Devices for the treatment of benign prostatic hyperplasia and related lower urinary tract symptoms
Inventors
Jen, Jimmy • Zaretzka, Dan • Chang, Kenneth Chih-Ping • VENKATESWARA-RAO, Kondapavulur T.
Assignees
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Publication Number
US-11812930-B2
Publication Date
2023-11-14
Expiration Date
Abstract
Devices and methods are disclosed for managing and/or treating body tissues obstructing a hollow body lumen, including the prostatic lobe tissues obstructing the urethra, for example conditions including benign prostatic hyperplasia (BPH), bladder outlet obstruction (BOO), benign prostatic obstruction (BPO) and associated lower urinary tract symptoms (LUTS). A retrieval sheath having an elongated shaft member with at least one region of modified flexibility that is configured compress the implant to a reduced profile for removal from the patient's body.
Core Innovation
The disclosure provides a sheath for retrieving or placing an implant from or at a placement location in a lumen of a body. The sheath includes an elongated shaft member with at least one shaft member region of modified flexibility and an atraumatic distal end configured to compress the implant to a reduced profile. The distal portion is configured for advancement of a cystoscope through a lumen of the shaft member having an inner diameter configured for cystoscope advancement.
The proximal end of the elongated shaft member includes a tubular portion and a flared portion with an inner surface and an outer surface. A hub is secured to the outside surface of the proximal end, with an opening that tapers from a proximal diameter greater than the inner diameter of the shaft member. The hub includes a proximal portion with a cylindrical portion and a frusto-conical projection that corresponds to the tubular portion and engages the inner surface of the flared portion, and a distal portion that engages the outer surface of the flared portion and threads with the proximal portion.
By the threaded engagement of the hub portions with the flared and tubular proximal portions of the shaft member, the sheath cooperatively compresses and secures the proximal end portions to form a sealing connection. A sealing connection is configured with the hub and the cystoscope such that a cystoscope introduced through at least one lumen of the shaft member can be advanced through the lumen of the body while maintaining the sealed interface. Relative movement with the sheath enables retrieving or releasing the implant while using direct visualization via the cystoscope.
Claims Coverage
The document contains two independent claims, one to a sheath and one to a method. The claims center on the constrained sheath structure that compresses an implant to a reduced profile and the sealing hub arrangement that cooperates with a cystoscope to enable retrieval or placement via relative movement.
Modified-flexibility sheath with atraumatic distal compressing end
An elongated shaft member with at least one shaft member region of modified flexibility and an atraumatic distal end configured to compress the implant to a reduced profile, with at least one lumen having an inner diameter configured for advancement of a cystoscope therethrough.
Tapered hub with threaded frusto-conical and cylindrical engagement forming a sealing connection
A hub secured to the outside surface of the proximal end, where the hub has an opening that tapers from a proximal diameter greater than the inner diameter of the shaft member, the proximal portion includes a cylindrical portion and a frusto-conical projection that engages the inner surface of the flared portion, and the distal portion engages the outer surface of the flared portion and threads together with the proximal portion to cooperatively compress and secure the flared and tubular portions to form a sealing connection.
Cystoscope introduction and advancement through sheath lumen
Introducing a cystoscope through at least one lumen of the shaft member and advancing the sheath and cystoscope through the lumen of the body.
Retrieving or placing by relative movement with sheath
Retrieving or releasing the implant via relative movement with the sheath after advancing the sheath and cystoscope through the lumen of the body.
Across both independent claims, the inventive coverage is the sheath architecture: a modified-flexibility elongated shaft with an atraumatic distal compressing end, combined with a tapered hub having cylindrical, frusto-conical, and threaded engagement that compresses proximal shaft portions to form a sealing connection, enabling cystoscope-mediated introduction, advancement, and retrieving or releasing the implant via relative movement.
Stated Advantages
Enables office/clinic retrieval with minimal trauma.
Compatibility with commercial flexible cystoscopes.
Reduced stiffness/kinking.
Controlled constrained configuration.
Reduced pain/bleeding compared with conventional sheaths.
Documented Applications
Retrieving or placing a prostatic expandable implant in a prostatic urethra/urethral patency context using cystoscopy-mediated sheath retrieval sequence in a LUTS/BPH context.
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