prostheses.
Disclosed is a prosthetic device. The prosthetic device comprises a column formed of resilient material and having a proximal end and a distal end. The prosthetic device comprises a bladder having a liquid cavity at the distal end. The bladder is inflatable and deflatable to increase and decrease a girth at the distal end of the prosthetic device. The prosthetic device comprises a liquid supply system that couples along the column to the bladder for selectively controlling liquid flow to the bladder to increase and decrease the girth.
In the embodiments described below, an implantable penile prosthesis includes a bladder at a distal end of the prosthesis. The bladder is inflatable and deflatable to change the girth of the prosthesis. A liquid supply system selectively controls flow of fluid to the bladder. The liquid supply system is manually actuatable by the patient.
The prosthetic device 100 comprises a bladder 108. The bladder 108 has a generally toroidal shape and is positioned and attached around an external surface to the column 102 adjacent the distal end 106. The bladder 108 surrounds a liquid cavity 110. The bladder 108 is inflatable by filling the liquid cavity 110 with a liquid 112 as illustrated. The bladder 108 is deflatable by draining the liquid 112 from the liquid cavity 110 of the bladder 108. In one embodiment, the liquid 112 comprises silicone oil. In another embodiment, the liquid 112 comprises a saline solution.
The bladder 108 is fluidly coupled to a liquid supply system 114. The liquid supply system 114 supplies liquid 112 for inflating the bladder 108, and receives liquid 112 when the bladder is deflated.
A liquid supply system 114 couples to the proximal end to receive a force for selectively pumping liquid 112 to the bladder 108. The liquid supply system 114 comprises a collapsible reservoir 116 that has a reservoir cavity 118 for holding the fluid 112. The collapsible reservoir 116 is collapsible by manually squeezing the proximal end 104 of the column 102. As the collapsible reservoir 116 collapses due to externally applied force, liquid 112 is forced out of the reservoir cavity 118 and flows through a passageway 120, a valve 122 and a passageway 124 to the liquid cavity 110, inflating the bladder 108. Inflating the bladder 108 increase girth 126 at the distal end 106. Alternatively, an external mechanical pressure or force is applied to the bladder 108, pumping liquid 112 from the bladder 108 to the reservoir cavity 118 to reduce the girth 126. The valve 122 controls the flow of liquid 112. The bladder 108 is described in more detail below by way of an example illustrated in
The bladder 300 comprises a main bladder body 306 that has a generally round cylindrical shape as illustrated. The main bladder body 306 comprises a bladder body inner wall 308. The inner wall 308 is supported on a central column that prevents any significant inflation of the inner wall 308. The main bladder body 306 comprises an outer wall 310. The outer wall 310 is inflatable by pressurized fluid in the main bladder body 306. The outer wall 310 and the inner wall 308 are joined along circular joining regions 312, 314. In one embodiment, the circular joining regions 312, 314 comprise non-sharp, rounded inner corner surfaces 316, 318. The joining regions 312, 314 are in tension when the bladder 300 is inflated. The rounding of the inner corner surfaces 316, 318 prevents stress concentrations at the inner corner surfaces and reduces risk of cracking the joining regions 312, 314. In one embodiment, the bladder 300 is a unitary body, completely free of joints, and is a single casting. In one exemplary process, the bladder 300 is rotationally cast to distribute resin on die surfaces. In another exemplary process, the bladder 300 is cast using a meltable or dissolvable casting insert to define hollow regions of the bladder 300, and the casting insert is later melted or dissolved to remove the insert. Other known methods of casting complex shapes in resilient materials can also be used.
The valve 400 comprises first check valve 408 and second check valve 410. Check valves 408, 410 are formed in round, fluidly parallel passageways in the valve body 402. The check valves 408, 410 check (prevent) backflow of fluid through the check valves 408, 410. One of the check valves 408, 410 opens and permits forward fluid flow when a pressure differential across the valve exceeds a pressure differential threshold P. The pressure differential threshold P is substantially equal to a force F exerted by one of the springs 416, 418 multiplied by an open cross-sectional area of one of the port openings 420, 422. When a pressure differential between a bladder and a reservoir is below the pressure differential threshold P, then there is no flow through either check valve 408, 410. Under these low differential pressure conditions, if the bladder is inflated, it will remain inflated. If the bladder is deflated, it will remain deflated. Under normal use and storage conditions, both check valves are closed. When the patient applies an external compressive force to an inflated bladder, the threshold is exceeded in a first direction and the external force deflates the bladder. When the patient applies an external compressive force to the reservoir, the threshold is exceeded in a second, opposite direction and the external force on the reservoir inflates the bladder. The threshold P is controllable by the design of the check valves 408, 410, e.g. the size of spring and the open area of the valve seat. If desired, different thresholds P can be set for each valve to accommodate differences in external forces application areas between the bladder and reservoir. The valve 400 shown is exemplary, and other known types of valves can be used. In an alternative embodiment, the liquid in the system can be prepressurized and one check valve can be used that is manually actuatable to inflate the bladder.
An increased, selectable girth for a portion of the malleable penile prosthesis is provided. A relatively short section of the distal end of the column has an increase in girth. This is the portion of the cylinder that would initially, and perhaps primarily, be involved during intromission and as such would be the part of the cylinder most effective for its intended purpose. The girth increase is at the distal end of the prosthesis. Cross-sectional area is increased by transferring fluid from a small implanted reservoir to an expandable bladder. The reservoir can be alternately pressurized or non-pressurized. If the reservoir is pressurized, a valve, which is either opened by the patient or by the act of straightening the cylinder, lets the pressurized fluid pass through a transfer tube into the bladder. To deflate the bladder, the patient squeezes the penis over the bladder forcing the fluid back into the reservoir either via a check valve in the valve or by squeezing the valve. If the reservoir is non-pressurized, the fluid can be forced from the reservoir; the patient squeezes the perineal area and forces the fluid into the bladder. As with the pressurized reservoir design, to deflate the bladder the patient squeezes the penis over the bladder region. The squeezing forces the fluid back into the reservoir either via a one way check valve, or by squeezing the valve.
The embodiment shown in
Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.
The present application claim priority to U.S. Provisional Patent Application No. 60/988,264, filed Nov. 15, 2007, and entitled “Prosthesis with Bladder that Adjust Girth”. The identified provisional patent application is hereby incorporated by reference in its entirety.
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