EP-4739256-A2 - INFLATABLE MEDICAL SYSTEM

Abstract

An inflatable medical system having an implantable, inflatable cuff, a fluid reservoir in fluid communication with the cuff, a fluid transfer device having a powered pump adapted for selective moving fluid between the reservoir and the cuff, at least one pressure sensor in operative communication with fluid in the cuff for providing a pressure signal indicative of fluid pressure in the cuff, a controller for receiving the pressure signal from the pressure sensor and controllably actuating the fluid transfer device, and an external actuator in wireless communication with the controller, the external actuator adapted for wirelessly providing a urination signal to the controller, such that upon receipt of the urination signal, the controller causes fluid to be moved from the cuff to the reservoir.

Inventors

• WEPRIN, SAMUEL
• NOEL, JOHN
• LEWIS, NICHOLAS
• BERK, Wendy
• DALBY, Derek
• GAIL, Caleb
• RAYE, Michael
• RIEMENSCHNITTER, Kyle

Assignees

• L&W Latency, Inc.

Dates

Publication Date

20260513

Application Date

20240705

Claims (20)

1. 1. An inflatable medical system comprising: (a) an implantable, inflatable cuff; (b) a fluid reservoir in fluid communication with the cuff; (c) a fluid transfer device comprising a powered first pump adapted for selective moving fluid between the reservoir and the cuff; (d) at least one pressure sensor in operative communication with fluid in the cuff for providing a pressure signal indicative of fluid pressure in the cuff; (e) a controller for receiving the pressure signal from the at least one pressure sensor and controllably actuating the fluid transfer device; and (f) an external actuator in wireless communication with the controller, said external actuator adapted for wirelessly providing a urination signal to the controller; wherein, upon receipt of the urination signal, the controller causes fluid to be moved from the cuff to the reservoir.
2. 2. The inflatable medical system of claim 1, further comprising at least one biometric sensor for providing a biometric signal indicative of a biometric characteristic of a user, wherein the biometric signal is used by the controller to control operation of the fluid transfer device.
3. 3. The inflatable medical system of claim 2, wherein said first pump is a piezoelectric pump.
4. 4. The inflatable medical system of claim 3, wherein said fluid transfer device further comprises a plurality of controllable valves.
5. 5. The inflatable medical system of claim 5, further comprising a pressure sensor in operative fluid communication with the cuff and adapted for providing a signal indicative of fluid pressure within the cuff to the controller.
6. 6. The inflatable medical system of claim 6, further comprising a manifold, wherein the first pump, valves, and pressure sensor are mounted to the manifold.
7. 7. The inflatable medical system of any one of claims 2-7, wherein said at least one biometric sensor is located within an implantable housing.
8. 8. The inflatable medical system of claim 7, wherein the fluid transfer device and said at least one biometric sensor are located in said implantable housing.
9. 9. The inflatable medical system of claim 7, wherein said at least one biometric sensor is a heartrate sensor, a blood oxygen sensor, or a temperature sensor.
10. 10. The inflatable medical system of claim 7, wherein said controller is adapted to receive a signal from said at least one biometric sensor, compare said signal to a predetermined value, and, if said signal deviates from the predetermined value by a predetermined amount and/or for a predetermined period of time, causes fluid to be moved from the cuff to the reservoir or from the reservoir to the cuff.
11. 11. The inflatable medical system of claim 7, wherein said at least one biometric sensor is an optical sensor.
12. 12. The inflatable medical system of claim 11, wherein the implantable housing includes a viewing window and said at least one biometric sensor is located in the housing for detecting a biometric condition of the patient through the window.
13. 13. The inflatable medical system of claim 1, wherein said external actuator comprises a discrete wearable or carryable device.
14. 14. The inflatable medical system of claim 13, wherein said external actuator comprises a piece of jewelry or a fob.
15. 15. The inflatable medical system of claim 13, wherein said external actuator comprises a ring, a watch, a watchband, a bracelet, or a necklace.
16. 16. The inflatable medical system of claim 15, wherein said external actuator does not include a display screen.
17. 17. The inflatable medical system of any one of claims 13-16, wherein said external actuator has at least one input device.
18. 18. The inflatable medical system of claim 17, wherein, upon receipt of the urination signal, the controller causes fluid to be moved from the cuff to the reservoir to deflate the cuff and allow urination, and further wherein the controller is configured to provide a predetermined delay between receipt of a urination signal from the external actuator and deflating the cuff.
19. 19. The inflatable medical system of any preceding claim, wherein the cuff comprises a single-chamber cuff, a dual -chamber cuff, or a tri-chamber cuff.
20. 20. An inflatable medical system comprising: (a) an implantable, inflatable cuff; (b) a fluid reservoir in fluid communication with the cuff; (c) a fluid transfer device comprising a powered first pump adapted for selective moving fluid between the reservoir and the cuff; (d) at least one pressure sensor in operative communication with fluid in the cuff for providing a pressure signal indicative of fluid pressure in the cuff; and (e) a controller for receiving the pressure signal from the at least one pressure sensor and controllably actuating the fluid transfer device; wherein said controller is adapted to receive a urination signal from an external control device, and, upon receipt of a urination signal the controller causes fluid to be moved from the cuff to the reservoir to deflate the cuff and allow urination.

Description

INFLATABLE MEDICAL SYSTEM CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to U.S. Provisional Patent Application No. 63/511,905, filed on July 5, 2023, entitled "Inflatable Medical System.” The entire disclosure of the foregoing provisional patent application is incorporated by reference herein. BACKGROUND [0002] Urinary incontinence is a common problem, particularly for older adults. Urinary incontinence often occurs because the urinary sphincter muscle is no longer able to impart sufficient force to close the urethra. One common treatment is the implantation of an artificial urinary sphincter in the form of an inflatable cuff that extends completely or partially around a portion of a patient’s urethra. The sphincter cuff is normally inflated with fluid in order to close off the urethra. The cuff is typically only manually deflatable, with fluid pumping provided by a compressible, fluid-filled pumping bulb implanted subcutaneously. For male patients, the pumping bulb is implanted in the scrotum and must be repeatedly squeezed in order to move fluid from the cuff into a balloon reservoir in order to deflate the sphincter cuff and allow urination. Such systems are inconvenient, difficult to operate, and problematic for a variety of other reasons. [0003] Similar systems are available for promoting weight loss, treating erectile dysfunction (“ED”), treating fecal incontinence, and other conditions. In the case of fecal incontinence, an inflatable sphincter cuff is positioned around the rectum or colon. For weight loss, an inflatable sphincter cuff is used as a gastric cuff (e.g., positioned around the upper portion of the stomach). For ED, a pair of inflatable penile prostheses are used (instead of an inflatable cuff). The inflatable prostheses are typically cylindrical in shape, and are implanted into the corpus cayemosae of the patient such that, upon inflation of the prostheses, the penis becomes erect. [0004] While a variety of devices and techniques may exist for providing a fluid inflatable, implantable member such as an urethral sphincter cuff, it is believed that no one prior to the inventors have made or used an invention as described herein. BRIEF DESCRIPTION OF THE DRAWINGS [0005] While the specification concludes with claims particularly pointing out and distinctly claiming the invention, it is believed that the invention will be better understood from the detailed description of certain embodiments thereof when read in conjunction with the accompanying drawings. Unless the context indicates otherwise, like numerals are used in the drawings to identify similar elements in the drawings. In addition, some of the figures may have been simplified by the omission of certain elements in order to more clearly show other elements. Such omissions are not necessarily indicative of the presence or absence of particular elements in any of the exemplary embodiments, except as may be explicitly stated in the corresponding detailed description. [0006] FIGURE 1 depicts a schematic illustration of one embodiment of an inflatable medical system of the present disclosure. [0007] FIGURE 1A is a schematic illustration of the external control device of the system of FIG. 1. [0008] [0009] FIGURE 2 is an isometric view of an alternative embodiment of an inflatable medical system of the present disclosure, with the cuff positioned about a urethra and in a deflated state. [0010] FIGURE 3 is an isometric view of a distal portion of the system of FIG. 2, with the cuff in an inflated state and applying clamping pressure to the urethra for closing off flow from the bladder through the urethra. [0011] FIGURE 4 is the same view as FIG. 2, with the cuff in an inflated state. [0012] FIGURE 5 is a top view of the system of FIG. 2 with the top portions of the first and second pump housings removed and the distal portion of the system omitted, with fluid pumped from the reservoir into the cuff. [0013] FIGURE 6 is an isometric view of the first pump housing of the system of FIG. 2 with the top portion of the first pump housing removed. [0014] FIGURE 7 is a top view of the first pump housing of the system of FIG. 2 with the top portion of the first pump housing removed. [0015] FIGURE 8 is an isometric view of the second pump housing of the system of FIG. 2 with the top portion of the second pump housing removed. [0016] FIGURE 9 is a top view of the second pump housing of the system of FIG. 2 with the top portion of the second pump housing removed. [0017] FIGURE 10A is a schematic illustration of the cuff inflation fluid path in the system of FIG. 2. [0018] FIGURE 10B is a schematic illustration of the cuff deflation fluid path in the system of FIG. 2. [0019] FIGURE 11A is a schematic illustration of an alternative embodiment of an inflatable medical system of the present disclosure, wherein two pumps and their associated valves are located in a single housing. [0020] FIGURE 11B is an isometric view of