Inflatable penile prosthesis having a cylinder with a core member

Abstract

According to one aspect, an implant includes an inflatable member and a pump assembly configured to facilitate transfer of a fluid to the inflatable member to place the inflatable member in an expanded configuration. The inflatable member has a sidewall defining a lumen and a core member disposed within the lumen. The core member has a surface and defines a plurality of closed cells. The fluid is configured to be disposed adjacent to the surface of the core member when the inflatable member is in the expanded configuration.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Patent Application No. 63 / 364,227, filed May 5, 2022, entitled "Inflatable Penile Prosthesis Having a Cylinder with a Core Member," and to its continuation, U.S. Application No. 18 / 311,501, filed May 3, 2023, entitled "Inflatable Penile Prosthesis Having a Cylinder with a Core Member," the entire disclosure of which is incorporated herein by reference.

[0002] This application also claims priority to U.S. Provisional Patent Application No. 63 / 364,227, filed May 5, 2022, the entire disclosure of which is incorporated herein by reference.

[0003] (Technical field) The present disclosure relates generally to body implants, and more particularly to body implants such as penile prostheses that include an inflatable member. [Background technology]

[0004] One treatment for male erectile dysfunction is the implantation of a penile prosthesis that mechanically erects the penis. Some existing penile prostheses include an inflatable cylinder or member that can be inflated or deflated using a pump mechanism. In some existing devices, the inflatable cylinder or member requires a relatively large force to inflate. Furthermore, in some existing devices, the pump mechanism may require many successive pumps or actuations to inflate the cylinder or member. Furthermore, in some existing devices, the inflatable cylinder or member may assume a flat, unnatural shape when in a deflated configuration. Summary of the Invention [Means for solving the problem]

[0005] According to one aspect, an implant includes an inflatable member and a pump assembly configured to facilitate transfer of a fluid to the inflatable member to place the inflatable member in an expanded configuration. The inflatable member has a sidewall defining a lumen and a core member disposed within the lumen. The core member has a surface and defines a plurality of closed cells. The fluid is configured to be disposed adjacent to the surface of the core member when the inflatable member is in the expanded configuration.

[0006] In some embodiments, the core member has a cylindrical shape. In some embodiments, the core member defines a lumen. In some embodiments, the core member has a cylindrical shape and defines a lumen. In some embodiments, the core member defines a lumen, the lumen configured to receive a fluid when the inflatable member is in the expanded configuration.

[0007] In some embodiments, the fluid is configured to be disposed between the core member and a surface of the sidewall when the inflatable member is in the inflated configuration, hi some embodiments, the fluid is configured to be disposed directly adjacent to the sidewall and directly adjacent to a surface of the sidewall when the inflatable member is in the inflated configuration.

[0008] In some embodiments, the sidewall is formed from a non-intumescent material. In some embodiments, the sidewall is formed from a single layer of material. In some embodiments, the sidewall is formed from a single layer of non-intumescent material.

[0009] In some embodiments, the apparatus includes a container operatively coupled to the pump assembly and configured to hold a fluid.

[0010] In some embodiments, the core member is formed from a closed cell silicone foam material.In some embodiments, the core member is formed from a closed cell urethane foam material.

[0011] In some embodiments, the inflatable member has a tubular shape when in the inflated configuration. In some embodiments, the inflatable member is configured to be set in an inflated configuration and a deflated configuration, and the inflatable member has a tubular shape when in the deflated configuration and has a tubular shape when in the inflated configuration.

[0012] According to another aspect, an implant includes an inflatable member, a reservoir, and a pump assembly. The pump assembly is operatively coupled to the container and the inflatable member. The pump assembly is configured to facilitate transfer of fluid from the reservoir to the inflatable member to place the inflatable member in an expanded configuration. The inflatable member has a sidewall defining a lumen and a core member disposed within the lumen. The core member defines a plurality of closed cells. The fluid is configured to be disposed adjacent the core member and outside of the closed cells when the inflatable member is in the expanded configuration.

[0013] In some embodiments, the fluid is configured to be disposed immediately adjacent to the core member when the inflatable member is in the expanded configuration.

[0014] In some embodiments, the core member has a cylindrical shape. In some embodiments, the core member defines a lumen. In some embodiments, the core member defines a lumen, the lumen configured to receive a fluid when the inflatable member is in the expanded configuration. [Brief description of the drawings]

[0015] [Figure 1] 1 illustrates a schematic diagram of an implant according to one embodiment.

[0016] [Diagram 2] 1 shows an implant according to another embodiment.

[0017] [Diagram 3] 3 illustrates the implant of FIG. 2 implanted within a patient according to one embodiment.

[0018] [Figure 4] FIG. 3 is a perspective view of a cylinder or inflatable member of the implant of FIG. 2.

[0019] [Diagram 5] 3A is a cross-sectional view of the cylinder or inflatable member of the implant of FIG. 2 in a contracted configuration along line CC in FIG. 3.

[0020] [Figure 6] 3A is a cross-sectional view of the cylinder or inflatable member of the implant of FIG. 2 in an expanded configuration along line CC in FIG. 3.

[0021] [Figure 7] FIG. 13 is a perspective view of a core member according to another embodiment.

[0022] [Figure 8] FIG. 8 is a cross-sectional view of a cylinder or inflatable member with a core member of FIG. 7. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] Detailed embodiments are disclosed herein. However, it should be understood that the disclosed embodiments are merely examples and can be embodied in various forms. Therefore, the specific structural and functional details disclosed herein should not be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching those skilled in the art that the embodiments can be variously utilized in substantially any suitable detailed structure. Moreover, the terms and expressions used herein are not intended to be limiting, but rather to provide an understandable description of the present disclosure.

[0024] The term "a" as used herein is 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., an open transition). The terms "coupled" or "moveably coupled" as used herein are defined as connected, although not necessarily directly and mechanically.

[0025] In general, the embodiments are directed to medical devices, such as penile prosthesis or other body implants. Hereinafter, the terms patient or user may be used for a person who may benefit from the medical devices or methods disclosed in this disclosure. For example, a patient may be a person in whose body a medical device or a method for operating a medical device according to the present disclosure is implanted. For example, in some embodiments, a patient may be a human male, a human female, or any other mammal.

[0026] The embodiments described herein can improve the performance of the inflatable member of the device. For example, the inflatable member can have improved stiffness or rigidity, improved reliability, or improved deflation or inflation times. In some embodiments, expanding the inflatable member can be facilitated by reducing the force, pressure, or fluid movement required to expand the inflatable member. Additionally, in some embodiments, the inflatable member can retain or maintain a tubular shape when the inflatable member is set in its contracted configuration.

[0027] An embodiment may include an inflatable penile prosthesis having a pump assembly, an inflatable member, and a reservoir. The inflatable member may be implanted in the corpus cavernosum of a patient or user, the reservoir may be implanted in the abdomen of the user, and the pump assembly may be implanted in the scrotum. The pump assembly may be switched between an inflated position and a deflated position, and a user may operate the device to set the inflatable penile prosthesis in either an inflated mode to transfer fluid from a container to the inflatable member or a deflated mode to return fluid from the inflatable member to the container.

[0028] FIG. 1 illustrates a schematic of an inflatable implant 100 according to one embodiment. In some embodiments, the implant 100 is a penile prosthesis. The inflatable implant 100 includes a reservoir 102, a cylinder or inflatable member 104, and a pump assembly 101 configured to transfer fluid between the reservoir 102 and the inflatable member 104. In some examples, the inflatable member 104 can be implanted in the corpus cavernosum of a user, the reservoir 102 can be implanted in the abdominal or pelvic cavity of a user (e.g., the reservoir 102 can be implanted in a lower portion of a user's abdominal cavity or an upper portion of a user's pelvic cavity), and the pump assembly 101 can be implanted in the user's scrotum.

[0029] The inflatable member 104 can become more rigid and / or expand upon injection of fluid into the cavity of the inflatable member 104. For example, upon injection of fluid into the inflatable member 104, the inflatable member 104 can increase its length and / or width while simultaneously increasing its rigidity. In some embodiments, the inflatable member 104 can include a pair of cylinders or at least two cylinders, for example, a first cylinder member and a second cylinder member. The volume of the inflatable member 104 can depend on the size of the cylinders. In some embodiments, the volume of fluid in each cylinder can vary from about 10 milliliters for small cylinders to about 50 milliliters for large sizes. In some embodiments, the first cylinder member can be larger than the second cylinder member. In another embodiment, the first cylinder member can be the same size as the second cylinder member.

[0030] In some embodiments, the inflatable member 104 or cylinder includes an outer sheath or tubular member 111 and a core member 113. In some embodiments, the outer sheath or tubular member 111 of the inflatable member 104 defines a lumen, and the core member 113 is disposed within the lumen.

[0031] In some embodiments, the outer sheath or tubular member 111 includes a single layer of material. Moreover, in some embodiments, the outer sheath or tubular member 111 is formed from a non-expanding material. In other words, the outer sheath or tubular member 111 is configured to maintain its dimensions and not stretch or expand when a fluid is disposed within the cavity of the outer sheath or tubular member 111. In other embodiments, the outer sheath or tubular member 111 is formed from multiple layers or multiple materials. For example, in some embodiments, the outer sheath or tubular member 111 can be formed from multiple layers. In some embodiments, the multi-layer outer sheath or tubular member 111 is configured not to expand.

[0032] In some embodiments, the core member 113 is formed from a closed cell (or compartment) material. In other words, the core member 113 can be formed from a material that defines a plurality of cavities or cells that are closed or fluidly isolated from one another (not fluidly connected to one another). In such embodiments, a fluid can be disposed adjacent to the core member 113, and the fluid does not enter the cavities or cells defined by the material forming the core member. In some embodiments, the core member 113 is formed from a closed cell silicone foam material. In other embodiments, the core member 113 is formed from a closed cell urethane foam material. In yet other embodiments, the core member 113 is formed from a different material.

[0033] In some embodiments, the inflatable member 104 includes an end cap or end tip. The end tip can be coupled to a terminal portion of the outer sheath. In some embodiments, the structural member is disposed within a lumen defined by the outer sheath and between the end cap or end tip.

[0034] In some embodiments, the core member 113 may allow the inflatable member 104 to inflate at a relatively low pressure. In some embodiments, this may allow a user to inflate the inflatable member 104 with fewer pumps or pump actuations, or may require a user to actuate the pump with less force to inflate the inflatable member 104. More details about the pump assembly 101 are provided below. Additionally, in some embodiments, the core member 113 of the inflatable member 104 may hold or maintain the inflatable member 104 in a tubular shape (or a more anatomically correct shape) when the inflatable member 104 is in its contracted configuration.

[0035] The reservoir 102 may include a container having an internal chamber configured to hold or contain a fluid used to inflate the inflatable member 104. The volume of the reservoir 102 may vary depending on the size of the inflatable penile prosthesis 100. In some embodiments, the volume of the reservoir 102 may be between 3 and 150 cubic centimeters. In some embodiments, the reservoir 102 is composed of the same material as the inflatable member 104. In other embodiments, the reservoir 102 is composed of a different material than the inflatable member 104.

[0036] The inflatable implant 100 may include a first conduit connector 103 and a second conduit connector 105. The first conduit connector 103 and the second conduit connector 105 may each define a lumen configured to transfer fluid to and from the pump assembly 101. The first conduit connector 103 may be coupled to the pump assembly 101 and the reservoir 102 such that fluid may be transferred between the pump assembly 101 and the reservoir 102 via the first conduit connector 103. For example, the first conduit connector 103 may define a first lumen configured to transfer fluid between the pump assembly 101 and the reservoir 102. The first conduit connector 103 may include a single or multiple tubular members for transferring fluid between the pump assembly 101 and the reservoir 102.

[0037] The second conduit connector 105 can be coupled to the pump assembly 101 and the inflatable member 104 such that fluid can be transferred between the pump assembly 101 and the inflatable member 104 via the second conduit connector 105. For example, the second conduit connector 105 can define a second lumen configured to transfer fluid between the pump assembly 101 and the inflatable member 104. The second conduit connector 105 can include a single or multiple tubular members for transferring fluid between the pump assembly 101 and the inflatable member 104. In some embodiments, the first conduit connector 103 and the second conduit connector 105 can include a silicone rubber material.

[0038] The pump assembly 101 can be switched between an inflation mode in which fluid in the reservoir 102 is transferred in a first direction (e.g., an inflation direction) via the pump assembly 101 to the inflatable member 104, and a deflation mode in which fluid in the inflatable member 104 is transferred in a second direction (e.g., a deflation direction) via the pump assembly 101 to the reservoir 102.

[0039] The pump assembly 101 includes a pump (also referred to as a pump bulb) 106 and a valve body 107. The valve body 107 also includes a selection member 109. The selection member 109 can be used to select or change the mode of the pump assembly. For example, the selection member 109 can be moved from a first position to a second position to set the device in its deflation mode. The selection member 109 can then be moved back to the first position to set the device in its inflation mode. In some embodiments, the selection member 109 is movable relative to the valve body 107. For example, in some embodiments, the selection member 109 can be slidably coupled to or slidable relative to the valve body 107.

[0040] The pump 106 can be squeezed or pressed by a user to facilitate the transfer of fluid from the reservoir 102 to the inflatable member 104. For example, in an inflation mode, while a user is operating the pump 106, the pump 106 can receive fluid from the reservoir 102 and then expel the fluid to the inflatable member 104. When the user switches to a deflation mode, at least a portion of the fluid can be automatically transferred back down to the reservoir 102 (due to the pressure differential from the inflatable member 104 to the reservoir 102). The user can then squeeze the inflatable member 104 to facilitate further transfer of fluid via the pump 106 or pump assembly 101 to the reservoir 102.

[0041] In some embodiments, the pump 106 can include a flexible member that defines a cavity. In some embodiments, the pump 106 can define a pump shell having a flexible bulb and a valve body connector, the valve body connector designed to fit at least partially over the valve body 107. In some embodiments, the pump 106 can include a pressure pump. In some embodiments, the pump 106 can include a circular or substantially circular portion. In some embodiments, the pump 106 can include ribs or indentations to assist a user in gripping the pump 106. In an inflation mode, the pump 106 can utilize suction and pressure to move fluid in and out of the cavity of the pump 106. For example, a user can push or squeeze the pump 106 to expel fluid from the cavity, and when the flexible member returns to its original shape, the resulting suction forces the fluid into the cavity of the pump 106. In some embodiments, the pump 106 can have a bulb spring constant designed to refill the pump 106 in a selected time frame.

[0042] As discussed above, the selection member 109 can be used to select or change the mode of the pump assembly. For example, in one embodiment, the selection member 109 can be set to the inflated position, and then the user can operate the pump 106 to inflate the inflatable member 104 (i.e., move fluid from the reservoir 102 to the inflatable member 104). For example, the user can repeatedly press or squeeze the pump 106 until the desired stiffness is achieved.

[0043] In some embodiments, when the reservoir 102 is at least partially pressurized, fluid can automatically flow out of the reservoir 102 and into the inflatable member 104 without the user having to press or squeeze the pump 106 until the pressure is at least partially equal between the reservoir 102 and the inflatable member 104.

[0044] Next, if the user wishes to deflate the inflatable member 104, the user moves the selection member 109 to its retracted position. The user can then operate the pump 106 to deflate the inflatable member 104 (i.e., move fluid from the inflatable member 104 to the reservoir 102). The pump 106 can then return to its original shape providing suction to draw fluid from the inflatable member 104 into the pump 106. The fluid from the inflatable member 104 fills the pump 106 (or at least partially fills the pump 106). This pump cycle is repeated until the inflatable member 104 is deflated.

[0045] In some embodiments, fluid can automatically flow out of the inflatable member 104 and into the reservoir 102 without the user having to press or squeeze the pump 106 until pressure is at least partially equal between the reservoir 102 and the inflatable member 104 (upon movement of the selection member 109 to the contracted position).

[0046] In some embodiments, after the expansion member 104 is deflated, the pump 106 can be squeezed to set the pump in a deflated position or configuration.

[0047] Figure 2 illustrates an implant 200 according to one embodiment. Figure 3 illustrates a schematic of the implant 200 positioned within the body of a user or patient.

[0048] In the illustrated embodiment, the implant 200 is a penile prosthesis. The implant 200 can include a pair of cylinders 204, where the pair of cylinders or inflatable members 204 are implanted into the penis 214. For example, one of the cylinders 204 can be located on one side of the penis 214. The other cylinder 204 of the cylinder pair (not shown in FIG. 3 ) can be located on the opposite side of the penis 214. The cylinder 204 can include a second end 224, a cavity or expansion chamber 222, and a first end 228 having a rear end 232.

[0049] The implant 200 includes a pump assembly 201 that can be implanted in the scrotum 218 of a patient. A pair of conduit connectors 205 can attach the pump assembly 201 to a pair of inflatable members or cylinders 204 such that the pump assembly 201 is in fluid communication with the pair of inflatable members or cylinders 204. The pump assembly 201 can also be in fluid communication with a reservoir 202 via a conduit connector 203. The reservoir 202 can be implanted in the abdomen 219 of a user. An expansion chamber or portion 222 of the cylinder 204 can be located within the penis 214. A second end 224 of the cylinder 204 can be located at least partially within the crown 226 or gland of the penis 214. A first end 228 can be implanted in the pubic region PR of a patient with a rear end 232 proximate the pubic bone PB.

[0050] To implant the inflatable member or cylinder 204, the surgeon first prepares the patient. For example, the surgeon often makes an incision in the penis-scrotum area where the base of the penis 214 meets the top of the scrotum 218. From the incision in the penis-scrotum, the surgeon can expand the patient's corpus cavernosum 240 to prepare the patient to receive the pair of inflatable members or cylinders 204. The corpus cavernosum is one of two parallel columns of erectile tissue that form the dorsal portion of the body of the penis 214, e.g., two elongated columns that run substantially the length of the penis 214. The surgeon also expands two areas of the pubic area (the first corpus cavernosum) to prepare the patient to receive the first end 228. The surgeon can measure the length of the first and second corpora cavernosum from the incision and the expanded area of ​​the pubic area to determine the appropriate size of the inflatable member or cylinder 204 for implantation.

[0051] After the patient has been prepared, the implant 200 is implanted in the patient. The second tip of the second end 224 of each cylinder 204 can be attached to a suture. The other end of the suture can be attached to a needle (e.g., a Keith needle). The needle is inserted through the incision into the expanded corpus cavernosum. The needle is then pushed through the crown or gland of the penis 226. The surgeon pulls on the suture to draw the cylinder 204 into the corpus cavernosum. This is done for each cylinder of the pair of cylinders 204. Once the expansion chamber 222 is in place, the surgeon can release the suture from the second tip. Next, the surgeon inserts the first end 228. The surgeon inserts the rear end of the cylinder 204 into the incision and pushes the first end 228 towards the pubic bone PB until each cylinder 204 is in place.

[0052] In the illustrated embodiment, each of the inflatable members or cylinders 204 are structurally and functionally similar, and therefore, only one of the inflatable members or cylinders will be described in detail.

[0053] Figure 4 is a perspective view of the cylinder or inflatable member of implant 200. Figure 5 is a cross-sectional view of the cylinder or inflatable member 204 of implant 200 when in a contracted configuration, taken along line CC in Figure 3. Figure 6 is a cross-sectional view of the cylinder or inflatable member 204 of implant 200 when in an expanded configuration, taken along line CC in Figure 3.

[0054] The inflatable members 204 can be configured to be more stiff when in an inflated configuration than when in a contracted configuration. Additionally, the inflatable members 204 can expand upon injection of a fluid into a cavity of the inflatable members 204. For example, upon injection of a fluid into the inflatable members 204, the inflatable members 204 can increase in stiffness while simultaneously increasing in length and / or width. The volume of the inflatable members 204 can depend on the size of the cylinders. In some embodiments, the volume of fluid in each cylinder can vary from about 10 milliliters for smaller cylinders to about 50 milliliters for larger sizes.

[0055] In the illustrated embodiment, the inflatable member or cylinder 204 includes an outer sheath or tubular member 292 and a core member 294. The outer sheath or tubular member 292 of the inflatable member 204 has a sidewall 299 and defines a lumen 293. The core member 294 is disposed within the lumen 293.

[0056] In the illustrated embodiment, the outer sheath or tubular member 292 includes a single layer of material. Moreover, in the illustrated embodiment, the outer sheath or tubular member 292 is formed from a non-distensible material. In other words, the outer sheath or tubular member 292 is configured to maintain its dimensions and / or not stretch or expand when a fluid is disposed within the outer sheath lumen 293. In some embodiments, the outer sheath 292 is formed from a woven material, such as a non-distensible woven material.

[0057] In the illustrated embodiment, the core member 294 is formed from a closed cell material. In other words, the core member 294 can be formed from a material that defines a plurality of cavities or cells 291 that are closed or fluidly isolated from one another (not fluidly connected to one another). In the illustrated embodiment, a fluid can be disposed adjacent to the core member 294, and the fluid does not enter the cavities or cells defined by the material forming the core member. In some embodiments, the core member 294 is formed from a closed cell silicone foam material. In other embodiments, the core member 294 is formed from a closed cell urethane foam material. In yet other embodiments, the core member 294 is formed from a different material.

[0058] As best shown in FIGS. 4-6, the core member 294 has a tubular shape and is elongated. The core member 294 is disposed within the lumen 293 and extends within the lumen 293 defined by the outer sheath 292 along the longitudinal axis of the outer sheath 292. In some embodiments, the core member 294 is configured to contract or be compressed when the inflatable member is set in the expanded configuration. Specifically, as best shown in FIG. 5, the core member 294 is sized as a diameter D1 when the inflatable member 204 is in a contracted configuration. As best shown in FIG. 6, the core member 294 is sized as a diameter D2 when the inflatable member 204 is in an expanded configuration. Because the core member 294 contracts when the inflatable member 204 is in an expanded configuration, the diameter D1 is greater than the diameter D2.

[0059] 6, when the inflatable member 204 is set in the expanded configuration, fluid is disposed between a surface of the core member 294 and the outer sheath 292. The fluid does not enter the bubbles or cavities 291 defined by the core member 294.

[0060] Core member 294 has a tubular or rod-like shape, although in other embodiments, the core member can be a different shape. Figure 7 is a perspective view of a core member 394 according to another embodiment. Core member 394 has a cylindrical shape and defines a lumen 395. Lumen 395 extends from one end of core member 394 to the other end of core member 394.

[0061] The core member 394 is formed from a closed cell material. In other words, the core member 394 can be formed from a material that defines a plurality of cavities or cells that are closed or fluidly isolated from one another (not fluidly connected to one another). In the illustrated embodiment, a fluid can be disposed adjacent to the core member 394, and the fluid does not enter the cavities or cells defined by the material forming the core member. In some embodiments, the core member 394 is formed from a closed cell silicone foam material. In other embodiments, the core member 394 is formed from a closed cell urethane foam material. In yet other embodiments, the core member 394 is formed from a different material.

[0062] The core member 394 may be disposed within a lumen defined by the outer sheath. As best seen in FIG. 8, when the inflatable member is set in the expanded configuration, a fluid is disposed between a surface of the core member 394 and the outer sheath 292. The fluid is also configured to be disposed within a lumen 395 defined by the core member 394. The fluid does not enter bubbles or cavities 393 defined by the core member 394.

[0063] In some embodiments, the core member 294 (or core member 394) can allow the inflatable member 204 to be inflated at a relatively lower pressure. In some embodiments, this can allow a user to inflate the inflatable member 204 with fewer pumps or pump actuations, or the user can actuate the pump with less force to inflate the inflatable member 204. More details on the pump assembly 201 are provided below. Additionally, in some embodiments, the core member 294 of the inflatable member 204 can hold or maintain the inflatable member 204 in a tubular shape (or a more anatomically correct shape) when the inflatable member 204 is in its contracted configuration.

[0064] The pump assembly 201 can be switched between an inflation mode in which fluid in the reservoir 202 is transferred in a first direction (e.g., an inflation direction) via the pump assembly 201 to the inflatable member 204 (or multiple inflatable members), and a deflation mode in which fluid in the inflatable member 204 (or inflatable member) is transferred in a second direction (e.g., a deflation direction) via the pump assembly 201 to the reservoir 202.

[0065] The pump assembly 201 includes a pump bulb or pump 231, a valve body 233, and a selection member 239. The selection member can be used to select or change the mode of the pump assembly 201. For example, the selection member 239 can be moved from a first position to a second position to set the device in its deflation mode. The selection member 239 can then be moved back to the first position to set the device in its inflation mode. In some embodiments, the selection member 239 is movable relative to the valve body 233. For example, the selection member 239 can be slidably coupled or slidable relative to the valve body 233. In some embodiments, the selection member 239 includes a stop member, such as a shoulder or detent, that engages with a member of the valve body 233 to help secure or hold the selection member 239 in one of its first and second positions. In another embodiment, the selection member 239 can be located or coupled to another portion of the device.

[0066] The pump 231 can be squeezed or pressed by a user to facilitate the transfer of fluid from the reservoir 202 to the inflatable member 204. For example, in an inflation mode, while a user is operating the pump 231, the pump 231 can receive fluid from the reservoir 202 and then expel the fluid to the inflatable member 204. When the user switches to a deflation mode, at least a portion of the fluid can be automatically transferred back down to the reservoir 202 (due to the pressure differential from the inflatable member 204 to the reservoir 202). The user can then squeeze the inflatable member 204 to facilitate further transfer of fluid via the pump 231 to the reservoir 202.

[0067] Next, when the user wishes to deflate the inflatable member 204, the user moves the selection member 239 to its deflated position. The user can then operate the pump 231 to deflate the inflatable member 204 (i.e., move fluid from the inflatable member 204 to the reservoir 202). For example, the user can repeatedly press or squeeze the pump 231 until deflation is complete. The pump 231 can then return to its original configuration providing suction that draws fluid from the inflatable member 204 into the pump 231. Fluid from the inflatable member 204 fills (or at least partially fills) the pump 231. This pump cycle is repeated until the inflatable member 204 is deflated.

[0068] In some embodiments, fluid can automatically flow out of the inflatable member 204 and into the reservoir 202 without the user having to press or squeeze the pump 231 until pressure is at least partially equal between the reservoir 202 and the inflatable member 204 (upon movement of the selection member 239 to its contracted position).

[0069] In some embodiments, after the expansion member 204 is deflated, the pump 231 can be squeezed to set the pump in a deflated position or configuration.

[0070] While certain features of the described embodiments have been described herein, many modifications, substitutions, changes, and equivalents will occur to those skilled in the art, and it is therefore to be understood that the appended claims are intended to cover all such modifications and variations as are within the scope of the embodiments. [Explanation of symbols]

[0071] 200 Implants 201 Pump assembly 202 Container 203 Conduit Connector 204 Cylinder 205 Conduit Connector 214 Penis 218 Scrotum 219 Abdomen 222 Expansion chamber 224 Second End 226 Crown of the penis 226 228 First End 231 Pump 232 Rear end 233 Valve body 239 Selected Part 1 240 Corpus cavernosum 291 Cavities or bubbles 292 Tubular members 293 Lumen 294 Core Members 299 Side wall LA Longitudinal Axis

Claims

1. An inflatable member; a pump assembly configured to facilitate transfer of fluid to the inflatable member to place the inflatable member in an inflated configuration; An implant comprising: The implant, wherein the inflatable member has a sidewall defining a lumen and a core member disposed within the lumen, the core member having a surface and defining a plurality of closed cells, the fluid being configured to be disposed adjacent to the surface of the core member when the inflatable member is in the expanded configuration.

2. The implant of claim 1 , wherein the core member has a cylindrical shape.

3. The implant of claim 1 , wherein the core member defines an internal cavity.

4. The implant of claim 1 , wherein the core member has a cylindrical shape and defines an internal cavity.

5. The implant of claim 1 , wherein the core member defines a lumen, the lumen configured to receive the fluid when the inflatable member is in the expanded configuration.

6. The implant of any of claims 1 to 5, wherein the fluid is configured to be disposed between the core member and a surface of the sidewall when the inflatable member is in the expanded configuration.

7. The implant of any of claims 1 to 5, wherein the fluid is configured to be disposed immediately adjacent to the side wall and immediately adjacent to a surface of the side wall when the inflatable member is in the expanded configuration.

8. The implant of any one of claims 1 to 7, wherein the sidewall is formed from a non-distensible material.

9. The implant of any one of claims 1 to 7, wherein the sidewall is formed from a single layer of material.

10. The implant of any one of claims 1 to 7, wherein the sidewall is formed from a single layer of non-distensible material.

11. The implant of any of claims 1-10, further comprising a reservoir operatively coupled to the pump assembly and configured to hold the fluid.

12. The implant of any one of claims 1 to 11, wherein the core member is formed from a closed cell silicone foam material.

13. The implant of any one of claims 1 to 11, wherein the core member is formed from a closed cell urethane foam material.

14. The implant of any of claims 1 to 13, wherein the inflatable member has a tubular shape when in the expanded configuration.

15. 14. The implant of any of claims 1 to 13, wherein the inflatable member is configured to be set in the inflated and deflated configurations, the inflatable member having a tubular shape when in the deflated configuration and having a tubular shape when in the expanded configuration.

16. An inflatable member; a pump assembly configured to facilitate transfer of fluid to the inflatable member to place the inflatable member in an inflated configuration; An implant comprising: The implant, wherein the inflatable member has a sidewall defining a lumen and a core member disposed within the lumen, the core member having a surface and defining a plurality of closed cells, the fluid being configured to be disposed adjacent to the surface of the core member when the inflatable member is in the expanded configuration.

17. The implant of claim 16 , wherein the core member has a cylindrical shape.

18. The implant of claim 16 , wherein the core member defines a lumen.

19. The implant of claim 16 , wherein the core member has a cylindrical shape and defines an internal cavity.

20. The implant of claim 16 , wherein the core member defines a lumen, the lumen configured to receive the fluid when the inflatable member is in the expanded configuration.

21. 17. The implant of claim 16, wherein the fluid is configured to be disposed between the core member and a surface of the sidewall when the inflatable member is in the expanded configuration.

22. 17. The implant of claim 16, wherein the fluid is configured to be disposed immediately adjacent the sidewall and immediately adjacent a surface of the sidewall when the inflatable member is in the expanded configuration.

23. 17. The implant of claim 16, wherein the sidewall is formed from a non-distensible material.

24. 17. The implant of claim 16, wherein the sidewall is formed from a single layer of material.

25. 17. The implant of claim 16, wherein the sidewall is formed from a single layer of non-distensible material.

26. 17. The implant of claim 16, further comprising a reservoir operatively coupled to the pump assembly and configured to hold the fluid.

27. 17. The implant of claim 16, wherein the core member is formed from a closed cell silicone foam material.

28. 17. The implant of claim 16, wherein the core member is formed from a closed cell urethane foam material.

29. 17. The implant of claim 16, wherein the inflatable member has a tubular shape when in the expanded configuration.

30. 17. The implant of claim 16, wherein the expandable member is configured to be set in the expanded and contracted configurations, the expandable member having a tubular shape when in the contracted configuration and having a tubular shape when in the expanded configuration.

31. An inflatable member; A reservoir; a pump assembly operatively coupled to the reservoir and the inflatable member, the pump assembly configured to facilitate the transfer of fluid from the reservoir to the inflatable member to set the inflatable member in an expanded configuration; and An implant comprising: The implant, wherein the inflatable member has a sidewall defining a lumen and a core member disposed within the lumen, the core member defining a plurality of closed cells, the fluid being configured to be adjacent the core member and disposed outside of the closed cells when the inflatable member is in the expanded configuration.

32. 32. The implant of claim 31, wherein the fluid is configured to be disposed immediately adjacent to the core member when the inflatable member is in the expanded configuration.

33. 32. The implant of claim 31 , wherein the core member has a cylindrical shape.

34. 32. The implant of claim 31 , wherein the core member defines an internal cavity.

35. 32. The implant of claim 31, wherein the core member defines an internal lumen, the internal lumen configured to receive the fluid when the inflatable member is in the expanded configuration.

Images