Details for Patent: 11,090,186

Which drugs does patent 11,090,186 protect, and when does it expire?

Patent 11,090,186 protects LILETTA and is included in one NDA.

This patent has twenty-four patent family members in nineteen countries.

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):	Rob Deckman, Richard E. Repp, Curt Guyer, Justin Westendorf, Timothy PARMER
Assignee:	Medicines360
Application Number:	US16/020,318
Patent Claim Types: see list of patent claims	Use; Delivery; Device;

Scope and claims of US Patent 11,090,186 and what parts of the insertion device are IP-critical

US 11,090,186 is directed to a specific IUD delivery workflow using an insertion device that couples (i) a sheath-slider mechanism guided by channels on a proximal user interface with (ii) a “soft motion control” tactile-feel feature and (iii) automated or semi-automated radial expansion of the IUD, ending in release. The claims are drafted as method claims that track both device structure and operational steps, then broaden into “hormonally treating” use via IUDs that deliver an active agent.

The patent’s practical value depends on how tightly competitors’ systems match the claimed control architecture (channel-guided sheath slider with a curved abutment interface to a string control slider, plus tactile soft-motion features) and whether radial expansion is staged in a way that is “automatically or semi-automatically increasing a radial diameter … and releasing” as the insertion sequence advances.

---

What patents protect the method of inserting an IUD using a slider-guided sheath with tactile feedback and radial expansion?

What US 11,090,186 claims cover at a high level

Independent claim 1 claims a method of inserting an IUD into a uterus using an insertion device that has a particular proximal interface and actuator geometry plus specific insertion mechanics:

Core elements (claim 1, claim language mapped to technical blocks)

1. Elongated sheath: elongated sheath with proximal/distal ends and a lumen defining an axis.
2. Elongated inner member: disposable within the sheath lumen.
3. Proximally positioned user interface containing one or more elongated guides:
   • Guides are elongated channels formed in an exterior surface of the user interface.
4. Moveable sheath slider:
   • Has proximal/distal ends and a curved surface
   • Slides proximally or distally along the axis inside the channels.
   • Controls axial movement of the elongated sheath.
5. String control slider:
   • Has a curved distal surface positioned to abut the curved surface of the sheath slider when adjacent.
6. String aperture on the user interface (proximal).
7. Soft motion control features along the channels:
   • Provide tactile feedback when the sheath slider moves from a first position to a second position corresponding to a “location for a soft motion control.”
8. IUD placement within the sheath at the distal end.
9. Insertion sequence:
   • Advancing insertion device and IUD into the uterus
   • Actuating sheath slider
   • At least one of:
     • moving sheath proximally and advancing IUD distally
   • Automatically or semi-automatically increasing a radial diameter of the IUD
   • Releasing the IUD from the insertion device

Independent claim 21 is a functional extension:

• It adds that the IUD delivers an active agent and includes delivering the active agent to the patient, while largely repeating the same insertion device architecture and radial-expansion/release mechanics.

What claim 1 is really “about”: the control system, not just the IUD

US 11,090,186 is not just “IUD insertion.” It is an IP claim on:

• A proximal user interface with channel guides,
• A moving sheath slider that mechanically couples to sheath axial movement,
• A coupled string control slider using a curved abutment interface,
• Tactile soft-motion features tied to slider travel positions,
• Radial expansion occurring in the same sequence before release.

That is a narrow but device-mechanical claim category. It is harder for a competitor to design around while keeping the same ergonomic control and tactile cues.

---

Which insertion-device features are claimed as structural limitations even though the claims are methods?

Even though the independent claims are “method” claims, they incorporate device definitions that operate as structural limitations. A method infringement analysis typically still requires the accused system to have these features or equivalents.

The “channels + slider” architecture (highest leverage design-around surface)

Claim 1 requires:

• one or more elongated channels formed in an exterior surface of the proximal user interface, and
• a moveable sheath slider that moves along the axis within those channels and controls axial movement of the elongated sheath.

Design implications

• If a competitor uses a different actuation geometry (for example, a linear actuator not constrained by channels on a user interface, or a cam/rotary mechanism without the claimed “channels” + “sheath slider within channels” relationship), it weakens literal match.
• If the competitor keeps channel guidance but alters slider structure such that it does not “control axial movement” in the claimed way, it may still argue non-infringement absent equivalents.

The curved abutment between sheath slider and string control slider

Claim 1 adds:

• sheath slider has a curved surface
• string control slider has a curved distal surface that abuts when adjacent

This is a specific mechanical coupling claim. If an accused design uses a different string-release mechanism (e.g., a separate latch, dedicated string clip, or a different coupling without curved abutment geometry), it is a direct separation point.

The “soft motion control features” and tactile-feedback positional logic

Claim 1 requires:

• soft motion control features along the channels
• tactile feedback when slider moves from a first position to a second position
• the second position corresponds to a “location for a soft motion control”

That ties tactile feel to slider travel positions tied to insertion steps. A competitor can reduce literal risk by:

• removing tactile bumps/deflections tied to specific channel positions, or
• using a tactile feedback mechanism not triggered by “soft motion control features along the length” of the channel, or
• using feedback that is not tied to a “first to second position” change corresponding to an insertion “location.”

---

What are the dependent claim fallbacks and how do they broaden or narrow the invention?

Claim 2: Channel geometry and staged width

Claim 2 narrows and specifies channel form:

• channel has length/width/depth
• channel width is at least one of:
  • variable length along the channel, and/or
  • staged width from two or more widths (first width and second width)

This is a geometrical refinement. Many competitor mechanisms may not match this exact channel profile.

Claim 3: In-plane channel profile shapes

Claim 3 further narrows channel in-plane profile:

• rectangular, s-shaped, c-shaped, u-shaped, w-shaped, circular, semi-circular, oval

This is another structural refinement. It also signals channel profiles are central to the tactile and slider travel behavior.

Claims 4–5: Sheath-slider surface profiles mechanically complement soft-motion features

Claim 4 requires:

• sheath slider has one or more surface profiles mechanically complementing the motion-control features

Claim 5 specifies the complementing surface profiles may be:

• non-planar, curved, angled surfaces

These dependent claims reinforce that the tactile experience depends on specific relative geometry between slider surfaces and soft-motion features.

Claims 6–8: Alignment surfaces between user interface and sheath slider

Claim 6 requires:

• alignment surfaces on both user interface and sheath slider
• aligning alignment surfaces as a step

Claim 7 adds:

• aligning a first sheath-slider alignment surface with a first user-interface alignment surface at a first position along the channel.

Claim 8 lists allowable alignment-surface shapes:

• curved, angled, tilted, dimensional surface

These claims likely cover “training wheels” geometry for consistent actuation. Competitors that do not include these alignment surfaces or that do not follow this alignment workflow may escape dependent-claim literal scope.

Claim 9: Housing the slider portion within a cavity

Claim 9 requires:

• housing at least a portion of the moveable sheath slider in a cavity at one or both:
  • proximal end of the elongated guide and/or
  • distal end of the elongated guide

This is a further mechanical refinement likely tied to travel endpoints and tactile events.

Claims 10–13: String control slider movement modes and telescoping

Claim 10:

• moving the string control slider within the elongated guides

Claim 11:

• moving sheath slider and string control slider simultaneously

Claim 12:

• moving them independently

Claim 13:

• telescoping movement along at least a first portion of the elongated guides

These dependent claims are important because they create infringement pathways depending on how an accused design decouples string-control motion from sheath motion.

Claims 14–16: String locking feature and unlocking by pushing strings

Claim 14:

• securing IUD strings with a string locking feature

Claim 15:

• locking feature comprises cleft/clamp/wedge/pincher/spring/teeth

Claim 16:

• pushing strings out of a cleft to unlock

This set is a second major design-around locus:

• competitors using other string retention/release geometries or different unlocking steps may not meet these limitations.

Claim 17: Atraumatic tip options

Claim 17:

• distal end atraumatic tip is rounded or tapered

This is likely broadly satisfied in many devices.

Claim 18: Feedback mechanisms

Claim 18:

• audible, visible, and/or tactile feedback

Claim 1 already requires tactile feedback from “soft motion control features.” Claim 18 broadens to additional feedback types.

Claims 19–22: Active-agent IUD and hormone scope

Claim 19:

• IUD delivers an active agent

Claim 20:

• active agent is a hormone used for treatment of menopausal troubles or contraception

Claim 21:

• method of hormonally treating patient includes inserting active-agent IUD using the insertion-device architecture and sequence; adds “delivering the active agent.”

Claim 22:

• hormone used for menopausal troubles or contraception

These claims expand applicability to hormonal IUDs, but the insertion-device mechanics remain the same infringement core.

---

What does the claim set suggest about the patent’s intended commercial coverage?

US 11,090,186 is drafted to cover:

1. Insertion mechanics (slider-sheathed delivery with tactile cueing and radial expansion)
2. String control (including locking and release coupling)
3. Radial expansion timing (auto or semi-auto expansion during actuation)
4. Platform extension to hormonally active IUDs.

This suggests the patent was built to follow a device platform rather than a single active-agent payload. The active-agent dependent claims (19–22) appear to broaden monetization to hormonal indications where IUDs deliver drugs beyond copper or non-drug mechanical constructs.

---

How strong is the patent estate for US 11,090,186 versus typical IUD insertion mechanisms?

Likelihood of literal match depends on 3 “must-have” feature clusters

1. Channel-guided sheath slider with tactile soft-motion features
2. Curved abutment between sheath slider and string control slider
3. Automatic or semi-automatic radial diameter increase and release in sequence

If an accused device uses:

• a different actuation pathway (no channel/slider constrained movement on a proximal user interface),
• tactile feedback not caused by channel-located “soft motion control features” triggered by slider position changes, and/or
• no curved abutment interface between slider components, then literal infringement risk drops sharply.

Dependent-claim geometry increases specificity and narrows literal coverage

Channel shapes (claim 3), staged width (claim 2), alignment surfaces (claims 6–8), cavity housing (claim 9), telescoping (claim 13), and locking types (claims 14–16) provide narrower fallback infringement hooks. Competitors that broadly match the platform idea but differ mechanically may avoid dependent-claim fallbacks even if they partially overlap with claim 1.

---

What generic or competitor entry risks exist for IUD insertion devices and hormonal IUD delivery systems?

Competitor risk is more “device” than “drug”

Unlike classic drug patents that bar generics by active ingredient, US 11,090,186 is a device-insertion method patent. The primary risk is for:

• IUD inserters built with similar slider and tactile cues and radial expansion release sequences, and
• hormonal IUD systems that incorporate that inserter concept.

If a competitor commercializes a hormonal IUD using an inserter that does not match the claimed slider-channel tactile radial-expansion sequence, the claim likely becomes difficult to enforce based on literal features alone.

Design-around options most consistent with the claim drafting

Without speculating about any specific competitor designs, the claim language identifies the most straightforward “avoidance” routes:

• avoid “one or more elongated channels formed in an exterior surface” on the user interface,
• avoid a “moveable sheath slider” traveling “within” such channels controlling sheath axial movement,
• remove or redesign the tactile “soft motion control features” tied to slider travel positions,
• avoid the curved abutment linkage between sheath slider and string control slider,
• avoid the claimed string locking feature repertoire and/or the unlocking by pushing strings out of a cleft.

---

How does the claim scope address hormonal treatment (menopausal troubles and contraception)?

US 11,090,186 adds an extended use framing in claims 19–22:

• the IUD delivers a “hormone used for the treatment of menopausal troubles or for contraception.”
• method 21 requires delivering the active agent “to the patient.”

This is not a broad “any hormone IUD” claim without device limitations. The insertion-device architecture and actuation steps remain required.

Business takeaway: a hormonal IUD manufacturer cannot treat this as merely an indication claim. It remains constrained by insertion-device mechanical steps and the radial expansion/release sequence.

---

Patent landscape map for US 11,090,186: what claims indicate about prior art and likely validity pressure

The claim drafting reflects common IUD insertion themes (sheath, inner member, radial expansion, strings). What is likely novel and contested is:

• the channel-guided slider interface on a proximal user interface,
• the specific coupling between sheath slider and string control slider via curved abutment,
• the “soft motion control features” producing tactile feedback at a defined second-position.

That pattern tends to invite prior art invalidity arguments centered on:

• user-interface guided sliders with tactile detents or bumps,
• inserters with proximal actuation for sheath retraction and radial deployment,
• string release and locking couplings.

The dependent claims also suggest the inventors expected novelty in fine geometry and tactile-feature implementation.

---

Key Takeaways

• US 11,090,186 is centered on a method of IUD insertion using a channel-guided, curved-surface sheath slider and a string control slider coupled by a curved abutment, with soft motion tactile feedback tied to slider travel positions.
• The claims also require automatic or semi-automatic radial expansion of the IUD followed by release during the same actuation sequence.
• Dependent claims lock in geometries (channel width staging and in-plane profiles), alignment surfaces, cavity housing, telescoping, and string locking/unlocking mechanisms.
• Claims 19–22 extend enforcement from mechanical insertion to hormonal IUDs for menopausal troubles or contraception, but still require the same insertion-device and actuation mechanics.
• Competitive risk is strongest where an accused system matches the control architecture (channels + sheath slider + tactile soft-motion features + curved abutment + radial expansion/release).

---

FAQs

1. Does US 11,090,186 protect any IUD insertion method, or only those using channels and a sheath slider?
   It protects methods that require the claimed insertion device features, including channel-guided movement of a moveable sheath slider on a proximal user interface and tactile soft-motion control features tied to slider positions.

2. Is the patent limited to IUDs that release hormones?
   No. Claim 1 covers insertion of an IUD generally, while claims 19–22 add method-of-hormonal-treatment coverage for hormonal IUDs for menopausal troubles or contraception.

3. What component is most critical for design-around efforts: the IUD or the inserter?
   The inserter/control mechanism is most critical because the claims require the specific channel-guided slider/tactile and string-control coupling architecture, plus radial expansion and release steps.

4. How do the dependent claims affect infringement strategy?
   Dependent claims add narrower geometric and functional limitations (channel shapes, staged widths, alignment surfaces, cavity housing, telescoping, string locking types), which can narrow literal coverage but create multiple infringement hooks if an accused product matches those specifics.

5. Do the method claims require actual delivery of the active agent to infringe claims 21–22?
   Claims 21–22 include steps requiring that the active agent is delivered to the patient, so infringement depends on the hormonal delivery workflow as claimed.

---

References

1. United States Patent No. 11,090,186.

Drugs Protected by US Patent 11,090,186

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Medicines360	LILETTA	levonorgestrel	SYSTEM;INTRAUTERINE	206229-001	Feb 26, 2015		RX	Yes	Yes						A METHOD FOR PREVENTION OF PREGNANCY

International Family Members for US Patent 11,090,186

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2012282832
Australia	2015221468
Brazil	112014000440
Brazil	122015016218