Two-piece penile prosthesis system with pump-operated deflation

Abstract

The present invention provides an inflatable penile prosthesis system comprising at least one inflatable assembly for implanting into corpus cavernosum of a penis, and having an inflatable member and a fluid reservoir; a pump assembly being configured to facilitate a transfer of fluid from the fluid reservoir to the inflatable member when in an inflation mode, and configured to facilitate a transfer of the fluid from the inflatable member to the fluid reservoir when in a deflation mode; and at least one inlet tubing providing a fluid conduit between the inflatable assembly and the pump assembly. The inlet tubing comprises a first fluid conduit fluidly coupling the pump assembly with the inflatable member; and a second fluid conduit fluidly coupling the pump assembly with the fluid reservoir positioned adjacent to the inflatable member.

Description

[0001] TWO-PIECE PENILE PROSTHESIS SYSTEM WITH PUMP-OPERATED DEFLATION

[0002] Technical Field of the Invention

[0003] The present invention relates to inflatable penile prosthesis systems, and more particularly, to an improved inflatable penile prosthesis system comprising a pump and an inflatable assembly including an inflatable member and a fluid reservoir, wherein deflation is initiated by activation of the pump and proceeds in a smooth and controlled manner that closely replicates the natural post-erection reduction in penile rigidity, without requiring manual compression of the inflatable member.

[0004] Background of the Invention

[0005] Penile prosthesis systems are surgically implantable medical devices designed to restore erectile function in male patients suffering from erectile dysfunction. Over the years, these prosthetic systems have evolved, with inflatable models gaining widespread acceptance due to their ability to provide a more natural erection and greater control over rigidity. Conventional inflatable penile prostheses generally include one or more hydraulically inflatable members implanted within the penis, a fluid reservoir in fluid communication with the inflatable member(s), and a pump assembly that facilitates fluid transfer from the reservoir to the inflatable member(s) to achieve inflation. To transition back to a non-erect state, the fluid must be returned to the reservoir, necessitating an active deflation process.

[0006] Despite advancements in inflatable penile prosthesis systems, certain challenges remain. Existing designs often present difficulties in user operation, increased risk of mechanical failure, and limitations in comfort and satisfaction. Efforts in the field continue to focus on overcoming these challenges to improve the effectiveness and usability of such prosthetic systems.

[0007] US Patent No. 5,263,981 discloses an exemplary two-piece penile prosthesis system. These two-piece systems typically comprise one or two penile prostheses implanted into the corpus cavernosum of the penis, each incorporating an inflatable member with an integrated fluid reservoir positioned at its proximal end. Additionally, these systems include a pump, generally implanted in the scrotum, that enables fluid transfer from the reservoirs to the inflatable members, thereby achieving inflation.However, conventional two-piece penile prostheses do not permit active deflation via the pump. Instead, the user must manually manipulate the penile prosthesis to induce deflation. This is typically achieved by squeezing the distal end of the inflatable member through the glans or by bending the prosthesis within the penis shaft to elevate internal pressure above a predefined threshold. Such methods not only cause discomfort or pain but also contribute to mechanical wear, thereby reducing the lifespan of the prosthesis and increasing the risk of component failure.

[0008] Another significant drawback of conventional two-piece system is the limited volumetric capacity of their integrated reservoirs, which is typically around 2-3 milliliters. Due to this limited capacity, deflation leads only to a slight reduction in rigidity rather than a significant decrease in penile volume. As a result, the penis does not return to a fully flaccid state following deflation, which compromises user comfort and natural postdeflation appearance. Consequently, the comfort level in existing two-piece systems, both the deflation initiation process and the post-deflation state remain suboptimal.

[0009] Although numerous patents and commercial products have addressed two-piece prosthesis designs, many of the associated limitations remain unsolved. A primary reason for this is that the operative mechanisms responsible for fluid transfer and retention are typically housed within the prosthesis body itself. This internalization not only reduces the available internal volume for fluid storage but also requires the application of very high localized pressure for initiating deflation. In practice, the user must often apply substantial manual force— such as bending or forcefully compressing the prosthesis— to achieve sufficient pressure for fluid return to the integrated reservoir. Such techniques are not only uncomfortable but may also lead to accelerated wear of internal components and reduced long-term device reliability.

[0010] Objects of the Invention

[0011] Primary object of the present invention is to provide an improved two-piece inflatable penile prosthesis system which eliminates the above-mentioned shortcomings in the present state of the art.

[0012] An object of the invention is to provide an inflatable penile prosthesis system that enhances overall comfort and ease of use.Another object of the present invention is to provide an inflatable penile prosthesis system enable a two-piece assembly with improved functionality and user experience.

[0013] Another object of the present invention is to provide an inflatable penile prosthesis system ensuring reduced surgical invasiveness while enhancing ease of use and user comfort.

[0014] Another object of the present invention is to simplify the structural design of inflatable penile prosthesis systems.

[0015] Another object is to minimize the number of independently movable components within the assembly, thereby reducing mechanical complexity and also minimizing the infection risk that may occur after the implantation surgery.

[0016] Another object of the present invention is to provide a pump that facilitates a streamlined, robust, and mechanically simplified penile prosthetic assembly.

[0017] The proposed system is designed to be easier to implant, more durable, and user-friendly while maintaining high reliability and functionality.

[0018] In one embodiment, ease of use may be achieved through a deflation release mechanism that allows fluid evacuation to continue as long as the pump system is actuated (e.g., via manual operation by the user). In another embodiment, the deflation may be initiated and completed through a single-actuation release mechanism, thereby further simplifying operation. Additionally, enhanced user comfort may be provided by enabling a greater degree of deflation, allowing the penile prosthesis to assume a more natural post-deflation state.

[0019] Summary of the Invention

[0020] The present invention provides an inflatable penile prosthesis system comprising at least one inflatable assembly for implanting into corpus cavernosum of a penis, and having an inflatable member and a fluid reservoir; a pump assembly being configured to facilitate a transfer of fluid from the fluid reservoir to the inflatable member when in an inflation mode, and configured to facilitate a transfer of the fluid from the inflatablemember to the fluid reservoir when in a deflation mode; and at least one inlet tubing providing a fluid conduit between the inflatable assembly and the pump assembly. The inlet tubing comprises a first fluid conduit fluidly coupling the pump assembly with the inflatable member; and a second fluid conduit fluidly coupling the pump assembly with the fluid reservoir positioned adjacent to the inflatable member.

[0021] According to an embodiment of the present invention, the transfer of fluid between the inflatable member and the fluid reservoir is solely controlled by the pump assembly through the inlet tubing, preventing any direct fluid communication between the inflatable member and the fluid reservoir.

[0022] According to an embodiment of the present invention, the inflatable assembly consists of the inflatable member and the fluid reservoir as a single integrated unit.

[0023] According to an embodiment of the present invention, the first fluid conduit and the second fluid conduit are configured to extend within a common lumen of the inlet tubing and are separated by an internal partition.

[0024] According to an embodiment of the present invention, the first fluid conduit and the second fluid conduit are arranged in a coaxial configuration within the inlet tubing.

[0025] According to an embodiment of the present invention, the first fluid conduit and the second fluid conduit are configured to have different cross-sectional areas to regulate fluid flow rates between the inflatable member and the fluid reservoir.

[0026] According to an embodiment of the present invention, the pump assembly comprises a pump bulb and a valve assembly, the valve assembly includes a shaft movably disposed within a valve body and configured to regulate operation of the pump assembly between the inflation mode and the deflation mode, wherein the shaft is configured to define a fluid passageway through the valve body to transfer fluid from the pump bulb to the first fluid conduit in the inflation mode; and the shaft is configured to redefine the fluid passageway through the valve body to transfer fluid from the first fluid conduit to the second fluid conduit in the deflation mode such that the pump bulb is bypassed.According to an embodiment of the present invention, a push button is operably connected to the shaft in a linear direction, enabling activation of the deflation mode by regulating the operation of the pump assembly based on a single instantaneous push by a user.

[0027] According to an embodiment of the present invention, the shaft is configured to move linearly within the valve assembly upon actuation of the push button in the deflation mode, thereby altering the fluid passageway to allow fluid contained within the inflatable member to first flow into the valve assembly, and then pass through the second fluid conduit into the fluid reservoir, thereby facilitating deflation.

[0028] According to an embodiment of the present invention, the shaft of the valve assembly is configured to define the fluid passageway in the inflation mode, such that upon compression of the pump bulb, the pressurized inflation fluid is directed through the first fluid conduit of the inlet tubing and into the inflatable member, thereby inflating the inflatable member.

[0029] According to an embodiment of the present invention, the prosthesis comprises two inflatable assemblies, each independently in fluid communication with the pump assembly.

[0030] According to an embodiment of the present invention, the inflatable penile prosthesis system comprises two inlet tubing that provides fluid communication between inflatable assembly and the pump assembly.

[0031] According to an embodiment of the present invention, the inflatable member and the fluid reservoir of the inflatable assembly are enclosed within a flexible casing.

[0032] According to an embodiment of the present invention, the flexible casing is formed from an elastomeric material that expands and contracts with the movement of fluid between the inflatable member and the fluid reservoir.

[0033] According to an embodiment of the present invention, the inflatable member includes a structural constraint that limits its maximum inflation volume to ensure anatomical compatibility and prevent tissue damage.Brief Description of the Figures

[0034] Fig. 1 is perspective view of an exemplary embodiment of inflatable penile prosthesis system according to the present invention, which is provided with a single inflatable member and in its inflated state.

[0035] FIG. 2 is side view of the inflatable penile prosthesis system shown in Fig. 1 illustrating the inflatable member in its deflated state.

[0036] FIG. 3 shows a cross-sectional view of the inflatable penile prosthesis system shown in Fig. 2.

[0037] Fig. 4 shows a cross-sectional view of the inflatable penile prosthesis system in inflation mode with the pump bulb squeezed.

[0038] FIG. 5 shows a cross-sectional view of the inflatable penile prosthesis system in inflation mode with the pump bulb released.

[0039] FIG. 6 shows a cross-sectional view of the inflatable penile prosthesis system in deflation mode.

[0040] FIG. 7 is perspective view of another exemplary embodiment of inflatable penile prosthesis system according to the present invention, which is provided with two inflatable members and in its inflated state.

[0041] FIG. 8 shows a cross-sectional view of the pump assembly, which is connected to two inlet tubing.

[0042] FIG. 9 shows a front view of the pump assembly shown in Fig.8.

[0043] Detailed Description of the Invention

[0044] The present invention relates to an inflatable penile prosthesis system (100) comprising at least one inflatable assembly (10) designed for implantation into the corpus cavernosum of a penis and includes an inflatable member (1) and a fluid reservoir (2). Fig. 1 is perspective view of an exemplary embodiment of inflatable penile prosthesis system (100) according to the present disclosure, which is provided with a single inflatable member (1). The inflatable penile prosthesis system (100) further comprises a pump assembly (3) configured to facilitate the transfer of inflation fluid from the fluid reservoir (2) to the inflatable member (1) during an inflation mode and from the inflatable member (1) to the fluid reservoir (2) during a deflation mode. Fig. 1 further illustrates the inflatable assembly (10) in an erectile state in which the inflation fluid is transferred into the inflatable member (1), substantially increasing its internal fluid pressure. As a result, the inflatable member (1) adopts a rigid structure, thereby positioning the inflatable assembly (10) in an erectile state. Fig. 2 is a side view of theinflatable penile prosthesis system (100) shown in Fig. 1 illustrating the inflatable member (1) in a deflated state. In that state, the inflation fluid is transferred from the inflatable member (1) and thus the internal fluid pressure of the inflatable member (1) is significantly reduced, resulting in a loss of rigidity and causing the inflatable assembly (10) to reach a non-erectile state. The fluidic connection between the inflatable assembly (10) and the pump assembly (3) is established through an inlet tubing (4), which comprises a first fluid conduit (41) connecting the pump assembly (3) to the inflatable member (1) and a second fluid conduit (42) connecting the pump assembly (3) to the fluid reservoir (2), wherein the fluid reservoir (2) is positioned adjacent to the inflatable member (1).

[0045] The inflatable penile prosthesis system according to the present invention is also called a two-piece penile prosthesis system.

[0046] According to an embodiment of the present invention, the transfer of fluid between the inflatable member (1) and the fluid reservoir (2) is exclusively managed by the pump assembly (3) through the inlet tubing (4), ensuring no direct fluid communication between the inflatable member (1) and the fluid reservoir (2). Thereby, the pump assembly (3) serves as the sole mechanism regulating fluid movement between the inflatable member (1) and the fluid reservoir (2), eliminating any unregulated fluid exchange between the inflatable member (1) and the fluid reservoir (2). This configuration offers the advantage of a mechanically simplified and a compact structure. In conventional two-piece prosthetic systems, fluid transfer between the inflatable member (1) and the fluid reservoir (2) is regulated by a complex control mechanism located into the inflatable assembly (10). However, the prosthesis system of the present invention eliminates the need for such a mechanism, thereby reducing the risk of technical failures commonly encountered in the conventional two-piece prosthetic systems that could necessitate implant replacement. This configuration also results in enhanced overall comfort and ease of use for the patient.

[0047] In a possible embodiment, the inflatable assembly (10) is configured as a single integrated unit consisting of the inflatable member (1) and the fluid reservoir (2). In this embodiment, the inflatable assembly (10) does not include any additional elements such as valves that facilitate direct fluid exchange between the inflatable member (1) and the fluid reservoir (2), control mechanisms, etc. As a result, the internal space of theinflatable assembly (10) is utilized more efficiently, allowing for increased volume capacity of both the inflatable member (1) and the fluid reservoir (2) compared to conventional two-piece prosthetic systems known in the prior art. This design enables the inflatable member (1) to achieve a wider range of inflation and deflation, thereby enhancing user comfort in both inflated and deflated states.

[0048] In the proposed inflatable penile prosthesis system (100), the first fluid conduit (41) and the second fluid conduit (42) are optionally configured to extend within a common lumen of the inlet tubing (4) and are separated by an internal partition. In this configuration, as shown in Figs. 3-6, the inlet tubing (4) is arranged to circumferentially enclose both the first fluid conduit (41) and the second fluid conduit (42). This arrangement enhances the mechanical strength of the first fluid conduit (41) and the second fluid conduit (42) by virtue of their enclosure by the inlet tubing (4), given that the first fluid conduit (41) and the second fluid conduit (42) are inherently delicate, thin (such as capillary) flexible hoses. Additionally, housing the first fluid conduit (41) and the second fluid conduit (42) within a single inlet tubing (4) streamlines the overall structure of the inflatable penile prosthesis system (100) and minimizes its volume. This configuration also enhances the ease of implantation, as consolidating both the first fluid conduit (41) and the second fluid conduit (42) of one inflatable assembly (10) within a single inlet tubing (4) simplifies surgical insertion. According to another embodiment of the present invention, the first fluid conduit (41) and the second fluid conduit (42) are alternatively arranged in a coaxial configuration within the inlet tubing (4). This coaxial placement of the conduits reduces the risk of bending or wear.

[0049] The first fluid conduit (41) and the second fluid conduit (42) extending within the inlet tubing (4) of the inflatable penile prosthesis system (100) are optionally configured to have different cross-sectional areas to regulate fluid flow rates and allow optimized control of fluid transfer between the inflatable member (1) and the fluid reservoir (2). In this configuration, one of the conduits, for example, the first fluid conduit (41), may have a larger diameter to facilitate a higher flow rate during inflation, while the second fluid conduit (42) may have a smaller diameter compared to the first fluid conduit (41) to enable a more controlled and gradual deflation process. This configuration helps to improve user comfort by preventing sudden pressure drops during deflation, thereby reducing discomfort and minimizing the risk of abrupt changes in rigidity. Additionally, by tailoring the conduit sizes to the specific fluid dynamics of the system, energyefficiency can be enhanced, as a larger conduit allows for more efficient fluid transfer during inflation, while a smaller conduit provides better regulation of deflation. This embodiment also offers the potential to reduce mechanical stress on internal components by ensuring a smoother and more predictable transition between the inflated and deflated states.

[0050] In an embodiment of the present invention, the inflatable penile prosthesis system (100) includes a pump assembly (3) optionally configured to be placed into scrotum of a user, comprising a pump bulb (30) and a valve assembly (5) as shown in Fig. 2 and 9. The valve assembly (5) incorporates a shaft (51), as shown in Fig. 3, movably disposed within a valve body, which regulates the operation of the pump assembly (3) between an inflation mode and a deflation mode. In the inflation mode, the shaft (51) defines a fluid passageway within the valve body, allowing fluid transfer from the pump bulb (30) to the first fluid conduit (41) (see Fig. 4). In the deflation mode, the shaft (51) redefines the fluid passageway to permit fluid transfer from the first fluid conduit (41) to the second fluid conduit (42), bypassing the pump bulb (30) (see Fig. 6). This configuration enhances operational efficiency by enabling smooth and controlled inflation and deflation processes. By bypassing the pump bulb (30) in the deflation mode, the system reduces unnecessary fluid resistance, thereby improving the speed and ease of deflation while maintaining consistent pressure control. In this embodiment, the inflatable penile prosthesis system (100) may further comprise a push button (50), as shown in Figs. 3-6 and 9, that is operably connected to the shaft (51) in a linear direction. Here, the push button (50) enables activation of the deflation mode through a single instantaneous push by the user, thereby regulating the operation of the pump assembly (3). The inclusion of a push button (50) simplifies the user experience by allowing quick and effortless transition into the deflation mode. This configuration eliminates the need for manual manipulation, thereby enhancing ease of use and user comfort. In an alternative implementation of this embodiment, the shaft (51) is configured to move linearly within the valve assembly (5) upon actuation of the push button (50) in the deflation mode. This movement alters the fluid passageway, enabling fluid within the inflatable member (1) to first flow into the valve assembly (5) before passing through the second fluid conduit (42) into the fluid reservoir (2), thereby facilitating deflation. This implementation provides an effective and controlled deflation process, ensuring a maximum evacuation of fluid from the inflatable member (1). The linear motion of the shaft (51) within the valve assembly (5) enables a smooth and predictable transition,reducing user effort while maintaining functional reliability. Additionally, the direct fluid routing improves drainage efficiency and reduces the likelihood of fluid retention, which could otherwise affect the performance of the prosthesis over time.

[0051] The inflatable penile prosthesis system (100) is optionally structured such that the shaft (51) of the valve assembly (5) redefines the fluid passageway in the inflation mode. Accordingly, as illustrated in Fig. 4, upon compression of the pump bulb (30), the pressurized inflation fluid (PP) contained within the pump bulb (30) is directed through the first fluid conduit (41) of the inlet tubing (4) and into the inflatable member (1), resulting in inflation of the inflatable member (1). This structure ensures a reliable and consistent inflation process, allowing for precise and controlled inflation of the inflatable member (1). By defining the fluid passageway in a manner that directs pressurized fluid efficiently, the system minimizes energy loss and optimizes inflation performance. During inflation, it is needed the pump bulb (30) to be repeatedly compressed (i.e., squeezed) and released (e.g., 3-4 times) to fully inflate the inflatable member (1) to bring the inflatable member (1) in an erectile state. Throughout inflation, each time the pump bulb (30) is squeezed, the inflation fluid within the pump bulb (30) is transferred to the inflatable member (1) via the first fluid conduit (41) of the inlet tubing (4) and each time the pump bulb (30) is released, the inflation fluid within the fluid reservoir (2) is transferred to the pump bulb (30) via the second fluid conduit (42) of the inlet tubing (4) and the redefined fluid passageway within the valve assembly (5), as shown in Fig.

[0052] 5, facilitated by check valves positioned within the fluid passageways of the pump assembly (3). This configuration ensures that the pump bulb (30) consistently contains a predetermined amount of inflation fluid, allowing the fluid reservoir (2) to maintain an internal volume smaller than the total fluid volume required for operation of the inflatable penile prosthesis system (100). Additionally, this embodiment enables the inflatable member (1) to receive the necessary inflation fluid with minimal pump actuations, as fluid transfer begins with the very first squeeze of the pump bulb (30) when the shaft (51) is in the inflation mode.

[0053] Fig. 7 shows a perspective view of the inflatable penile prosthesis system (100) comprising two inflatable assemblies (10) according to an embodiment of the present invention, each independently in fluid communication with the pump assembly (3). This configuration can be adapted to accommodate the anatomical requirements of the patient receiving the prosthesis, thereby increasing anatomical compatibility based onthe structure and needs of the user's body and improving user comfort. In the disclosed embodiment, the inflatable penile prosthesis system (100) optionally includes two separate inlet tubing (4), establishing fluid communication between each of the inflatable assemblies (10) and the pump assembly (3). The presence of the two separate inlet tubing (4) optimizes the fluid transfer process by ensuring that each inflatable assembly (10) receives an adequate and controlled amount of fluid during inflation. By providing separate fluid pathways for each inflatable assembly (10), the system ensures a balanced and natural inflation and deflation process, reducing pressure disparities that may arise during operation.

[0054] According to another embodiment, the inflatable penile prosthesis system (100) comprises a flexible casing (11) that encloses both the inflatable member (1) and the fluid reservoir (2). The flexible casing (11) serves multiple purposes, including providing structural integrity to the inflatable assembly (10) and reducing the risk of mechanical damage or fluid leakage. Additionally, by enclosing the internal components within a unified structure, the flexible casing (11) helps maintain a consistent shape and contour, thereby improving the overall aesthetic appearance of the prosthesis and preventing visible irregularities that may otherwise occur due to changes in fluid volume in the inflatable element (1) or fluid reservoir (2). In an alternative implementation of the present embodiment, the flexible casing (11) is formed from an elastomeric material capable of expanding and contracting in response to the movement of fluid between the inflatable member (1) and the fluid reservoir (2). The elastomeric nature of the flexible casing (11) allows it to conform dynamically to variations in fluid volume, facilitating a smooth transition between the inflated and deflated states. This material selection enhances user comfort by preventing excessive rigidity or stiffness in the prosthesis while also reducing mechanical stress on the internal components. Furthermore, the flexibility of the flexible casing (11) contributes to the longevity of the prosthesis by minimizing wear and tear associated with repeated inflation and deflation cycles.

[0055] In certain embodiments, the inflatable member (1) includes a structural constraint that is configured to limit its maximum inflation volume in order to maintain anatomical compatibility and reduce the risk of tissue damage. The structural constraint may be formed as an integrated component of the inflatable member (1) or as an external sleeve or sheath that encases the inflatable portion. The constraint may define a maximum expansion diameter or length of the inflatable member (1), limiting radial expansion andlongitudinal expansion to a predetermined length range based on patient-specific parameters. In one embodiment, the constraint prevents inflation beyond a predetermined pressure, thereby avoiding overstretching of the penile tissue or surrounding anatomical structures. The purpose of this configuration is to prevent overexpansion, which may cause patient discomfort, mechanical failure, or undesired anatomical deformation. The predetermined threshold may be selected based on clinical considerations, such as the average volume needed to achieve functional rigidity without exceeding the physiological limits of the surrounding tissue.

[0056] In the above-mentioned, mutually combinable and compatible embodiments, the inflatable assembly (10) is configured to be actuated by an externally positioned pump assembly (3). Unlike conventional systems in which the deflation function is performed by an internal component integrated within the inflatable assembly (10) itself— often requiring direct compression or deformation— the present configuration allows fluid transfer to be controlled externally, thereby improving ease of use and reducing mechanical stress on internal components.

[0057] The embodiments and alternatives described above enhance the functionality, durability and user experience of the inflatable penile prosthesis system (100), providing a reliable and anatomically adaptable solution for users in need of such a medical prosthesis. It will be appreciated that various embodiments and alternatives described above can be combined within the same prosthesis system to achieve multiple benefits simultaneously.

Claims

Claims:

1. An inflatable penile prosthesis system (100) comprising:- at least one inflatable assembly (10) for implanting into corpus cavernosum of a penis, and having an inflatable member (1) and a fluid reservoir (2); and- a pump assembly (3) being configured to facilitate a transfer of fluid from the fluid reservoir (2) to the inflatable member (1) when in an inflation mode, and configured to facilitate a transfer of the fluid from the inflatable member (1) to the fluid reservoir (2) when in a deflation mode, and- at least one inlet tubing (4) providing a fluid conduit between the inflatable assembly (10) and the pump assembly (3), wherein the inlet tubing (4) comprises:a first fluid conduit (41) fluidly coupling the pump assembly (3) with the inflatable member (1), anda second fluid conduit (42) fluidly coupling the pump assembly (3) with the fluid reservoir (2) positioned adjacent to the inflatable member (1).

2. The inflatable penile prosthesis system (100) according to claim 1, wherein the transfer of fluid between the inflatable member (1) and the fluid reservoir (2) is solely controlled by the pump assembly (3) through the inlet tubing (4), preventing any direct fluid communication between the inflatable member (1) and the fluid reservoir (2).

3. The inflatable penile prosthesis system (100) according to claim 1, the inflatable assembly (10) consists of the inflatable member (1) and the fluid reservoir (2) as a single integrated unit.

4. The inflatable penile prosthesis system (100) according to any one of the preceding claims, wherein the first fluid conduit (41) and the second fluid conduit (42) are configured to extend within a common lumen of the inlet tubing (4) and are separated by an internal partition.

5. The inflatable penile prosthesis system (100) according to any one of the preceding claims, wherein the first fluid conduit (41) and the second fluid conduit (42) are arranged in a coaxial configuration within the inlet tubing (4).

6. The inflatable penile prosthesis system (100) according to any one of the preceding claims, wherein the first fluid conduit (41) and the second fluid conduit (42)are configured to have different cross-sectional areas to regulate fluid flow rates between the inflatable member (1) and the fluid reservoir (2).

7. The inflatable penile prosthesis system (100) according to any one of the preceding claims, wherein the pump assembly (3) comprises a pump bulb (30) and a valve assembly (5), the valve assembly (5) including a shaft (51) movably disposed within a valve body and configured to regulate operation of the pump assembly (3) between the inflation mode and the deflation mode, wherein:- the shaft (51) is configured to define a fluid passageway through the valve body to transfer fluid from the pump bulb (30) to the first fluid conduit (41) in the inflation mode; and- the shaft (51) is configured to redefine the fluid passageway through the valve body to transfer fluid from the first fluid conduit (41) to the second fluid conduit (42) in the deflation mode such that the pump bulb (30) is bypassed.

8. The inflatable penile prosthesis system (100) according to claim 7, wherein a push button (50) is operably connected to the shaft (51) in a linear direction, enabling activation of the deflation mode by regulating the operation of the pump assembly (3) based on a single instantaneous push (50) by a user.

9. The inflatable penile prosthesis system (100) according to claim 8, wherein the shaft (51) is configured to move linearly within the valve assembly (5) upon actuation of the push button (50) in the deflation mode, thereby altering the fluid passageway to allow fluid contained within the inflatable member (1) to first flow into the valve assembly (5), and then pass through the second fluid conduit (42) into the fluid reservoir (2), thereby facilitating deflation.

10. The inflatable penile prosthesis system (100) according to any one of the claims 7, 8 or 9, wherein, the shaft (51) of the valve assembly (5) is configured to define the fluid passageway in the inflation mode, such that upon compression of the pump bulb (30), the pressurized inflation fluid (PP) is directed through the first fluid conduit (41) of the inlet tubing (4) and into the inflatable member (1), thereby inflating the inflatable member (1).

11. The inflatable penile prosthesis system (100) according to any one of the preceding claims, wherein the prosthesis comprises two inflatable assemblies (10), each independently in fluid communication with the pump assembly (3).

12. The inflatable penile prosthesis system (100) according to claim 11 comprising two inlet tubing (4) that provides fluid communication between inflatable assembly (10) and the pump assembly (3).

13. The inflatable penile prosthesis system (100) according to any one of the preceding claims, wherein the inflatable member (1) and the fluid reservoir (2) of the inflatable assembly (10) are enclosed within a flexible casing (11).

14. The inflatable penile prosthesis system (100) according to claim 13, wherein the flexible casing (11) is formed from an elastomeric material that expands and contracts with the movement of fluid between the inflatable member (1) and the fluid reservoir (2).

15. The inflatable penile prosthesis system (100) according to any one of the preceding claims, wherein the inflatable member (1) includes a structural constraint that limits its maximum inflation volume to ensure anatomical compatibility and prevent tissue damage.

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