Systems and methods for delivering multiple ocular implants
Systems and methods for delivering multiple ocular implants to reduce intraocular pressure are disclosed. The ocular implants can be implanted at multiple sites within a single human eye without requiring removal of the delivery apparatus from the eye. A system for delivering multiple ocular implants can include a plurality of implants, an external housing, and an introducer assembly. The external housing can provide access to an implant singulation actuator and an implant delivery actuator. The introducer assembly can comprise an auto-retracting introducer portion. The delivery apparatus can include an infinite activation mechanism/portion and/or a manual singulation mechanism/portion.
1. An implant delivery apparatus configured to deliver a plurality of implants for treating an ocular disorder, the apparatus comprising:
an external housing comprising:
an opening;
a trigger button configured to be actuated by a user extending out of the opening to effect implant delivery;
a singulation portion comprising a singulation actuator extending out of the opening, the singulation actuator being configured to be manually actuated by the user so as to singulate a respective one of the plurality of implants for delivery upon each manual actuation of the singulation actuator such that the plurality of implants are delivered one at a time;
an introducer tube extending from the external housing at an angle offset from a longitudinal axis of the implant delivery apparatus; and
a trocar configured to extend within and through the introducer tube, wherein the plurality of implants are configured to be positioned and advanced along the trocar.
2. The implant delivery apparatus of claim 1 , further comprising:
an auto-retracting introducer assembly configured to surround at least a portion of the introducer tube, the introducer assembly comprising a flexible proximal retraction member that is configured to buckle along its length and a distal introducer tip that is configured to be inserted through an opening in eye tissue to facilitate insertion of the introducer tube within an eye,
wherein a proximal end of the proximal retraction member is coupled to a distal end portion of the external housing, and
wherein a distal end of the proximal retraction member comprises an interface component sized and shaped to interface with a boundary of the opening in the eye tissue and to prevent continued advancement of the distal introducer tip within the eye such that the proximal retraction member buckles along its length as the introducer tube is advanced further within the eye through the opening in the eye tissue.
3. The implant delivery apparatus of claim 2 , wherein the interface component is generally cone-shaped.
4. The implant delivery apparatus of claim 2 , wherein the proximal retraction member comprises multiple openings positioned along its length at spaced-apart locations designed to facilitate bending of the proximal retraction member in a desired bending configuration.
5. The implant delivery apparatus of claim 1 , wherein each manual actuation of the singulation actuator causes the respective one of the plurality of implants to be positioned in a same “ready-to-fire position” along the trocar.
6. The implant delivery apparatus of claim 5 , further comprising a singulation tube operably coupled to the singulation actuator, wherein the singulation tube is configured to engage a proximal end of one of the plurality of implants and advance the respective implant to the “ready-to-fire position” along the trocar upon the manual actuation of the singulation actuator.
7. The implant delivery apparatus of claim 1 , wherein the trigger button is operably coupled to an actuation biasing member that is configured to generate an implantation impulse sufficient to effect implant delivery by capturing and converting energy used to press the trigger button without use of pre-stored energy that is stored prior to pressing of the trigger button.
8. The implant delivery apparatus of claim 7 , wherein the actuation biasing member comprises a leaf spring.
9. The implant delivery apparatus of claim 1 , wherein the plurality of implants comprises at least three implants.
10. The implant delivery apparatus of claim 1 , wherein the trocar comprises a plurality of separation regions positioned at spaced-apart locations along a length of the trocar, the separation regions configured to separate the plurality of implants from each other until the singulation actuator of the singulation portion interacts with a respective one of the plurality of implants upon manual actuation of the singulation actuator by the user.
11. The implant delivery apparatus of claim 10 , wherein the separation regions comprise splayed trocar regions comprising a plurality of slits around a circumference of the trocar at the plurality of spaced-apart locations, and wherein the splayed trocar regions comprise a heat set shape such that in a resting configuration, the plurality of slits are splayed outward such that a cross-sectional dimension of the trocar along the splayed trocar regions is larger than a cross-sectional dimension of the trocar between the splayed trocar regions.
12. The implant delivery apparatus of claim 1 , wherein the angle is between 5 and 12 degrees.
13. An implant delivery apparatus configured to deliver a plurality of implants for treating an ocular disorder, the apparatus comprising:
an external housing comprising:
an opening; an
a trigger button configured to be actuated by a user extending out of the opening,
wherein the trigger button comprises an actuator that is configured to be manually actuated by the user to effect implant delivery;
an actuation biasing member operably coupled to the trigger button such that, upon pressing of the trigger button, energy sufficient to deliver a respective implant of the plurality of implants is generated by the actuation biasing member without use of pre-stored energy that is stored prior to pressing of the trigger button; and
a trocar configured to extend from a distal end of the external housing, wherein the plurality of implants are configured to be positioned and advanced along the trocar.
14. The implant delivery apparatus of claim 13 , wherein the actuation biasing member comprises a leaf spring.
15. The implant delivery apparatus of claim 14 , wherein the leaf spring is configured to bend upon pressing of the trigger button by the user, thereby generating the energy sufficient to effect delivery of the respective implant.
16. The implant delivery apparatus of claim 13 , further comprising a singulation handle extending out of the opening, wherein the singulation handle is configured to be manually actuated by the user so as to facilitate on-demand manual singulation to effect selection of one of the plurality of implants for delivery one at a time.
17. The implant delivery apparatus of claim 13 , wherein the trocar comprises multiple singulation regions spaced apart along a length of the trocar, the singulation regions being configured to facilitate mechanical separation of the plurality of implants from each other.
18. The implant delivery apparatus of claim 17 , wherein the singulation regions comprise splayed regions formed by slits in the trocar at each of the singulation regions.
19. An implant delivery apparatus configured to deliver a plurality of implants for treating an ocular disorder, the apparatus comprising:
an external housing comprising:
an opening;
a trigger button extending out of the opening, the trigger button configured to be manually actuated by a user to effect implant delivery;
a singulation handle extending out of the opening, the singulation handle configured to be manually actuated by the user so as to facilitate on-demand manual singulation to effect selection of a respective one of the plurality of implants for delivery of the plurality of implants one at a time; and
a trocar configured to extend from a distal end of the external housing, wherein the plurality of implants are configured to be positioned and advanced along the trocar,
wherein the trocar comprises a plurality of separation regions formed by slits along a length of the trocar at spaced-apart locations along the length of the trocar, the separation regions configured to mechanically separate the plurality of implants from each other until a singulation actuator operably coupled to the singulation handle interacts with the respective one of the plurality of implants upon manual actuation of the singulation handle by the user.
20. The apparatus of claim 19 , wherein the separation regions comprise splayed regions formed by slits in the trocar at each of the spaced-apart locations along the length of the trocar, wherein the splayed regions comprise a heat set shape such that, in a resting configuration, the slits are splayed outward such that a cross-sectional dimension of the trocar along the splayed regions is larger than a cross-sectional dimension of the trocar between the splayed regions.