Implantable inflatable device and therapeutic methods

Abstract

To provide an implantable inflatable device.SOLUTION: An implantable inflatable device (100) includes a fluid reservoir (110) defining a cavity, an inflatable member (150), a pump assembly (130) configured to transfer fluid from the fluid reservoir to the inflatable member, and a programmable control module. The programmable control module is configured to activate the pump assembly to transfer fluid from the fluid reservoir to the inflatable member.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of and claims priority to U.S. Non-provisional Patent Application No. 18 / 155,534, entitled "Implantable Inflatable Device and Treatment Method," filed January 17, 2023, which claims priority to U.S. Provisional Patent Application No. 63 / 266,918, entitled "Implantable Inflatable Device and Treatment Method," filed January 19, 2022, the disclosures of which are incorporated herein by reference in their entirety.

[0002] This application also claims priority to U.S. Provisional Patent Application No. 63 / 266,918, filed January 19, 2022, the disclosure of which is incorporated herein by reference in its entirety.

[0003] This disclosure relates generally to body implants, and more particularly to body 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 fluid flow between different portions of the implantable device to provide for 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 inflate or deflate, or inflate and deflate, the inflatable member according to a schedule. Thus, a need exists for an implantable inflatable device that is configured to inflate or deflate, or inflate and deflate multiple times according to a defined schedule. Summary of the Invention [Means for solving the problem]

[0005] According to an aspect, an 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, and a programmable control module, the programmable control module configured to activate the pump assembly to transfer fluid from the fluid reservoir to the inflatable member.

[0006] In some embodiments, the programmable control module is configured to be controlled by a device positioned outside the patient's body.

[0007] In some embodiments, the programmable control module is configured to activate the pump assembly according to a schedule. In some embodiments, the programmable control module is configured to activate the pump assembly while the user is sleeping. In some embodiments, the programmable control module is configured to activate the pump assembly such that the inflatable member is inflated and deflated according to a schedule. In some embodiments, the programmable control module is configured to activate the pump assembly such that the inflatable member is inflated and deflated while the user is sleeping. In some embodiments, the programmable control module is configured to activate the pump assembly such that the inflatable member is inflated and deflated according to a schedule.

[0008] In some embodiments, the programmable control module is configured to activate the pump assembly such that the inflatable member is inflated and deflated multiple times over a period of several hours. In some embodiments, the programmable control module is configured to activate the pump assembly such that the frequency of pump actuation is pulsating over a period of time. In some embodiments, the programmable control module is configured to activate the pump assembly such that the frequency of pump actuation is pulsating multiple times over a period of 10 minutes.

[0009] In some embodiments, the expandable member is configured to be positioned within the patient's pelvic region, hi some embodiments, the expandable member is configured to be positioned at least partially within the patient's penis.

[0010] In some embodiments, the device includes a tubular member operatively connecting the fluid reservoir and the pump assembly, hi some embodiments, the tubular member operatively connecting the inflatable member and the pump assembly.

[0011] In some embodiments, the device includes a first tubular member operatively connecting the fluid reservoir and the pump assembly, and a second tubular member operatively connecting the pump assembly and the inflatable member.

[0012] In some embodiments, the method includes activating a pump assembly of an inflation device disposed within a user's body such that pressure within an inflatable member of the inflation device is increased or decreased multiple times according to a schedule.

[0013] In some embodiments, the pressure within the inflatable member of the inflation device increases and decreases multiple times while the user sleeps. In some embodiments, the pressure within the inflatable member of the inflation device increases and decreases multiple times over a period of several hours. In some embodiments, the pressure within the inflatable member of the inflation device increases and decreases multiple times over a period of several minutes.

[0014] In some embodiments, the inflation device is disposed at least partially within the pelvic region of the user. In some embodiments, the inflation device is disposed at least partially within the penis of the user. In some embodiments, an inflatable member of the inflation device is disposed at least partially within the pelvic region of the user. In some embodiments, the inflation device is disposed at least partially within the penis of the user. In some embodiments, the inflation device includes a fluid reservoir. In some embodiments, the inflation device includes a programmable control module, the programmable control module configured to activate the pump assembly. [Brief explanation of the drawings]

[0015] [Figure 1] 1 is a schematic diagram of an implantable inflatable device according to an embodiment. [Figure 2] 1 is a perspective view of an implantable inflatable device according to an embodiment. [Figure 3] 3 is a schematic diagram of a pump assembly of the implantable inflatable device of FIG. 2. [Figure 4] 10 is a graph showing the pressure of the inflatable member at different times. [Figure 5] FIG. 1 is a cross-sectional view of a patient's penis. [Figure 6] FIG. 1 is a cross-sectional view of a patient's penis with a portion of an implantable inflatable device disposed therein. [Figure 7] 1 is a graph showing the frequency of pump actuation at different times. DETAILED DESCRIPTION OF THE INVENTION

[0016] Detailed implementations are disclosed herein. However, it is understood that the disclosed implementations are merely examples that may 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 claims and as a representative basis for teaching those skilled in the art to variously use the implementations in substantially any suitable detailed structure. Furthermore, the terms and phrases used herein are intended to provide an understandable description of the present disclosure, rather than as limitations.

[0017] The terms "a" or "an," as used herein, are defined as one or more than one. The term "another," as used herein, is defined as at least a second or a third or more. The terms "including" and / or "having," as used herein, are defined as comprising (i.e., an open transition). The terms "coupled" or "movably coupled," as used herein, are defined as connected, although not necessarily directly and mechanically.

[0018] Generally, the implementations relate to bodily implants. The terms patient or user may be used below for individuals who may benefit from the medical devices or methods disclosed in the present disclosure. For example, a patient may be an individual whose body is implanted with a medical device or using the disclosed methods for operating a medical device according to the present disclosure.

[0019] 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 implementations, the inflatable member 150 is operatively or fluidly coupled to the pump assembly 130 through a different mechanism.

[0020] Implantable inflatable device 100 can be configured to be implanted within a patient's or user's body. For example, in some embodiments, implantable inflatable device 100 is a penile implant. In such embodiments, inflatable member 150 can be implanted in the patient's or user's corpus cavernosum, fluid reservoir 110 can be implanted in the user's abdominal or pelvic cavity (e.g., 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 pump assembly 130 can be implanted in a portion of the user's body, such as the user's abdomen. In other embodiments, 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, implantable inflatable device 100 can be an artificial sphincter, such as an artificial urinary sphincter.

[0021] Pump assembly 130 may include a pump or more than one pump configured to pump fluid into expandable member 150 during an inflation cycle. In some examples, one or more pumps may be mechanically and / or programmatically controlled by a controller. For example, in the illustrated embodiment, device 100 includes a programmable control module 160.

[0022] It is contemplated that expandable member 150 may expand upon injection of a fluid into a cavity of expandable member 150. For example, upon injection of a fluid into expandable member 150, expandable member 150 may increase its length and / or width as well as increase its stiffness. In some examples, expandable member 150 may include a pair of expandable cylinders or at least two cylinders, e.g., a first cylinder member and a second cylinder member. The volume capacity of expandable member 150 may depend on the size of the expandable cylinders.

[0023] The fluid reservoir 110 may include a container having an interior cavity or chamber configured to hold or contain the fluid used to inflate the expandable member 150. The volumetric capacity of the fluid reservoir 110 may vary. In some examples, the volumetric capacity of the fluid reservoir 110 may be from 3 to 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 contains a larger volume of fluid than the expandable member 150.

[0024] In the illustrated embodiment, programmable control module 160 is operatively coupled to pump assembly 130. In some embodiments, programmable control module 160 is configured to activate and deactivate one or more pumps. Thus, programmable control module 160 is configured to activate or deactivate one or more pumps to control the pressure or state (inflated or deflated) of inflatable member 150.

[0025] In some embodiments, programmable control module 160 can be programmed to start or stop one or more pumps according to a schedule. For example, in some embodiments, programmable control module 160 is configured to inflate and deflate expandable member 150 while the user is sleeping. In some embodiments, implant 100 includes an accelerometer. The accelerometer can be configured to determine when the patient is sleeping. In other embodiments, implant 100 includes another means or mechanism for determining when the patient is sleeping. In some embodiments, programmable control module 160 is configured to inflate and deflate expandable member 160 multiple times over a period of several hours.

[0026] FIG. 2 illustrates an inflatable penile prosthesis 200 having a pump assembly 230 according to an embodiment. The pump assembly 230 can include a valve, a manually operated pump bulb, or an electronically controlled pump. The penile prosthesis 200 can 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 in the penis. For example, one of the inflatable cylinders 250 can be positioned on one side of the penis, and the other inflatable cylinder 250 can be positioned on the other side of the penis. Each inflatable cylinder 250 can include a first end portion that is a cavity or inflation chamber and a second end portion having a posterior tip. The first end portion of the inflatable cylinder 250 can be positioned at least partially within the coronal portion of the penis. The second end portion can be implanted in the patient's pubic region with the posterior 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 user's abdomen.

[0028] To implant the inflatable cylinder 250, the surgeon first prepares the patient. The surgeon often makes an incision in the penoscrotal region, for example, where the base of the penis meets the top of the scrotum. From the penoscrotal incision, the surgeon can expand the patient's corpus cavernosum to prepare the patient to receive the inflatable cylinder 250. The corpus cavernosum is one of two parallel columns of erectile tissue that form the dorsal portion of the penile body, e.g., two elongated columns that extend the substantial length of the penis. The surgeon also expands 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 expanded area of ​​the pubic region to determine the appropriate size for implanting the inflatable cylinder 250.

[0029] After the patient is prepared, the penile prosthesis 200 is implanted into the patient. The tip of the first end portion of each inflatable cylinder 250 can be attached to a suture. The other end of the suture can be attached to a needle (e.g., a Keith needle). The needle is inserted into the incision and into the dilated corpus cavernosum. The needle is then pushed through the coronal portion of the penis. The surgeon pulls tight on the suture to draw the inflatable cylinder 250 into the corpus cavernosum. This is done for each inflation cylinder 250 of the pair. With the inflation chamber 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 presses 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.

[0031] A user can use the external device 201 to control the inflatable penile prosthesis 200. In some examples, the user can use the external device 201 to inflate or deflate the inflatable cylinder 250. For example, in response to a user using the external device 201 to activate an inflation cycle, the external device 201 can send a wireless signal to the electronic pump assembly 206 or a programmable control module to initiate an inflation cycle that transfers fluid from the fluid reservoir 210 to the inflatable cylinder 250. In some examples, in response to a user using the external device 201 to activate a deflation cycle, the external device 201 can send a wireless signal to the electronic pump assembly 206 or a programmable control module to initiate a deflation cycle that transfers fluid from the inflatable cylinder 250 to the fluid reservoir 210. In some examples, during the deflation cycle, fluid is pumped back until the pressure in the inflatable cylinder 250 reaches a partial inflation pressure.

[0032] 3 illustrates an example of an electronic pump assembly 306 and a portion of a programmable control module 370, according to an embodiment. Electronic pump assembly 306 may be an example of electronic pump assembly 130 of FIG. 1 and / or electronic pump assembly 230 of FIG. 2 and may include any of the details described with reference to device 100 of FIG. 1 and / or 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 the user having to manually activate the pump (e.g., squeeze and release the pump bulb).

[0034] Electronic pump assembly 306 includes pump 320-1 disposed in fluid passage 327 (e.g., a fill passage) and active valve 318 disposed in fluid passage 324 (e.g., a void passage). Pump 320-1 may be an electromagnetic pump or a piezoelectric pump. Pump 320-1 may include passive check valves 323 and 325. Fluid passage 327 may be a fluid branch that is separate from (and parallel to) fluid passage 324. Fluid passage 327 is a passage that transports fluid from a fluid reservoir to the inflatable member. Fluid passage 324 is a passage that transports fluid from the inflatable member to the fluid reservoir. Pump 320-1 is disposed in parallel with active valve 318.

[0035] In some examples, electronic pump assembly 306 can include active valve 319 in series with pump 320-1 (e.g., pump 320-1 and active valve 319 are disposed in fluid passage 327). In some examples, electronic pump assembly 306 can include pump 320-2 in series with active valve 318 (e.g., pump 320-2 and active valve 318 are disposed in fluid passage 324). Pump 320-2 can be an electromagnetic pump or a piezoelectric pump. Pump 320-2 can include passive check valve 323 and passive check valve 325. In some examples, electronic pump assembly 306 includes active valve 348 in fluid communication with a fluid reservoir. Active valve 348 can be in series with either active valve 318 (and pump 320-2) or pump 320-1 (and active valve 319). In some examples, electronic pump assembly 306 includes an active valve 352 in fluid communication with 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 one-way or two-way. 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 320-2 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 in fluid passage 327. In some examples, one or more additional active valves and / or one or more additional pumps are disposed in series in fluid passage 324. In some examples, electronic pump assembly 306 can include one or more additional (and parallel) fluid passages, each of which 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, which receives the measured pressures from the pressure sensors 330 and 331.

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

[0040] In the illustrated embodiment, programmable control module 370 is operatively coupled to pump assembly 306. Specifically, in the illustrated embodiment, programmable control module 370 is operatively coupled to pumps 320-1 and 320-2. In some embodiments, programmable control module 370 is configured to start and stop pumps 320-1 and 320-2. Thus, programmable control module 370 is configured to start or stop the pumps to control the pressure or state (inflated or deflated) of the inflatable member.

[0041] In some embodiments, programmable control module 370 is programmed to start or stop pumps 320-1 and 320-2 according to a schedule. For example, in some embodiments, programmable control module 370 is configured to inflate and deflate the inflatable member while the user is sleeping. In some embodiments, the implant includes an accelerometer. The accelerometer can be configured to determine when the patient is sleeping. In other embodiments, the implant includes another means or mechanism for determining when the patient is sleeping. In some embodiments, programmable control module 370 is configured to inflate and deflate the inflatable member multiple times over a period of several hours.

[0042] 4 is a graph of the pressure of the inflatable member of the device over a period of time. In this example, the pressure of the inflatable member is increased and decreased four times over a ten-hour period. For example, this could occur while the patient is sleeping. In some embodiments, the programmable control module is programmed or configured to increase or decrease the pressure of the inflatable member multiple times over several hours. In the graph shown, the period of high pressure (or inflated state) is less than one hour, and the time period between high pressures is approximately two hours. In other embodiments, the time periods may be different.

[0043] In some embodiments, the expansion and contraction schedule aids in the stretching of the body tissue surrounding the implant. For example, it may be useful or beneficial to stretch the surrounding body tissue after implantation of the device. The expansion and contraction cycle may help facilitate the stretching of the surrounding body tissue. In some cases, stretching the body tissue may be beneficial to the health of the surrounding body tissue.

[0044] In some cases, the patient is required to inflate and deflate the device periodically over a period of time after implantation. In such cases, the patient or physician can program the device to inflate or deflate according to a desired schedule. In some embodiments, the schedule is set so that the device is inflated and deflated once per day. In other embodiments, the schedule is set so that the device is inflated once per day for a period of several weeks, and can then be inflated and deflated more or less frequently than once per day.

[0045] In some embodiments, the implantable inflatable device can be used to heal or repair tissue within a patient's body. For example, in some embodiments, the implantable inflatable device can be implanted into the penis of a patient suffering from Peyronie's disease. As shown in FIG. 5, Peyronie's disease is a penile condition caused by fibrous scar tissue ST, or plaque, forming inside the penis P. As a result, the penis can become bent or kinked, especially when the penis is in an erect state.

[0046] In some cases, an implantable inflation device is placed within a patient's penis to assist in the treatment of Peyronie's disease. For example, in a Peyronie's disease modeling intervention procedure, a device can be placed within a patient's penis and repeatedly inflated and deflated to remove, crack, or break down scar tissue or plaque. In some cases, a programmable control module can be set to inflate and deflate the device according to an optimal schedule to treat a condition such as Peyronie's disease.

[0047] 6 illustrates a portion of an implantable expansion device 600 placed within a patient's penis P. In this illustration, scar tissue or plaque has been dislodged or otherwise removed from the penile tissue.

[0048] In some cases, biofilms accumulate on or around the devices once they are placed within the patient's body, which can lead to the growth of microorganisms on or near the implanted device, which can cause infection within the patient's body.

[0049] In some cases, pulsating, vibrating, or rapidly small movements of the implanted device can help prevent or reduce the buildup of biofilm, thus reducing the risk of infection in the patient's body. Thus, in some embodiments, the programmable control module can pulse or otherwise increase or decrease the frequency of pump actuation multiple times over a short period of time. Figure 7 is a graph showing an exemplary schedule of frequency change over a period of time. In this example, the period of time is approximately 10 minutes. During this 10-minute period, the frequency pulses or changes multiple times.

[0050] In some embodiments, the vibrations of the pump cause the device to pulsate or vibrate. For example, in some embodiments, the vibrations of the pump are transmitted through the fluid to other parts, such as the inflatable member and reservoir, causing other parts of the device to vibrate or move slightly. Additionally, in some embodiments, the pump cycles cause pressure oscillations within the inflatable member, causing the inflatable member to vibrate or move slightly.

[0051] In some embodiments, the device may be set or programmed to pulse during recreational activities such as sexual intercourse.

[0052] While certain features of the above implementations have been illustrated herein above, many modifications, substitutions, changes, and equivalents will now occur to those skilled in the art. It is therefore to be understood that the appended claims are intended to cover all such modifications and variations as fall within the scope of the embodiments. [Explanation of symbols]

[0053] 100 Implantable inflatable device 110 fluid reservoir 130 Pump Assembly 150 Expandable member 160 Programmable Control Module

Claims

1. 1. An implantable inflatable device comprising: a fluid reservoir defining a cavity; an expandable member; a pump assembly configured to transfer fluid from the fluid reservoir to the inflatable member; a programmable control module operatively coupled to the pump assembly; Including, The implantable inflatable device, wherein the programmable control module is configured to activate the pump assembly so that the inflatable member is inflated and deflated according to a schedule while the user is sleeping.

2. The implantable inflatable device of claim 1 , wherein the programmable control module is configured to be controlled by a device located outside the patient's body.

3. The implantable inflatable device of claim 1 , wherein the programmable control module is configured to activate the pump assembly according to a schedule.

4. The implantable inflatable device of claim 1 , wherein the programmable control module is configured to activate the pump assembly while a user is sleeping.

5. The implantable inflatable device of claim 1 , wherein the programmable control module is configured to activate the pump assembly to inflate and deflate the inflatable member while a user is sleeping.

6. 10. The implantable inflatable device of claim 1, wherein the programmable control module is configured to activate the pump assembly to inflate and deflate the inflatable member multiple times over a period of several hours.

7. The implantable inflatable device of claim 1 , wherein the programmable control module is configured to activate the pump assembly such that the frequency of pump activation pulsates over a period of time.

8. The implantable inflatable device of claim 1 , wherein the programmable control module is configured to activate the pump assembly such that the frequency of pump activation is pulsated multiple times over a 10 minute period.

9. The implantable inflatable device of claim 1 , wherein the inflatable member is configured to be placed within a pelvic region of a patient.

10. The implantable expandable device of claim 1 , wherein the expandable member is configured to be disposed at least partially within a patient's penis.

11. The implantable inflatable device of claim 1 , further comprising a tubular member operatively connecting said fluid reservoir and said pump assembly.

12. The implantable inflatable device of claim 1 , further comprising a tubular member operatively connecting said inflatable member and said pump assembly.

13. a first tubular member operatively connecting the fluid reservoir and the pump assembly; The implantable inflatable device of claim 1 , further comprising a second tubular member operatively connecting said pump assembly and said inflatable member.

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