Kit for and method of assembling an applicator for inserting an implant
The invention pertains to a kit for assembling a disposable applicator for inserting an implant, in particular a rod-like implant containing an active substance, under the skin of a human or animal, the kit comprising a first component, in turn comprising a main housing part providing a handle for grasping and maneuvering the applicator, a cannula, and a cannula holder mounted in the main housing part, the main housing part having an opening which allows introduction of an implant into the proximal end of the cannula or the cannula holder, and, a second component for closing said opening, in turn comprising a second housing part and a rod attached to or forming an integral whole with the second housing part and mountable inside the cannula or the cannula holder.
1. A method of assembling a disposable applicator comprising:
providing a first component comprising a main housing part, a cannula, and a cannula holder, wherein the main housing part provides a handle for grasping and maneuvering the applicator, the cannula holder being slideably mounted in the main housing part for retracting the cannula into the main housing part, the main housing part having an opening which allows introduction of an implant into a proximal end of the cannula or the cannula holder;
providing a second component separate from the first component, for closing said opening, the second component comprises a second housing part and a rod, wherein the second housing part is at least partially complementary in shape to the main housing part and the rod being attached to or forming an integral whole with the second housing part;
before fitting the second component to the first component, introducing an implant through the opening in the main housing and into the proximal end of the cannula or the cannula holder; and
fitting the second component to the first component, wherein the rod is mounted inside the cannula or the cannula holder by fitting the second component to the first component, and wherein the opening in the main housing is closed by fitting the second component to the first component.
2. The method according to claim 1 , wherein the implant is taken from a reel and cut to size prior to introducing the implant into the proximal end of the cannula or the cannula holder.
3. The method according to claim 1 , wherein the cannula holder is manufactured by introducing at least the proximal end of the cannula into a mold and molding the cannula holder about the proximal end.
4. The method according to claim 1 , wherein at least the first component is inspected for compliance with production specifications prior to introduction of the implant.
5. The method according to claim 1 , irreversibly attaching the main housing part to the second housing part.
6. The method according to claim 1 , wherein a distance between the opening and proximal end of a lumen of the cannula or the cannula holder is less than 20 mm.
7. The method according to claim 1 , wherein proximal end of a lumen of the cannula is provided with a funnel-shaped entrance.
8. The method according to claim 1 , wherein a diameter of a narrowest portion of the funnel-shaped entrance of the cannula is equal to or smaller than an inner diameter of the cannula.
9. The method according to claim 1 , wherein the first component comprises a mechanism having a lever extending along at least part of the cannula, which lever is rotatable or slidable or flexible between a first position, wherein the implant is secured inside the cannula or the cannula holder, and a second position, wherein the implant is disengaged.
10. The method according to claim 1 , wherein said method comprises enclosing the assembled disposable applicator within a sterile package.
11. The method according to claim 1 , wherein said method comprises closing the opening in the main housing part for introduction of the implant by attaching the second component to the first component.
12. The method according to claim 1 , wherein the second component is configured so that the rod is mounted in the cannula or cannula holder by attachment of the second component to the first component.
13. The method according to claim 1 , wherein said method comprises retracting the cannula and the cannula holder over the rod via an actuator connected to the cannula holder.
14. The method according to claim 1 , wherein the handle comprises a guiding means extending between an actuator and the main housing, wherein the actuator is configured to slide on the handle via the guiding means.
15. The method according to claim 1 , wherein said method comprises inserting the implant into proximal end of the cannula holder located in the main housing part.
16. The method according to claim 1 , wherein said method comprises retracting the cannula into the main housing part via the cannula holder, wherein the cannula is fixed to the cannula holder.
17. The method according to claim 1 , wherein the implant is a non-biodegradable rod measuring 40 mm in length and 2 mm in diameter and containing etonogestrel.