Implantable expandable device

Abstract

An implantable fluid operated expandable device (200) may include a fluid reservoir (202) configured to hold a fluid, an expandable member (204), and a fluid structure providing fluid transfer between the fluid reservoir and the expandable member. The fluid reservoir, expandable member, and fluid structure may be included in a single unit or a single housing, thus providing a relatively compact implantable fluid operated expandable device. The relatively simple, compact device allows for simplified insertion into a patient and allows for simplified user operation.

Description

[0001] Cross-references to related applications

[0002] This application is a continuation of and claims priority to U.S. non-provisional patent application No. 18 / 733,329 entitled "Implantable Inflatable Device," filed June 4, 2024, which claims priority to U.S. provisional patent application No. 63 / 507,873 entitled "Implantable Inflatable Device," filed June 13, 2023, 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 / 507,873, filed June 13, 2023, the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0004] This disclosure relates generally to body implants, and particularly to expandable body implants. Background Technology

[0005] Implantable fluid manipulation devices typically include one or more valves positioned within the fluid passages of the implantable device to guide and control fluid flow between different parts of the device. The flow of fluid into and out of one or more fluid-filled components of the implantable device can be controlled to achieve expansion, contraction, pressurization, depressurization, activation, deactivation, etc., of one or more fluid-filled components. Implantable fluid manipulation devices that include a pump and valve system and a fluid reservoir within a single implantable device can provide simplified, less invasive insertion of the implantable device and / or simplified user operation of the implantable device. Summary of the Invention

[0006] In some aspects, the technology described herein relates to an implantable, fluid-operated, expandable device comprising: a housing; a fluid reservoir received within the housing; an expandable member received within the housing; a fluid component disposed within the housing, the fluid component providing fluid communication between the fluid reservoir and the expandable member; and a fluid flow control system disposed on the housing and configured to provide fluid flow from the fluid reservoir to the expandable member in a first operating mode in response to an input at a first fluid flow control device of the fluid flow control system, and to provide fluid flow from the expandable member to the fluid reservoir in a second operating mode in response to an input at a second fluid flow control device of the fluid flow control system.

[0007] In some embodiments, the implantable, fluid-operated, expandable device is a penile prosthesis comprising: a proximal end located at a first end portion of the housing; a distal end located at a second end portion of the housing; and an expandable portion located at a middle portion of the housing corresponding to the expandable member.

[0008] In some embodiments, the first fluid flow control device includes an extendable sphere disposed in the distal end; and the second fluid flow control device includes a valve actuation device disposed in the middle portion of the housing.

[0009] In some embodiments, the fluid component includes: a supply tube connecting a fluid reservoir and a sphere positioned at a distal end; a first valve positioned in the supply tube; a port connecting the sphere to the expandable member; a second valve positioned at the port connecting the sphere to the expandable member; a fluid passage connecting the expandable member and the fluid reservoir; and a third valve positioned in the fluid passage connecting the expandable member and the fluid reservoir.

[0010] In some embodiments, the first fluid flow control device includes a sphere disposed in a distal end, wherein, in response to a first actuation of the sphere positioned in the distal end: a first valve closes to prevent fluid in the sphere from flowing into a supply pipe; a second valve opens to allow fluid held in the sphere to flow from the sphere to an expandable member to expand the expandable member; and a third valve closes to prevent fluid from flowing from the expandable member into a fluid reservoir.

[0011] In some embodiments, in response to a second manipulation of the sphere located at the distal end: a first valve opens to allow fluid to flow from the supply line into the sphere to refill it; a second valve closes to prevent fluid from flowing from the sphere into the supply line; and a third valve closes to prevent fluid from flowing from the expandable member into the fluid reservoir.

[0012] In some implementations, the first manipulation of the sphere is compression of the sphere, and the second manipulation is releasing the compression of the sphere.

[0013] In some embodiments, the second fluid flow control device includes a valve actuation device disposed in the middle portion of the housing, wherein, in response to actuation of the valve actuation device: a third valve opens to allow fluid to flow from the expandable member to the fluid reservoir to cause the expandable member to contract; a first valve closes to prevent fluid in the sphere from flowing into the supply pipe; and a second valve closes to prevent fluid retained in the sphere from flowing into the expandable member.

[0014] In some embodiments, the valve actuation device includes: a button portion disposed in a recess formed in the outer peripheral surface of the housing; and at least one arm extending radially inward from the button portion into the housing for selectively engaging a third valve.

[0015] In some implementations, in the unactuated state of the valve actuation device: the third valve is positioned to close the fluid passage between the expandable member and the fluid reservoir.

[0016] In some embodiments, in the actuated state of the valve actuation device: at least one arm moves radially inward in response to the pressing of the button portion; a third valve moves in response to the force applied to the third valve by at least one arm to open a fluid passage between the expandable member and the fluid reservoir; and fluid flows from the expandable member to the fluid reservoir to cause the expandable member to contract.

[0017] In some embodiments, the third valve is axially oriented within the housing, wherein at least one arm is configured to apply a radial force to the third valve, which causes the third valve to move in the axial direction to open a fluid passage between the expandable member and the fluid reservoir.

[0018] In some embodiments, the third valve is radially oriented within the housing, and at least one arm is configured to apply a radial force to the third valve, which causes the third valve to move in a radial direction to open a fluid passage between the expandable member and the fluid reservoir.

[0019] In some embodiments, the button portion includes one of the following: an annular button disposed in the recess and extending around a central portion of the recess forming the housing; an arcuate button disposed in the recess and extending partially around a central portion of the recess forming the housing; or a plurality of arcuate buttons disposed in the recess and spaced apart along a central portion of the recess forming the housing.

[0020] In some embodiments, the expandable member includes: an inner wall and an outer wall defining an expansion tube extending longitudinally along a central portion of the housing; a plurality of first openings formed between the inner wall and the outer wall extending longitudinally along the length of the expandable member; a plurality of second openings formed between the inner wall and the outer wall, alternating with the plurality of first openings extending longitudinally along the length of the expandable member; and a central opening defined by the inner wall extending longitudinally along the length of the expandable member, wherein, in an expanded state, the plurality of first openings and the plurality of second openings are configured to be filled with fluid to allow the expandable member to expand.

[0021] In some aspects, the technology described herein relates to an implantable, fluid-operated, expandable device comprising: a housing; a fluid reservoir received within the housing; an expandable member received within the housing; a fluid component disposed within the housing, the fluid component providing fluid communication between the fluid reservoir and the expandable member; and a fluid flow control system disposed on the housing and configured to provide fluid flow from the fluid reservoir to the expandable member in a first operating mode in response to an input at a first fluid flow control device of the fluid flow control system, and to provide fluid flow from the expandable member to the fluid reservoir in a second operating mode in response to an input at a second fluid flow control device of the fluid flow control system.

[0022] In some embodiments, the implantable, fluid-operated, expandable device is a penile prosthesis comprising: a proximal end located at a first end portion of the housing; a distal end located at a second end portion of the housing; and an expandable portion located at a middle portion of the housing corresponding to the expandable member.

[0023] In some embodiments, the first fluid flow control device includes an extendable sphere disposed in the distal end; and the second fluid flow control device includes a valve actuation device disposed in the middle portion of the housing.

[0024] In some embodiments, the fluid component includes: a supply tube connecting a fluid reservoir and a sphere positioned at a distal end; a first valve positioned in the supply tube; a port connecting the sphere to the expandable member; a second valve positioned at the port connecting the sphere to the expandable member; a fluid passage connecting the expandable member and the fluid reservoir; and a third valve positioned in the fluid passage connecting the expandable member and the fluid reservoir.

[0025] In some embodiments, the first fluid flow control device includes a sphere disposed in a distal end, wherein, in response to a first actuation of the sphere positioned in the distal end: a first valve closes to prevent fluid in the sphere from flowing into a supply pipe; a second valve opens to allow fluid held in the sphere to flow from the sphere to an expandable member to expand the expandable member; and a third valve closes to prevent fluid from flowing from the expandable member into a fluid reservoir.

[0026] In some embodiments, in response to a second manipulation of a sphere positioned in the distal end: a first valve opens to allow fluid to flow from the supply line into the sphere to refill it; a second valve closes to prevent fluid from flowing from the sphere into the supply line; and a third valve closes to prevent fluid from flowing from the expandable member into the fluid reservoir.

[0027] In some implementations, the first manipulation of the sphere is compression of the sphere, and the second manipulation is releasing the compression of the sphere.

[0028] In some embodiments, the second fluid flow control device includes a valve actuation device disposed in the middle portion of the housing, wherein, in response to actuation of the valve actuation device: a third valve opens to allow fluid to flow from the expandable member to the fluid reservoir to cause the expandable member to contract; a first valve closes to prevent fluid in the sphere from flowing into the supply pipe; and a second valve closes to prevent fluid retained in the sphere from flowing into the expandable member.

[0029] In some embodiments, the valve actuation device includes: a button portion disposed in a recess formed in the outer peripheral surface of the housing; and at least one arm extending radially inward from the button portion into the housing for selectively engaging a third valve.

[0030] In some implementations, in the unactuated state of the valve actuation device: the third valve is positioned to close the fluid passage between the expandable member and the fluid reservoir.

[0031] In some embodiments, in the actuated state of the valve actuation device: at least one arm moves radially inward in response to the pressing of the button portion; a third valve moves in response to the force applied to the third valve by at least one arm to open a fluid passage between the expandable member and the fluid reservoir; and fluid flows from the expandable member to the fluid reservoir to cause the expandable member to contract.

[0032] In some embodiments, the third valve is axially oriented within the housing, wherein at least one arm is configured to apply a radial force to the third valve, which causes the third valve to move in the axial direction to open a fluid passage between the expandable member and the fluid reservoir.

[0033] In some embodiments, the third valve is radially oriented within the housing, and at least one arm is configured to apply a radial force to the third valve, which causes the third valve to move in a radial direction to open a fluid passage between the expandable member and the fluid reservoir.

[0034] In some embodiments, the button portion includes one of the following: an annular button disposed in the recess and extending around a central portion of the recess forming the housing; an arcuate button disposed in the recess and extending partially around a central portion of the recess forming the housing; or a plurality of arcuate buttons disposed in the recess and spaced apart along a central portion of the recess forming the housing.

[0035] In some embodiments, the expandable member includes: an inner wall and an outer wall defining an expansion tube that extends longitudinally along a middle portion of the housing; a plurality of first openings formed between the inner wall and the outer wall and extending longitudinally along the length of the expandable member; and a plurality of second openings formed between the inner wall and the outer wall, arranged alternately with the plurality of first openings and extending longitudinally along the length of the expandable member, wherein, in an expanded state, the plurality of first openings and the plurality of second openings are configured to be filled with fluid to allow the expandable member to expand.

[0036] In some embodiments, the inner wall defines a central opening extending longitudinally along the length of the expandable member, wherein at least some of the fluid components are received within the space defined by the central opening.

[0037] In some aspects, the technology described herein relates to a fluid flow control system for an implantable, fluid-operated expandable device, the fluid flow control system comprising: a housing; a first fluid flow control device disposed at a distal end portion of the housing, the first fluid flow control device comprising: a sphere disposed at a distal end defining the distal end portion of the housing; a first valve positioned in a supply line connecting the sphere to a fluid reservoir; and a second valve positioned in a port connecting the sphere and the expandable member; and a second fluid flow control device disposed at a middle portion of the housing, the second fluid flow control device comprising: a valve actuation device configured to selectively actuate a third valve disposed in a fluid passage connecting the expandable member and the fluid reservoir, the valve actuation device comprising: a button portion disposed in a recess formed in an outer peripheral surface of the housing; and at least one arm extending radially inward from the button portion into the housing for selectively engaging the third valve.

[0038] In some embodiments, in a first operating mode of the implantable, fluid-operated, expandable device, in response to compression of a sphere positioned in the distal end: a first valve closes to prevent fluid in the sphere from flowing into the supply line; a second valve opens to allow fluid held in the sphere to flow from the sphere to the expandable member to expand the expandable member; and a third valve closes to prevent fluid from flowing from the expandable member into the fluid reservoir; and in response to releasing the compression of the sphere positioned in the distal end: a first valve opens to allow fluid to flow from the supply line into the sphere to refill the sphere; a second valve closes to prevent fluid from flowing from the sphere into the supply line; and a third valve closes to prevent fluid from flowing from the expandable member into the fluid reservoir.

[0039] In some embodiments, in a second operating mode of the implantable fluid-operated expandable device, in response to the pressing of the button portion of the second fluid flow control device: in response to the force applied to the third valve by the arm portion, the third valve opens to allow fluid to flow from the expandable member to the fluid reservoir to cause the expandable member to contract; the first valve closes to prevent fluid in the sphere from flowing into the supply pipe; and the second valve closes to prevent fluid retained in the sphere from flowing into the expandable member.

[0040] In some implementations, the fluid flow control system, expandable components, and fluid reservoir are integrated into a single unit. Attached Figure Description

[0041] Figure 1 This is a block diagram of an example implantable, fluid-operated, expandable device.

[0042] Figure 2A This is a perspective view of an implantable, fluid-operated, expandable device, based on one aspect of an example.

[0043] Figure 2B It is along Figure 2A The cross-sectional view taken by line AA.

[0044] Figure 3A and Figure 3B It is along Figure 2A The cross-sectional view taken by line AA shows the first operating mode of an example implantable fluid-operated expandable device.

[0045] Figure 3C It is along Figure 2A The cross-sectional view taken by line BB shows the flow of the second operating mode of the example implantable fluid-operated expandable device.

[0046] Figure 4A An example distal end portion of an example implantable, fluid-operated, expandable device is shown.

[0047] Figure 4B An example distal end portion of an example implantable, fluid-operated, expandable device is shown.

[0048] Figure 5A It is along Figure 2A A cross-sectional view taken by line CC shows an example expandable member 240 of an example implantable fluid-operated expandable device.

[0049] Figure 5B It is along Figure 2A A cross-sectional view taken by line CC shows an example expandable member 240 of an example implantable fluid-operated expandable device.

[0050] Figure 5C It is along Figure 2A A cross-sectional view taken by line CC shows an example expandable member 240 of an example implantable fluid-operated expandable device.

[0051] Figure 6A Features of an example actuator for an example implantable, fluid-operated, expandable device are shown.

[0052] Figure 6B Features of an example actuator for an example implantable, fluid-operated, expandable device are shown.

[0053] Figure 6C Features of an example actuator for an example implantable, fluid-operated, expandable device are shown.

[0054] Figure 7A This is a cross-sectional view of an example valve in an axial orientation.

[0055] Figure 7B This is a cross-sectional view of an example valve in a radial orientation. Detailed Implementation

[0056] 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 construed as limiting, but merely as the basis for the claims and as a representative basis for teaching those skilled in the art to employ embodiments differently in any suitable detailed structure in practice. Furthermore, the terms and phrases used herein are not intended to be limiting, but are intended to provide an understandable description of this disclosure.

[0057] As used herein, the term "a (or an)" is defined as one or more. As used herein, the term "another" is defined as at least a second or more. As used herein, the terms "comprising" and / or "having" are defined as including (i.e., open transitions). As used herein, the terms "link" or "movably linked" are defined as a connection, although not necessarily directly and mechanically.

[0058] Generally, the implementation is directed toward body implants. The terms "patient" or "user" may be used below for a person who benefits from the medical device or method disclosed in this disclosure. For example, a patient may be a person with a medical device implanted in their body or a person who has implanted a medical device using the method disclosed in this disclosure for operating the medical device.

[0059] Figure 1This is a block diagram of an example implantable, fluid-operated, expandable device. This example implantable, fluid-operated, expandable device may include an expandable member that can be selectively expanded with fluid stored in a fluid reservoir. In a first operating mode (e.g., an expansion mode or a pressurization mode), a fluid flow system may guide fluid from the fluid reservoir to the expandable member to cause the expandable member to expand. In a second operating mode (e.g., a contraction mode or a depressurization mode), the fluid flow system may guide fluid from the expandable member (in the expanded state) back to the fluid reservoir to cause the expandable member to contract. In some examples, the fluid flow system may include one or more components disposed in one or more fluid passages connecting the fluid reservoir and the expandable member. In some examples, the fluid flow system may include, for example, one or more pumping devices that cause fluid to flow from the fluid reservoir toward the expandable member in the first operating mode and from the expandable member toward the fluid reservoir in the second operating mode. In some examples, one or more valves may be disposed in the fluid passages to control the fluid flow between the fluid reservoir and the expandable member in both the first and second operating modes. In some examples, one or more pressure sensors may be provided in the fluid passage and / or at the fluid reservoir and / or at the expandable member to detect and / or monitor the corresponding pressure in the implantable fluid-operated expandable device.

[0060] Figure 2A This is a perspective view of an implantable, fluid-operated, expandable device 200, based on one aspect of an example. Figure 2B It is along Figure 2AThe image shows a cross-sectional view of an example implantable fluid-operated expandable device 200, taken by line AA. The example implantable fluid-operated expandable device 200 includes a reservoir portion 202 storing fluid for expanding an expandable portion 204. In response to manipulation of a fluid flow control system 206, fluid can flow from the reservoir portion 202 to the expandable portion 204 via a fluid structure including a fluid component received within the device 200, for expanding the expandable portion 204. In response to manipulation of the fluid flow control system 206, fluid can flow from the expandable portion 204 back to the reservoir portion 202 via the fluid component received within the device 200. In some examples, the fluid flow control system 206 may include one or more fluid flow devices that provide fluid flow in a first operating mode (e.g., an expansion mode or a pressurization mode as described above). Manipulation of one or more of the fluid flow devices can actuate operation of the example device 200 in a first operating mode in which fluid flows from the reservoir portion 202 to the expandable portion 204. In some examples, the fluid flow control system 206 may include one or more fluid flow devices that provide fluid flow in a second operating mode (e.g., a contraction mode or a decompression mode as described above). Manipulation of one or more of the fluid flow devices may actuate the example device 200 in a second operating mode in which fluid flows from the expandable portion 204 to the reservoir portion 202.

[0061] The storage section 202, the expandable section 204, and the fluid flow control system 206 can be connected in and / or on the housing 290 of the example device 200. Figure 2A In the illustrated example arrangement, a storage portion 202 is formed at the proximal end portion 292 of the example device 200, and an expandable portion 204 is formed at the middle portion 294 of the example device 200. Figure 2A In the illustrated example arrangement, a first example fluid flow control device of the fluid flow control system 206 is disposed at the distal end portion 296 of the example device 200, and a second example fluid flow control device of the fluid flow control system 206 is disposed at the intermediate portion 294 of the example device 200. The first fluid flow control device and / or the second fluid flow control device can be operated and / or controlled by a user to provide fluid flow between the storage portion 202 and the expandable portion 204 according to the desired operating mode of the example device 200.

[0062] Figure 2AThe example implantable fluid-operated expandable device 200 shown is in the form of an expandable penile prosthesis. All components of the example device 200 are integrated into a single unit to provide simplified implantation of the device 200 within a patient and simplified operation of the device 200 by the patient. The components of the example implantable fluid-operated expandable device 200 are integrated into a single device, thereby providing simplified insertion within a patient and simplified operation of the device 200 by the patient. The principles described herein can be applied to other types of implantable fluid-operated expandable devices, particularly those relying on the control of fluid flow into and out of the expandable portion of the device to achieve expansion, pressurization, activation, contraction, decompression, disabling, etc. Figure 2A The example implantable fluid-operated expandable device 200 shown is a single-piece implantable fluid-operated expandable device. Compared to multi-piece devices that include, for example, a separate fluid reservoir and / or a separate fluid control device (including various pumps and / or valves and / or electronic controls), the single-piece implantable fluid-operated expandable device provides a simplified, less invasive insertion into the patient's body. Compared to multi-piece devices that include, for example, a separate fluid reservoir and / or a separate fluid control device (including various pumps and / or valves and / or electronic controls), the single-piece implantable fluid-operated device provides the user with simplified operation of the example device 200.

[0063] like Figure 2B As shown in more detail, the example device 200 includes a distal end 210 formed at a distal end portion 296 and a proximal end 230 formed at a proximal end portion 292. In examples where the device 200 is in the form of a penile prosthesis, the proximal end 230 facilitates implantation and anchoring of the example device 200 in a patient and / or maintains the implantation position and / or orientation of the example device 200 in the patient. A fluid reservoir 220 is disposed at the proximal end portion 292 of the example device 200, extending inward from and connected to the proximal end 230. Fluid is stored in an internal volume or internal space 222 defined within the fluid reservoir 220. In some examples, a reinforcement 224 may be positioned within the internal space 222 of the fluid reservoir 220. The reinforcement 224 may extend between the proximal and distal end portions of the fluid reservoir 220. In some examples, the reinforcement 224 can maintain a certain amount of stiffness in the reservoir portion 202 of the example device 200 in the implanted state, particularly in the expanded state of the expandable portion 204 of the device 200, wherein little or no fluid is retained in the fluid reservoir 220.

[0064] An expandable member 240 is mounted in the intermediate portion 294 of the example device 200. The expandable member 240 is in communication, e.g., fluid communication, with a fluid reservoir 220. In some examples, at least one fluid passage provides communication between the expandable member 240 and the fluid reservoir 220. This at least one fluid passage may allow fluid held in the fluid reservoir 220 to be selectively supplied to the expandable member 240 to expand it. This at least one fluid passage may also allow fluid filling the expandable member 240 to return to the fluid reservoir 220 to contract it. Figure 2B In the example arrangement shown, the supply tube 250 extends between the fluid reservoir 220 and the spherical object 212 positioned in the distal end 210.

[0065] In some examples, the distal end 210 and the sphere 212 are extendable, such that manipulation of the distal end 210 / sphere 212 can draw fluid from at least one fluid passage into the sphere 212, and / or can guide fluid held in the sphere 212 into the expandable member 240. In some examples, the distal end 210 and the sphere 212 may define a first fluid flow control device of the fluid flow control system 206 of the example device 200. That is, manipulation of the first fluid flow control device defined by the distal end 210 and the sphere 212 can initiate operation of the example device 200 in a first mode (i.e., in the expansion mode). In some examples, in response to manipulation of the sphere 212, i.e., squeezing and / or pressing the sphere 212, fluid can be drawn from the fluid reservoir 220 into the sphere 212 through the supply tube 250. In response to the release of the squeeze and / or press on the sphere 212, fluid can flow from the sphere 212 into the expandable member 240 to fill the expandable member 240 with fluid and expand the expandable member 240.

[0066] exist Figure 2B In the example arrangement shown, the first valve 271 is positioned between the sphere 212 and the corresponding end portion of the supply pipe 250. Figure 2B In the illustrated example arrangement, a first valve 271 is positioned at the end of the connection inlet port 214 of the supply line 250 through which fluid from the fluid reservoir 220 is introduced into the sphere 212. In some examples, the first valve 271 is a check valve or one-way valve, oriented to prevent fluid from flowing from the sphere 212 into the supply line 250 during operation, for example, in a first mode (i.e., expansion mode), and to prevent fluid from flowing back from the sphere 212 into the supply line 250 during expansion of the expandable member 240. Figure 2B In the example arrangement shown, the second valve 272 is positioned between the sphere 212 and the expandable member 240. Figure 2BIn the example arrangement shown, a second valve 272 is positioned at the outlet port 216 of the sphere 212 through which fluid from the sphere 212 can flow to the expandable member 240. In some examples, the second valve 272 is a check valve or one-way valve, which is oriented to prevent fluid from flowing from the expandable member 240 into the sphere 212, for example, after expansion of the expandable member 240 has been achieved, so that the desired expansion pressure can be maintained in the expandable member 240.

[0067] exist Figure 2B In the example shown, the third valve 273 is positioned between the fluid reservoir 220 and the expandable portion 204 of the example device 200, specifically between the fluid reservoir 220 and the expandable member 240. In some examples, the third valve 273 is a check valve or a one-way valve. In the first operating mode, i.e., during the expansion of the expandable member 240 and / or when the fluid pressure in the expandable member 240 is maintained after expansion is complete, the third valve 273 is in an unactuated state, such as... Figure 2B As shown in the diagram. In the unactuated state, the third valve 273 prevents fluid from flowing from the expandable member 240 back into the fluid reservoir 220, in order to maintain the expansion pressure in the expandable member 240 and thus prevent the expansion member 240 from contracting.

[0068] In some examples, device 200 may include an actuation device 260. When actuated by a user, actuation device 260 may actuate a third valve 273 to initiate operation of the example device 200 in a second operating mode (i.e., a contraction mode), in which fluid flows from the expandable member 240 back to the fluid reservoir 220 to cause the expandable member 240 to contract. In some examples, actuation device 260 may define, alone or together with the third valve 273, a second fluid flow control device of the fluid flow control system 206 of the example device 200. User manipulation of actuation device 260 may move the third valve 273 to an actuated position. In the actuated position of the third valve 273, a fluid passage 245 between the expandable member 240 and the fluid reservoir 220 is opened. The opening of the fluid passage 245 between the expandable member 240 and the fluid reservoir 220 allows fluid to flow from the expandable member 240 into the fluid reservoir 220, thereby allowing the contraction of the expandable member 240.

[0069] In some examples, a fourth valve 274 may be located at port 225 of fluid reservoir 220, providing fluid communication between fluid reservoir 220 and fluid passage 245. In some examples, the fourth valve 274 is a check valve or one-way valve, oriented to prevent fluid from flowing out of fluid reservoir 220 when example device 200 is in an inactive or retracted state. That is, the fourth valve 274 can prevent the expandable member 240 from unintentionally expanding due to fluid accidentally flowing from fluid reservoir 220 through port 225 into supply line 250.

[0070] Figures 3A-3C This is a cross-sectional view of the example device 200, showing fluid flow through it. Specifically, Figure 3A and Figure 3B It is along Figure 2A The cross-sectional view taken by line AA shows the fluid flow during the expansion of the expandable member 240 of the example device 200 in the first operating mode of the example device 200. Figure 3C It is along Figure 2A The cross-sectional view taken by line BB shows the fluid flow in the second operating mode of the example device 200, i.e., during the contraction of the expandable member 240 of the example device 200.

[0071] The operation of the example device 200 in the first operating mode and the expansion of the expandable member 240 will be referenced. Figure 3A and Figure 3B The following description is provided. To initiate operation of the example device 200 in a first operating mode and to expand the expandable member 240, a user can manipulate the distal end 210 / sphere 212. Manipulation of the distal end 210 / sphere 212 may include pressing and / or squeezing the distal end 210 / sphere 212, for example, repeatedly pressing / squeezing and releasing the distal end 210 / sphere 212. Figure 3A As shown by the dashed line, an input at sphere 212 (in the form of pressing and / or squeezing the distal end 210 / sphere 212) can compress sphere 212. The compression of sphere 212 and the resulting corresponding pressure force the fluid held in sphere 212 to flow out through outlet port 216 of sphere 212. Specifically, the pressure generated by the compression of sphere 212 and the corresponding fluid flow out of sphere 212 cause a second valve 272 located at outlet port 216 of sphere 212 to move in the direction of arrow F1. This movement of the second valve 272 in the direction of arrow F1 opens outlet port 216, allowing fluid held in sphere 212 to flow to expandable member 240, causing expandable member 240 to expand. Figure 3AIn the example arrangement shown, the pressure generated by pressing / squeezing the sphere 212 causes the first valve 271 to move in the direction of arrow F2, thus closing the inlet port 214 and restricting the fluid flow between the sphere 212 and the supply pipe 250, so that substantially all the fluid held in the sphere 212 can flow to the expandable member 240.

[0072] In order to continue operation of the example device 200 in the first operating mode and to continue the expansion of the expandable member 240, the user can continue to manipulate the distal end 210 / sphere 212. For example, as referenced above. Figure 3A As stated, when the fluid held in the sphere 212 has been supplied to the expandable member 240, the pressure / squeezing on the sphere 212 can be released, such as... Figure 3B As shown in the diagram, the input at sphere 212 (in the form of releasing a press / squeeze on sphere 212) can generate a suction force within sphere 212. This suction force generated at sphere 212 can move the first valve 271 in the direction of arrow F2, thus opening inlet 214 and allowing fluid to flow from fluid reservoir 220 through supply pipe 250 and inlet port 214 and into sphere 212 to fill sphere 212 with fluid. This suction force generated at sphere 212 can pull the second valve 272 in the direction of arrow F2, thereby closing outlet port 216, so that the fluid drawn into sphere 212 remains in sphere 212 when sphere 212 is refilled.

[0073] like Figure 3A The pressed / squeezed sphere 212 shown is used to deliver fluid from the sphere 212 to the expandable member 240, and then as... Figure 3B The release of the squeeze / pressure on the sphere 212 shown to refill the sphere 212 with fluid can be repeated until the desired expansion level and / or the desired expansion pressure of the expandable member 240 is achieved.

[0074] As mentioned above Figure 3A and Figure 3B In the first operating mode, the first valve 271 and the second valve 272 can be alternately closed and opened to allow fluid to flow from the sphere 212 to the expandable member 240, and from the fluid reservoir 220 through the supply pipe 250 to the sphere 212 to refill the sphere 212 with fluid. When in the first operating mode (i.e., the expansion mode), the third valve 273 can remain in a position and configuration that closes the fluid passage 245 between the expandable member 240 and the fluid reservoir 220, as... Figure 3A and Figure 3B As shown. That is to say, in Figure 3A and Figure 3BIn the unactuated state shown, the third valve 273 closes the fluid passage 245 to maintain fluid within the expandable member 240 as it expands. Similarly, once the desired expansion pressure is achieved in the expandable member 240, the third valve 273 can remain in the position of closing the fluid passage 245, thus maintaining fluid within the expandable member 240 and sustaining the desired expansion pressure within it. Once the desired expansion pressure is achieved and sustained in the expandable member 240, the first valve 271 is positioned to close the inlet port 214, the second valve 272 is positioned to close the outlet port 216, the third valve 273 is positioned to close the fluid passage 245, and the fourth valve 274 is positioned to close the port 225 leading to the fluid reservoir 220.

[0075] The operation of the example device 200 in the second operating mode and the retraction of the expandable member 240 will be referenced. Figure 3C The following description is provided. To initiate operation of the example device 200 in the second operating mode and to depressurize or retract the expandable member 240, a user can manipulate the actuator 260 to actuate the third valve 273, as described above. In some examples, manipulation of the actuator 260 includes, for example, pressing the button portion 262 of the actuator 260 in the direction of arrow F3. In some examples, the configuration of the button portion 262 of the actuator 260 is detectable externally to the example device 200, allowing the button portion 262 to be positioned and manipulated by the user. Input at the actuator 260 (in the form of manipulation of the button portion 262 of the actuator 260, such as pressing and / or pressing and holding the button portion 262) can initiate operation of the example device 200 in the second operating mode and to depressurize and / or retract the expandable member 240.

[0076] like Figure 3C As shown, the actuation device 260 may include one or more arm portions 264 extending radially inward from the button portion 262 of the actuation device 260. The inner peripheral end portions of the arm portions 264 contact the corresponding surface of the third valve 273. Figure 3C In the illustrated arrangement, the contour of the inner circumferential end portion of the arm portion 264 corresponds to the contour of the contact surface of the third valve 273, such that movement of the arm portion 264 of the actuator 260 causes a reaction movement of the third valve 273. Figure 3CIn the illustrated example arrangement, the inner circumferential end portion of the arm portion 264 is angled, with the contact surfaces of the third valve 273 oriented at complementary angles. In this example arrangement, pressing the button portion 262 in the direction of arrow F3 causes the arm portion 264 to move radially inward. This radial inward movement of the arm portion 264 causes the third valve 273 to move in the direction of arrow F2 through the interaction between the inner circumferential end portion of the arm portion 264 and the corresponding outer contact surface of the third valve 273. The movement of the third valve 273 in the direction of arrow F2 opens the fluid passage 245, allowing fluid to flow from the expandable member 240 back to the fluid reservoir 220 through the fluid passage 245. The fluid flow through the fluid passage 245 causes the fourth valve 274 to move in the direction of arrow F1, thus opening the port 225 leading to the fluid reservoir 220 and allowing fluid to return to the fluid reservoir 220. The actuator 260 can be operated in such a manner, i.e., pressing and holding the button portion 262 of the actuator 260, until the desired decompression or contraction level is achieved. Once the desired decompression and / or contraction level is achieved, the desired contraction pressure is maintained, wherein the first valve 271 is positioned to close the inlet port 214, the second valve 272 is positioned to close the outlet port 216, the third valve 273 is positioned to close the fluid passage 245, and the fourth valve 274 is positioned to close the port 225 leading to the fluid reservoir 220.

[0077] Figure 4A and Figure 4B An example configuration of the distal end 210 is shown, which can be coupled to the reference above. Figures 2A-3C The example described is an implantable, fluid-operated, expandable device 200. Specifically, Figure 4A The first example distal end 210A is shown, while Figure 4B A second example distal end 210B is shown. Either the first example distal end 210A or the second example distal end 210B can be incorporated into the above reference. Figures 2A-3C The described implantable, fluid-operated, expandable device 200. Figure 4A The first example distal end 210A shown includes a needle guide opening 215A. In some examples, the needle guide opening 215A can provide insertion of a needle and device traction suture through the first example distal end 210A. The needle and device traction suture can facilitate and guide the placement of an implantable, fluid-operated, expandable device 200 within the patient, such that the proximal end 230 can be properly positioned and attached, and the first example distal end 210A can be positioned within the distal corpus cavernosum. Figure 4B The second example shown has a needle-free configuration at the distal end 210B.

[0078] Figures 5A-5C It is along Figure 2A The cross-sectional view captured by the CC line. Figures 5A-5C An example configuration of the expandable member 240 is shown, which can be incorporated into the reference above. Figures 2A-3C The example described is an implantable, fluid-operated, expandable device 200. Specifically, Figure 5A This is a cross-sectional view showing the features of the first example expandable member 240A. Figure 5B This is a cross-sectional view showing the features of the second example expandable member 240B, and Figure 5C This is a cross-sectional view illustrating the features of the third example expandable member 240C. Any of the first example expandable member 240A, the second example expandable member 240B, or the third example expandable member 240C can be incorporated into the above reference. Figures 2A-3C The described implantable, fluid-operated, expandable device 200.

[0079] like Figures 5A-5C As shown, the first example expandable member 240A, the second example expandable member 240B, and the third example expandable member 240C each include a first (inner) wall 241 and a second (outer) wall 242. In some examples, the first (inner) wall 241 and the second (outer) wall 242 may define an expansion tube that extends longitudinally along corresponding portions of the example device 200. In some examples, the second (outer) wall 242 may define corresponding portions of the housing 290. Figures 5A-5C In each of the example arrangements shown, the first wall 241 and the second wall 242 each have a substantially circular cross-section, for purposes of discussion and illustration only. Figures 5A-5C In each example arrangement shown, the first wall 241 and the second wall 242 are arranged substantially concentrically, for the purposes of discussion and illustration only. Figures 5A-5C In each of the example arrangements shown, the central opening 243 of the expandable member 240 is defined by the first wall 241. In some examples, components of an implantable, fluid-operated expandable device 200 may be received in the central opening 243. For example, as... Figures 2B-3C As shown, the supply tube 250 may extend through the central opening 243 of the expandable member 240. In some examples, the first valve body supporting the first valve 271 and / or the second valve 272 may extend at least partially into the central opening 243 at the distal end portion of the expandable member 240, such as... Figures 2B-3C As shown in the diagram. In some examples, the second valve body supporting the third valve 273 and / or the fourth valve 274 may extend at least partially into the central opening 243 at the proximal end portion of the expandable member 240, as shown in the diagram. Figures 2B-3C As shown in the image.

[0080] In some examples, the first wall 241 and / or the second wall 242 may be made of fabric or woven material. In some examples, a silicon layer may be formed on the outer peripheral portion of the expandable member 240. In some examples, the silicon layer on the outer peripheral portion of the expandable member 240 may define a corresponding portion of the housing 290 of an example implantable fluid-operated expandable device 200.

[0081] like Figure 5A As shown, the first example expandable member 240A includes a first plurality of openings 246A and a second plurality of openings 248A defined between a first wall 241 and a second wall 242. Specifically, Figure 5A The first example expandable member 240A shown includes two generally circular first openings 246A positioned between two generally arcuate second openings 248A, thus defining two expansion sections of the first example expandable member 240A. In some examples, the first plurality of openings 246A and / or the second plurality of openings 248A may communicate with the outlet port 216 of the sphere 212, such that fluid from the sphere 212 may fill the first plurality of openings 246A and / or the second plurality of openings 248A to expand the first example expandable member 240A. In some examples, the first plurality of openings 246A and / or the second plurality of openings 248A may communicate with a fluid passage 245, such that fluid may flow from the first plurality of openings 246A and / or the second plurality of openings 248A to the fluid passage 245 to contract the first example expandable member 240A.

[0082] exist Figure 5A In the example arrangement shown, the first plurality of openings 246A has a substantially circular cross-section, while the second plurality of openings 248A has a substantially arcuate cross-section, for purposes of discussion and illustration only. The principles described herein can be applied to configurations where the first plurality of openings 246A and / or the second plurality of openings 248A have other cross-sectional shapes and / or profiles and / or combinations thereof. Figure 5A In the illustrated example arrangement, the first plurality of openings 246A and the second plurality of openings 248A are arranged alternately around the central axis of the first example expandable member 240A, for purposes of discussion and illustration only. Figure 5A In the example arrangement shown, the first plurality of openings 246A and the second plurality of openings 248A are arranged symmetrically about the central plane of the first example expandable member 240A, for purposes of discussion and illustration only. The principles described herein can be applied to other arrangements of the first plurality of openings 246A and / or the second plurality of openings 248A.

[0083] like Figure 5BAs shown, the second example expandable member 240B, the first plurality of openings 246B, and the second plurality of openings 248B are defined between the first wall 241 and the second wall 242. Specifically, Figure 5B The second example expandable member 240B shown includes three generally circular first openings 246B positioned between three generally arcuate second openings 248B, thus defining three expansion segments of the second example expandable member 240B. In some examples, the first plurality of openings 246B and / or the second plurality of openings 248B may communicate with the outlet port 216 of the sphere 212, such that fluid from the sphere 212 may fill the first plurality of openings 246B and / or the second plurality of openings 248B to expand the second example expandable member 240B. In some examples, the first plurality of openings 246B and / or the second plurality of openings 248B may communicate with a fluid passage 245, such that fluid may flow from the first plurality of openings 246B and / or the second plurality of openings 248B to the fluid passage 245 to contract the second example expandable member 240B.

[0084] exist Figure 5B In the example arrangement shown, the first plurality of openings 246B has a substantially circular cross-section, while the second plurality of openings 248B has a substantially arcuate cross-section, for purposes of discussion and illustration only. The principles described herein can be applied to configurations where the first plurality of openings 246B and / or the second plurality of openings 248B have other cross-sectional shapes and / or profiles and / or combinations thereof. Figure 5B In the illustrated arrangement, the first plurality of openings 246B and the second plurality of openings 248B are arranged alternately around the central axis of the second exemplary expandable member 240B, for purposes of discussion and illustration only. Figure 5B In the example arrangement shown, the first plurality of openings 246B and the second plurality of openings 248B are arranged symmetrically about the central plane of the second example expandable member 240B, for purposes of discussion and illustration only. The principles described herein can be applied to other arrangements of the first plurality of openings 246B and / or the second plurality of openings 248B.

[0085] like Figure 5C As shown, the third example expandable member 240C includes a first plurality of openings 246C and a second plurality of openings 248C defined between a first wall 241 and a second wall 242. Specifically, Figure 5CThe third example expandable member 240C shown includes four generally circular first openings 246C positioned between four generally arcuate second openings 248C, thus defining four expansion segments of the third example expandable member 240C. In some examples, the first plurality of openings 246C and / or the second plurality of openings 248C may communicate with an outlet port 216 of the sphere 212, such that fluid from the sphere 212 may fill the first plurality of openings 246C and / or the second plurality of openings 248C to expand the third example expandable member 240C. In some examples, the first plurality of openings 246C and / or the second plurality of openings 248C may communicate with a fluid passage 245, such that fluid may flow from the first plurality of openings 246C and / or the second plurality of openings 248C to the fluid passage 245 to contract the third example expandable member 240C.

[0086] exist Figure 5C In the example arrangement shown, the first plurality of openings 246C has a substantially circular cross-section, while the second plurality of openings 248C has a substantially arcuate cross-section, for purposes of discussion and illustration only. The principles described herein can be applied to configurations where the first plurality of openings 246C and / or the second plurality of openings 248C have other cross-sectional shapes and / or profiles and / or combinations thereof. Figure 5C In the illustrated arrangement, the first plurality of openings 246C and the second plurality of openings 248C are arranged alternately around the central axis of the third exemplary expandable member 240C, for purposes of discussion and illustration only. Figure 5C In the example arrangement shown, the first plurality of openings 246C and the second plurality of openings 248C are arranged symmetrically about the central plane of the third example expandable member 240C, for purposes of discussion and illustration only. The principles described herein can be applied to other arrangements of the first plurality of openings 246C and / or the second plurality of openings 248C.

[0087] Figures 6A-6C Each presents a side view and an axial end view of an example configuration of the actuator 260, which can be incorporated into the above reference. Figures 2A-3C The example described is an implantable, fluid-operated, expandable device 200. Specifically, Figure 6A Features of the first example actuator 260A are shown. Figure 6B Features of the second example actuator 260B are shown, and Figure 6C Features of the third example actuator 260C are shown. Any of the first example actuator 260A, the second example actuator 260B, or the third example actuator 260C can be incorporated into the above reference. Figures 2A-3C The described implantable, fluid-operated, expandable device 200.

[0088] like Figures 6A-6C As shown, the first example actuation device 260A, the second example actuation device 260B, and the third example actuation device 260C each include a button portion 262 that is detectable and accessible to a user at the peripheral portion of the example implantable fluid-operated expandable device 200. In some examples, the button portion 262 may be disposed in a recess 291 defined in the peripheral portion of the housing 290 of the example device 200 to accommodate and / or facilitate depressurization of the button portion 262 relative to the housing 290. As described above, depressurization of the button portion 262 of the actuation device 260 may cause one or more arm portions 264 ( Figures 6A-6C (Not shown) moves radially inward, thus actuating the third valve 273 and opening the fluid passage 245 between the expandable member 240 and the fluid reservoir 220.

[0089] like Figure 6A As shown, the button portion 262 of the first example actuation device 260A includes a single actuation button 262A positioned in a recessed portion 291 of the housing 290. Figure 6A In the example arrangement shown, the single actuation button 262A is a ring-shaped button that extends completely around the circumferential surface located at the recessed portion 291 of the housing 290. In some examples, a single ring-shaped actuation button 262A extending completely around the housing 290 in this way can increase the operating area of ​​the button portion 262, thus facilitating user operation of the actuation device 260.

[0090] like Figure 6B As shown, the button portion 262 of the second example actuation device 260B includes a plurality of actuation buttons 262B positioned in a recessed portion 291 of the housing 290. Figure 6B In the example arrangement shown, a plurality of actuation buttons 262B are arranged along a circumferential surface located at a recess 291 in the housing 290, spaced apart from each other. This arrangement of the plurality of actuation buttons 262B can create a contour variation in the region of the actuation device 260, which improves the detectability of the actuation device 260 to the user, and thus facilitates the user's operation of the actuation device 260. Figure 6B The example second example actuation device 260B shown includes three actuation buttons 262B, but this is for discussion and illustration purposes only. More or fewer actuation buttons 262B may be disposed in the recess 291 of the housing 290, and the arrangement of the more or fewer actuation buttons may be similar to or different from... Figure 6B The example layout is shown below.

[0091] like Figure 6CAs shown, the button portion 262 of the third example actuation device 260C includes a single actuation button 262A positioned in a recessed portion 291 of the housing 290. Figure 6C In the example arrangement shown, a single actuation button 262C extends partially around a circumferential surface located at a recess 291 in the housing 290. In some examples, a single actuation button 262B extending partially around the housing 290 in this manner can improve the detectability of the actuation device 260 to the user, while also increasing the actuation area of ​​the button portion 262, thus facilitating user operation of the actuation device 260. Figure 6C The example third example actuation device 260C shown includes a single actuation button 262C that extends approximately two-thirds of the distance from the outer periphery of a recess 291 located on the housing 290 of the example device 200, for purposes of discussion and illustration only. Figure 6C Compared to the example arrangement shown, a single actuation button 262C can extend to cover a larger or smaller portion of the circumferential surface of the recessed portion 291 of the housing 290.

[0092] Figure 7A and Figure 7B This is a close-up cross-sectional view showing the interaction between the actuator 260 and the third valve 273. Specifically, Figure 7A The axial orientation of an example third valve 273A in an example implantable fluid-operated expandable device 200 is shown. Figure 7A The axial orientation of the example third valve 273A shown is substantially the same as that of the reference above. Figures 2B-3C The example arrangement of the third valve 273 in the fluid passage 245 described is the same, and therefore repeated detailed descriptions will be omitted except where necessary for clarity. Figure 7B The radial orientation of another example third valve 273B in an example implantable fluid-operated expandable device 200 is shown.

[0093] like Figure 7A As shown, the example third valve 273A is positioned within a fluid passage 245 connecting the expandable member 240 and the fluid reservoir 220 (via the fourth valve 274 and port 225 leading to the fluid reservoir 220). In an unactuated or stationary state, the biasing member 275A biases the example third valve 273A in the direction of arrow F1 to a position that closes the fluid passage 245. As mentioned above regarding... Figures 3A-3CThe example third valve 273A, by closing the fluid passage 245, prevents fluid from flowing from the expandable member 240 to the fluid reservoir 220, thus maintaining the desired expansion pressure in the expandable member 240 (including maintaining the expandable member 240 in an expanded or contracted state). A force applied along arrow F3 to the button portion 262 of the actuator 260 (to initiate operation in the second mode or the contraction of the expandable member 240) can then apply a radial force to the example third valve 273A, causing it to move axially in the direction of arrow F2, thereby opening the fluid passage 245 and allowing fluid to flow from the expandable member 240 to the fluid reservoir 220.

[0094] exist Figure 7B In the illustrated example arrangement, the example third valve 273B is radially oriented within the radially oriented fluid passage 245B. In the unactuated or stationary state, the biasing member 275B biases the example third valve 273B in the direction of arrow F4 to a position that closes the fluid passage 245B. In this position, the example third valve 273B closes the fluid passage 245B and prevents fluid from flowing from the expandable member 240 to the fluid reservoir 220, thus maintaining the desired expansion pressure in the expandable member 240 (including maintaining the expanded state or the contracted state of the expandable member 240). A force applied to the button portion 262 of the actuating device 260 in the direction of arrow F3 (to initiate operation in the second mode or the contraction of the expandable member 240) can then apply a radial force to the example third valve 273B, which causes the example third valve 273A to move radially in the direction of arrow F3, thus opening the fluid passage 245B and allowing fluid to flow from the expandable member 240 to the fluid reservoir 220.

[0095] While certain features of the described embodiments have been illustrated as described herein, many modifications, substitutions, alterations, and equivalents will now occur to those skilled in the art. Therefore, it should be understood that the appended claims are intended to cover all such modifications and alterations falling within the scope of the embodiments.

Claims

1. An implantable, fluid-operated, expandable device, comprising: case; A fluid reservoir, which is received within the housing; An expandable member is received within the housing; A fluid component, disposed within the housing, provides fluid communication between the fluid reservoir and the expandable member; and A fluid flow control system is disposed on the housing and configured to provide fluid flow from the fluid reservoir to the expandable member in a first operating mode in response to an input at a first fluid flow control device of the fluid flow control system, and to provide fluid flow from the expandable member to the fluid reservoir in a second operating mode in response to an input at a second fluid flow control device of the fluid flow control system.

2. The implantable, fluid-operated, expandable device according to claim 1, wherein, The implantable, fluid-operated, expandable device is a penile prosthesis, comprising: The proximal end is located at the first end portion of the housing; The distal end, located at the second end portion of the housing; and An expandable portion, located in the middle part of the housing, corresponds to the expandable member.

3. The implantable, fluid-operated, expandable device according to claim 1 or 2, wherein... The first fluid flow control device includes an extendable sphere disposed in the distal end; and The second fluid flow control device includes a valve actuation device disposed in the middle portion of the housing.

4. The implantable, fluid-operated, expandable device according to claim 1 or 2, wherein, The fluid component includes: A supply tube that connects the fluid reservoir and a sphere positioned at the distal end; The first valve is located in the supply pipe; Connect the sphere to the port of the expandable member; A second valve is positioned at the port where the sphere is connected to the expandable member; The fluid passage connecting the expandable member and the fluid reservoir; and The third valve is located in the fluid passage connecting the expandable member and the fluid reservoir.

5. The implantable, fluid-operated, expandable device according to claim 4, wherein, The first fluid flow control device includes a sphere disposed in the distal end, and wherein, in response to a first manipulation of the sphere positioned in the distal end: The first valve is closed to prevent fluid in the sphere from flowing into the supply pipe; The second valve opens to allow fluid held in the sphere to flow from the sphere to the expandable member, causing the expandable member to expand; and The third valve is closed to prevent fluid from flowing from the expandable member into the fluid reservoir.

6. The implantable, fluid-operated, expandable device according to claim 5, wherein, In response to a second manipulation of the sphere positioned in the distal end: The first valve opens to allow fluid to flow from the supply pipe into the sphere to refill it; The second valve is closed to prevent fluid from flowing from the sphere into the supply pipe; and The third valve is closed to prevent fluid from flowing from the expandable member into the fluid reservoir.

7. The implantable, fluid-operated, expandable device according to claim 6, wherein, The first manipulation of the sphere is to compress the sphere, and the second manipulation is to release the compression of the sphere.

8. The implantable, fluid-operated, expandable device according to claim 4, wherein, The second fluid flow control device includes a valve actuation device disposed in the middle portion of the housing, wherein, in response to operation of the valve actuation device: The third valve opens to allow fluid to flow from the expandable member to the fluid reservoir, causing the expandable member to contract; The first valve is closed to prevent fluid in the sphere from flowing into the supply pipe; and The second valve is closed to prevent fluid held in the sphere from flowing to the expandable member.

9. The implantable, fluid-operated, expandable device according to claim 8, wherein, The valve actuation device includes: The button portion is disposed in a recess formed in the outer peripheral surface of the housing; and At least one arm extends radially inward from the button portion into the housing to selectively contact the third valve.

10. The implantable, fluid-operated, expandable device according to claim 9, wherein, In the non-actuated state of the valve actuation device: The third valve is positioned to close the fluid passage between the expandable member and the fluid reservoir.

11. The implantable, fluid-operated, expandable device according to claim 9, wherein, In the actuated state of the valve actuation device: The at least one arm moves radially inward in response to pressure on the button portion; The third valve moves in response to a force applied to it by the at least one arm to open a fluid passage between the expandable member and the fluid reservoir; and Fluid flows from the expandable member to the fluid reservoir to cause the expandable member to contract.

12. The implantable, fluid-operated, expandable device according to claim 11, wherein, The third valve is axially oriented within the housing, wherein the at least one arm is configured to apply a radial force to the third valve, the radial force causing the third valve to move in the axial direction to open a fluid passage between the expandable member and the fluid reservoir.

13. The implantable, fluid-operated, expandable device according to claim 11, wherein, The third valve is radially oriented within the housing, and wherein the at least one arm is configured to apply a radial force to the third valve, the radial force causing the third valve to move in a radial direction to open a fluid passage between the expandable member and the fluid reservoir.

14. The implantable, fluid-operated, expandable device according to claim 9, wherein, The button portion includes one of the following: A ring-shaped button is arranged in the recess and extends around the middle portion of the housing forming the recess; An arc-shaped button is arranged in the recess and extends partially around the middle portion of the housing that forms the recess; or Multiple arc-shaped buttons are arranged in the recess and spaced apart along the middle portion of the housing that forms the recess.

15. The implantable, fluid-operated, expandable device according to claim 1 or 2, wherein, The expandable component includes: Inner and outer walls defining an expansion tube that extends longitudinally along the middle portion of the housing; Multiple first openings are formed between the inner wall and the outer wall, extending longitudinally along the length of the expandable member; A plurality of second openings, formed between the inner wall and the outer wall, are arranged alternately with the plurality of first openings and extend longitudinally along the length of the expandable member; and A central opening, defined by the inner wall, extends longitudinally along the length of the expandable member. In the expanded state of the expandable member, the plurality of first openings and the plurality of second openings are configured to be filled with fluid so as to expand the expandable member.

16. An implantable, fluid-operated, expandable device, comprising: case; A fluid reservoir, which is received within the housing; An expandable member is received within the housing; A fluid component, disposed within the housing, provides fluid communication between the fluid reservoir and the expandable member; and A fluid flow control system is disposed on the housing and configured to provide fluid flow from the fluid reservoir to the expandable member in a first operating mode in response to an input at a first fluid flow control device of the fluid flow control system, and to provide fluid flow from the expandable member to the fluid reservoir in a second operating mode in response to an input at a second fluid flow control device of the fluid flow control system.

17. The implantable, fluid-operated, expandable device according to claim 16, wherein, The implantable, fluid-operated, expandable device is a penile prosthesis, comprising: The proximal end is located at the first end portion of the housing; The distal end, located at the second end portion of the housing; and An expandable portion, located in the middle part of the housing, corresponds to the expandable member.

18. The implantable, fluid-operated, expandable device of claim 17, wherein... The first fluid flow control device includes an extendable sphere disposed in the distal end; and The second fluid flow control device includes a valve actuation device disposed in the middle portion of the housing.

19. The implantable, fluid-operated, expandable device according to claim 17, wherein, The fluid component includes: A supply tube that connects the fluid reservoir and a sphere positioned at the distal end; The first valve is located in the supply pipe; Connect the sphere to the port of the expandable member; A second valve is positioned at the port where the sphere is connected to the expandable member; The fluid passage connecting the expandable member and the fluid reservoir; and The third valve is located in the fluid passage connecting the expandable member and the fluid reservoir.

20. The implantable, fluid-operated, expandable device according to claim 19, wherein, The first fluid flow control device includes a sphere disposed in the distal end, and wherein, in response to a first manipulation of the sphere positioned in the distal end: The first valve is closed to prevent fluid in the sphere from flowing into the supply pipe; The second valve opens to allow fluid held in the sphere to flow from the sphere to the expandable member, causing the expandable member to expand; and The third valve is closed to prevent fluid from flowing from the expandable member into the fluid reservoir.

21. The implantable, fluid-operated, expandable device according to claim 20, wherein, In response to a second manipulation of the sphere positioned in the distal end: The first valve opens to allow fluid to flow from the supply pipe into the sphere to refill it; The second valve is closed to prevent fluid from flowing from the sphere into the supply pipe; and The third valve is closed to prevent fluid from flowing from the expandable member into the fluid reservoir.

22. The implantable, fluid-operated, expandable device according to claim 21, wherein, The first manipulation of the sphere is to compress the sphere, and the second manipulation is to release the compression of the sphere.

23. The implantable, fluid-operated, expandable device according to claim 19, wherein, The second fluid flow control device includes a valve actuation device disposed in the middle portion of the housing, wherein, in response to operation of the valve actuation device: The third valve opens to allow fluid to flow from the expandable member to the fluid reservoir, causing the expandable member to contract; The first valve is closed to prevent fluid in the sphere from flowing into the supply pipe; and The second valve is closed to prevent fluid held in the sphere from flowing to the expandable member.

24. The implantable, fluid-operated, expandable device according to claim 23, wherein, The valve actuation device includes: The button portion is disposed in a recess formed in the outer peripheral surface of the housing; and At least one arm extends radially inward from the button portion into the housing to selectively contact the third valve.

25. The implantable, fluid-operated, expandable device according to claim 24, wherein, In the non-actuated state of the valve actuation device: The third valve is positioned to close the fluid passage between the expandable member and the fluid reservoir.

26. The implantable, fluid-operated, expandable device according to claim 24, wherein, In the actuated state of the valve actuation device: The at least one arm moves radially inward in response to the pressing of the button portion; The third valve moves in response to a force applied to it by the at least one arm to open a fluid passage between the expandable member and the fluid reservoir; and Fluid flows from the expandable member to the fluid reservoir to cause the expandable member to contract.

27. The implantable, fluid-operated, expandable device according to claim 26, wherein, The third valve is axially oriented within the housing, wherein the at least one arm is configured to apply a radial force to the third valve, the radial force causing the third valve to move in the axial direction to open a fluid passage between the expandable member and the fluid reservoir.

28. The implantable, fluid-operated, expandable device according to claim 26, wherein, The third valve is radially oriented within the housing, and wherein the at least one arm is configured to apply a radial force to the third valve, the radial force causing the third valve to move in a radial direction to open a fluid passage between the expandable member and the fluid reservoir.

29. The implantable, fluid-operated, expandable device according to claim 24, wherein, The button portion includes one of the following: A ring-shaped button is arranged in the recess and extends around the middle portion of the housing forming the recess; An arc-shaped button is arranged in the recess and extends partially around the middle portion of the housing that forms the recess; or Multiple arc-shaped buttons are arranged in the recess and spaced apart along the middle portion of the housing that forms the recess.

30. The implantable, fluid-operated, expandable device according to claim 17, wherein, The expandable component includes: Inner and outer walls defining an expansion tube that extends longitudinally along the middle portion of the housing; A plurality of first openings are formed between the inner wall and the outer wall, extending longitudinally along the length of the expandable member; and A plurality of second openings, formed between the inner wall and the outer wall, are arranged alternately with the plurality of first openings and extend longitudinally along the length of the expandable member. In the expanded state of the expandable member, the plurality of first openings and the plurality of second openings are configured to be filled with fluid so as to expand the expandable member.

31. The implantable, fluid-operated, expandable device according to claim 16, wherein, The inner wall defines a central opening extending longitudinally along the length of the expandable member, wherein at least some of the fluid components are received within the space defined by the central opening.

32. A fluid flow control system for an implantable, fluid-operated expandable device, comprising: case; A first fluid flow control device is disposed at the distal end portion of the housing, the first fluid flow control device comprising: A spherical object disposed in the distal end of the portion defining the distal end of the housing; A first valve is positioned in the supply pipe connecting the sphere to the fluid reservoir; and A second valve is positioned in the port connecting the sphere and the expandable member; A second fluid flow control device is disposed in the middle portion of the housing, and the second fluid flow control device includes: A valve actuation device configured to selectively actuate a third valve disposed in a fluid passage connecting the expandable member and the fluid reservoir, the valve actuation device comprising: The button portion is disposed in a recess formed in the outer peripheral surface of the housing; and At least one arm extends radially inward from the button portion into the housing to selectively contact the third valve.

33. The fluid flow control system according to claim 32, wherein, In the first operating mode of the implantable, fluid-operated, expandable device, In response to compression of the sphere positioned in the distal end: The first valve is closed to prevent fluid in the sphere from flowing into the supply pipe; The second valve opens to allow fluid held in the sphere to flow from the sphere to the expandable member, causing the expandable member to expand; and The third valve is closed to prevent fluid from flowing from the expandable member into the fluid reservoir; and In response to releasing the compression on the sphere positioned in the distal end: The first valve opens to allow fluid to flow from the supply pipe into the sphere to refill it; The second valve is closed to prevent fluid from flowing from the sphere into the supply pipe; and The third valve is closed to prevent fluid from flowing from the expandable member into the fluid reservoir.

34. The fluid flow control system according to claim 32, wherein, In the second operating mode of the implantable, fluid-operated, expandable device, In response to pressing the button portion of the second fluid flow control device: In response to a force applied to the third valve by the arm portion, the third valve opens to allow fluid to flow from the expandable member to the fluid reservoir, causing the expandable member to contract. The first valve is closed to prevent fluid in the sphere from flowing into the supply pipe; and The second valve is closed to prevent fluid held in the sphere from flowing to the expandable member.

35. The fluid flow control system according to claim 32, wherein, The fluid flow control system, the expandable component, and the fluid reservoir are integrated into a single unit.

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