Dilating device and method for prostatic urethra

Inventors

Bachar, Yehuda

Assignees

Butterfly Medical Ltd

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Publication Number

US-11027106-B2

Patent

Publication Date

2021-06-08

Expiration Date


Abstract

A dilating device for the prostatic urethra comprising: Prostatic implant includes independently actuatable distal retractor incorporating and proximal retractor. Retractors may be connected via a spine member. System and method include implant manipulator detachably connected to implant, for manipulating and forcing implant into close proximity, for delivery into subject.

Core Innovation

A urological implant and delivery system is described for dilation, retraction, and support within the prostatic urethra. The system includes implants having independently actuatable distal and proximal retractors with curved wing-like structures that extend from an implant spine member along a spinal longitudinal axis. Tissue support members engage anterior and posterolateral interlobar grooves, and cranial and caudal nose portions prevent cranial-caudal migration of the implant.

A related system architecture uses a cystoscope, a compression sleeve, and an implant manipulator with a tether or tubular member to transition an implant between a fully collapsed delivery configuration, a partially collapsed positioning configuration, and an expanded deployed configuration. When deployed, radially directed outward forces and lateral pressing forces anchor and press prostate tissue in relation to the interlobar grooves. The described structure supports both mechanical placement and controlled deployment to dilate and stabilize the prostatic urethra region.

A dilating device is further described having at least three laterally connected longitudinal ridges, including a central anterior ridge and two peripheral posterolateral ridges. The ridges compress within a deployment lumen and expand to a normally-open configuration so as to engage corresponding grooves and exert radially outward dilation forces on the prostatic urethra. The device includes nose portions that resist migration and includes alignment via torque and strings, including releasable string and alignment lumen, to position the device for groove engagement and expansion.

Claims Coverage

One independent claim is provided. The independent claim includes a method-level inventive set of features comprising a specific dilating device geometry with symmetrically opposing distally protruding nose portions, groove alignment and positioning near the bladder neck, lateral stretching of the posterolateral sides of the prostatic urethra while preventing migration into the urinary bladder, followed by expansion to exert radially outward force for dilation.

Symmetrically opposing distally protruding nose portions for prostatic urethra dilation

A method inserting a dilating device into the prostatic urethra that includes a first elongated edge member with a first distally protruding nose portion and a second elongated edge member with a second distally protruding nose portion symmetrically opposing each other across a spinal longitudinal axis, the nose portions protruding distally from the dilating device.

Groove alignment and bladder-neck positioning on opposite lateral sides

Aligning the first elongated edge member and the second elongated edge member with posterolateral interlobar grooves of the prostatic urethra and positioning the first distally protruding nose portion and the second distally protruding nose portion within the prostatic urethra on opposite lateral sides of a posterior portion thereof proximal to a bladder neck.

Lateral stretching to prevent migration into the urinary bladder

Stretching laterally posterolateral sides of the prostatic urethra adjacent to the bladder neck with the first distally protruding nose portion and the second distally protruding nose portion, thereby preventing migration of the dilating device into a urinary bladder of the patient via the positioning and stretching.

Expanded open configuration exerting radially outwards force to dilate

Expanding the dilating device to an open configuration within the prostatic urethra and exerting a radially outwards force on the prostatic urethra with the expanded dilating device to dilate the prostatic urethra.

Across the provided independent claim, the inventive coverage centers on a dilating device with symmetrically opposing distally protruding nose portions across a spinal longitudinal axis, alignment with posterolateral interlobar grooves and positioning near the bladder neck on opposite lateral sides, lateral stretching of the posterolateral urethral sides adjacent to the bladder neck to prevent migration into the urinary bladder, and expanding to an open configuration to exert a radially outwards force that dilates the prostatic urethra.

Stated Advantages

Prevents migration of the dilating device into a urinary bladder of the patient.

Dilation of the prostatic urethra by exerting radially outwards force with the expanded dilating device.

Documented Applications

Method for dilating a prostatic urethra of a patient.

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