IMPLANTABLE INFLATABLE DEVICE HAVING A FILTER - Patent application

JP2024545130A5Active Publication Date: 2025-06-09BOSTON SCIENTIFIC SCIMED INC
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Patent Information

Application Number
JP2024534266
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2022-12-19
Filing Date
2022-12-20
Publication Date
2025-06-09
Estimated Expiration
2042-12-20

AI Technical Summary

Technical Problem

Implantable expandable devices face challenges in preventing particles from entering the pump or pump assembly, which can lead to occlusion and failure.

Method used

Incorporating a filter member within the device to allow fluid passage while blocking larger particles, positioned between the fluid reservoir and the pump assembly, and optionally within connecting members, with self-cleaning capabilities to maintain functionality.

Benefits of technology

The filter effectively prevents particle ingress, reducing the risk of pump or valve failure and maintaining system integrity by allowing fluid flow while trapping larger particles.

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Abstract

The implantable expandable device (100) includes a fluid reservoir (110) defining a cavity, an expandable member (150), a pump assembly (130) configured to transfer fluid from the fluid reservoir to the expandable member, and a filter member (120). Fluid is configured to pass through the filter member as the pump assembly transfers fluid from the fluid reservoir to the expandable member.
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Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of and claims priority to U.S. Nonprovisional Patent Application No. 18 / 068,081, entitled "IMPLANTABLE INFLATABLE DEVICE HAVING A FILTER," filed December 19, 2022, which claims priority to U.S. Provisional Patent Application No. 63 / 265,810, entitled "IMPLANTABLE INFLATABLE DEVICE HAVING A FILTER," filed December 21, 2021, the disclosure of which is incorporated by reference in its entirety herein.

[0002] This application also claims priority to U.S. Provisional Patent Application No. 63 / 265,810, filed December 21, 2021, the disclosure of which is incorporated by reference in its entirety herein.

[0003] FIELD OF THE DISCLOSURE This disclosure relates generally to bodily implants, and more specifically to bodily implants that include an expandable member, a fluid reservoir, and a pump. [Background technology]

[0004] Implantable inflatable devices often include one or more pumps that regulate the flow of fluid between different portions of the implantable device to provide inflation and deflation of one or more fluid-fillable implant components of the device. For example, some implantable inflatable devices include an inflatable member, a fluid reservoir, and a pump or pump assembly. In such implantable inflatable devices, it may be desirable to keep particles out of the pump or pump assembly. For example, it may be desirable to keep particles out of the pump or pump assembly to help prevent pump or valve blockage. Thus, there is a need for an implantable inflatable device that includes a system for keeping particles out of or away from the pump or pump assembly. Summary of the Invention [Means for solving the problem]

[0005] According to an aspect, an implantable expandable device includes a fluid reservoir defining a cavity, an expandable member, a pump assembly configured to transfer fluid from the fluid reservoir to the expandable member, and a filter member. Fluid is configured to pass through the filter member when the pump assembly transfers fluid between the fluid reservoir and the expandable member. For example, in some embodiments, fluid is configured to pass through the filter member when the pump assembly transfers fluid from the fluid reservoir to the expandable member. In some embodiments, fluid is configured to pass through the filter member when the pump assembly transfers fluid from the expandable member to the fluid reservoir. In some embodiments, fluid is configured to pass through the filter member when the pump assembly transfers fluid from the expandable member to the fluid reservoir and when the pump assembly transfers fluid from the fluid reservoir to the expandable member.

[0006] In some embodiments, the pump assembly includes a pump and the filter is operatively coupled between the pump and the fluid reservoir, hi some embodiments, the pump assembly includes a pump and the filter is operatively coupled between the pump and the inflatable member.

[0007] In some embodiments, the expandable device includes a connecting member extending between the fluid reservoir and the pump assembly to operatively couple the fluid reservoir to the pump assembly, and the filter is disposed within the connecting member. In some embodiments, the expandable device includes a connecting member extending between the expandable member and the pump assembly to operatively couple the expandable member to the pump assembly, and the filter is disposed within the connecting member.

[0008] In some embodiments, the filter is a self-cleaning filter. In some embodiments, the filter defines a fluid passageway having a tapered shape. In some embodiments, the filter defines a first opening, a second opening, and a lumen extending between the first opening and the second opening, the first opening having a size, the second opening having a size, and the size of the first opening being greater than the size of the second opening. In some embodiments, the filter defines a first opening, a second opening, a third opening, and a fluid passageway fluidly coupling the first opening, the second opening, and the third opening.

[0009] In some embodiments, the filter defines a first opening, a second opening, a third opening, and a fluid passageway fluidly coupling the first opening, the second opening, and the third opening, where the first opening has a size, the second opening has a size, and the third opening has a size, where the size of the first opening is different from the size of the second opening and different from the size of the third opening. In some embodiments, the filter has a first side and a second side opposite the first side, and the filter defines a first opening, a second opening, a third opening, and a fluid passageway fluidly coupling the first opening, the second opening, and the third opening, where the first opening is disposed on the first side of the filter, the second opening is disposed on the second side of the filter, and the third opening is disposed on the second side of the filter.

[0010] In some embodiments, the filter is a lattice filter.In some embodiments, the filter defines a fluid passageway having a tortuous path.

[0011] In some embodiments, the filter is disposed within the pump assembly. In some embodiments, the pump assembly includes a housing having a stationary member.

[0012] In some embodiments, the implantable inflatable device includes a fluid reservoir defining a cavity, an inflatable member, a pump assembly configured to transfer fluid from the fluid reservoir to the inflatable member, a first connecting member extending between the fluid reservoir and the pump assembly, a second connecting member extending between the inflatable member and the pump assembly, and a filter member.

[0013] In some embodiments, the filter member is disposed within the first connecting member. In some embodiments, the filter member is disposed within the second connecting member. In some embodiments, the filter is a self-cleaning filter. In some embodiments, the filter defines a fluid passageway having a tapered shape. [Brief description of the drawings]

[0014] [Figure 1] 1 is a schematic diagram of an implantable inflatable device according to an embodiment. [Diagram 2] FIG. 1 is a perspective view of an implantable expandable device according to an embodiment. [Diagram 3] 3 is a schematic diagram of a pump assembly of the implantable inflatable device of FIG. 2. [Figure 4] FIG. 4 is a perspective view of a pump assembly of the implantable inflatable device of FIG. 3. [Diagram 5] FIG. 4 is an exploded side view of a pump assembly of the implantable inflatable device of FIG. 3. [Figure 6] 4 is an exploded perspective view of a pump assembly of the implantable inflatable device of FIG. 3. [Figure 7] 3 is a perspective view of a filter of the implantable expandable device of FIG. 2. [Figure 8] FIG. 8 is a cross-sectional view of the filter of FIG. [Figure 9] FIG. 4 is a cross-sectional view of a filter according to another embodiment. [Figure 10] FIG. 4 is a cross-sectional view of a filter according to another embodiment. [Figure 11] FIG. 13 is a perspective view of a filter according to another embodiment. [Figure 12] FIG. 12 is a top view of the filter of FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] Detailed implementations are disclosed herein. However, it is understood that the implementations of the present disclosure 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 a basis for the scope of the claims, and further, as merely a representative basis for teaching those skilled in the art to employ these implementations in a variety of virtually any suitable detailed structure. Moreover, the terms and expressions used herein are not intended to be limiting, but are intended to provide an understandable description of the present disclosure.

[0016] The terms "a" or "an," as used herein, are defined as one or more than one. The term "another" is defined as at least a second or a third or more. As used herein, the terms "including" and / or "having" are defined as comprising (i.e., an open transition). As used herein, the terms "coupled" or "movably coupled" are defined as connected, although not necessarily directly and mechanically.

[0017] In general, the implementations relate to body implants. In the following, the terms patient or user may be used for individuals who may benefit from the medical devices or methods of the present disclosure. For example, a patient may be an individual having a body in which a medical device of the present disclosure is implanted or in which a method disclosed for operating a medical device is used.

[0018] FIG. 1 is a schematic diagram of an implantable inflatable device 100. The device 100 includes a fluid reservoir 110, a pump assembly 130, and an inflatable member 150. The fluid reservoir 110 is operatively or fluidly coupled to the pump assembly 130 through a connecting member 170. The connecting member 170 can be a tubular member such as kink resistant tubing (KRT). In other implementations, the fluid reservoir 110 is operatively or fluidly coupled to the pump assembly 130 through a different mechanism. Similarly, the inflatable member 150 is operatively or fluidly coupled to the pump assembly 130 through a connecting member 190. The connecting member 190 can be a tubular member such as kink resistant tubing (KRT). In other embodiments, the inflatable member 150 is operatively or fluidly coupled to the pump assembly 130 through a different mechanism.

[0019] The implantable inflatable device 100 can be configured to be implanted in a patient's or user's body. For example, in some embodiments, the implantable inflatable device 100 is a penile implant. In some embodiments, the inflatable member 150 can be implanted in the patient's or user's corpus cavernosum, the fluid reservoir 110 can be implanted in the user's abdominal or pelvic cavity (e.g., the fluid reservoir 110 can be implanted in a lower portion of the user's abdominal cavity or an upper portion of the user's pelvic cavity), and the pump assembly 130 can be implanted in a portion of the user's body, such as the user's abdomen. In other embodiments, the implantable inflatable device 100 is implanted in a different portion of the patient's body and / or for a different purpose. For example, in some embodiments, the implantable inflatable device 100 can be an artificial sphincter, such as an artificial urinary sphincter.

[0020] The pump assembly 130 may include a pump or more than one pump configured to pump fluid into the expandable member 150 during an inflation cycle. In some examples, the pump or pumps may be manually controlled by a user or may be mechanically and / or programmatically controlled by a controller.

[0021] The expandable member 150 can have the ability to expand upon injection of a fluid into its cavity. For example, the expandable member 150 can increase in length and / or width as well as stiffness upon injection of a fluid therein. In some examples, the expandable member 150 can include a pair of expandable cylinders or at least two cylinders, e.g., a first cylinder member and a second cylinder member. The volumetric capacity of the expandable member 150 can be based on the size of the expandable cylinders.

[0022] The fluid reservoir 110 may include a container having an internal cavity or chamber configured to hold or contain a fluid used to inflate the expandable member 150. The volume capacity of the fluid reservoir 110 may vary. In some examples, the volume capacity of the fluid reservoir 110 may be between 3 cubic centimeters and 150 cubic centimeters. In some examples, the fluid reservoir 110 is composed of the same material as the expandable member 150. In other examples, the fluid reservoir 110 is composed of a different material than the expandable member 150. In some examples, the fluid reservoir 110 encloses a larger volume of fluid than the expandable member 150.

[0023] In the illustrated embodiment, the implantable inflatable device 100 includes a filter 120. In some embodiments, the filter 120 is configured to allow the fluid of the device 100 to pass therethrough, and is configured to prevent larger particles of material that may be present in the fluid from passing through the filter 120. For example, in some embodiments, it may be desirable to prevent larger particles from entering or approaching the pumps or valves of the pump assembly 130. Such particles may cause damage to the pumps or valves or prevent them from operating properly.

[0024] Filter 120 can be positioned in various locations within device 100, and some embodiments can include more than one filter 120. In some embodiments, filter 120 is positioned within pump assembly 130. In some embodiments, filter 120 is positioned between pump assembly 130 and fluid reservoir 110. For example, filter 120 can be positioned within connecting member 170. In other embodiments, filter 120 is positioned between pump assembly and inflatable member 150. For example, filter 120 can be positioned within connecting member 190.

[0025] In the illustrated embodiment, the pump assembly 130 includes a coupling or fixation member (anchor member) 160. The coupling or fixation member 160 may be coupled to and extend from a housing of the pump assembly 130. The coupling or fixation member 160 is configured to facilitate fixing or coupling of the pump assembly 130 within the patient's body.

[0026] FIG. 2 illustrates an inflatable penile prosthesis 200 having a pump assembly 230 according to an embodiment. The pump assembly 230 may include a valve and may include a manually operated pump bulb or an electronically controlled pump. The penile prosthesis 200 may include one or more inflatable members or cylinders 250. In the illustrated embodiment, the prosthesis 200 includes a pair of inflatable cylinders 250. The inflatable cylinders 250 are configured to be implanted within the penis. For example, one of the inflatable cylinders 250 may be disposed on one side of the penis and the other of the inflatable cylinders 250 may be disposed on the other side of the penis. Each inflatable cylinder 250 may include a first end portion, a cavity or expansion chamber, and a second end portion having a rear tip. The first end portion of the inflatable cylinder 250 may be disposed at least partially within the glans portion of the penis. The second end portion may be implanted within the patient's pubic region with the rear tip proximate the pubic bone.

[0027] The pump assembly 230 can be implanted within the patient's body. In some embodiments, the pump assembly 230 can be implanted within the patient's abdomen. A pair of conduit connectors 290 can attach the pump assembly 230 to the inflatable cylinder 250 such that the pump assembly 230 is in fluid communication with the inflatable cylinder 250. Similarly, the pump assembly 230 can be in fluid communication with the fluid reservoir 210 through a connecting member or conduit connector 270. The fluid reservoir 210 can be implanted within the abdomen of the user.

[0028] To implant the expandable cylinder 250, the surgeon will first prepare the patient. In many cases, the surgeon will create an incision, for example, in the penoscrotal region where the base of the penis meets the top of the scrotum. In other cases, the surgeon may create the incision in a different location. The surgeon may expand the patient's corpus cavernosum from the penoscrotal incision to prepare the patient to receive the expandable cylinder 250. The corpus cavernosum is two parallel columns of erectile tissue, for example, two elongated columns that extend substantially the entire length of the penis forming the back of the penis's body. The surgeon will also expand two areas of the pubic region to prepare the patient to receive the second end portion. The surgeon can measure the length of the corpus cavernosum from the incision and the length of the expanded region of the pubic region to determine the appropriate size of the expandable cylinder 250 to be implanted.

[0029] After the patient is prepared, the penile prosthesis 200 is implanted in the patient. The tip of the first end portion of each inflatable cylinder 250 can be connected to a suture. The other end of the suture can be connected to a needle member (e.g., a Keith needle). The needle member is inserted into the incision and into the expanded corpus cavernosum. The needle member is then pushed through the glans of the penis. The surgeon pulls on the suture to retract the inflatable cylinder 250 into the corpus cavernosum. This retraction is performed for each inflatable cylinder 250 of the pair. Once the expansion chamber is in place, the surgeon can remove the suture from the tip. The surgeon then inserts the second end portion. The surgeon inserts the rear end of the inflatable cylinder 250 into the incision and pushes the second end portion toward the pubic bone until each inflatable cylinder 250 is in place.

[0030] In some embodiments, the pump assembly 230 includes an electric pump or pump system. An example electric pump system is illustrated in FIG.

[0031] In other embodiments, the pump assembly 230 is a manual pump. In such embodiments, a pump bulb of the pump assembly 230 can be squeezed or pressed by a user to facilitate the transfer of fluid from the fluid reservoir 210 to the inflatable cylinder 250. For example, in an inflation mode, while a user is actuating the pump bulb, the pump bulb can receive fluid from the fluid reservoir 210 and then deliver it to the inflatable cylinder 250. When a user switches to a deflation mode, at least a portion of the fluid can be delivered back to the fluid reservoir 210 (due to the pressure differential from the inflatable cylinder 250 to the fluid reservoir 210). Thereafter, a user can squeeze the inflatable cylinder 250 to facilitate further transfer of fluid through the pump assembly 230 to the fluid reservoir 210.

[0032] 3 illustrates an example of a portion of an electronic pump assembly 306, according to an embodiment. The electronic pump assembly 306 may be an example of the electronic pump assembly 130 of FIG. 1 and / or the electronic pump assembly 230 of FIG. 2 and may include any of the details discussed with respect to the device 100 of FIG. 1 and / or the device 200 of FIG. 2.

[0033] The electronic pump assembly 306 is configured to transfer fluid between the fluid reservoir and the inflatable member. The electronic pump assembly 306 can automatically transfer fluid between the fluid reservoir and the inflatable member without a user having to manually actuate the pump (e.g., squash and release a pump bulb).

[0034] The electronic pump assembly 306 includes a pump 320-1 disposed in a fluid passage 324 (e.g., a fill passage) and an active valve 318 disposed in a fluid passage 327 (e.g., a drain passage). The pump 320-1 can be an electromagnetic pump or a piezoelectric pump. The pump 320-1 can include a passive check valve 323 and a passive check valve 325. The fluid passage 327 can be a separate (and parallel) fluid branch to the fluid passage 324. The fluid passage 327 is a passage that transfers fluid from the fluid reservoir to the expandable member. The fluid passage 324 is a passage that transfers fluid from the expandable member to the fluid reservoir. The pump 320-1 is disposed in parallel with the active valve 318.

[0035] In some examples, the electronic pump assembly 306 can include an active valve 319 in series with a pump 320-1 (e.g., pump 320-1 and active valve 319 are disposed in a fluid passage 327). In some examples, the electronic pump assembly 306 can include a pump 320-2 in series with an active valve 318 (e.g., pump 320-2 and active valve 318 are disposed in a fluid passage 324). Pump 320-2 can be an electromagnetic pump or a piezoelectric pump. Pump 320-2 can include a passive check valve 323 and a passive check valve 325. In some examples, the electronic pump assembly 306 includes an active valve 348 fluidly connected to a fluid reservoir. The active valve 348 can be in series with either the active valve 318 (and pump 320-2) or the pump 320-1 (and active valve 319). In some examples, electronic pump assembly 306 includes an active valve 352 fluidly connected to the inflatable member. Active valve 352 can be in series with either active valve 319 (and pump 320-1) or pump 320-2 (and active valve 318).

[0036] Active valve 348, pump 320-1, active valve 318, active valve 352, active valve 318, and pump 320-2 can be electronically controlled by a controller and / or driver. Pump 320-1 and pump 320-2 can be unidirectional or bidirectional. With respect to fluid path 327, in some examples, pump 320-1 and active valve 319 can be swapped (e.g., when active valve 319 is in series between active valve 348 and pump 320-1). With respect to fluid path 324, in some examples, active valve 318 and pump 320-2 can be swapped (e.g., when pump 320-1 is in series between active valve 318 and active valve 348).

[0037] In some examples, one or more additional active valves and / or one or more additional pumps are disposed in series within fluid passage 327. In some examples, one or more additional active valves and / or one or more additional pumps are disposed in series within fluid passage 324. In some examples, electronic pump assembly 306 can include one or more additional (and parallel) fluid passages, where each additional (and parallel) fluid passage can include one or more active valves and one or more pumps.

[0038] In some examples, the electronic pump assembly 306 can include a pressure sensor 330 and a pressure sensor 331. The pressure sensors 330 and 331 are connected to a controller, where the controller receives the measured pressures from the pressure sensors 330 and 331.

[0039] The pressure sensor 330 is configured to measure the pressure in the inflatable member. In some embodiments, the pressure sensor is between the valve 352 and the inflatable member. The controller can receive the measured pressure from the pressure sensor 330 and automatically control the active valve and / or pump to adjust the pressure. In some examples, the pressure sensor 331 is configured to measure the pressure in the fluid reservoir. In some embodiments, the pressure sensor 331 can detect intra-abdominal pressure (which may increase during activities such as exercise), and the controller can control the active valve and pump to minimize or prevent accidental inflation. In some examples, the electronic pump assembly 306 can include one or more pressure sensors elsewhere therein. For example, the pressure sensor can be located between the active valve 348 and the pump 320-1. In some examples, the pressure sensor can be located between the pump 320-1 and the active valve 319. In some examples, the pressure sensor can be located between the active valve 348 and the active valve 318. In some examples, the pressure sensor may be located between the active valve 318 and the pump 320-2.

[0040] Fig. 4 is a perspective view of a pump assembly of the implantable inflatable device of Fig. 3. Fig. 5 is an exploded side view of the pump assembly of the implantable inflatable device of Fig. 3. Fig. 5 is an exploded perspective view of the pump assembly of the implantable inflatable device of Fig. 3.

[0041] The pump assembly 306 includes a manifold plate 353, a battery 354, and a housing 356. The housing 356 includes a first portion 358 and a second portion 359. The first portion 358 is configured to be coupled to the manifold plate 353. The second portion 359 is configured to be coupled to the opposite side of the manifold plate 353. Thus, two sealed chambers are formed. Specifically, a chamber 372 and a chamber 374 are formed and individually sealed. Thus, in the event of a system failure, there is no transfer or diffusion of fluids or materials between the two chambers 372 and 374.

[0042] In the illustrated embodiment, the pump assembly 306 includes a connecting member 362. The connecting member 362 is configured to facilitate coupling or securing of the pump assembly 306 within a patient's body. The connecting member 362 forms a loop or opening and extends from the housing 356. As such, the connecting member 362 can be sutured or otherwise coupled to the patient's body tissue.

[0043] FIG. 7 is a perspective view of filter 420. FIG. 8 is a cross-sectional view of filter 420. Filter 420 is configured to be disposed within an inflatable implant such as that of FIG. 1 or FIG. 2. Filter 420 is configured to allow system fluid to pass therethrough and not allow larger particles in the fluid to pass therethrough. Thus, the filter can be positioned to help prevent particles from entering the pump or valves of the pump assembly. In some embodiments, filter 420 helps prevent pressure spikes in the system.

[0044] In the illustrated embodiment, the filter 420 includes a first side 422 and an opposing second side 424. The filter 420 is configured to allow fluid to pass through the filter 420 from one side to the other. In the illustrated embodiment, the filter 420 defines a fluid path or passage 426 from the first side 422 to the second side 424. In the illustrated embodiment, the first side 422 of the filter defines an opening 428. The opening 428 has a size, such as a diameter or an opening area. The second side 424 of the filter 420 defines a second opening 432. The second opening 432 has a size, such as a diameter or an opening area. The size of the second opening 432 is smaller than the size of the first opening 428. The lumen or passage 426 extends from the first opening 428 to the second opening 432. Thus, the lumen or passage is tapered.

[0045] In some embodiments, the filter 420 is configured to be oriented such that the first side 422 is positioned toward the pump or pump assembly. In other words, the filter 420 is disposed within the device such that the first side 422 is disposed between the second side 424 and the pump or pump assembly. In other embodiments, the filter may be oriented such that the second side 424 is positioned toward the pump or pump assembly.

[0046] In some embodiments, the filter 420 is disposed within the pump assembly. In other embodiments, the filter 420 is disposed within a connecting member, such as a tubular member, that connects the pump assembly to other portions of the device. For example, in some embodiments, the filter 420 is disposed within a connecting member that extends between a fluid reservoir and the pump assembly. In other embodiments, the filter 420 is disposed within a connecting member that extends between the pump assembly and the inflatable member.

[0047] In some embodiments, filter 420 is configured to collect or trap particles at or near second side 424 or at openings 432 defined by second side 424. For example, in some embodiments, filter 420 is configured to trap particles within a smaller portion of a lumen or passageway.

[0048] In some embodiments, filter 420 is self-cleaning. For example, in some embodiments, if a particle becomes trapped or lodged within the lumen at a smaller spot or portion of the lumen, pressure from the fluid flowing from the larger portion of the lumen will force the particle out of filter 420. Additionally, in some embodiments, if a particle becomes trapped or lodged in an opening in the filter, the flow of fluid is believed to move or remove the particle that is trapped or lodged near the opening.

[0049] The filter 420 can be manufactured from a variety of materials. For example, in some embodiments, the filter is manufactured from a titanium material, a stainless steel material, a ceramic material, or a polymeric material. In some embodiments, the material can provide additional features or functionality to the filter. For example, in some embodiments, the filter or portions thereof can be hydrophilic or hydrophobic. In some embodiments, the filter is manufactured using a molding or sintering process. In other embodiments, the filter is formed using a printing or machining method. In other embodiments, the filter is formed using an electrospinning process or method.

[0050] 9 is a cross-sectional view of a filter 520 according to an embodiment. The filter 520 is configured to be placed within an inflatable implant such as that of FIG. 1 or FIG. 2. The filter 520 is configured to allow the system fluid to pass therethrough and is configured to not allow larger particles in the fluid to pass therethrough. Thus, the filter can be positioned to help prevent particles from entering the pump or valves of the pump assembly. In some embodiments, the filter 520 helps prevent pressure spikes in the system.

[0051] In the illustrated embodiment, filter 520 includes a first side 522 and an opposing second side 524. Filter 520 is configured to allow fluid to pass through filter 520 from one side to the other. In the illustrated embodiment, filter 520 defines a plurality of fluid paths or passages 526 from first side 522 to second side 524. In the illustrated embodiment, first side 522 of filter defines openings 528 and 529. Each of openings 528 and 529 has a size, such as a diameter or an opening area. Second side 524 of filter 520 defines opening 532. Opening 532 has a size, such as a diameter or an opening area. The size of opening 532 is greater than the size of openings 528 and 529. Lumen or passage 526 forms a Y-shape (or forms separate branches) and extends from openings 528 and 529 to opening 532. Thus, as shown, in some embodiments, the first side 522 of the filter 520 defines more openings than the second side 524 of the filter 520. In such embodiments, the fluid path narrows from the first side 522 to the second side 524 and widens from the second side 524 to the first side 522. In some embodiments, two openings defined by the first side are fluidly coupled to a single opening defined by the second side. In other embodiments, more than two openings defined by the first side are fluidly coupled to a single opening defined by the second side.

[0052] 10 is a cross-sectional view of a filter 620 according to an embodiment. The filter 620 is configured to be placed within an expandable implant such as that of FIG. 1 or FIG. 2. The filter 620 is configured to allow the system fluid to pass therethrough and is configured to not allow larger particles in the fluid to pass therethrough. Thus, the filter can be positioned to help prevent particles from entering the pump or valves of the pump assembly. In some embodiments, the filter 620 helps prevent pressure spikes in the system.

[0053] In the illustrated embodiment, filter 620 includes a first side 622 and an opposing second side 624. Filter 620 is configured to allow fluid to pass through filter 620 from one side to the other. In the illustrated embodiment, filter 620 defines a plurality of fluid paths or passages 626 from first side 622 to second side 624. In the illustrated embodiment, first side 622 of filter defines openings 628 and 629. Each of openings 628 and 629 has a size, such as a diameter or an opening area. Second side 624 of filter 620 defines opening 632. Opening 632 has a size, such as a diameter or an opening area. The size of opening 632 is greater than the size of openings 628 and 629. Lumen or passage 626 forms a Y-shape (or forms separate branches) and extends from openings 628 and 629 to opening 632.

[0054] In the illustrated embodiment, the size of opening 628 is larger than the size of opening 629. In some embodiments, the portion of lumen or pathway 626 leading to opening 628 can be used for laminar flow and the portion of lumen or pathway 626 leading to opening 629 can be used for turbulent flow.

[0055] FIG. 11 is a perspective view of a filter 720 according to an embodiment. FIG. 12 is a top view of the filter 720. The filter 720 is configured to be placed within an expandable implant such as that of FIG. 1 or FIG. 2. The filter 720 is configured to allow the system fluid to pass therethrough and not allow larger particles in the fluid to pass therethrough. Thus, the filter can be positioned to help prevent particles from entering the pump or valves of the pump assembly. In some embodiments, the filter 620 helps prevent pressure spikes in the system.

[0056] In some embodiments, the filter 720 defines a fluid path that is non-linear, curved, or tortuous. In some embodiments, the particle is trapped in a curved path that entraps or captures it. In some embodiments, the filter 720 is a lattice filter. In the illustrated embodiment, the filter 720 is a spiral filter, such as a wall spiral. In some embodiments, the filter 720 is formed using an electrospinning method or process.

[0057] While certain features of the described implementations have been illustrated as described herein, many modifications, substitutions, changes, and equivalents will now occur to those of ordinary skill in the art, and it is therefore to be understood that the appended claims are intended to cover all such modifications and changes as fall within the scope of the embodiments. [Explanation of symbols]

[0058] 100 Implantable inflatable device 110 Fluid Reservoir 120 Filters 130 Pump Assembly 150 Expandable member

Claims

1. A fluid reservoir defining a cavity, An expandable member, A pump assembly configured to transfer fluid from the fluid reservoir to the expandable member, A filter member configured such that the fluid passes through the filter member when the pump assembly transfers the fluid between the fluid reservoir and the expandable member, Including, The filter member is a self-cleaning filter, or, The filter member is a lattice filter or a gyroide filter, or the filter member is an embedded expandable device defining a fluid path that is a non-linear, curved or serpentine path.

2. The pump assembly includes a pump, and the filter member is operatively coupled between the pump and the fluid reservoir. The expandable device according to claim 1.

3. The pump assembly includes a pump, and the filter member is operatively coupled between the pump and the expandable member. The expandable device according to claim 1.

4. A connecting member extending between the fluid reservoir and the pump assembly and operatively coupling the fluid reservoir to the pump assembly, further including the connecting member in which the filter member is disposed. The expandable device according to claim 1.

5. A connecting member extending between the expandable member and the pump assembly and operatively coupling the expandable member to the pump assembly, further including the connecting member in which the filter member is disposed. The expandable device according to claim 1.

6. The filter member is a self-cleaning filter, and the filter member defines a fluid path having a tapered shape. The expandable device according to claim 1.

7. The filter member is a self-cleaning filter, and the filter member defines a lumen extending between a first opening, a second opening, and the first opening and the second opening. The first opening has a size, the second opening has a size, and the size of the first opening is larger than the size of the second opening. The expandable device according to claim 1. **Claim 8**: The filter member is a self-cleaning filter, and the filter member defines a first opening, a second opening, a third opening, and a fluid path fluidly coupling the first opening, the second opening, and the third opening. The expandable device according to claim 1. **Claim 9**: The filter member is a self-cleaning filter, and the filter member defines a first opening, a second opening, a third opening, and a fluid path fluidly coupling the first opening, the second opening, and the third opening. The first opening has a size, the second opening has a size, the third opening has a size, and the size of the first opening is different from the size of the second opening and also different from the size of the third opening. The expandable device according to claim 1. **Claim 10**: The filter member is a self-cleaning filter, and the filter member has a first side and a second side opposite the first side. The filter member defines a first opening, a second opening, a third opening, and a fluid path fluidly coupling the first opening, the second opening, and the third opening. The first opening is disposed on the first side of the filter member, the second opening is disposed on the second side of the filter member, and the third opening is disposed on the second side of the filter member. The expandable device according to claim 1. **Claim 11** The filter member is disposed within the pump assembly. The expandable device according to claim 1. **Claim 12** The pump assembly includes a housing having a fixing member. The expandable device according to claim 1. **Claim 13** A fluid reservoir defining a cavity; An expandable member; A pump assembly configured to transfer fluid from the fluid reservoir to the expandable member; A first connection member extending between the fluid reservoir and the pump assembly; A second connection member extending between the expandable member and the pump assembly; A filter member; Comprising The filter member is a self-cleaning filter or the filter member defines a tapered fluid path. An implantable expandable device. **Claim 14** The filter member is disposed within the first connection member. The expandable device according to claim 13.

15. The expandable device according to claim 13, wherein the filter member is disposed within the second connecting member.