Claims for Patent: 11,090,186

Summary for Patent: 11,090,186

Title:	Methods for using intrauterine systems and IUD insertion devices
Abstract:	The present disclosure is related to methods of using an intrauterine system (insertion device) including an intrauterine device (IUD), an insertion device or applicator for inserting the IUD into the cervix of a female patient, methods related to the insertion procedure, and methods of manufacture for the insertion device.
Inventor(s):	Deckman; Rob (San Bruno, CA), Repp; Richard E. (San Jose, CA), Guyer; Curt (Dublin, CA), Westendorf; Justin (River Falls, WI), Parmer; Timothy (Brooklyn Park, MN)
Assignee:	MEDICINES360 (San Francisco, CA)
Application Number:	16/020,318
Patent Claims:	1. A method of inserting an IUD into a uterus with an insertion device comprising the steps of: providing the insertion device wherein the insertion device comprises an elongated sheath having a proximal end and a distal end, a lumen extending between the proximal end and the distal end defining an axis for operation of the insertion device, an elongated inner member having a proximal end and a distal end disposable within the lumen of the elongated sheath, a proximally positioned user interface, wherein the proximally positioned user interface further comprises one or more elongated guides formed at least partially therein and along at least a portion of a length thereof wherein the one or more elongated guides are one or more elongated channels formed in an exterior surface of the proximally positioned user interface, and a moveable sheath slider having a proximal end, a distal end, and a curved surface wherein the moveable sheath slider is configured to move proximally or distally along the axis within the one or more channels formed in the exterior surface of the user interface in communication with the elongated sheath wherein the moveable sheath slider controls axial movement of the elongated sheath along the axis, a string control slider having a curved distal surface for abutting with the curved surface of the moveable sheath slider when the sheath slider is adjacent the string control slider, and a string aperture positioned proximally on the user interface, wherein the elongated guide further comprises one or more of at least one of soft motion control features along the length of the one or more channels formed in the exterior surface of the user interface wherein the one or more soft motion control features provides tactile feedback to a user when the moveable sheath slider moves from a first position along the length of the one or more channels to a second position along the length of the one or more channels corresponding to a location for a soft motion control, and the IUD positioned within the elongated sheath at the distal end of the elongated sheath; advancing the insertion device and the IUD into the uterus; actuating the sheath slider of the insertion device; at least one of moving the elongated sheath proximally and advancing the IUD distally; automatically or semi-automatically increasing a radial diameter of the IUD; and releasing the IUD from the insertion device. 2. The method of inserting the IUD into the uterus of claim 1, wherein the one or more elongated guides of the insertion device have a length, a width and a depth, and further wherein the elongated guide width is at least one of a variable length along and a staged width selected from two or more of a first width and a second width. 3. The method of inserting the IUD into the uterus of claim 1, wherein the one or more elongated guides of the insertion device have an in-plane profile selected from rectangular, s-shaped, c-shaped, u-shaped, w-shaped, circular, semi-circular, and oval. 4. The method of inserting the IUD into the uterus of claim 1, wherein the sheath slider the insertion device comprises one or more surface profiles adapted and configured to mechanically complement the one or more motion control features. 5. The method of inserting the IUD into the uterus of claim 4, wherein the one or more surface profiles of the sheath slider of the insertion device are selected from the group comprising one or more of each of non-planar surfaces, curved surfaces, and angled surfaces. 6. The method of inserting the IUD into the uterus of claim 1, wherein the proximally positioned user interface and the sheath slider of the insertion device further comprise one or more alignment surfaces further comprising the step of aligning the alignment surfaces of the user interface and the alignment surfaces of the sheath slider. 7. The method of inserting the IUD into the uterus of claim 6 further comprising the step of aligning a first sheath slider alignment surface of the insertion device with a first user interface alignment surface of the insertion device at a first position along a length of the one or more elongated guides. 8. The method of inserting the IUD into the uterus of claim 7, wherein the one or more sheath slider alignment surfaces and the one or more user interface alignment surfaces of the insertion device are selected from the group comprising a curved surface, an angled surface, a tilted surface and a dimensional surface. 9. The method of inserting the IUD into the uterus of claim 1, further comprising the step of housing at least a portion of the moveable sheath slider of the insertion device in a cavity on one or more of the proximal end of the elongated guide and the distal end of the elongated guide. 10. The method of inserting the IUD into the uterus of claim 1, further comprising the step of moving the string control slider within the one or more elongated guides. 11. The method of inserting the IUD into the uterus of claim 1, further comprising the step of moving the moveable sheath slider and the string control slider of the insertion device simultaneously within the one or more elongated guides. 12. The method of inserting the IUD into the uterus of claim 1, further comprising the step of moving the moveable sheath slider and the string control slider of the insertion device independently within the one or more elongated guides. 13. The method of inserting the IUD into the uterus of claim 1, further comprising the step of moving the sheath slider and the string control slider of the insertion device telescopically along at least a first portion of the one or more elongated guides. 14. The method of inserting the IUD into the uterus of claim 1, further comprising the step of securing one or more strings of the IUD with a string locking feature of the insertion device. 15. The method of inserting the IUD into the uterus of claim 14, wherein the string locking feature comprises one or more of a cleft, a clamp, a wedge, a pincher, a spring, or teeth. 16. The method of inserting the IUD into the uterus of claim 14, further comprising the step of pushing one or more strings of the IUD out of a cleft of the insertion device to unlock the one or more strings of the IUD. 17. The method of inserting the IUD into the uterus of claim 1, wherein the distal end of the elongated sheath of the insertion device has an atraumatic tip selected from the group comprising a rounded tip and a tapered tip. 18. The method of inserting the IUD into the uterus of claim 1, the method further comprising the step of providing a feedback mechanisms selected from the group comprising audible feedback, visible feedback, and tactile feedback. 19. The method of inserting the IUD into the uterus of claim 1 wherein the IUD delivers an active agent. 20. The method of inserting the IUD into the uterus of claim 19 wherein the active agent is a hormone used for the treatment of menopausal troubles or for contraception. 21. A method of hormonally treating a patient comprising the steps of: providing an IUD which delivers an active agent; inserting the IUD with the active agent into a uterus of the patient with an insertion device wherein the insertion device comprises an elongated sheath having a proximal end and a distal end, a lumen extending between the proximal end and the distal end defining an axis for operation of the insertion device, an elongated inner member having a proximal end and a distal end disposable within the lumen of the elongated sheath, a proximally positioned user interface, wherein the proximally positioned user interface further comprises one or more elongated guides formed at least partially therein and along at least a portion of a length thereof wherein the one or more elongated guides are one or more elongated channels formed in an exterior surface of the proximally positioned user interface, and a moveable sheath slider having a proximal end, a distal end, and a curved surface wherein the moveable sheath slider is configured to move proximally or distally along the axis within the one or more channels formed in the exterior surface of the user interface in communication with the elongated sheath wherein the moveable sheath slider controls axial movement of the elongated sheath along the axis, a string control slider having a curved distal surface for abutting with the curved surface of the moveable sheath slider when the sheath slider is adjacent the string control slider, and a string aperture positioned proximally on the user interface, wherein the elongated guide further comprises one or more of at least one of soft motion control features along the length of the one or more channels formed in the exterior surface of the user interface wherein the one or more soft motion control features provides tactile feedback to a user when the moveable sheath slider moves from a first position along the length of the one or more channels to a second position along the length of the one or more channels corresponding to a location for a soft motion control, and the IUD positioned within the elongated sheath at the distal end of the elongated sheath; advancing the insertion device and the IUD with the active agent into the uterus; actuating the sheath slider of the insertion device; at least one of moving the elongated sheath proximally and advancing the IUD with the active agent distally; automatically or semi-automatically increasing a radial diameter of the IUD with the active agent; releasing the IUD with the active agent from the insertion device; and delivering the active agent from the IUD to the patient. 22. The method of claim 21 wherein the active agent is a hormone used for the treatment of menopausal troubles or for contraception.