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US-12616563-B2 - Device for mitigating urinary incontinence post prostatectomy

US12616563B2US 12616563 B2US12616563 B2US 12616563B2US-12616563-B2

Abstract

The disclosure relates to apparatus and methods for managing a shape of a junction between a bladder and urethra, for example, to promote urinary continence after a prostatectomy.

Inventors

  • Bruce Choi

Assignees

  • LEVEE MEDICAL, INC.

Dates

Publication Date
20260505
Application Date
20241105

Claims (20)

  1. 1 . A device for mitigating urinary incontinence post prostatectomy, the device comprising: an implant having a first portion and a second portion, wherein the first and second portions are configured to form a hollow interior area within the implant extending along a longitudinal axis thereof, wherein: the first portion and the second portion are each configured to form a tubular shaped wall centered about the longitudinal axis, the first portion is configured to receive a portion of a urethra therein, the second portion is configured to receive an extended portion of a bladder therein, and the implant is configured to encase the portion of the urethra and the extended portion of the bladder in the hollow interior area of the implant; and wherein the device is further configured: to lengthen the extended portion of the bladder along the longitudinal axis by extending and narrowing the extended portion of the bladder within the hollow interior area of the device to increase effective urethral length sufficient to mitigate stress that the bladder places on one or more sphincter muscles controlling passage of liquid from the bladder to the urethra to thereby mitigate incontinence.
  2. 2 . The device of claim 1 , wherein the second portion has a tapered shape about the longitudinal axis that tapers outward from a first end of the second portion to a second end of the second portion, the second end being wider than the first end.
  3. 3 . The device of claim 1 , wherein the device is configured to extend and narrow the extended portion of the bladder through the second portion of the implant and into the first portion of the implant, further increasing effective urethral length.
  4. 4 . The device of claim 1 , wherein the implant is compressible and configured to expand in a direction of the longitudinal axis from a compressed state to a deployed state.
  5. 5 . The device of claim 4 , wherein the implant is configured to be retained in the compressed state by one or more compressing members.
  6. 6 . The device of claim 5 , wherein the one or more compressing members comprise a first compressing member and a second compressing member; wherein: the first compressing member is removably disposed around at least a portion of the tubular shaped wall of the first portion such that at least part of the first portion is retained in the compressed state until removal of the first compressing member, and the second compressing member is removably disposed around at least a portion of the tubular shaped wall of the second portion such that at least part of the second portion is retained in the compressed state until removal of the second compressing member.
  7. 7 . The device of claim 1 , wherein the first portion has a distal end that is distal from the second portion, and wherein the distal end is configured to be sutured on or close to a pelvic floor associated with the urethra.
  8. 8 . The device of claim 1 , wherein the implant comprises one or more loops that facilitate attaching the implant to one or more of the bladder, the urethra, and a pelvic floor.
  9. 9 . The device of claim 1 , wherein the implant comprises a memory shape material.
  10. 10 . The device of claim 1 , wherein the first portion and the second portion are removably coupled to one another.
  11. 11 . The device of claim 1 , wherein the implant has a substantially cylindrical shape.
  12. 12 . The device of claim 1 , wherein the implant comprises a tapered shape about the longitudinal axis that tapers outward from a first end of the implant to a second end of the implant, the second end being wider than the first end.
  13. 13 . The device of claim 1 , wherein the implant further comprises an antibacterial biomaterial.
  14. 14 . The device of claim 1 , wherein the implant is formed of a surgical thread.
  15. 15 . The device of claim 1 , further comprising a flange configured to secure the implant to the urethra or the extended portion of the bladder.
  16. 16 . The device of claim 1 , wherein the tubular shaped wall includes an inner surface and an outer surface, forming an encasement.
  17. 17 . The device of claim 1 , wherein the first portion and the second portion are integrally formed to have a unibody construction-continuous and non permeable.
  18. 18 . A device for mitigating urinary incontinence post prostatectomy, the device comprising: a compressible implant configured to expand and compress along a longitudinal axis between a compressed state and an expanded state, the compressible implant having a first portion and a second portion that extend along, and are centered about, the longitudinal axis, the compressible implant forming a hollow interior area within the compressible implant that is centered about the longitudinal axis, wherein the first portion and the second portion are each configured to form a tubular shaped wall centered about the longitudinal axis; and wherein the compressible implant is configured to increase an effective urethral length by extending and narrowing an extended portion of a bladder along the longitudinal axis while constraining the extended portion of the bladder within the hollow interior area of the compressible implant to mitigate stress that the bladder places on one or more sphincter muscles controlling passage of liquid from the bladder to a urethra surgically attached to the bladder to thereby mitigate incontinence.
  19. 19 . The device of claim 18 , wherein the compressible implant comprises loops that facilitate securing the compressible implant to one or more of the bladder, the urethra, and a pelvic floor.
  20. 20 . The device of claim 18 , wherein when the compressible implant is in the expanded state, the second portion has a tapered shape about the longitudinal axis that tapers outward from a first end of the second portion to a second end of the second portion, the second end being wider than the first end.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. patent application Ser. No. 17/012,555, filed 14 Sep. 2020, the entirety of which is hereby incorporated by reference for all purposes as if fully set forth herein. TECHNICAL FIELD The present disclosure relates generally apparatus and methods for supporting a connection of a bladder and urethra, and more particularly, to apparatus and methods for managing a shape of a junction between the bladder and the urethra to promote urinary continence after a prostatectomy. BACKGROUND Conventional prostatectomy procedures (e.g., radical prostatectomy or simple prostatectomy) remove all or part of the prostate gland, which is positioned at the base of the bladder and around the urethra. These procedures may use various techniques, including a robot-assisted prostatectomy, an open prostatectomy, or a laparoscopic prostatectomy. During the prostatectomy, at least a portion of the prostate gland and at least a portion of the urethra surrounded by the prostate gland is removed from the patient, resulting in the bladder being detached from the remaining portion of the urethra. Subsequent to removing the prostate gland, the bladder is attached to the remaining portion of the urethra. However, as the length of the urethra is now shortened, connecting the bladder to the urethra results in a strained connection that can cause urinary incontinence post-prostatectomy. SUMMARY The present disclosure relates generally to supporting a connection of a bladder and urethra, for example, managing a shape of a junction between the bladder and the urethra to promote urinary continence after a prostatectomy. In one or more cases, the disclosed technology relates to a device managing a shape of a junction between the bladder and the urethra. In one or more cases, the device comprises an implant having a first portion and a second portion forming a hollow interior area within the implant extending along a longitudinal axis thereof. In one or more cases, the first portion and the second portion each comprising a tubular shape centered about the longitudinal axis. In one or more cases, the first portion is configured to receive a portion of a urethra therein and to be attached thereto. In one or more cases, the second portion is configured to receive an extended portion of a bladder therein and to be attached thereto. In one or more cases, the implant is configured to encase a surgical connection of the urethra and the bladder in the hollow interior area of the implant and to support the operation of one or more sphincter muscles controlling the passage of liquid from the bladder to the urethra. In one or more cases, the disclosed technology relates to a method of managing a shape of a junction between the bladder and the urethra to control the bladder. In one or more cases, the method comprises inserting a urethra through a hollow interior area of a device. In one or more cases, the hollow interior area extends along a longitudinal axis of the device. In one or more cases, the method includes attaching the urethra to the bladder. In one or more cases, the method includes attaching a first portion of the device to the urethra. In one or more cases, the first portion comprises a tubular shape centered about the longitudinal axis. In one or more cases, the method includes expanding the device longitudinally along the longitudinal axis to a deployed state in which a portion of the bladder extends into the second portion. In one or more cases, the method comprises attaching a second portion of the device to the bladder. In one or more cases, the second portion comprises a tubular shape centered about the longitudinal axis. The foregoing and other objects, features, and advantages of the disclosure will be apparent from the following more particular descriptions of the embodiments as illustrated in the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS The following drawings are illustrative of particular embodiments of the present disclosure and therefore do not limit the scope of the present disclosure. The drawings are not to scale and are intended for use in conjunction with the explanations in the following detailed description. FIG. 1A is a perspective view of an example support apparatus in a compressed state. FIG. 1B is a perspective view of the example support apparatus in a partially expanded state. FIG. 1C is a perspective view of the example support apparatus in a fully expanded state. FIG. 2A illustrates the example support apparatus inserted over a sphincter muscle. FIG. 2B illustrates a cross-sectional view of the example support apparatus attached to the one or more example sphincter muscles. FIG. 3A is a top view of the example support apparatus, in which one or more example inflation balloons are in a deflated state. FIG. 3B is a top view of the example support apparatus, in which the one or more example inflation balloons are in an inflated