Patent Publication Number: US-2016220373-A1

Title: Penile prosthetic assembly having selectively controlled vibratory unit

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application claims priority under applicable sections of 35 USC §111 and 37 CFR §1.53 to U.S. Application Ser. No. 62/161,643, filed May 14, 2015 and entitled: PENILE PROSTHETIC ASSEMBLY HAVING SELECTIVELY CONTROLLED VIBRATORY UNIT, and U.S. Application Ser. No. 62/125,797, filed Feb. 3, 2015, and entitled: ERECTILE DEVICE. The contents of each of these applications is herein incorporated by reference in their entirety. 
    
    
     TECHNICAL FIELD 
     This application generally relates to the field of prosthetic devices and more specifically to a penile prosthetic assembly having a set of surgically implantable cylinders, including an integrated or attached vibratory unit(s) that is selectively engageable by a user, for example, for the treatment of severe erectile dysfunction (ED). The vibratory unit can be used in conjunction with malleable (non-inflatable) and/or inflatable cylinders that are used to produce an erection-like state and in which the integrated or attached vibratory unit can be controlled by a wired or a wireless connection. 
     BACKGROUND 
     As is known, the treatment of erectile dysfunction (ED) is caused by the inability of a male adult to maintain an erection that is sufficient for sexual activity. An initial treatment for this condition may be prescribed by a physician or other caregiver in the form of an oral prescriptive mediation such as Viagra (Sildenafil citrate), Cialis (Tadalafil), Levitra (Vardenafil HCl) or other vasodilatory drugs. If these treatments are ineffective or unsuccessful, then other options may be considered. These options may include use of a vacuum erectile device, intra-urethral medications, or penile injection therapy. If these latter options also are unsuccessful then a further treatment option, penile prosthesis implantation, may be considered. 
     Penile prosthetic devices or assemblies are completely implanted surgically within the body of a patient. The function of the penile prosthetic device is to produce an erection-like state that enables a man to have normal sexual activity. Neither the operation to implant the prosthesis nor the apparatus itself will interfere with the patient&#39;s sensation, orgasm, ejaculation or urination. 
     More specifically, there are two erection chambers (corpora cavernosa) located within the penis. A penile prosthetic device typically includes flexible cylinders made from a medical grade material (silicone) that are capable of producing a rigidity or firmness to enable the man to have sexual intercourse when the cylinders are disposed within the corpora chambers. The types of prosthetic devices can include malleable versions or inflatable versions. Inflatable penile prostheses are fluid-filled devices that can be utilized for erection that allow for control of rigidity and size, in a manner that is more natural akin to a normal penis. 
     There is a continuing and general need to improve upon penile prosthetic apparatus in this field. 
     BRIEF DESCRIPTION 
     According to one aspect, there is described a penile prosthetic assembly comprising at least one cylinder made from a medical grade material that is configured for surgical implantation within the corpora chambers of a penis. A vibratory unit is attached and operatively connected to the at least one cylinder, the vibratory unit including a motor connected to a portable power source. A control mechanism selectively operates the vibratory unit. 
     In one version, the control mechanism is an actuable control that is surgically implanted and made accessible to the patient. According to another version, a control unit can be wirelessly connected to the penile prosthetic assembly, and more specifically the vibratory unit, for enabling remote operation. 
     When the vibratory unit is activated by the user, the implanted cylinders and therefore the entire penis is caused to vibrate, adding to the sensation of the partner during intercourse. 
     According to another version, the implanted cylinders are hollow and made from a flexible medical grade material. The cylinders are connected to a fluid source such as a fluid reservoir, wherein the prosthetic assembly further includes a pump that is connected to a portable power source such as batteries. The pump is configured to selectively pump contained fluid from the fluid reservoir into the interior of the cylinders. In this version, the control mechanism can further include at least one implantable switch or alternatively, a remote control unit, in order to selectively energize and deenergize the pump and/or the vibratory unit. 
     According to another version, there is provided a penile prosthetic assembly comprising a pump, a reservoir containing a volume of fluid, and a set of cylinders fluidically connected to the pump and reservoir. The cylinders, pump and reservoir are sized for implantation within the penis and configured such that fluid can be pumped into and out of the cylinders to enable inflation and deflation thereof. A vibratory unit is attached and operatively connected to the cylinders, wherein the assembly further includes a portable power source preferably connected to the pump and the vibratory unit. A control mechanism selectively controls the operation of the vibratory unit and the pump. 
     In one version, the vibratory unit includes a motor disposed upon each of the flexible hollow cylinders which is connected to the portable power source, e.g., a battery. The vibratory unit can be controlled by an actuable switch that is surgically implanted and otherwise is accessible to the patient. According to another version, a control unit is wirelessly connected to the prosthetic assembly to enable remote operation. 
     One advantage provided by the herein described assembly is that of providing a further improvement in the treatment of severe erectile dysfunction. 
     These and other features and advantages will be readily apparent to one of sufficient skill from the following Detailed Description, which should be read in conjunction with the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  depicts a perspective view of a penile prosthetic assembly made in accordance with an embodiment of the present invention; and 
         FIG. 2  depicts a perspective view of a penile prosthetic assembly made in accordance with another embodiment in accordance with the present invention. 
     
    
    
     DETAILED DESCRIPTION 
     The following relates to a penile prosthetic assembly made in accordance with various embodiments. It will be readily apparent, however, that other variations and modifications can be made within the spirit and scope of this description. In addition, various terms are used throughout the description in order to provide an adequate frame of reference with regard to the accompanying drawings. These terms, unless so specifically indicated, should not be regarded as overly limiting in terms of the scope of the herein described prosthetic apparatus. In addition, the drawings are intended to adequately depict sufficient details of the apparatus. To that end, the drawings should not be relied upon for scaling purposes. 
     Referring to  FIG. 1 , a penile prosthetic assembly  10  is provided in accordance with a first embodiment. The penile prosthetic assembly  10  is defined by a plurality of interconnected components including a compact pneumatic pump  14  that is connected to a portable power source, such as a battery  18 , through a corresponding set of electrical leads  22 . The pump  14  is manufactured from a biocompatible material, such as silicone, and can include a reciprocating piston or other suitable element that is disposed within a pump housing. Alternatively, the pump can be made in accordance with other suitable designs that are capable of pumping a fluid. According to this specific embodiment, the pump  14  is configured to direct fluid from the confines of a sealed reservoir  26  to and from a set of flexible hollow cylinders  34 . The sealed reservoir  26  contains a volume of fluid that can be accessed through a port  27  at one end of the reservoir  26  by an extending end of a flexible fluid conduit or hose  28 , the latter being connected to respective inlet and outlet ports of the pump  14 . According to this embodiment, the contained fluid is saline, although other suitable bio-compatible fluids can be alternatively be used. 
     Each of the pair of hollow cylinders  34  are fluidically connected to the compact pump  14  by means of a corresponding pair of hoses  30 , allowing fluid to be pumped into and from each cylinder  34  and to and from the reservoir  26  via the conduit  28 . Each of the cylinders  34  is defined by an elongate configuration, including a port  31  disposed at one end thereof. The port  31  is configured to receive an end of the hose  30  to permit fluid from the sealed reservoir  26  to be selectively pumped into and out of the interior of each cylinder  34 . The cylinders  34  are further defined by a hollow interior according to this embodiment, wherein each of the cylinders  34  and hoses  28 ,  30  are fabricated from a medical grade material, such as silicone. It will be apparent that other suitable materials can be utilized provided these materials enable inflation of the hollow cylinders  34  through fluid expansion of same. 
     Still referring to  FIG. 1  and according to this exemplary embodiment, each of the flexible hollow cylinders  34  of the prosthesis  10  further includes a vibratory unit  60  having a set of extending electrical leads  64 . More specifically, each of the vibratory units  60  comprise a motor, although any suitable device that is capable of producing a vibratory or oscillatory effect can be alternatively provided. As to attachment, the vibratory units  60  can be disposed within a compartment formed within the interior of the cylinder  34  or alternatively, the vibratory units  60  can be disposed on the exterior of the cylinders  34  and secured by suitable means, such as adhesives. According to this specific embodiment, the vibratory units  60  are commonly located at one end of the cylinders  34 , but it will be readily apparent that the units  60  can be disposed upon any suitable portion thereof. According to this specific embodiment, each of the electrical leads  64  extending from the vibratory units  60  are further connected to an actuable switch  70  and the battery  18  that enables selective energization of the vibratory motors  60  via a portable power source (battery)  18 . Alternatively, the units  60  could contain their own independent power source in lieu of the battery  18 . Similar control means (not shown) are provided for selectively energizing the pump  14  to enable inflation of the cylinders  34 . 
     In use, the herein described prosthetic assembly  10  can be surgically implanted with the cylinders  34  being implanted within the corpora chambers of the penis of the patient. The reservoir  26  and battery  18  are preferably implanted in the retropubic space and the pump  14  of the assembly  10  is preferably implanted within the patient&#39;s scrotom. Prior to assembly, a cover  119 ,  FIG. 2 , is placed onto the battery  18 . 
     According to this embodiment, the actuable switch  70  is disposed in relation to the pump  14  and is accessible to the patient following implantation to enable selective energization of the vibratory units  60 . When the actuable switch  70  is engaged, the vibratory units  60  cause the cylinders  34  to vibrate, which further causes the entire penis to vibrate as well, thereby creating stimulation. The actuable switch  70  may include one or multiple settings, enabling the vibratory rate to be adjusted. 
     A penile prosthetic assembly  100  in accordance with another embodiment is shown in  FIG. 2  prior to its implantation. Similarly, this prosthetic assembly  100  is defined by a plurality of interconnected components including a compact pneumatic pump  114  that is connected to a portable power source, such as at least one battery  118 , through a corresponding set of electrical leads  122 . The pump  114  is manufactured from a biocompatible material, such as silicone, and can include a reciprocating piston or other suitable element or can be made in accordance with other suitable designs that are capable of pumping a fluid. According to this exemplary embodiment, the pump  114  is configured to direct fluid from the confines of a sealed reservoir  126  to and from a set of flexible hollow cylinders  134 . As in the preceding embodiment, the reservoir  126  contains a volume of fluid that can be accessed through a port  127  at one end of the reservoir  126  to an extending end of a flexible fluid conduit or hose  128  connected to the inlet and outlets of the pump  114 . According to this embodiment, the contained fluid is saline, although other suitable fluids can alternatively be used. 
     Each of the pair of hollow cylinders  134  are fluidically connected to the compact pump  114  by means of a corresponding pair of hoses  130 . Each of the cylinders  134  is defined by an elongate configuration, including a port  131  disposed at one end thereof. The port  131  is configured to receive an end of the hose  130  to permit fluid from the reservoir  126  to be selectively pumped into and out of the interior of each cylinder  134 . The cylinders  134  are further defined by a hollow interior according to this embodiment, wherein each of the cylinders  134  and hoses  128 ,  130  are fabricated from a medical grade material, such as silicone. It will be apparent that other suitable materials can be utilized provided they enable inflation of the hollow cylinders  134  through fluid expansion of same. 
     Still referring to  FIG. 2  and according to this specific embodiment, each of the flexible hollow cylinders  134  of the prosthesis  10  further includes a vibratory unit  160  having a set of extending electrical leads  164 . More specifically, each of the vibratory units  160  comprise a motor, although any suitable device capable of producing a vibratory or oscillatory effect can be provided. As to attachment, the vibratory units  160  can be disposed within a compartment formed within the interior of the cylinder  134  or alternatively the vibratory units  160  can be disposed on the exterior of the cylinders  134  and secured by suitable means, such as adhesives. According to this specific embodiment, the vibratory units  160  are commonly located at one end of the cylinders  134 , but it will be readily apparent that the units  160  can be disposed along any suitable portion thereof. According to this specific embodiment, each of the electrical leads  164  extending from the vibratory units  160  are further connected to a suitable portable power source (e.g., the battery  118 ) that enables selective energization of the vibratory units  160 . Alternatively and though not shown, the vibratory units  160  can include an independent discrete power source. The vibratory unit  160  can be configured to provide pulsations over varying durations and cycles, thereby comprising various operating modes. 
     In lieu of an actuable switch and according to this embodiment, a remote control unit  180  can be connected, preferably in a wireless manner such as Bluetooth, Zigbee or other local RF or IR wireless protocol, to the herein described assembly  100  wherein the control unit includes a corresponding receiver/transmitter and optionally a small microcontroller that is used to transmit control signals to activate the pump  114  or vibratory unit(s)  160 . The implanted assembly  100  further includes a receiver that receives the at least one RF or IR (or other wireless signal) in which the received signal is used in order to engage or disengage operation of the pump  114  and/or the vibratory unit  160 . According to this embodiment, the remote control unit  180  is defined by a housing  182  having a plurality of actuable buttons  186  that define a user interface and in which the operation of each of the inflation and vibratory functions (e.g., pulsatile or other modes) can be enabled selectively by the patient remotely. 
     In use and according to the embodiment shown in  FIG. 2 , the assembly  100  is surgically implanted with the exception of the remote control unit  180 . Following implantation, the control unit  180  can be then used to selectively operate either the inflation of the hollow cylinders  134  and/or activate the vibratory units  160  of the implanted prosthetic assembly  100 . Separate controls  186  can be provided for each function on the user interface of the housing of the remote control unit  180 . Alternatively, either the vibratory units  160  and/or the pump  114  can be operated such as using an implanted switch  70 ,  FIG. 1 . 
     Preferably, the portable battery  18 ,  118  is analogous to those used in other implantable devices, such as pacemakers and sacral neuromodulators, and designed with a working life lasting upwards of five (5) years with continuous use. If replacement of the portable battery  18 ,  118  is required, a minor surgical procedure would involve a small incision in the retropubic space in which the battery  18 ,  118  is preferably implanted, as noted above. 
     PARTS LIST FOR FIGS.  1 - 2   
       10  penile prosthetic assembly 
       14  pump 
       18  battery 
       19  battery cover 
       22  electrical leads 
       26  reservoir, fluid 
       27  port, reservoir 
       29  hose or conduit 
       30  hoses 
       31  port, cylinder 
       34  set of hollow flexible cylinders 
       60  vibratory unit 
       64  electrical leads 
       70  switch 
       100  penile prosthesis assembly 
       114  pump 
       118  battery 
       119  battery cover 
       122  electrical leads 
       126  reservoir, fluid 
       127  port, reservoir 
       129  hose or conduit 
       130  hoses 
       131  port, cylinder 
       134  set of hollow flexible cylinders 
       160  vibratory unit 
       164  electrical leads 
       180  remote control unit 
       182  housing 
       186  buttons, actuable 
     The herein described embodiments are intended to be examples and it should be apparent that various modifications and variations can be effected by a person of sufficient skill in the field. For example and though the vibratory units discussed herein pertain to an inflatable prosthetic device, it will be readily apparent that non-inflatable (i.e., malleable) versions, such as those described in U.S. Pat. Nos. 3,987,789 and 4,267,829 can also be employed, the contents of these patents being herein incorporated by reference in their entirety.