Implantable biocompatible expander suitable for treatment of constrictions of body lumen
An implantable biocompatible expander suitable for implantation into a urinary duct, comprises an elongated sinusoidal ring comprising at least two proximal prongs and at least two distal prongs, wherein the expander is resiliently deformable from a relaxed radially expanded orientation to a radially contracted orientation suitable for transluminal delivery through the urinary duct. The expander is configured to exert an outward radial force against a wall of the urinary duct when in-situ within the urinary duct. In particular, the expander is suitable for treatment of benign prostatic hyperplasia and configured for implantation into the prostatic urethra between, and substantially spanning the prostatic urethra between, the bladder neck and external sphincter.
1. A method of treating benign prostatic hyperplasia, the method comprising:
inserting a distal end of a delivery tube of an implant delivery device through a urethra,
the delivery device comprising:
the delivery tube comprising a hollow distal end holding an implant in a contracted state;
the implant being self-expandable from the contracted state to an expanded state,
the implant comprising a single elongated undulating ring comprising a plurality of proximal apices, a plurality of distal apices, and a plurality of struts extending between the proximal apices and the distal apices, the struts being curved outwardly along a length from proximal to distal apex and tapering inwardly at each apex so that the implant has a substantially barrel shape along the length,
a jig comprising a first projection engaging a first proximal apex of the plurality of proximal apices while a portion of the delivery tube radially opposed to the first proximal apex blocks disengagement of the first proximal apex from the first projection of the jig when the implant is at least partially within the delivery tube,
the first projection of the jig being disposed distally and proximally of the first proximal apex;
a handle comprising an actuator operable to change a relative longitudinal position between the delivery tube and the jig;
a light; and
an imaging device;
illuminating the urethra and the plurality of distal apices with the light;
viewing the urethra using the imaging device prior to, during, and after deployment of the implant;
viewing the plurality of distal apices using the imaging device during and after deployment of the implant; and
operating the actuator to deploy the implant to the expanded state in the urethra in a correct position by effecting relative longitudinal movement between the delivery tube and the jig to clear the delivery tube from the first proximal apex, hence disengaging the first proximal apex from the first projection of the jig to release the implant from the delivery device, wherein in the correct position the implant:
effects dilation of the urethra by exerting outward radial pressure on walls of the urethra,
matches a cross-sectional shape of the urethra, and
is longitudinally between a bladder neck and an external sphincter.
2. The method of claim 1 , wherein operating the actuator to deploy the implant comprises:
operating the actuator to partially eject the implant; and
operating the actuator to fully eject the implant to deliver the implant in the urethra in the correct position.
3. The method of claim 1 , wherein the first projection enables the jig to both push and pull the implant relative to the delivery tube while holding the implant.
4. The method of claim 1 , wherein operating the actuator to deploy the implant comprises:
operating the actuator to move the delivery tube relative to the implant to a partial deployment position to partially deploy the implant; and
operating the actuator to move the delivery tube relative to the implant to a full deployment position to fully deploy the implant and to deliver the implant in the urethra in the correct position.
5. The method of claim 1 , wherein the first projection enables the jig to both push and pull the implant delivery device while holding the implant.
6. A method of treating benign prostatic hyperplasia, the method comprising:
inserting a distal end of a delivery tube of an implant delivery device along a urethra,
the delivery device comprising:
the delivery tube comprising a hollow distal end holding an implant in a contracted state;
the implant being self-expandable from the contracted state to an expanded state,
the implant comprising a single elongated undulating ring comprising a plurality of proximal apices, a plurality of distal apices, and a plurality of struts extending between the proximal apices and the distal apices, the struts being curved outwardly along a length from proximal to distal apex and tapering inwardly at each apex so that the implant has a substantially barrel shape along the length;
a jig comprising projections configured to hold at least one of the plurality of proximal apices while the delivery tube opposed to the at least one of the plurality of proximal apices blocks disengagement of the at least one of the plurality of proximal apices from the projections of the jig when the implant is at least partially within the delivery tube, the projections being disposed distally and proximally of the at least one of the plurality of proximal apices;
a handle comprising an actuator operable to change a relative longitudinal position between the delivery tube and the jig; and
an imaging device;
viewing the urethra and the plurality of distal apices using the imaging device; and
operating the actuator to deploy the implant to the expanded state in the urethra in a correct position by effecting relative longitudinal movement between the delivery tube and the jig to clear the delivery tube from the at least one of the plurality of proximal apices, hence disengaging the at least one of the plurality of proximal apices from the projections of the jig, wherein in the correct position the implant:
effects dilation of the urethra by exerting outward radial pressure on walls of the urethra, and
is longitudinally between a bladder neck and an external sphincter.
7. The method of claim 6 , wherein in the correct position the implant matches a cross-sectional shape of the urethra.
8. The method of claim 6 , wherein operating the actuator to deploy the implant comprises:
operating the actuator to partially eject the implant; and
operating the actuator to fully eject the implant to deliver the implant in the urethra in the correct position.
9. The method of claim 6 , wherein the implant delivery device comprises a light, and further comprising illuminating the urethra with the light.
10. The method of claim 6 , viewing the urethra using the imaging device is at least one of during deployment of the implant, prior to deployment of the implant, or after deployment of the implant.
11. A method of treating benign prostatic hyperplasia, the method comprising:
inserting a distal end of a delivery tube of an implant delivery device along a urethra,
the delivery tube holding an implant in a contracted state,
wherein the implant is self-expandable from the contracted state to an expanded state when released from the delivery tube and takes a form of a single elongated undulating ring comprising a plurality of proximal apices, a plurality of distal apices, and a plurality of struts extending between the proximal apices and the distal apices, the struts being curved outwardly along a length from proximal to distal apex and tapering inwardly at each apex so that the implant has a substantially barrel shape along the length,
the delivery tube holding at least one of the plurality of proximal apices engaged between projections of a jig of the implant delivery device by blocking disengagement of the at least one of the plurality of proximal apices from between the projections of the jig while the implant is at least partially within the delivery tube, the projections of the jig being disposed distally and proximally of the at least one of the plurality of proximal apices;
viewing the urethra and the plurality of distal apices using an imaging device; and
by effecting relative longitudinal movement between the delivery tube and the jig to clear the delivery tube from the at least one of the plurality of proximal apices, disengaging the at least one of the plurality of proximal apices from the projections of the jig to release the implant from the implant delivery device, thereby positioning the implant in the urethra in the expanded state in a correct position, wherein in the correct position the implant:
effects dilation of the urethra by exerting outward radial pressure on walls of the urethra, and
is longitudinally between a bladder neck and an external sphincter.
12. The method of claim 11 , wherein in the correct position the implant matches a cross-sectional shape of the urethra.
13. The method of claim 11 , wherein operating an actuator to deploy the implant comprises:
operating the actuator to partially eject the implant; and
operating the actuator to fully eject the implant to deliver the implant in the urethra in the correct position.
14. The method of claim 11 , wherein the projections enables the jig to both push and pull the implant delivery device while engaging a proximal portion of the implant.
15. The method of claim 11 , wherein the projections enables the jig to both push and pull the implant while holding the implant.
16. The method of claim 11 , wherein the implant delivery device comprises an imaging device, and further comprising viewing the urethra using the imaging device is at least one of during deployment of the implant, prior to deployment of the implant, or after deployment of the implant.
17. The method of claim 11 , wherein the implant delivery device comprises a light, and further comprising illuminating the urethra with the light.
18. The method of claim 11 , wherein the implant in the correct position moves with a shape of the walls of the urethra during exposure to different forces during expansion of the urethra and contraction of the urethra.
19. The method of claim 11 , wherein the implant in the correct position moves with a shape of the walls of the urethra during exposure to different forces during urination and ejaculation.
20. The method of claim 11 , wherein the implant delivery device comprises an imaging device, and further comprising viewing the urethra using the imaging device is at least one of during deployment of the implant, prior to deployment of the implant, or after deployment of the implant, and wherein operating an actuator to deploy the implant comprises:
operating the actuator to partially eject the implant; and
operating the actuator to fully eject the implant to deliver the implant in the urethra in the correct position.