Patent Description:
One treatment for male erectile dysfunction is the implantation of a penile prosthesis that mechanically erects the penis. Some existing penile prostheses include inflatable cylinders or members that can be susceptible to undesired expansion properties. For example, some known inflatable members are formed with fabric or knit materials which can have imperfections. Such imperfections can lead to irregular diametric and length expansion properties. Additionally, some known inflatable members may not provide sufficient stiffness and rigidity when inflated.

Accordingly, it would be useful to provide a bodily implant, such as a penile prosthesis that includes an improved inflatable member.

Document <CIT> discloses apparatus and associated methods related to implantable penile prosthesis, including an expandable polymeric sleeve that may be positioned over an inner inflatable body to limit a maximum expansion of the inner body.

Document <CIT> discloses an implantable inflatable penile prosthesis cylinder having a longitudinal axis and including an inflatable portion. The inflatable portion includes a chamber that defines an inflatable chamber. The chamber wall includes at least one thin wall section and at least one thick wall section. The at least one thin wall section stretches a greater amount than the at least one thick wall section in a plane extending perpendicular to the longitudinal axis when the inflatable chamber is transitioned from a deflated state to an inflated state.

Document <CIT> discloses an inflatable penile prosthesis cylinder including an inflatable chamber and a constraining sleeve of fabric. The inflatable chamber is configured to expand in response to an increase in pressure within the chamber. The sleeve of fabric constrains the expansion of the chamber. The sleeve of fabric includes a corrugation to facilitate expansion of the sleeve.

Any embodiments or examples not falling within the scope of the claims are provided for illustratory purposes only.

According to an aspect, an inflatable penile prosthesis includes an inflatable member, the inflatable member having a reinforced portion; a reservoir configured to hold fluid; and a pump assembly configured to facilitate a transfer of the fluid from the reservoir to the inflatable member when the prosthesis is in an inflation mode, and facilitate a transfer of the fluid from the inflatable member to the reservoir when the prosthesis is in a deflation mode.

In some embodiments, the inflatable member defines a cavity. In some embodiments, the inflatable member includes a sidewall that defines a cavity. In some embodiments, the inflatable member includes a sidewall that defines a cavity, the sidewall having a first portion and a second portion, the first portion of the sidewall having a first thickness, the second portion of the sidewall having a second thickness, the first thickness being greater than the second thickness.

In some embodiments, the inflatable member is configured to stretch. In some embodiments, the inflatable member is formed of a elastomeric polymer.

In some embodiments, the inflatable member includes a sidewall having an outer surface, the outer surface of the including a plurality of projections. In some embodiments, the inflatable member includes a sidewall having an outer surface and an inner surface opposite the outer surface, the inner surface including a plurality of projections. In some embodiments, the inflatable member includes a sidewall having an outer surface and an inner surface opposite the outer surface, the inner surface defining a cavity configured to receive the fluid, the inner surface including a plurality of projections. In some embodiments, the inflatable member includes a sidewall having an outer surface and an inner surface opposite the outer surface, the inner surface being smooth, the outer surface including a plurality of projections In some embodiments, the inflatable member includes a sidewall having an outer surface and an inner surface opposite the outer surface, the outer surface being smooth, the inner surface including a plurality of projections. In some embodiments, the inflatable member includes a sidewall having an outer surface and an inner surface opposite the outer surface, the outer surface including a plurality of projections, the inner surface including a plurality of projections.

In some embodiments, the inflatable member is formed of a homogenous material.

In some embodiments, the inflatable member includes a frame portion and a casing portion. In some embodiments, the inflatable member includes a frame portion and a casing portion, the casing portion surrounding the frame portion. In some embodiments, the inflatable member includes a frame portion and a casing portion, the frame portion includes a plurality of woven filaments.

According to another aspect, a bodily implant includes an inflatable member, the inflatable member having a sidewall defining a cavity configured to receive fluid, the sidewall including a first portion having a first thickness and a second portion having a second thickness, the first thickness being greater than the second thickness; a reservoir configured to the fluid; and a pump assembly configured to facilitate a transfer of the fluid from the reservoir to the inflatable member.

According to another aspect, a bodily implant includes an inflatable member, the inflatable member having a frame and a casing; a reservoir configured to the fluid; and a pump assembly configured to facilitate a transfer of the fluid from the reservoir to the inflatable member.

In some embodiments, the casing of the inflatable member surrounds the frame of the inflatable member.

Detailed embodiments are disclosed herein. However, it is understood that the disclosed embodiments are merely examples, which may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the embodiments in virtually any appropriately detailed structure. Further, the terms and phrases used herein are not intended to be limiting, but to provide an understandable description of the present disclosure.

The terms "a" or "an," as used herein, are defined as one or more than one. The term "another," as used herein, is defined as at least a second or more. The terms "including" and/or "having", as used herein, are defined as comprising (i.e., open transition). The term "coupled" or "moveably coupled," as used herein, is defined as connected, although not necessarily directly and mechanically.

In general, the embodiments are directed to medical devices such as penile prostheses or other bodily implants. The term patient or user may hereafter be used for a person who benefits from the medical device or the methods disclosed in the present disclosure. For example, the patient can be a person whose body is implanted with the medical device or the method disclosed for operating the medical device by the present disclosure. For example, in some embodiments, the patient may be a human male, a human female, or any other mammal.

The terms proximal and distal described in relation to various devices, apparatuses, and components as discussed in the subsequent text of the present disclosure are referred with a point of reference. The point of reference, as used in this description, is a perspective of a person who implants the inflatable penile prosthesis. The person may be a surgeon, a physician, a nurse, a doctor, a technician, and the like who may perform the implantation procedure. The term proximal refers to an area or portion that is closer or closest to the person during the implantation procedure. The term distal refers to an area or portion that is farther or farthest from the person.

The embodiments discussed herein may improve the performance of an inflatable member of the device. For example, the inflatable member may have improved stiffness or rigidity, improved reliability, improved visualization with imaging devices, such as a MRI or an X-ray device, or improved deflation or inflation times.

The embodiments according to the invention include an inflatable penile prosthesis having a pump assembly, an inflatable member, and a reservoir. The inflatable member may be implanted into the corpus cavemosae of a patient or user, the reservoir may be implanted in the user's abdomen, and the pump assembly may be implanted in the scrotum. The pump assembly may switch between an inflation position and a deflation position such that a user can operate the device to place the inflatable penile prosthesis in either an inflation mode to transfer fluid from the reservoir to the inflatable member or a deflation mode to transfer the fluid from the inflatable member back to the reservoir.

<FIG> schematically illustrates an inflatable penile prosthesis <NUM> according to an aspect. The inflatable penile prosthesis <NUM> may include a reservoir <NUM>, an inflatable member <NUM>, and a pump assembly <NUM> configured to transfer fluid between the reservoir <NUM> and the inflatable member <NUM>. In some examples, the inflatable member <NUM> may be implanted into the corpus cavemosae of the user, the reservoir <NUM> may be implanted in the abdomen or pelvic cavity of the user (e.g., the reservoir <NUM> may be implanted in the lower portion of the user's abdominal cavity or the upper portion of the user's pelvic cavity), and the pump assembly <NUM> may be implanted in the scrotum of the user.

The inflatable member <NUM> may be capable of expanding upon the injection of fluid into a cavity of the inflatable member <NUM>. For instance, upon injection of the fluid into the inflatable member <NUM>, the inflatable member <NUM> may increase its length and/or width, as well as increase its rigidity. In some examples, the inflatable member <NUM> may include a pair of cylinders or at least two cylinders, e.g., a first cylinder member and a second cylinder member. The volumetric capacity of the inflatable member <NUM> may depend on the size of the cylinders. In some examples, the volume of fluid in each cylinder may vary from about <NUM> milliliters in smaller cylinders and to about <NUM> milliliters in larger sizes. In some examples, the first cylinder member may be larger than the second cylinder member. In other examples, the first cylinder member may have the same size as the second cylinder member.

In some embodiments, the inflatable member <NUM> is reinforced. In some embodiments, the reinforced inflatable member provides increased stiffness or rigidity. In some embodiments, the reinforced inflatable member provides improved reliability or longevity as the reinforced inflatable member may include less layers of material which can become degraded through friction and movement with respect to each other.

For example, in some embodiments, the inflatable member <NUM> includes a sidewall that defines the cavity that is configured to receive the fluid. In some embodiments, the sidewall of the inflatable member <NUM> includes portions or sections that have a larger size or width than other portions or sections of the inflatable member <NUM>. The larger portions of the sidewall may provide strength or reinforcement to the inflatable member <NUM>. In some embodiments, the sidewall includes projections, such as ridges or bumps. The projections may be included on (or extend from) either or both of an outer surface and an inner surface of the inflatable member <NUM>. The projections may provide strength or reinforcement to the inflatable member <NUM>.

In other embodiments, the inflatable member <NUM> includes a frame member or portion and a casing member or portion. The frame member may be coupled to the casing member and provide support or structure to the inflatable member <NUM>. In some embodiments, the frame member is disposed on an outer surface of the casing member. In other embodiments, the frame member is disposed on an inner surface of the casing member. In yet other embodiments, the frame member is disposed within the casing member. In other words, the casing member surrounds or encases the frame member.

The reservoir <NUM> may include a container having an internal chamber configured to hold fluid that is used to inflate the inflatable member <NUM>. The volumetric capacity of the reservoir <NUM> may vary depending on the size of the inflatable penile prosthesis <NUM>. In some examples, the volumetric capacity of the reservoir <NUM> may be <NUM>-<NUM> cubic centimeters. In some examples, the reservoir <NUM> is constructed from the same material as the inflatable member <NUM>. In other examples, the reservoir <NUM> is constructed from a different material than the inflatable member <NUM>.

In some examples, the reservoir <NUM> may be pressurized. In some examples, the reservoir <NUM> is pressurized less than or equal to a pressurized threshold. In some examples, the reservoir <NUM> is pressurized to be equal to or less than diastolic pressure in order to ensure that the reservoir <NUM> is not over pressurized. In some examples, the pressurized threshold is <NUM>/Hg. In some examples, the pressurized threshold is greater than <NUM>/Hg. In other examples, the pressurized threshold is less than <NUM>/Hg. In some examples, the reservoir <NUM> includes a pressure regulating balloon. In other examples, the reservoir <NUM> is not pressurized (e.g., static). In some examples, reservoir <NUM> may include a single container configured to hold the fluid, which may or may not be pressurized. In some examples, the reservoir <NUM> includes a primary container (or primary chamber) and a secondary container (or secondary chamber), where the primary container/chamber may hold the fluid that is transferred to the inflatable member <NUM>, and the secondary container/chamber may include gas or secondary fluid that is used to pressurize the fluid in the primary container/chamber.

The inflatable penile prosthesis <NUM> may include a first conduit connector <NUM> and a second conduit connector <NUM>. Each of the first conduit connector <NUM> and the second conduit connector <NUM> may define a lumen configured to transfer the fluid to and from the pump assembly <NUM>. The first conduit connector <NUM> may be coupled to the pump assembly <NUM> and the reservoir <NUM> such that fluid can be transferred between the pump assembly <NUM> and the reservoir <NUM> via the first conduit connector <NUM>. For example, the first conduit connector <NUM> may define a first lumen configured to transfer fluid between the pump assembly <NUM> and the reservoir <NUM>. The first conduit connector <NUM> may include a single or multiple tube members for transferring the fluid between the pump assembly <NUM> and the reservoir <NUM>.

The second conduit connector <NUM> may be coupled to the pump assembly <NUM> and the inflatable member <NUM> such that fluid can be transferred between the pump assembly <NUM> and the inflatable member <NUM> via the second conduit connector <NUM>. For example, the second conduit connector <NUM> may define a second lumen configured to transfer fluid between the pump assembly <NUM> and the inflatable member <NUM>. The second conduit connector <NUM> may include a single or multiple tube members for transferring the fluid between the pump assembly <NUM> and the inflatable member <NUM>. In some examples, the first conduit connector <NUM> and the second conduit connector <NUM> may include a silicone rubber material.

The pump assembly <NUM> may switch between an inflation mode in which the fluid in the reservoir <NUM> is transferred to the inflatable member <NUM> through the pump assembly <NUM> in a first direction (e.g., inflation direction) and a deflation mode in which the fluid in the inflatable member <NUM> is transferred back to the reservoir <NUM> through the pump assembly <NUM> in a second direction (e.g., deflation direction).

The pump assembly <NUM> may include a pump <NUM> and a valve body <NUM>. The valve body <NUM> also includes a selection member <NUM>. The selection member <NUM> may be used to select or change the mode in which the pump assembly is in. For example, the selection member <NUM> may be moved from a first position to a second position to place the device in its deflation mode. The selection member <NUM> may then be moved back to its first position to place the device in its inflation mode. In some embodiments, the selection member <NUM> is movable with respect to the valve body <NUM>. For example, in some embodiments, the selection member <NUM> is slidably coupled or slideable with respect to the valve body <NUM>.

The pump <NUM> may be squeezed or depressed by the user in order to facilitate the transfer of fluid from the reservoir <NUM> to the inflatable member <NUM>. For example, in the inflation mode, while the user is operating the pump <NUM>, the pump <NUM> may receive the fluid from the reservoir <NUM>, and then output the fluid to the inflatable member <NUM>. When the user switches to the deflation mode, at least some of the fluid can automatically be transferred back to the reservoir <NUM> (due to the difference in pressure from the inflatable member <NUM> to the reservoir <NUM>). Then, the user may squeeze the inflatable member <NUM> to facilitate the further transfer of fluid through the pump <NUM> to the reservoir <NUM>.

In some examples, the pump <NUM> may include a flexible member defining a cavity. In some examples, the pump <NUM> may define a pump shell having a flexible bulb and a valve body connector, where the valve body connector is designed to fit at least partially over the valve body <NUM>. In some examples, the pump <NUM> may include a squeeze pump. In some examples, the pump <NUM> may include a portion that is round or substantially round. In some examples, the pump <NUM> may include ribbing or dimples to aid the user in gripping the pump <NUM>. The pump <NUM> may use suction and pressure to move the fluid in and out of the cavity of the pump <NUM> in the inflation mode. For example, the user may depress or squeeze the pump <NUM> to expel the fluid out of the cavity, and, when the flexible member returns to its original shape, the resulting suction pushes the fluid into the cavity of the pump <NUM>. In some examples, the pump <NUM> may have a bulb spring rate that is designed to refill the pump <NUM> in a selected time frame.

As discussed above, the selection member <NUM> may be used to select or change the mode in which the pump assembly is in. In some embodiments, the selection member <NUM> includes or defines at least one opening, hole, or lumen. The selection member <NUM> is configured to be moved from one position in which it allows fluid to flow through one or more of the channels and another position in which it allows fluid to flow though a different or a different set of channels. For example, in one embodiment, the selection member <NUM> may be placed in the inflate position and the user may then operate the pump <NUM> to inflate the inflatable member <NUM> (i.e., move the fluid from the reservoir <NUM> to the inflatable member <NUM>). For example, the user may repeatedly depress or squeeze the pump <NUM> until the desired rigidity is achieved.

In some examples, if the reservoir <NUM> is at least partially pressurized, the fluid may automatically flow out of the reservoir <NUM> and into the inflatable member <NUM> without the user depressing or squeezing the pump <NUM> until the pressure is at least partially equalized between the reservoir <NUM> and the inflatable member <NUM>.

Then, when the user wants to deflate the inflatable member <NUM>, the user moves selection member <NUM> to its deflate position. The user may then operate the pump <NUM> to deflate the inflatable member <NUM> (i.e., move the fluid from the inflatable member <NUM> to the reservoir <NUM>). The pump <NUM> may then return to its original form, which provides a suction force causing fluid to be drawn into the pump <NUM> from the inflation member <NUM>. The fluid from the inflation member <NUM> fills the pump <NUM> (or at least partially fills the pump <NUM>). This pump cycle is repeated until the inflatable member <NUM> is deflated.

In some examples, the fluid may automatically (upon movement of the selection member <NUM> to its deflate position) flow out of the inflatable member <NUM> and into the reservoir <NUM> without the user depressing or squeezing the pump <NUM> until the pressure is at least partially equalized between the reservoir <NUM> and the inflatable member <NUM>.

In some examples, after the inflation member <NUM> has been deflated, the pump <NUM> may be squeezed to place the pump in a contracted position or configuration.

<FIG> illustrates an inflatable penile prosthesis <NUM> implanted within a user according to an aspect. <FIG> illustrate the inflatable penile prosthesis <NUM>.

The inflatable penile prosthesis <NUM> may include a pair of cylinders <NUM>, and the pair of cylinders <NUM> are implanted in a penis <NUM>. For example, one of the cylinders <NUM> may be disposed on one side of the penis <NUM>. The other cylinder <NUM> (not shown in <FIG>) of the pair of cylinders may be disposed on the other side of the penis <NUM>. The cylinder <NUM> may include a distal end portion <NUM>, a cavity or inflation chamber <NUM>, and a proximal end portion <NUM> having a rear tip <NUM>.

The inflatable penile prosthesis <NUM> may include a pump assembly <NUM>, which may be implanted into the patient's scrotum <NUM>. A pair of conduit connectors <NUM> may attach the pump assembly <NUM> to the pair of inflatable members or cylinders <NUM> such that the pump assembly <NUM> is in fluid communication with the pair of inflatable members or cylinders <NUM>. Also, the pump assembly <NUM> may be in fluid communication with a reservoir <NUM> via a conduit connector <NUM>. The reservoir <NUM> may be implanted into the user's abdomen <NUM>. The inflation chamber or portion <NUM> of the cylinder <NUM> may be disposed within the penis <NUM>. The distal end portion <NUM> of the cylinder <NUM> may be at least partially disposed within the crown portion <NUM> of the penis <NUM>. The proximal end portion <NUM> may be implanted into the patient's pubic region PR with the rear tip <NUM> proximate the pubic bone PB.

In order to implant the inflatable members or cylinders <NUM>, the surgeon first prepares the patient. The surgeon often makes an incision in the penoscrotal region, e.g., where the base of the penis <NUM> meets with the top of the scrotum <NUM>. From the penoscrotal incision, the surgeon may dilate the patient's corpus cavemosae <NUM> to prepare the patient to receive the pair of inflatable members or cylinders <NUM>. The corpus cavemosum is one of two parallel columns of erectile tissue forming the dorsal part of the body of the penis <NUM>, e.g., two slender columns that extend substantially the length of the penis <NUM>. The surgeon will also dilate two regions of the pubic area (proximal corpora cavernosae) to prepare the patient to receive the proximal end portion <NUM>. The surgeon may measure the length of the proximal and distal corpora cavernosae from the incision and the dilated region of the pubic area to determine an appropriate size of the inflatable members or cylinders <NUM> to implant.

After the patient is prepared, the inflatable penile prosthesis <NUM> is implanted into the patient. The distal tip of the distal end portion <NUM> of each cylinder <NUM> may be attached to a suture. The other end of the suture may be attached to a needle member (e.g., Keith needle). The needle member is inserted into the incision and into the dilated corpus cavemosum. The needle member is then forced through the crown of the penis <NUM>. The surgeon tugs on the suture to pull the cylinder <NUM> into the corpus cavemosum. This is done for each cylinder of the pair of cylinders <NUM>. Once the inflation chamber <NUM> is in place, the surgeon may remove the suture from the distal tip. The surgeon then inserts the proximal end portion <NUM>. The surgeon inserts the rear end of the cylinder <NUM> into the incision and forces the proximal end portion <NUM> toward the pubic bone PB until each cylinder <NUM> is in place.

In the illustrated embodiment, each of the inflatable members or cylinders <NUM> is structurally and functionally similar. Accordingly, only one of the inflatable members or cylinders will be discussed in detail. The inflatable member <NUM> may be capable of expanding upon the injection of fluid into a cavity of the inflatable member <NUM>. For instance, upon injection of the fluid into the inflatable member <NUM>, the inflatable member <NUM> may increase its length and/or width, as well as increase its rigidity. The volumetric capacity of the inflatable member <NUM> may depend on the size of the cylinders. In some examples, the volume of fluid in each cylinder may vary from about <NUM> milliliters in smaller cylinders and to about <NUM> milliliters in larger sizes.

As best illustrated in <FIG>, in the illustrated embodiment, the inflatable member <NUM> is reinforced. In some embodiments, the reinforcement provides increased stiffness or rigidity. In some embodiments, the reinforced inflatable member provides improved reliability or longevity as the reinforced inflatable member may include less layers of material which can become degraded through friction and movement with respect to each other. Additionally, the reinforcement may provide a specific inflation profile (a consistent inflation or an inflation that is varied) based on the location of the reinforcement along the inflatable member <NUM>.

In the illustrated embodiment, the inflatable member <NUM> includes a sidewall <NUM> that defines the cavity or inflation chamber <NUM> that is configured to receive the fluid. Specifically, in the illustrated embodiment, the sidewall <NUM> of the inflatable member <NUM> includes portions or sections that have a larger size or width than other portions or sections of the inflatable member <NUM>. As best illustrated in <FIG>, portion <NUM> of the sidewall <NUM> has a width or size W1 and portion <NUM> of the sidewall <NUM> has a width or size W2. Width or size W2 is larger than width or size W1.

The larger portions of the sidewall <NUM> may provide strength or reinforcement to the inflatable member <NUM>. For example, in some the illustrated embodiment, portion <NUM> of the sidewall <NUM> may have more strength than portion <NUM> of the sidewall <NUM>. Additionally, portion <NUM> of the sidewall <NUM> may be configured to inflate, expand, or stretch more than portion <NUM> of the sidewall <NUM>. In the illustrated embodiment, the sidewall <NUM> includes several sections that have larger widths or sizes and several sections that have smaller widths or sizes.

In the illustrated embodiment, the sidewall <NUM> includes an outer surface <NUM> and an inner surface <NUM>. In the illustrated embodiment, the patterned portion <NUM> extends from the outer surface <NUM>. Accordingly, the outer surface <NUM> includes a series of ridges and troughs. In other words, the outer surface <NUM> is not smooth or consistent. Rather, the outer surface is rough or not smooth. In the illustrated embodiment, the inner surface <NUM> is relatively smooth and does not include any ridges or troughs.

In some embodiments, the pattern <NUM> includes projections. In the illustrated embodiment, the projections are a series of lines, such as a series of intersection lines. In other embodiments, the projections are a series of bumps, domes, or dimples.

In some embodiments, the inflatable member <NUM> is single layer or single tube. In some embodiments, the inflatable member <NUM> is formed of or from a homogenous material. For example, in some embodiments, the inflatable member is formed of a biocompatible material. In some embodiments, the inflatable member is formed of a polymer or a polymeric material. In some embodiments, the inflatable member <NUM> includes an expansion rate or profile that simulates or matches that of a natural erection.

In other embodiments, the inner surface includes a series or projections, ridges or troughs and the outer surface is relatively smooth. For example, as illustrated in <FIG>, in one embodiment, the inflatable member <NUM> includes a sidewall <NUM>. The outer surface <NUM> is relatively consistent or smooth and the inner surface <NUM> includes projections and is not smooth.

According to the invention, both the inner surface and the outer surface include projections, ridges or troughs. For example, in <FIG>, in one embodiment, the inflatable member <NUM> includes a sidewall <NUM>. The outer surface <NUM> of the sidewall <NUM> includes projections and is not smooth and the inner surface <NUM> includes projections and is not smooth. As illustrated in <FIG>, in one embodiment, not forming part of the invention, the projections on the inner surface <NUM> are aligned with the projections of the outer surface <NUM>. As illustrated in <FIG>, in another embodiment of the inflatable member <NUM>, forming part of the invention, the projections of the inner surface <NUM> are offset from the projections of the outer surface <NUM>.

The pump assembly <NUM> may switch between an inflation mode in which the fluid in the reservoir <NUM> is transferred to the inflatable member <NUM> (or inflatable members) through the pump assembly <NUM> in a first direction (e.g., inflation direction) and a deflation mode in which the fluid in the inflatable member <NUM> (or inflatable members) is transferred back to the reservoir <NUM> through the pump assembly <NUM> in a second direction (e.g., deflation direction).

The pump assembly <NUM> includes a pump <NUM> and a valve body <NUM>, and a selection member <NUM>. The selection member may be used to select or change the mode in which the pump assembly <NUM> is in. For example, the selection member <NUM> may be moved from a first position to a second position to place the device in its deflation mode. The selection member <NUM> may then be moved back to its first position to place the device in its inflation mode. In some embodiments, the selection member <NUM> is movable with respect to the valve body <NUM>. For example, the selection member <NUM> may be slidably coupled or slideable with respect to the valve body <NUM>. In some embodiments, the selection member <NUM> includes stop members, such as shoulders or detents that engage members of the valve body <NUM> to lock or help retain the selection member <NUM> in one of its first and second positions.

In the illustrated embodiment, the pump <NUM> includes a flexible member defining a cavity. In some examples, the pump may include a squeeze pump.

Then, when the user wants to deflate the inflatable members <NUM>, the user moves selection member <NUM> to its deflate position. The user may then operate the pump <NUM> to deflate the inflatable members <NUM> (i.e., move the fluid from the inflatable members <NUM> to the reservoir <NUM>). For example, the user may repeatedly depress or squeeze the pump <NUM> until the deflation is completed. The pump <NUM> may then return to its original form, which provides a suction force causing fluid to be drawn into the pump <NUM> from the inflation members <NUM>. The fluid from the inflation members <NUM> fills the pump <NUM> (or at least partially fills the pump <NUM>). This pump cycle is repeated until the inflatable members <NUM> are deflated.

<FIG> illustrate an inflatable member <NUM> according to another embodiment. <FIG> illustrates the inflatable member <NUM> in a partial break-away view. In the illustrated embodiment, the inflatable member <NUM> includes a frame portion <NUM> and a casing portion <NUM>.

The frame portion or member <NUM> is configured to provide strength and rigidity to the inflatable member <NUM>. In some embodiments, the frame portion or member <NUM> is formed of a metal material. For example, in some embodiments, the frame portion or member <NUM> is formed of nitinol. In other embodiments, the frame portion or member <NUM> is formed of a polymer, such as an elastomeric polymer or a non-elastomeric polymer. In some embodiment, the frame portion or member <NUM> is configured to stretch or expand when the inflation member <NUM> is inflated. In some embodiments, the frame portion or member <NUM> is formed of a shape memory material. In some embodiments, the frame portion or member includes a plurality of member or portions that are interwoven or otherwise combined to form the frame portion or member.

The casing portion <NUM> is coupled to the frame portion or member <NUM>. The casing portion <NUM> may be formed of a polymer material. In some embodiments, the casing portion <NUM> is formed of a elastomeric polymer. As best illustrated in <NUM>, in the illustrated embodiment, the casing portion <NUM> surrounds the frame portion <NUM>. In other words, the frame portion <NUM> is disposed within the casing portion <NUM>. In other embodiments, the frame portion <NUM> may be disposed on or proximate an outer surface or an inner surface of the casing portion <NUM>.

Claim 1:
An inflatable penile prosthesis, comprising:
an inflatable member (<NUM>) having a reinforced portion, the inflatable member (<NUM>) including a sidewall (<NUM>) defining a cavity, the sidewall (<NUM>) having an outer surface (<NUM>) and an inner surface (<NUM>) opposite the outer surface (<NUM>), the outer surface (<NUM>), at the reinforced portion, including a plurality of projections extending from the outer surface (<NUM>), the inner surface (<NUM>), at the reinforced portion, including a plurality of projections extending from the inner surface (<NUM>);
a reservoir (<NUM>) configured to hold fluid; and
a pump assembly (<NUM>) configured to facilitate a transfer of the fluid from the reservoir (<NUM>) to the inflatable member (<NUM>) when the prosthesis is in an inflation mode, and facilitate a transfer of the fluid from the inflatable member (<NUM>) to the reservoir (<NUM>) when the prosthesis is in a deflation mode;
characterised in that the plurality of projections of the inner surface are offset from the plurality of projections of the outer surface.