Urethral needle guide device
Inventors
Witzmann, Michael M. • Brazil, James D. • Klein, Dean A. • Jaeger, Thomas M.
Assignees
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Publication Number
US-8147397-B1
Publication Date
2012-04-03
Expiration Date
Abstract
Methods and devices for treating female urinary incontinence by injecting bulking material into the female urethral wall. Some devices include a handle, an elongate member attached to the handle, and a vacuum generating syringe removably secured to the handle. The elongate member can include a distal portion projecting distally from the handle, the distal portion having a wide proximal region, a narrowing shoulder, and a narrow distal region. The elongate member can include one or more vacuum ports on either side of the shoulder region. The shoulder can include a distally facing needle aperture allowing passage of a needle for injecting bulking agent. A rotatable connection between the elongate member and the handle facilitates rotatable positioning of the elongate member to permit injection of bulking material at different locations around the urethral wall. In use, the urethral tissue can be pulled to conform against the device elongate member by generating a vacuum through the elongate member ports, inserting the needle through the elongate member and needle aperture, and predictably injecting bulking material inside of and along the immobilized urethral wall. The self contained vacuum generator, simple design and wide allowable margin of needle travel allow for use in a practitioner's office.
Core Innovation
The invention relates to an apparatus for augmenting urethral tissue by injecting a bulking agent into the female urethral wall to treat urinary incontinence. The apparatus includes a handle and an elongate member rotatably coupled to the handle so that the handle is held stationary while the elongate member rotates about a center of rotation. The elongate member includes a channel for receiving a needle and a vacuum lumen for drawing a vacuum.
The elongate member has a distal portion with generally rounded outer surfaces that include a proximal region and a distal region extending beyond a shoulder region in a generally rounded columnar shape with a smooth generally rounded distal end. A vacuum lumen extends through the proximal region and into the distal region, where the vacuum lumen is in fluid communication with at least one outwardly opening vacuum port disposed on the generally rounded outer surface. The proximal region ends at the shoulder region, and the channel extends the length of the proximal region to a distal aperture disposed in the shoulder region proximate the vacuum port.
The distal region is generally cylindrical along its entire length, rotates about the center of rotation, and extends beyond the distal aperture with a generally uniform circumference and an even surface that allows the urethral tissue to lie evenly along the generally rounded outer surface, with disruption generally limited to the outwardly opening vacuum port. Vacuum-assist immobilizes urethral tissue into a conforming transition region while injection is performed, and rotation enables circumferential injection at multiple urethral sites with a substantially constant needle depth beneath the urethral wall. The document further describes optional features including sealing components for maintaining vacuum, visualization and pressure sensing, adjustable penetration depth, and embodiments using a battery vacuum pump to reduce tethering.
Claims Coverage
The independent claim covers an apparatus for augmenting urethral tissue using a rotatable needle-receiving elongate member with a vacuum lumen and outwardly opening vacuum ports, including specific outer-surface geometry that supports even urethral tissue contact during rotation. The main inventive features are refined by dependent claims that add vacuum generation via a device and syringe structure, connector interfaces, and optional viewing/sensing subsystems.
Rotatable handle-held apparatus with needle channel and vacuum lumen
A handle; and an elongate member rotatably coupled to the handle so that the handle can be held in a stationary position as the elongate member is rotated with respect to the handle about a center of rotation, the elongate member having a channel for receiving a needle and a vacuum lumen for drawing a vacuum.
Proximal and distal rounded regions with shoulder and smooth distal end
The elongate member further having a distal portion extending distally from the handle, the distal portion having two regions, a proximal region and a distal region; wherein the proximal and distal regions each have generally rounded outer surfaces; wherein the distance around the generally rounded outer surface of the proximal region is greater than the distance around the generally rounded outer surface of the distal region; the proximal region extending to and ending at a shoulder region and the distal region extending beyond the shoulder region in a generally rounded columnar shape having a smooth generally rounded distal end.
Outwardly opening vacuum port on the generally rounded distal surface
The vacuum lumen extends through the proximal region and into the distal region where the vacuum lumen is in fluid communication with the at least one outwardly opening vacuum port disposed on the generally rounded outer surface of the distal region; wherein the proximal region ends at the shoulder region and the channel extends the length of the proximal region and communicates with and terminates at a distal aperture disposed in the shoulder region proximate the at least one vacuum port.
Even urethral tissue contact via cylindrical distal region rotating about center of rotation
The distal region is generally cylindrical in shape along its entire length and rotates about the center of rotation when the elongate member is rotated; wherein the distal region extends beyond the distal aperture and has a generally uniform circumference and an even surface, which allows the urethral tissue to lie evenly along the generally rounded outer surface.
Vacuum port through the distal side wall
The distal region has a side wall, and at least one vacuum port extends through the side wall of the distal region of the elongate member.
Vacuum generating device operably coupled to the handle
The apparatus further includes a vacuum generating device operably coupled to the handle for providing a vacuum to the vacuum lumen.
Syringe with plunger and barrel generating vacuum
The syringe includes a plunger sealingly and slidably disposed within a barrel, where the barrel interior is in fluid communication with the vacuum lumen so vacuum is generated by retracting the plunger within the barrel.
Luer fitting in communication with the vacuum lumen
A Luer fitting is in communication with the vacuum lumen, such that the syringe is in fluid communication with the vacuum lumen through the Luer fitting.
Remote viewing device and optical signal transmission line
The apparatus further includes a remote viewing device disposed on the elongate member and an optical signal transmission line extending from the remote viewing device.
Overall, the claim set focuses on a rotatable, handle-held needle and vacuum system with defined rounded geometry and outwardly opening vacuum ports that maintain an even urethral tissue interface during rotation, with dependent features covering vacuum generation using a syringe and optional connector/interface and optional remote viewing.
Stated Advantages
Enables vacuum-assisted immobilization by drawing urethral tissue into a conforming immobilized transition region.
Allows circumferential injection at multiple urethral sites during rotation.
Maintains a substantially constant needle depth beneath the urethral wall.
Allows urethral tissue to lie evenly along the generally rounded outer surface during rotation.
Optionally provides visualization using a remote viewing device.
Optionally provides pressure sensing (as described in the document summary).
Documented Applications
Augmenting urethral tissue to treat female urinary incontinence by injecting a bulking agent into the female urethral wall.
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