Intrauterine systems, IUD insertion devices, and related methods and kits therefor

• US 10,028,858 B2
• Filed: 07/02/2012
• Issued: 07/24/2018
• Est. Priority Date: 07/11/2011
• Status: Active Grant

• Current Assignee: Medicines360
• Original Assignee: Medicines360
• Inventors: Deckman, Rob, Repp, Richard E., Guyer, Curt, Westendorf, Justin, Parmer, Timothy
• Primary Examiner(s): Nia, Alireza
• Assistant Examiner(s): Berezik, Rachel
• Application Number:
  US13/539,843
• Publication Number:
  US 20130014762A1
• Time in Patent Office: 2,213 Days
• CPC Class Codes: A61F 6/12 Inserters or removers
• CPC Class Codes: A61F 6/144 with T-configuration
• CPC Class Codes: A61F 6/18 Inserters or removers ; Apparatus for loading an intra-uterine device into an insertion tube

Abstract

Intrauterine systems and components thereof. The systems include an intrauterine device (IUD), an insertion device or applicator for inserting the IUD into the cervix of a female patient. The insertion device includes an elongated sheath; an elongated inner member positioned within a lumen of the elongated sheath; a handle with one or more elongated guides; and a moveable sheath slider. Additionally, methods related to the insertion procedure, and methods of manufacture for the insertion device.

Claims

1. An insertion device for inserting an IUD comprising:

an elongated sheath having a proximal end and a distal end, a lumen extending between the proximal end and the distal end wherein the elongated sheath defines an axis for operation of the insertion device and wherein the IUD is positionable within the elongated sheath at the distal end of the elongated sheath;

an elongated inner member having a proximal end and a distal end disposable within the lumen of the elongated sheath wherein a proximal end of the IUD is positionable adjacent the distal end of the elongated inner member;

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.

2. The insertion device of claim 1, wherein the one or more elongated guides 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 insertion device of claim 1, wherein the one or more elongated guides have an in-plane profile selected from rectangular, s-shaped, c-shaped, u-shaped, w-shaped, circular, semi-circular, and oval.

4. The insertion device of claim 1, wherein the sheath slider comprises one or more surface profiles adapted and configured to mechanically complement the one or more motion control features.

5. The insertion device of claim 4, wherein the one or more surface profiles of the sheath slider are selected from the group comprising one or more of each of non-planar surfaces, curved surfaces, and angled surfaces.

6. The insertion device of claim 1, wherein the proximally positioned user interface and the sheath slider further comprises one or more alignment surfaces, wherein the one or more alignment surfaces of the user interface is adapted and configured to mechanically complement the one or more alignment surfaces of the sheath.

7. The insertion device of claim 6 wherein a first sheath slider alignment surface aligns with a first user interface alignment surface at a first position along a length of the one or more elongated guides.

8. The insertion device of claim 6, wherein the one or more sheath slider alignment surfaces and the one or more user interface alignment surfaces are selected from the group comprising a curved surface, an angled surface, a tilted surface and a dimensional surface.

9. The insertion device of claim 1, wherein the one or more elongated guides further comprises one or more cavities on one or more of the proximal end of the elongated guide and the distal end of the elongated guide wherein the one or more cavities are adapted and configured to house at least a portion of the movable sheath slider.

10. The insertion device of claim 1, wherein the string control slider is adaptable and configurable to securely move within the one or more elongated guides.

11. The insertion device of claim 1, wherein the moveable sheath slider and the string control slider are adapted and configured to operate at least one of simultaneously and independently within the one or more elongated guides.

12. The insertion device of claim 1, wherein the sheath slider and the string control slider are telescopically movable along at least a first portion of the one or more elongated guides, and further wherein the sheath slider and the string control slider are configurable such that at least one of the sheath slider and the string slider partially surrounds the remaining slider.

13. The insertion device of claim 1, wherein the sheath slider and string control slider are further configurable to comprise one or more vertical surfaces, wherein the one or more vertical surfaces are selected from the group comprising a first sheath slider vertical surface, a second sheath slider vertical surface, a first string control slider vertical surface, and a second string control vertical surface, wherein one or more of the vertical surfaces are configured to form an aligned adjacent surface at one or more positions along a length of the one or more elongated guides.

14. The insertion device of claim 1, wherein the sheath slider and the string control slider have a combined width less than or equal to at least one of 0.75 inches (19 mm), 0.7 inches (17.8 mm), 0.5 inches (12.7 mm), 0.35 inches (8.9 mm), or 0.25 inches (6.3 mm).

15. The insertion device of claim 1, wherein the insertion device is configurable to receive the IUD within a distal end of the lumen of the elongated sheath and wherein the insertion device further comprises at least one string locking feature adaptable and configurable to secure one or more string components of the IUD.

16. The insertion device of claim 15, wherein the at least one string locking feature comprises one or more of a cleft, a clamp, a wedge, a pincher, a spring, or teeth.

17. The insertion device of claim 16, wherein the string locking feature comprises a cleft, and the string locking feature comprises a movable member which pushes the one or more strings out of the cleft to unlock the one or more strings.

18. The insertion device of claim 1, wherein the distal end of the elongated sheath has an atraumatic tip selected from the group comprising a rounded tip and a tapered tip.

19. The insertion device of claim 18, wherein the distal end of the elongated sheath has an outer diameter of about 3 mm to 5 mm.

20. The insertion device of claim 18, wherein the distal end of the elongated sheath has an outer diameter which is equal to or less than 80%, 50%, 30% of the outer diameter of the proximal end of the elongated sheath.

21. The insertion device of claim 18, wherein the distal end of the elongated sheath has an outer diameter which is less than a maximum cross-sectional dimension of the IUD positionable within the lumen of the elongated sheath.

22. The insertion device of claim 18, wherein the distal end of the elongated sheath further comprises one or more slits or flaps at a forward end of the sheath.

23. The insertion device of claim 1 further comprising one or more feedback mechanisms selected from the group comprising audible, visible, and tactile.

24. The insertion device of claim 1 wherein an elongate member of the IUD comprises a core part around which a jacket-like polymeric reservoir containing an active agent has been fitted.

25. The insertion device of claim 24 wherein the active agent is a hormone used for the treatment of menopausal troubles or for contraception.

26. The insertion device of claim 1 wherein the IUD includes an active agent that is a hormone used for treatment of menopausal troubles or for contraception.