Retracting or/and supporting periurethral tissue
Inventors
Assignees
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Publication Number
US-10507122-B2
Publication Date
2019-12-17
Expiration Date
Abstract
Urological (prostatic) implant, system, and method for retracting or/and supporting periurethral tissue enclosing a prostatic urethra along lengths of prostate lobes, for example, in BPH patients. Prostatic implant includes independently actuatable distal retractor incorporating craniolateral corners and proximal retractor incorporating caudolateral corners. Retractors may be connected via elongated spine member, and formed as paired curved wing-liked structures having interconnecting members. May further include tissue support members extending between elongated edge members connecting retractors to spine member, and tissue support members extending between elongated edge members and spine member. Tissue support members are sized and configured for supporting portions of prostatic lateral lobes when spine member engages anterior interlobar groove extending between prostatic lateral lobes, and when elongated edge members engage posterolateral interlobar grooves. System and method include implant manipulator detachably connected to implant elongated edge members, for manipulating and forcing implant caudolateral corners into close proximity, for delivery into subject.
Core Innovation
The disclosed invention relates to an implant for retracting or supporting periurethral tissue enclosing a prostatic urethra. The implant includes first and second elongated edge members having first and second craniolateral corners that are symmetrically opposed relative to a spinal longitudinal axis, and a pair of interconnecting members connects the elongated edge members across the spinal longitudinal axis and supports a collapsible-expandable frame that engages periurethral anatomy along the prostatic urethra.
The implant further includes a first distal retractor and first and second elastic portions incorporated in the first and second elongated edge members. The elastic portions are non-stressed when the first elongated edge member is pivotally positioned centrally away from the second elongated edge member about the spinal longitudinal axis to form a predetermined maximal spanning angle, and stress increases when an increased moment of force pivotally shifts the first elongated edge member towards the second elongated edge member about the spinal longitudinal axis.
In the prostatic urethra, the edge members are configured to exert radially directed pushing forces to inhibit rotational movement and to maintain prostatic urethral lumen size by engaging interlobar grooves. The disclosure includes cranial-nose portions resting on urinary bladder neck ledges to inhibit cranial dislodgement, caudal-nose portions resting on a narrowing imposed by the external urethral sphincter adjacent the verumontanum to inhibit caudal shift, and tissue support members for supporting prostatic lateral lobes by engaging anterior and posterolateral interlobar grooves.
Claims Coverage
The consolidated content includes three independent claims directed to an implant structure with elastic portions and pivoting edge members, an implant configured for groove engagement with continuous radially directed pushing force and lumen maintenance, and a system combining the implant with an implant manipulator using a tubular member and a releasably intertwined tether.
Elastic portions with predetermined maximal spanning angle
An implant comprising first and second symmetrically opposed elongated edge members connected by a pair of interconnecting members at a spinal longitudinal axis, including a first distal retractor and first and second elastic portions incorporated in the first and second elongated edge members, wherein the first and second elastic portions are non-stressed when the first elongated edge member is pivotally positioned centrally away from the second elongated edge member to form a predetermined maximal spanning angle, and wherein at least one of the elastic portions exhibits an increase in stress in response to an increased moment of force pivotally shifting the first elongated edge member towards the second elongated edge member.
Continuous radially directed pushing force to maintain lumen and inhibit rotation
An implant comprising a spinal longitudinal axis; a first elongated edge member and a second elongated edge member symmetrically opposed laterally relative to the spinal longitudinal axis; at least one pair of interconnecting members connecting the first elongated edge member to the second elongated edge member symmetrically distanced laterally on opposite sides of the spinal longitudinal axis and wherein the first and second elongated edge members equally displaced in a posterior direction engage a left posterolateral interlobar groove with the first elongated edge member and a right posterolateral interlobar groove with the second elongated edge member, with the spinal longitudinal axis aligned to an anterior interlobar groove, and configured to continuously exert a radially directed pushing force between the first and second elongated edge members within a range of between about 100 grams and about 1,000 grams to maintain a lumen size of at least 1 mm in the prostatic urethra and inhibit rotational movement with respect to the anterior interlobar groove and the left and right posterolateral interlobar grooves.
Implant manipulator with tubular member and releasably intertwined tether
A system comprising an implant comprising a plurality of elongated edge members interconnected in a form of a collapsible-expandable frame expandable to support periurethral tissue by exerting pushing forces upon interlobar grooves, wherein a first elongated edge member includes first craniolateral and first caudolateral corners and a second elongated edge member includes second craniolateral and second caudolateral corners opposing the first corners, and an implant manipulator detachably connected to the first and second elongated edge members and configured to manipulate and force the first and second caudolateral corners into close proximity with each other, wherein the implant manipulator comprises a tubular member and a tether releasably intertwined through both of the implant first and second caudolateral corners and is configured for pulling the implant via the tether against a distal end of the tubular member.
Across the three independent claims, the inventive scope covers an implant using first and second elastic portions that are non-stressed at a central pivot position to form a predetermined maximal spanning angle with stress increasing upon pivot toward the other edge member, an implant that continuously exerts a radially directed pushing force between laterally opposed elongated edge members engaging left and right posterolateral interlobar grooves and aligned to an anterior interlobar groove to maintain at least a 1 mm lumen and inhibit rotational movement, and a system where an implant manipulator with a tubular member and a releasably intertwined tether pulls the implant to force caudolateral corners into close proximity as part of a collapsible-expandable frame.
Stated Advantages
Maintains a lumen size of at least 1 mm in the prostatic urethra.
Inhibits rotational movement of the implant with respect to the anterior interlobar groove and the left and right posterolateral interlobar grooves.
Prevents cranial dislodgement into the urinary bladder.
Prevents caudal shift of the implant.
Supports periurethral tissue by exerting pushing forces upon interlobar grooves.
Documented Applications
Urological/prostatic implant for benign prostatic hyperplasia (BPH) involving retracting or supporting periurethral tissue enclosing a prostatic urethra along the prostate lobes.
Delivery and manipulation of the implant for placement in the prostatic urethra, optionally under cystoscopic visualization (cystoscope lumen).
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