Inflatable penis prosthesis having cylinder with core member

By using a combination of multi-closed structure and non-extended materials in penis prosthesis, penis prosthesis that expands under low pressure and maintains a natural shape is achieved, solving the problems of large force and unnatural shape in the prior art, and improving the Equipment performance and convenience of use.

CN119183369APending Publication Date: 2024-12-24BOSTON SCIENTIFIC SCIMED INC
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Patent Information

Application Number
CN202380038565.6
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2023-05-03
Filing Date
2023-05-04
Publication Date
2024-12-24

AI Technical Summary

Technical Problem

Existing penile prostheses require relatively large amounts of force when expanded and may exhibit an unnatural flat shape when contracting configurations, and the pump mechanism needs to be activated multiple times.

Method used

An implant including an expandable member and a pump assembly is designed, and the expansion member is expanded at low pressure and contracted by transfer of fluid using a plurality of closed-cell structures of the core member and the side walls of non-extended material. Maintains the tubular shape while maintaining the pump assembly toggles between expansion and contraction modes.

Benefits of technology

It realizes the penis prosthesis expanding under less force and low pressure, and maintains its natural shape when contracting, reducing the number of activations of the pump mechanism, and improving the reliability and convenience of use of the equipment.

✦ Generated by Eureka AI based on patent content.

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Abstract

According to one aspect, an implant (200) includes an expandable member (204) and a pump assembly (201). A pump assembly (201) is configured to facilitate transfer of fluid to the expandable member to place the expandable member in the expanded configuration. The expandable member has a sidewall (299) defining a lumen and a core member (294) disposed within the lumen. The core member has a surface and defines a plurality of closed pores. The fluid is configured to be disposed adjacent a surface of the core member when the expandable member is in the expanded configuration.
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Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application is a continuation of and claims priority to U.S. non-provisional patent application No. 18 / 311,501, filed on May 3, 2023, entitled “INFLATABLE PENILE PROSTHESIS HAVING ACYLINDER WITH A CORE MEMBER,” which claims priority to U.S. Provisional Patent Application No. 63 / 364,227, filed on May 5, 2022, entitled “INFLATABLE PENILE PROSTHESIS HAVING A CYLINDER WITH ACORE MEMBER,” the disclosure of which is incorporated herein by reference in its entirety.

[0003] This application also claims priority to U.S. Provisional Patent Application No. 63 / 364,227, filed on May 5, 2022, the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0004] The present disclosure relates generally to body implants and, more particularly, to body implants, such as penile prostheses, that include expandable members. Background Art

[0005] One treatment for male erectile dysfunction is to implant a penile prosthesis that mechanically erects the penis. Some existing penile prostheses include an expandable cylinder or member that can be expanded or contracted using a pump mechanism. In some existing devices, the expandable cylinder or member requires a relatively large amount of force to expand. In addition, in some existing devices, the pump mechanism may require many consecutive squeezes or activations to expand the cylinder or member. Furthermore, in some existing devices, the expandable cylinder or member may assume a flat, unnatural shape when in the contracted configuration. Summary of the invention

[0006] According to one aspect, an implant includes an expandable member and a pump assembly. The pump assembly is configured to facilitate the transfer of fluid to the expandable member to place the expandable member in an expanded configuration. The expandable member has a side wall 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 expandable member is in the expanded configuration.

[0007] 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 an inner cavity. In some embodiments, the core member defines an inner cavity that is configured to receive fluid when the expandable member is in an expanded configuration.

[0008] In some embodiments, the fluid is configured to be disposed between the core member and a surface of the sidewall when the expandable member is in the expanded configuration. In some embodiments, the fluid is configured to be disposed directly adjacent to the sidewall and a surface of the sidewall when the expandable member is in the expanded configuration.

[0009] In some embodiments, the sidewalls are formed of a non-expandable material. In some embodiments, the sidewalls are formed of a single layer of material. In some embodiments, the sidewalls are formed of a single layer of non-expandable material.

[0010] In some embodiments, the apparatus includes a reservoir operably coupled to the pump assembly and configured to store a fluid.

[0011] In some embodiments, the core member is formed of a closed cell silicone foam material. In some embodiments, the core member is formed of a closed cell urethane foam material.

[0012] In some embodiments, the expandable member has a tubular shape when in the expanded configuration. In some embodiments, the expandable member is configured to be placed in an expanded configuration and a collapsed configuration, the expandable member having a tubular shape when in the collapsed configuration and having a tubular shape when in the expanded configuration.

[0013] According to another aspect, an implant includes an expandable member, a reservoir, and a pump assembly. The pump assembly is operably coupled to the reservoir and the expandable member. The pump assembly is configured to facilitate transfer of fluid from the reservoir and to the expandable member to place the expandable member in an expanded configuration. The expandable member has a sidewall defining a lumen and a core member disposed within the lumen. The core member defines a plurality of obturators. The fluid is configured to be disposed adjacent to the core member and outside the obturator when the expandable member is in the expanded configuration.

[0014] In some embodiments, the fluid is configured to be disposed directly adjacent to the core member when the expandable member is in the expanded configuration.

[0015] 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 configured to receive a fluid when the expandable member is in the expanded configuration. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 An implant according to an embodiment is schematically shown.

[0017] Figure 2 An implant according to another embodiment is shown.

[0018] Figure 3 The implantation of the patient in accordance with the embodiment is shown Figure 2 implants.

[0019] Figure 4 yes Figure 2 A perspective view of the cylindrical or expandable member of an implant.

[0020] Figure 5 is along Figure 3 The line CC intercepted in the contracted configuration Figure 2 A cross-sectional view of a cylindrical or expandable member of an implant.

[0021] Figure 6 is along Figure 3 The line CC intercepted in the expanded configuration Figure 2 A cross-sectional view of a cylindrical or expandable member of an implant.

[0022] Figure 7 is a perspective view of a core member according to another embodiment.

[0023] Figure 8 Is has Figure 7 A cross-sectional view of a cylindrical or expandable member of a core member. DETAILED DESCRIPTION

[0024] Detailed embodiments are disclosed herein. However, it should be understood that the disclosed embodiments are merely examples, which may be embodied in various forms. Therefore, the specific structural and functional details disclosed herein should not be interpreted as limiting, but only as a basis for the claims and as a representative basis for teaching those skilled in the art to adopt the embodiments differently in almost any appropriately detailed structure. In addition, the terms and phrases used herein are not intended to be limiting, but to provide an understandable description of the present disclosure.

[0025] 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 transitions). The terms "coupled" or "removably coupled" as used herein are defined as connected, although not necessarily directly and mechanically.

[0026] In general, embodiments are directed to medical devices, such as penile prostheses or other body implants. The term patient or user may be used hereinafter for a person who benefits from a medical device or method disclosed in the present disclosure. For example, a patient may be a person whose body has a medical device implanted therein or a method for operating the medical device disclosed by the present disclosure. For example, in some embodiments, a patient may be a human male, a human female, or any other mammal.

[0027] The embodiments discussed herein can improve the performance of the expandable member of the device. For example, the expandable member can have improved stiffness or rigidity, improved reliability, or improved contraction or expansion time. In some embodiments, the expansion of the expandable member can be facilitated by requiring less force, less pressure, or less fluid transfer to expand the expandable member. Additionally, in some embodiments, the expandable member can maintain or maintain a tubular shape when the expandable member is in its contracted configuration.

[0028] Embodiments may include an inflatable penile prosthesis having a pump assembly, an inflatable member, and a reservoir. The inflatable member may be implanted in the corpora cavernosa 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 switchable between an inflated position and a retracted position such that a user may operate the device to place the inflatable penile prosthesis in an inflated mode to transfer fluid from the reservoir to the inflatable member or in a retracted mode to transfer fluid from the inflatable member back to the reservoir.

[0029] Figure 1 An inflatable implant 100 according to one aspect is schematically illustrated. In some embodiments, the implant 100 is a penile prosthesis. The inflatable implant 100 includes a reservoir 102, a cylindrical or inflatable member 104, and a pump assembly 101, which is 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 user's corpora cavernosa, the reservoir 102 can be implanted in the user's abdomen or pelvis (e.g., the reservoir 02 can be implanted in the lower portion of the user's abdomen or the upper portion of the user's pelvis), and the pump assembly 101 can be implanted in the user's scrotum.

[0030] When fluid is injected into the cavity of expandable member 104, expandable member 104 can become more rigid and / or expand. For example, when fluid is injected into expandable member 104, expandable member 104 can increase its length and / or width, as well as increase its rigidity. In some examples, expandable member 104 may include a pair of cylinders or at least two cylinders, such as a first cylindrical member and a second cylindrical member. The volume capacity of expandable member 104 can depend on the size of the cylinders. In some examples, the volume of fluid in each cylinder can vary from about 10 milliliters in a smaller cylinder and vary to about 50 milliliters in a larger size. In some examples, the first cylindrical member can be larger than the second cylindrical member. In other examples, the first cylindrical member can have the same size as the second cylindrical member.

[0031] In some embodiments, the expandable 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 expandable member 104 defines a lumen, and the core member 113 is disposed within the lumen.

[0032] In some embodiments, the outer sheath or tubular member 111 comprises a single layer of material. Additionally, in some embodiments, the outer sheath or tubular member 111 is formed of a non-expandable material. In other words, the outer sheath or tubular member 111 is configured to maintain its size and not stretch or expand when a fluid is disposed within the lumen of the outer sheath or tubular member 111. In other embodiments, the outer sheath or tubular member 111 is formed of multiple layers or materials. For example, in some embodiments, the outer sheath or tubular member 111 can be formed of more than one layer. In some embodiments, the multi-layer outer sheath or tubular member 111 is configured not to expand.

[0033] In some embodiments, core member 113 is formed by closed cell material. In other words, core member 113 can be formed by the material that limits multiple cavities or cells, and these cavities or cells are closed or fluid-isolated from each other (they are not fluid-coupled from each other). In such embodiments, fluid can be set to be adjacent to core member 113, and fluid will not enter the cavity or cell defined by the material forming core member. In some embodiments, core member 113 is formed by closed cell silicone foam material. In other embodiments, core member 113 is formed by closed cell polyurethane foam material. In yet other embodiments, core member 113 is formed by different materials.

[0034] In some embodiments, the expandable member 104 includes an end cap or end tip member. The end tip member can be coupled to the end portion of the outer sheath. In some embodiments, the structural member is disposed within the lumen defined by the outer sheath and is disposed between the end cap or end tip member.

[0035] In some embodiments, the core member 113 can allow the expandable member to expand at a relatively low pressure. In some embodiments, this can allow the user to expand the expandable member 104 with fewer pumps or activations of the pump, or can allow the user to apply less force to the pump to expand the expandable member 104. The details of the pump assembly 101 are described below. In addition, in some embodiments, the core member 113 of the expandable member 104 can allow the expandable component 104 to maintain or maintain a tubular shape (or a more anatomically correct shape) when the expandable member 104 is in its collapsed configuration.

[0036] The reservoir 102 can include a container having an internal chamber that is configured to hold or contain a fluid used to inflate the expandable member 104. The volume capacity of the reservoir 102 can vary depending on the size of the inflatable penile prosthesis 100. In some examples, the volume capacity of the reservoir 102 can be 3 to 150 cubic centimeters. In some examples, the reservoir 102 is constructed of the same material as the expandable member 104. In other examples, the reservoir 102 is constructed of a different material than the expandable member 104.

[0037] The expandable implant 100 may include a first catheter connector 103 and a second catheter connector 105. Each of the first catheter connector 103 and the second catheter connector 105 may define a lumen configured to transfer fluid to and from the pump assembly 101. The first catheter connector 103 may be coupled to the pump assembly 101 and the reservoir 102 such that the fluid may be transferred between the pump assembly 101 and the reservoir 102 via the first catheter connector 103. For example, the first catheter connector 103 may define a first lumen configured to transfer fluid between the pump assembly 101 and the reservoir 102. The first catheter connector 103 may include a single or multiple tubular members for transferring fluid between the pump assembly 101 and the reservoir 102.

[0038] The second conduit connector 105 can be coupled to the pump assembly 101 and the expandable member 104 so that fluid can be transferred between the pump assembly 101 and the expandable 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 expandable member 104. The second conduit connector 105 may include a single or multiple tube members for transferring fluid between the pump assembly 101 and the expandable member 104. In some examples, the first conduit connector 103 and the second conduit connector 105 may include a silicone rubber material.

[0039] The pump assembly 101 can switch between an expansion mode (in which the fluid in the reservoir 102 is transferred to the expandable member 104 in a first direction (e.g., an expansion direction) through the pump assembly 101) and a contraction mode (in which the fluid in the expandable member 104 is transferred back to the reservoir 102 in a second direction (e.g., a contraction direction) through the pump assembly 101).

[0040] The pump assembly 101 includes a pump (also referred to as a pump bulb member) 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 in which the pump assembly is located. For example, the selection member 109 can be moved from a first position to a second position to place the device in its contraction mode. The selection member 109 can then be moved back to its first position to place the device in its expansion 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 is slidably coupled or slidable relative to the valve body 107.

[0041] The pump 106 may be squeezed or pressed by the user in order to facilitate the transfer of fluid from the reservoir 102 to the expandable member 104. For example, in the expansion mode, when the user is operating the pump 106, the pump 106 may receive fluid from the reservoir 102 and then output the fluid to the expandable member 104. When the user switches to the deflation mode, at least some of the fluid may be automatically transferred back to the reservoir 102 (due to the pressure differential from the expandable member 104 to the reservoir 102). The user may then squeeze the expandable member 104 to facilitate further transfer of fluid to the reservoir 102 through the pump 106 or pump assembly 101.

[0042] In some examples, the pump 106 may include a flexible member defining a cavity. In some examples, the pump 106 may define a pump housing having a flexible bulb and a valve body connector, wherein the valve body connector is designed to be at least partially mounted on the valve body 107. In some examples, the pump 106 may include a squeeze pump. In some examples, the pump 106 may include a circular or substantially circular portion. In some examples, the pump 106 may include ribs or depressions to help the user grip the pump 106. In the expansion mode, the pump 106 may use suction and pressure to move fluid into and out of the cavity of the pump 106. For example, the user may press or squeeze the pump 106 to expel the fluid from the cavity, and when the flexible member returns to its original shape, the suction generated pushes the fluid into the cavity of the pump 106. In some examples, the pump 106 may have a bulb spring rate designed to refill the pump 106 in a selected time frame.

[0043] As discussed above, selection member 109 can be used to select or change the mode that the pump assembly is in. For example, in one embodiment, selection member 109 can be placed in an expanded position, and the user can then operate pump 106 to expand expandable member 104 (i.e., move fluid from reservoir 102 to expandable member 104). For example, the user can repeatedly press or squeeze pump 106 until a desired stiffness is achieved.

[0044] In some examples, if reservoir 102 is at least partially pressurized, fluid may automatically flow out of reservoir 102 and into expandable member 104 without the user having to press or squeeze pump 106 until pressure is at least partially equalized between reservoir 102 and expandable member 104 .

[0045] Then, when the user wants to deflate the expandable member 104, the user moves the selection member 109 to its deflated position. The user can then operate the pump 106 to deflate the expandable member 104 (i.e., move fluid from the expandable member 104 to the reservoir 102). The pump 106 can then return to its original form, which provides suction, causing fluid from the expansion member 104 to be drawn into the pump 106. The fluid from the expansion member 104 fills the pump 106 (or at least partially fills the pump 106). This pump cycle repeats until the expandable member 104 is deflated.

[0046] In some examples, fluid can automatically (when selection member 109 is moved to its retracted position) flow out of expandable member 104 and into reservoir 102 without the user having to press or squeeze pump 106 until pressure is at least partially equalized between reservoir 102 and expandable member 104.

[0047] In some examples, after the expansion member 104 has been deflated, the pump 106 may be squeezed to place the pump in a deflated position or configuration.

[0048] Figure 2 An implant 200 according to one aspect is shown. Figure 3 An implant 200 is schematically shown placed within the body of a user or patient.

[0049] In the illustrated embodiment, the implant 200 is a penile prosthesis. The implant 200 may include a pair of cylinders 204, and the pair of cylinders or expandable members 204 are implanted in the penis 214. For example, one of the cylinders 204 may be disposed on one side of the penis 214. The other cylinder 204 ( Figure 3 214. The cylinder 204 may include a second end portion 224, a cavity or expansion chamber 222, and a first end portion 228 having a rear tip 232.

[0050] The implant 200 includes a pump assembly 201 that can be implanted in a patient's scrotum 218. A pair of catheter connectors 205 can attach the pump assembly 201 to the pair of expandable members or cylinders 204 so that the pump assembly 201 is in fluid communication with the pair of expandable members or cylinders 204. In addition, the pump assembly 201 can be in fluid communication with a reservoir 202 via a catheter connector 203. The reservoir 202 can be implanted in the patient's abdomen 219. The expansion chamber or portion 222 of the cylinder 204 can be disposed within the penis 214. The second end portion 224 of the cylinder 204 can be at least partially disposed within the corona 226 or gland of the penis 214. The first end portion 228 can be implanted in the patient's pubic region PR, with the rear tip 232 proximate the pubic bone PB.

[0051] To implant the inflatable members or cylinders 204, the surgeon first prepares the patient. The surgeon often makes an incision in the penoscrotal region (e.g., where the base of the penis 214 meets the top of the scrotum 218). From the penoscrotal incision, the surgeon can dilate the patient's corpora cavernosa 240 to prepare the patient to receive the pair of inflatable members or cylinders 204. The corpora cavernosa are one of the two parallel columns of erectile tissue that form the back of the body of the penis 214, e.g., two elongated columns that extend substantially the length of the penis 214. The surgeon will also dilate two areas of the pubic region (the first corpora cavernosa) to prepare the patient to receive the first end portion 228. The surgeon can measure the length of the first corpora cavernosa and the second corpora cavernosa based on the incision and the dilated area of ​​the pubic region to determine the appropriate size of the inflatable member or cylinder 204 to be implanted.

[0052] After preparing the patient, the implant 200 is implanted in the patient. The second tip of the second end portion 224 of each cylinder 204 can be attached to a suture. The other end of the suture can be attached to a needle member (e.g., a Keith needle). The needle member is inserted into the incision and inserted into the expanded corpus cavernosum. The needle member is then forced through the crown or gland of the penis 226. The surgeon pulls the suture to pull 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 remove the suture from the second tip. The surgeon then inserts the first end portion 228. The surgeon inserts the rear end of the cylinder 204 into the incision and forces the first end portion 228 toward the pubic bone PB until each cylinder 204 is in place.

[0053] In the illustrated embodiment, each of the expandable members or cylinders 204 are similar in structure and function. Therefore, only one of the expandable members or cylinders will be discussed in detail.

[0054] Figure 4 is a perspective view of the cylindrical body or expandable member of implant 200. Figure 5 is along Figure 3 2 is a cross-sectional view of the cylindrical body or expandable member 204 of the implant 200 when in a collapsed configuration, taken along line CC. Figure 6 is along Figure 3 2 is a cross-sectional view of the cylindrical body or expandable member 204 of the implant 200 when in an expanded configuration, taken along line CC.

[0055] The expandable member 204 can be configured to be more rigid when in an expanded configuration than when in a contracted configuration. Additionally, the expandable member 204 can be capable of expanding when a fluid is injected into the cavity of the expandable member 204. For example, when a fluid is injected into the expandable member 204, the expandable member 204 can increase its length and / or width, as well as increase its rigidity. The volume capacity of the expandable member 204 can depend on the size of the cylinder. In some examples, the volume of fluid in each cylinder can vary from about 10 milliliters in a smaller cylinder and vary to about 50 milliliters in a larger size.

[0056] In the illustrated embodiment, the expandable 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 expandable member 204 has a sidewall 299 and defines a lumen 293. The core member 294 is disposed within the lumen 293.

[0057] In the illustrated embodiment, the outer sheath or tubular member 292 comprises a single layer of material. Additionally, in the illustrated embodiment, the outer sheath or tubular member 292 is formed of a non-expandable material. In other words, the outer sheath or tubular member 292 is configured to maintain its size and / or not stretch or expand when a fluid is disposed within the lumen 293 of the outer sheath. In some embodiments, the outer sheath 292 is formed of a fabric material, such as a non-expandable fabric material.

[0058] In the illustrated embodiment, core member 294 is formed by closed cell material. In other words, core member 294 can be formed by the material that defines multiple cavities or cells 291, and these cavities or cells are closed or fluid-isolated from each other (they are not fluid-coupled from each other). In the illustrated embodiment, fluid can be set to be adjacent to core member 294, and fluid will not enter the cavity or cell defined by the material forming core member. In certain embodiments, core member 294 is formed by closed cell silicone foam material. In other embodiments, core member 294 is formed by closed cell polyurethane foam material. In other embodiments, core member 294 is formed by different materials.

[0059] like Figures 4 to 6As best shown in FIG. 2 , the core member 294 has a tubular shape and is elongated. The core member 294 is disposed within the lumen 293 and extends along the longitudinal axis of the outer sheath 292 within the lumen 293 defined by the outer sheath 292. In some embodiments, the core member 294 is configured to compress or be compressed when the expandable member is placed in the expanded configuration. Specifically, as shown in FIG. Figure 5 As best shown in FIG. 2 , when the expandable member 204 is in the collapsed configuration, the core member 294 has a size, such as a diameter D1. Figure 6 , when the expandable member 204 is in the expanded configuration, the core member 294 has a size, such as a diameter D2. When the core member 294 is compressed when the expandable member 204 is in the expanded configuration, the diameter D1 is greater than the diameter D2.

[0060] like Figure 6 , when the expandable member 204 is placed in the expanded configuration, the fluid is disposed between the surface of the core member 294 and the outer sheath 292. The fluid does not enter the cells or lumens 291 defined by the core member 294.

[0061] While core member 294 has a tubular or rod-like shape, in other embodiments, the core member may have a different shape. Figure 7 394 is a perspective view of a core member 394 according to another embodiment. The core member 394 has a cylindrical shape and defines a lumen 395. The lumen 395 extends from one end of the core member 394 to the other end of the core member 394.

[0062] The core member 394 is formed by a closed cell material. In other words, the core member 394 can be formed by a material that defines a plurality of cavities or cells, which are closed or fluidically isolated from each other (they are not fluidically coupled to each other). In the illustrated embodiment, a fluid can be arranged adjacent to the core member 394, and the fluid will not enter the cavity or cell defined by the material forming the core member. In some embodiments, the core member 394 is formed by a closed cell silicone foam material. In other embodiments, the core member 394 is formed by a closed cell polyurethane foam material. In yet other embodiments, the core member 394 is formed by different materials.

[0063] The core member 394 may be disposed within a lumen defined by the outer sheath. Figure 8 Best shown, when the expandable member is placed in the expanded configuration, the fluid is disposed between the surface of the core member 394 and the outer sheath 292. The fluid is also configured to be disposed within the lumen 395 defined by the core member 394. The fluid does not enter the cells or cavities 393 defined by the core member 394.

[0064] In some embodiments, the core member 294 (or core member 394) can allow the expandable member 204 to expand at a relatively low pressure. In some embodiments, this can allow the user to expand the expandable member 204 with fewer pumps or activations of the pump, or can allow the user to apply less force to the pump to expand the expandable member 204. The details of the pump assembly 201 are described below. In addition, in some embodiments, the core member 294 of the expandable member 204 can allow the expandable member 204 to maintain or maintain a tubular shape (or a more anatomically correct shape) when the expandable member 204 is in its collapsed configuration.

[0065] The pump assembly 201 can switch between an expansion mode (in which the fluid in the reservoir 202 is transferred to the expandable member 204 in a first direction (e.g., an expansion direction) through the pump assembly 201) and a contraction mode (in which the fluid in the expandable member 204 (or expandable member) is transferred back to the reservoir 202 in a second direction (e.g., a contraction direction) through the pump assembly 201).

[0066] The pump assembly 201 includes a pump ball member or pump 231, a valve body 233, and a selection member 239. The selection member can be used to select or change the mode in which the pump assembly 201 is located. For example, the selection member 239 can be moved from a first position to a second position to place the device in its contraction mode. The selection member 239 can then be moved back to its first position to place the device in its expansion mode. In some embodiments, the selection member 239 is movable relative to the valve body 233. For example, the selection member 239 can be slidingly 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 stopper, which engages with a member of the valve body 233 to lock the selection member 239 or help maintain it in one of its first and second positions. In other embodiments, the selection member 239 can be disposed or coupled to another part of the device.

[0067] The pump 231 can be squeezed or pressed by the user to facilitate the transfer of fluid from the reservoir 202 to the expandable member 204. For example, in the expansion mode, when the user is operating the pump 231, the pump 231 can receive fluid from the reservoir 202 and then output the fluid to the expandable member 204. When the user switches to the contraction mode, at least some of the fluid can be automatically transferred back to the reservoir 202 (due to the pressure difference from the expandable member 204 to the reservoir 202). The user can then squeeze the expandable member 204 to facilitate further transfer of fluid to the reservoir 202 through the pump 231.

[0068] Then, when the user wants to deflate the expandable member 204, the user moves the selection member 239 to its deflated position. The user can then operate the pump 231 to deflate the expandable member 204 (i.e., move fluid from the expandable member 204 to the reservoir 202). For example, the user can repeatedly press or squeeze the pump 231 until the deflation is complete. The pump 231 can then return to its original form, which provides suction, causing fluid to be drawn from the expansion member 204 into the pump 231. The fluid from the expansion member 204 fills the pump 231 (or at least partially fills the pump 231). The pump cycle repeats until the expandable member 204 is deflated.

[0069] In some examples, fluid can automatically (when selection member 239 is moved to its retracted position) flow out of expandable member 204 and into reservoir 202 without the user having to press or squeeze pump 231 until pressure is at least partially equalized between reservoir 202 and expandable member 204.

[0070] In some examples, after expansion member 204 has been deflated, pump 231 can be squeezed to place the pump in a deflated position or configuration.

[0071] While certain features of the described embodiments have been shown as described herein, many modifications, substitutions, changes and equivalents will now occur to those skilled in the art. It should therefore be understood that the appended claims are intended to cover all such modifications and changes as fall within the scope of the embodiments.

Claims

1. An implant comprising: an expandable member; as well as a pump assembly configured to facilitate transfer of a fluid to the expandable member to place the expandable member in an expanded configuration, The expandable 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 the surface of the core member when the expandable member is in the expanded configuration.

2. The implant according to claim 1, wherein The core member has a cylindrical shape.

3. The implant according to claim 1, wherein The core member defines a lumen.

4. The implant according to claim 1, wherein The core member has a cylindrical shape and defines a lumen.

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

6. The implant according to any one 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 expandable member is in the expanded configuration.

7. The implant according to any one of claims 1 to 5, wherein: The fluid is configured to be disposed directly adjacent to the sidewall and a surface directly adjacent to the sidewall when the expandable member is in the expanded configuration.

8. An implant according to any one of claims 1 to 7, wherein The sidewalls are formed from a non-expandable material.

9. The implant according to any one of claims 1 to 7, wherein: The sidewalls are formed from a single layer of material.

10. The implant according to any one of claims 1 to 7, wherein The sidewalls are formed from a single layer of non-expandable material.

11. The implant according to any one of claims 1 to 10, further comprising: A reservoir is operably coupled to the pump assembly and configured to store the fluid.

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

13. An implant according to any one of claims 1 to 11, wherein The core member is formed of a closed cell polyurethane foam material.

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

15. An implant according to any one of claims 1 to 13, wherein The expandable member is configured to be placed in the expanded configuration and the collapsed configuration, the expandable member having a tubular shape when in the collapsed configuration and having a tubular shape when in the expanded configuration.

16. An implant comprising: an expandable member; as well as a pump assembly configured to facilitate transfer of a fluid to the expandable member to place the expandable member in an expanded configuration, The expandable 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 the surface of the core member when the expandable member is in the expanded configuration.

17. The implant according to 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 a lumen.

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

21. 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 expandable member is in the expanded configuration.

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

23. The implant of claim 16, wherein: The sidewalls are formed from a non-expandable material.

24. The implant of claim 16, wherein: The sidewalls are formed from a single layer of material.

25. The implant of claim 16, wherein: The sidewalls are formed from a single layer of non-expandable material.

26. The implant of claim 16, further comprising: A reservoir is operably coupled to the pump assembly and configured to store the fluid.

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

28. The implant of claim 16, wherein: The core member is formed of a closed cell polyurethane foam material.

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

30. The implant of claim 16, wherein: The expandable member is configured to be placed in the expanded configuration and the collapsed configuration, the expandable member having a tubular shape when in the collapsed configuration and having a tubular shape when in the expanded configuration.

31. An implant comprising: an expandable member; Storage container; as well as a pump assembly operably coupled to the reservoir and the expandable member, the pump assembly being configured to facilitate transfer of fluid from the reservoir and to the expandable member to place the expandable member in an expanded configuration, The expandable 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 disposed adjacent the core member and outside of the closed cells when the expandable member is in the expanded configuration.

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

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

34. The implant of claim 31, wherein: The core member defines a lumen.

35. The implant of claim 31, wherein The core member defines a lumen configured to receive the fluid when the expandable member is in the expanded configuration.