Patent Application
20240335290
Inflatable penile prosthetics have proven useful in treating erectile dysfunction. The typical inflatable penile prosthetic has an implant in the penis, a reservoir implanted in the abdomen, and a pump implanted in the scrotum to move liquid out from the reservoir and into the implant in the penis.
Improvements to inflatable penile prosthetics would be welcomed by both patients and surgeons.
A tidal pump is described that allows for volume amplification when inflating an inflatable penile prosthesis. The tidal pump is a named architecture for this form of pump for an inflatable penile prosthesis where the inflatable portion of the penile implant is utilized to actuate the pump with an initial volume of liquid, and the pump responds by transferring a second volume of liquid along with the initial volume of liquid back to the inflatable implant. The pump is generally located between an inflatable implant and a reservoir, with an outlet of the pump communicating with the implant and an inlet of the pump communicating with the reservoir. During use of the system, a squeezing action applied to the inflatable implant by squeezing the penis pushes (or pressurizes) a first volume of liquid out of the implant and into an outlet of the pump, which moves or displaces a piston inside of the pump and also displaces an upper check valve in the pump. Movement of the piston draws a second volume of liquid out from a reservoir through the upper check valve and into an inlet of the pump. The pump now contains the first volume of liquid that entered the pump through the outlet and the second volume of liquid that entered the pump through the inlet. The eventual return of the piston pushes the first volume and the second volume of liquid out of the outlet of the pump and into to the inflatable implant. Advantageously, the squeeze of the implant displacing the first volume of liquid results in both the first volume of liquid plus the second volume of liquid entering back into the implant, which could allow a user to inflate the implant with fewer squeezes of the disclosed tidal pump as compared to a traditional pump usually implanted in the scrotum. Thus, the tidal pump produces a net gain of liquid (i.e., the second volume of liquid) delivered to the inflatable implant with every squeeze of the implant, as one example. For these reasons, the tidal pump is referred to as a volume amplification mechanism when used with a penile implant.
The tidal pump is connected between penile cylinder(s) of the implant and a reservoir of the prosthesis, for example with tubing, or kink-resistance reinforced (reinforced with metal or nylon) polymer tubing. A squeezing pressure applied to the penile cylinder through the penis moves a first liquid volume out of the cylinder and into a first chamber of the tidal pump, which displaces a piston inside of the tidal pump and opens an upper check valve. Displacement of the piston creates a vacuum space (a second chamber or a suction chamber) between the piston and the housing of the tidal pump, and a second liquid volume is drawn out of the reservoir, through the upper check valve, and into the suction chamber. A return spring pushes the piston back to its starting position, which pushes both the first liquid volume and the second liquid volume out of the tidal pump and into the penile cylinders. Thus, the volume gained in the penile cylinder with use of the tidal pump is about equal to the volume of the second chamber. Repeated squeezing of the penile cylinder leads to an accumulation of liquid in the cylinder, which inflates the cylinder and results in an erection when the prosthesis is implanted.
The above description will allow a person of skill in the art to understand that a single squeeze of the penile cylinder results in a subsequent return of liquid back into the cylinder that is larger than the amount of liquid initially displaced out of the cylinder. If the first chamber has the same size as the second chamber (the suction chamber), then the liquid volume moved from the tidal pump back into the cylinder is amplified by a factor of 2 (e.g., the volume in the first chamber and the volume from the second chamber from the tidal pump is returned to the cylinder in exchange for the volume in the first chamber that initially came from the cylinder). Thus, each squeeze of the cylinder in this example results in a 2-for-1 amplification of fluid volume back to the cylinder (a volume gain). Other ratios of the size of the first chamber to the second chamber are possible, so that the tidal pump may be configured or designed to adjust the liquid volume gain based upon a selected design of the geometries of the first and second chambers in the tidal pump. A typical volume gain for the tidal pump is between the range from 0.5 to 1.0 cc.
The beneficial volume gain described above is balanced by the role of the spring constant for the return spring. The pressure of the squeeze to the implant cylinder applies a force to the face of the piston. The return spring will compress in response to this force (this is Hooke's law: F=k*displacement, where k is the spring constant). If a user applies a forceful squeeze to the cylinder, then the spring of a given constant k will displace according to Hooke's law and return a proportionally large volume of liquid gain. If, however, the user applies a weak or gentle squeeze to the cylinder, the same spring will not displace the same amount, thus returning a small liquid gain. Consequently, the beneficial liquid gain achieved by a selected geometry of the tidal pump chambers is balanced by the spring constant of the return spring. In other words, the trade-off is generally between designing a tidal pump that performs with a few high-pressure cylinder squeezes providing repeated large volume gains (for people with strong hands), or many low-pressure cylinder squeezes providing repeated smaller volume gains (for people with limited dexterity or strength in their hands).
In any regard, the tidal pump described in this application allows for a range of volume gains based on a selected geometry between the two chambers and the selected spring constant k.
Embodiments of the tidal pumps may use either simple constant K springs, or rising rate springs depending on the desired characteristics, equally alternative embodiments can be conceived using pneumatic or other gas springs.
One embodiment of an inflatable penile prosthesis comprising a tidal pump coupled in fluidic communication between a reservoir and a penile implant comprises: a housing having an inlet end attachable to the reservoir and an outlet end attachable to the penile implant; a first piston biased within the housing by a return spring such that a displacement of the first piston away from the outlet end of the housing opens a first chamber communicating with the penile implant and a second chamber communicating with the reservoir; a first check valve positioned between the first chamber and the outlet end; and a second check valve positioned between the second chamber and the inlet end; wherein a first volume of liquid moved from the penile implant into the first chamber displaces the first piston to form a suction within the second chamber that draws a second volume of liquid from the reservoir and into the second chamber; wherein a return of the first piston toward the outlet end of the housing moves the first volume of liquid and the second volume of liquid into the penile implant.
One embodiment of an inflatable penile prosthesis having a pump coupled in fluidic communication between a reservoir and a penile implant provides a pump comprising:
The penile implant described in this application would be implanted within the penis and the pump would be implanted in the body but outside of the penis, for example within the abdomen or within the scrotum. The pump communicates with a reservoir. One embodiment locates the pump inside of a reservoir and both the pump and the reservoir are implanted in the body. The reservoir and the pump could be separate units and connected by suitable tubing. Benefits and advantages of the tidal pump include inflation of the implanted penile implant by the user through the action of squeezing of the penis. Each squeeze applied to the penis by the user sends liquid into the pump and results in more liquid (e.g., a volume gain) returned from the pump back to the implant in the penis, and this volume gain accumulates with subsequent squeezes to inflate the penile implant thus treating erectile dysfunction. The advantages include: a more natural approach to achieving an erection; the option of removing the pump from inside the scrotum, as some users occasionally find it challenging to squeeze a pump bulb when it is located within the scrotum; and a potentially smaller pump footprint, which allows for increased patient comfort.
Benefits and advantages of the tidal pump include a smaller plan form for implantation in a pump that moves liquid into a penile implant through the squeezing of the implant. Since the penile portion of the implant is in an implant cylinder within the penis, the user may easily access the implant cylinder to initiate the squeezing that begins the liquid pumping process.
Other advantages of the tidal pump include that the pump can be inserted into the reservoir, thus the system of parts represents a two-piece implant of 1) a pump inside of a reservoir, and 2) the penile implants coupled to the pump. This architecture obviates a three-piece system having a penile implant coupled to both a body-implanted reservoir and a pump, where the pump has a pump body and a pump bulb that are usually implanted into a scrotum of a patient. Other advantages of the tidal pump include fewer tube-to-component connections to be made by the surgeon during implantation.
The check valves described in this application are configured as one-way check valves that allow liquid to move through the check valve in one direction and prevent the liquid from moving through the check valve in the opposite direction. Other forms of check valves are envisioned to be acceptable.
An aspect of this embodiment includes, wherein the first chamber is located between a face of the piston and the outlet end of the housing and the second chamber is located between a side wall of the piston and an internal wall of the housing.
An aspect of this embodiment includes, wherein the first check valve is formed in the face of the piston, and the second check valve seals the trailing end of the piston relative to the internal wall of the housing.
An aspect of this embodiment includes, wherein the first chamber is co-axial with the second chamber.
An aspect of this embodiment further comprises: a second piston within the housing, where the first piston and the second piston are oriented side-by-side and the first chamber is separated away from the second chamber.
An aspect of this embodiment includes, wherein the first check valve is located between the first piston and the second piston, and the second check valve is located between the reservoir and the housing.
An aspect of this embodiment includes, wherein the first chamber is co-axial with the second chamber, and further comprising: a second piston biased within the housing, where the first piston and the second piston are each movable within the housing and the second piston is nested inside of the first piston.
An aspect of this embodiment includes, wherein the second piston is coupled with the first piston by a pulley strap.
A method of inflating the penile implant of this embodiment includes:
One embodiment of an inflatable penile prosthesis comprising a tidal pump coupled in fluidic communication between a reservoir and a penile implant comprises: a housing having an inlet end attachable to the reservoir and an outlet end attachable to the penile implant, with the housing forming a first chamber adapted for fluid communication with the penile implant; a piston retained in the housing, with a face of the piston disposed within the chamber and a portion of the piston spaced a distance away an internal wall of the housing to form a suction chamber adapted for fluid communication with the reservoir; a return spring coupled between the piston and the housing; an upper check valve coupled to the piston, with the piston sealed relative to the suction chamber; and a lower check valve formed on the outlet end of the housing.
One embodiment of an inflatable penile prosthesis comprising a tidal pump coupled in fluidic communication between a reservoir and a penile implant comprises: a housing having an external wall, an internal wall, an inlet end attachable to the reservoir, and an outlet end attachable to the penile implant; a piston inserted in the housing, with the piston having a face end oriented toward the outlet end of the housing and a trailing end oriented toward the inlet end of the housing; a return spring connected between the trailing end of the piston and the inlet end of the housing; a first fluid chamber located between the face end of the piston and the outlet end of the housing; and a second fluid chamber located between the piston and the internal wall of the housing.
Another embodiment of an inflatable penile prosthesis comprising a pump coupled in fluidic communication between a reservoir and a penile implant includes a pump comprising:
An aspect of this embodiment includes, wherein the first chamber is located between a face of the first piston and the outlet end of the housing, and the suction chamber is located between a side wall of the first piston and an internal wall of the housing. This structure advantageously provides a compact pump with co-axial chambers.
An aspect of this embodiment further comprises:
An aspect of this embodiment includes, wherein the first check valve is located between the first piston and the second piston, and the second check valve is located between the reservoir and the housing.
An aspect of this embodiment includes, wherein the first chamber is co-axial with the suction chamber, and further comprising:
Another embodiment of an inflatable penile prosthesis comprising a pump coupled in fluidic communication between a reservoir and a penile implant provides a pump comprising:
An aspect of this embodiment includes a first check valve disposed between the first fluid chamber and the penile implant.
Another aspect of this embodiment includes a second check valve disposed between the second fluid chamber and the reservoir.
The accompanying drawings are included to provide a further understanding of embodiments and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments and together with the description explain principles of embodiments. Other embodiments and advantages of embodiments will be readily appreciated as they become better understood by reference to the following detailed description. The elements of the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding similar parts.
In the following Detailed Description, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. In this regard, directional terminology, such as “top,” “bottom,” “front,” “back,” “leading,” “trailing,” etc., is used regarding the orientation of the Figure(s) being described. Because components of embodiments can be positioned in several different orientations, the directional terminology is used for purposes of illustration and is in no way limiting. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present invention. The following detailed description, therefore, is not to be taken in a limiting sense, and the scope of the present invention is defined by the attached claims.
The features of the various exemplary embodiments described in this application may be combined with each other, unless specifically noted otherwise.
The term “proximal” in this application means that part that is situated next to or near the point of attachment or origin or a central point; for example, as located toward a center of the human body. The portion of an implant that is closest to a center of a patient's body is the proximal portion of the implant. Also, for a surgical tool having a handle and a working head, the handle held by the surgeon is a proximal portion of the tool.
The term “distal” in this application means that part that is situated away from the point of attachment or origin or the central point; for example, as located away from the center of the human body. The working head of the surgical tool is distal relative to the proximal handle.
End means endmost. A distal end is the furthest endmost location of a distal portion of a thing being described, whereas a proximal end is the nearest endmost location of a proximal portion of the thing being described. The portion next to or adjacent to an end is an end portion. For example, a 12-inch ruler has a center at 6 inches, a first end at zero inches and a second, opposite end at 12 inches, a first end portion adjacent to the first end and a second end portion adjacent to the second end.
The tidal pump 22 (or pump 22) includes a housing 30 having an inlet end 32 attachable to the reservoir 24 (
One suitable spring 38 includes a spring with a 1.4 lb/in spring rate, 4 inches in total length, and with a pre-compression length of 1.35 inches when in the ‘at rest’ position shown in
The pump 22 has a housing diameter of approximately 16 mm (1.6 cm) and length in a range from about 6 to 12 cm. The cross-sectional shape is circular, but other cross-sectional shapes are also acceptable.
The process described above for the exemplary four stages (
Several parameters influence the performance of the tidal pumps, including the diameters of the piston 36 and its housing 30, the size and spring constant of the spring 38, and the overall stroke length of the piston 36 in the pump 22. We observed that a relatively high squeezing pressure was called for even when the implants 26 were not fully filled with saline. Analysis showed that the spring force configuration as well as the relative sizes of the primary and secondary chambers 50, 52 contributed to the difficult use. For example, when there was no system pressure in the implants 26 (i.e., the implant 26 was incompletely filled with liquid) the user was called upon to add 10 psi of squeezing pressure to get just a small amount of fluid gain (e.g., about 0.1 cc). Furthermore, at higher pressures above about 10 psi, the amount of fluid gain that could be achieved per cycle decreased. This was because the amount of available piston stroke decreased as system pressure increased, reaching a limit for the prototype system of about 15 psi. One psi is equal to 6.89 kilopascals, so a 10 psi squeeze pressure correlates to 68.9 kPa.
However, it is noted that the performance of the tidal pump 22 was successful in inflating the implant 26, resulting in additive liquid gain in the implant 26 with each squeeze of the cylinder of the implant 26. Starting at low system pressure inside of the implant 26, each squeeze of the cylinder of the implant 26 added about 1 cc of liquid, which increased the system pressure (and rigidity of the implant 26). For system pressures between zero psi and 7 psi, each squeeze of the implant 26 caused the pump 22 to return from 0.2 cc (at a system pressure of 1 psi for example) up to 1 cc (at a system pressure of 7 psi). Above the 7 psi system pressure, squeezing of the implant 26 becomes more difficult since the implant is filling with liquid. Thus, the additive liquid gain at higher system pressures of about 8 to 15 psi reduces from about 1 cc per squeeze down to 0.2 cc or less per squeeze around the 15 psi system pressure. Consequently, subsequent squeezes of the cylinder of the implant 26 added more liquid into the implant, but the subsequent squeezes called for more hand force.
The tidal pump 122 includes a housing 130 having an inlet end 132 attachable to the reservoir 124 and an outlet end 134 attachable to the penile implant 126, for example by suitable tubing. A first piston 136 is biased within the housing 130 by a return spring 138 and a second piston 139 is located within the housing 130 oriented side-by-side and spaced away from the first piston 136. The housing 130 includes the container holding the first piston 136 and the container holding the second piston 139. A first check valve 140 is placed between the second chamber 152 and the penile prosthesis 126, orientated to only allow flow from the chamber 152 into the prosthesis 126. A second check valve 142 is situated between the reservoir 124 and the inlet end 132, this valve 142 is orientated to only allow flow from reservoir 124 to the chamber inlet 132. The housing 130 thus forms an enclosure for both the first piston 136 and the second piston 139, and when these pistons are displaced, they each create an open space, or a chamber 150, 152, respectively. In this embodiment, the second piston 139 does not have a return spring, since the first piston 136 is coupled or connected to the second piston 139 by a rigid brace 154.
Squeezing or pressurizing the implant cylinder 126 moves liquid into the housing 130 to displace the first piston 136. The displacement of the first piston 136 away from the outlet end of 134 the housing 130 opens the first chamber 150 communicating with the penile implant 126, and since the first piston 136 is rigidly coupled to the second piston 139 by the brace 154, the movement of the first piston 136 results in movement of the second piston 139, which opens the second chamber 152 communicating with the reservoir 124. The opening of the second chamber 152 forms a low-pressure void (or suction) in the second chamber 152, which draws a second volume of liquid out of the reservoir 124. The return spring 138 displaces the first piston 136 (and thus also the second piston 139) back toward the bottom of the stroke, which moves both of the first volume of liquid in the first chamber 150 and the second volume of liquid in the second chamber 152 into the implant cylinder 126.
The architecture of the tidal pump 122 represents a first prototype and is bulkier than the tidal pump 22. However, the tidal pump 122 shares a common architecture with the embodiments including a piston and two chambers, where a displacement of a first liquid volume out of the penile cylinder and into a first chamber displaces a piston, and the piston displacement creates suction in a second chamber to draw a second liquid volume out of the reservoir and into the second chamber. The movement of the piston back to its starting position pushes both the first liquid volume and the second liquid volume out of the tidal pump and into the penile cylinders.
With reference to
The first piston 236 is biased within the housing 230, and the second piston 239 biased within the housing 230, where the first piston 236 and the second piston 239 are each movable within the housing 230 and the second piston 239 is nested inside of the first piston 236. In one embodiment, the first piston 236 and the second piston 239 are co-axial. The second piston 239 is biased by a return spring 238.
A pulley strap 260, described below, mechanically couples the second piston 239 with the first piston 236 such that the bias force on the first piston 236 is double the spring force on the second piston 239. In one example, the pulley strap 260 has a first portion exterior to the first piston 236 and a second portion interior to the first piston 236 that couples with the second piston 239, as shown toward the inlet end 232 of the pump 222 in
A first check valve 240 or lower check valve 240 is formed in the face 241 of the piston 236 adjacent to the outlet end 234. A second check valve 242 or upper check valve 242 is positioned at a leading portion of the piston 239 to communicate with the inlet end 232 of the housing 230. In one embodiment, the second check valve 242 is an O-ring check valve. In an alternative embodiment, the second check valve 242 is located within a face of the second piston 239.
In
In this embodiment, the second piston 239 is attached to the housing 230 by the strap 260 or pulley connection. The strap 260 is coupled to the second piston 239 at a first end 262 of the strap 260 and to the housing 230 at an opposite second end 264 of the strap 260 (See
The housing 230 is a telescoping housing that is compact when implanted (with a length T1 in
The nested pistons 236, 239 locate the first chamber to be co-axial with the second chamber 252, which beneficially makes the pump 222 shorter for implantation. When the nested pistons 236, 239 are compressed together, the total length is reduced, which is useful when the surgeon implants the pump 222. Naturally, when the nested pistons 236, 239 expand, axial space is occupied, so the surgeon will take this into account. The pulley strap 260 biases the first piston 236 during its stroke, and thus the spring constant of the spring 238 may beneficially be of a smaller value (the force to displace the spring can be smaller), which allows the spring 238 to be smaller in size. In some embodiments, the spring constant for the spring 238 may be specified to be half of the spring constant of the spring 38 described above due to the mechanical advantage of the pulley system.
The pump 222 can be configured to perform similarly to the tidal pump 22 by utilizing or optimizing the ratio of the diameters of the piston 236, 239 along with a tuned selection of a spring constant for spring 238. As one example of the performance of the tidal pump 222, the fluid amplification for a squeeze pressure of 10 psi is about 0.2 cc per squeeze. The liquid amplification (in the case of saline liquid) can be adjusted by adjusting the proportional volumes of the first chamber 250 relative to the volume of the second chamber 252.
In general, the tidal pumps 22, 122 and 222 can be configured identically by selecting appropriate area ratios of the two pistons (which affect the sizes of the chambers) and spring constant for each embodiment. In some cases, tidal pump 22 will have advantages over other such tidal pumps when comparing main spring size and body compactness.
A variety of tidal pumps are described. A method of inflating a penile implant by utilizing any of the tidal pumps includes:
The providing of the inflatable penile prosthesis includes providing an implant in a package along with instructions for implantation and use.
Although specific embodiments have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that a variety of alternate and/or equivalent implementations may be substituted for the specific embodiments shown and described without departing from the scope of the present invention. This application is intended to cover any adaptations or variations of medical devices as discussed herein. Therefore, it is intended that this invention is limited only by its claims and their equivalents.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 17666581 | Feb 2022 | US |
| Child | 18743160 | US |
