United States Patent 10,028,858: Scope, Claims, and Patent Landscape for an IUD Insertion Device
What does US 10,028,858 claim?
US Patent 10,028,858 claims an IUD insertion device built around a distal-loaded IUD within an elongated sheath, and a proximal user interface that drives IUD sheath movement through one or more elongated guides/channels and a movable sheath slider. The independent claim (claim 1) is the technical backbone; dependent claims then tighten scope around guide geometry, tactile “soft motion” feedback, telescoping motion, string handling/locking, sheath dimensional limits, distal atraumatic tip design, and optional feedback mechanisms. Claims 24 to 26 expand toward an IUD that includes an active agent hormone.
Independent claim 1 (core architecture)
Claim 1 requires all of the following, in combination:
- Insertion device for inserting an IUD, including:
- Elongated sheath with:
- proximal end and distal end
- lumen extending between ends
- sheath defines an axis
- IUD positionable within the sheath at the distal end
- Elongated inner member disposable within the lumen:
- proximal end and distal end
- the proximal end of the IUD is positionable adjacent the distal end of the inner member
- Proximally positioned user interface with:
- one or more elongated guides formed at least partially therein
- one or more elongated channels formed in an exterior surface of the user interface
- Moveable sheath slider with:
- proximal end, distal end, and curved surface
- configured to move proximally or distally along the axis within the channels
- the slider controls axial movement of the elongated sheath
- String control slider with:
- curved distal surface that abuts the curved surface of the moveable sheath slider when adjacent
- String aperture positioned proximally on the user interface
- Soft motion control / tactile feedback:
- the elongated guide includes one or more soft motion control features along the channel length
- the features provide tactile feedback when the moveable sheath slider moves from a first position to a second position corresponding to a location for a soft motion
This defines a specific mechanical control system:
- the user interfaces with a slider system in channels;
- the slider’s position triggers sheath axial movement;
- and the channel includes tactile “step points” that correspond to “soft motion” locations.
The claim also couples sheath motion with string control through the curved abutting slider interaction.
How broad are the claim elements?
Across dependent claims 2–26, the scope stretches in three directions:
- Guides/channel shape and feature configuration (geometry breadth)
- Motion transfer and tactile feedback (function and feel breadth)
- IUD string management and sheath geometry (operational and dimensional breadth)
- IUD active agent/hormone concept (content breadth, but only if the dependent claims are asserted)
Guide geometry and channel profiles (claims 2–3)
- Claim 2: elongated guide has length/width/depth and guide width can be:
- variable along length, and/or
- staged width selected from at least two widths (first width and second width)
- Claim 3: elongated guide in-plane profile may be selected from:
- rectangular, s-shaped, c-shaped, u-shaped, w-shaped, circular, semi-circular, oval
These phrases are “select-from” in nature, so they support multiple design variants.
Soft motion control interface between slider and channel (claims 4–5)
- Claim 4: sheath slider has surface profiles that mechanically complement the motion control features
- Claim 5: surface profiles are selected from:
- non-planar surfaces, curved surfaces, angled surfaces
Alignment surfaces (claims 6–8)
- Claim 6: user interface and sheath slider include alignment surfaces mechanically complementing each other
- Claim 7: first slider alignment surface aligns with first user interface alignment surface at a first position along guide length
- Claim 8: alignment surfaces are selected from:
- curved, angled, tilted, dimensional surfaces
Accommodation of sliders in cavities (claim 9)
- guide includes cavities at proximal and distal guide ends to house at least a portion of the movable sheath slider
String control / slider mobility and independence (claims 10–13)
- Claim 10: string control slider is adaptable/configurable to securely move within guides
- Claim 11: movable sheath slider and string control slider can operate:
- simultaneously and/or independently
- Claim 12: telescopic movement along the guide:
- sheath slider and string control slider telescopically movable along at least a first portion
- sliders can be configured so at least one partially surrounds the remaining slider
- Claim 13: vertical surfaces on sliders:
- selected as first/second sheath slider vertical surfaces and first/second string control vertical surfaces
- vertical surfaces form aligned adjacent surfaces at positions along guide length
Combined widths (claim 14)
- sheath slider + string control slider combined width is:
- ≤ 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)
This acts like a dimensional ceiling.
What additional features narrow the device (claims 15–23)?
Claims 15–23 narrow string locking, distal sheath geometry, optional distal slits/flaps, and feedback.
String locking features (claims 15–17)
- Claim 15: device includes string locking feature(s) to secure one or more IUD string components
- Claim 16: locking feature comprises one or more of:
- cleft, clamp, wedge, pincher, spring, teeth
- Claim 17: example embodiment:
- locking feature comprises a cleft
- includes a movable member that pushes the strings out of the cleft to unlock them
Atraumatic distal tip geometry and sheath sizing (claims 18–22)
- Claim 18: distal sheath tip is atraumatic:
- rounded tip or tapered tip
- Claim 19: distal outer diameter about 3 mm to 5 mm
- Claim 20: distal outer diameter equals or is ≤ 80% / 50% / 30% of proximal outer diameter
- Claim 21: distal outer diameter is less than or equal to 80%? (as written it is “less than maximum cross-sectional dimension of the IUD,” so the functional constraint is:)
- distal outer diameter is less than the IUD maximum cross-sectional dimension (as positioned in sheath)
- Claim 22: distal end further comprises one or more slits or flaps at the forward end of sheath
Feedback mechanisms (claim 23)
- feedback mechanisms selected from:
- audible, visible, tactile
How far do the claims reach into active-agent IUDs (claims 24–26)?
Claims 24–26 tie the insertion device to an IUD that includes an active agent hormone.
- Claim 24: IUD elongate member has a core part with a jacket-like polymeric reservoir containing active agent fitted around it
- Claim 25: active agent is a hormone used for:
- treatment of menopausal troubles or for contraception
- Claim 26: IUD includes an active agent that is a hormone used for:
- treatment of menopausal troubles or for contraception
This adds product-content dependence: infringement against the insertion device may require the claimed active-agent/hormone IUD configuration if those dependent claims are asserted.
Claim coverage map (what must exist for infringement vs. what are optional add-ons)
| Claim element bucket |
Required in claim 1 |
Further narrowed in dependent claims |
Scope impact |
| Elongated sheath + lumen + axis |
Yes |
Distal tip and sheath dimensions in 18–22 |
Baseline structure is broad but anchored to sheath/lumen/axis control system |
| Distal-loaded IUD + inner member |
Yes |
Little further refinement beyond dimensions |
Preserves most IUD insertion device relevance |
| Proximal user interface with channels/guides |
Yes |
Geometry/profile in 2–3; cavities in 9; alignment surfaces in 6–8 |
Strong mechanical limitation that can be designed around via lack of channels/guide features |
| Moveable sheath slider with curved surface controlling sheath axial motion |
Yes |
Complementary surface profiles in 4–5 |
Key mechanical coupling element |
| String control slider and curved abutment behavior |
Yes |
Telescoping/independent operation in 11–13; security within guides in 10 |
Provides multiple infringement hooks tied to string mechanism and slider interaction |
| Soft motion tactile feedback |
Yes |
“soft motion control features” along channel are intrinsic to 1 |
Must exist for literal coverage of 1 |
| String locking feature(s) |
Not in 1 |
15–17 (cleft/clamp/wedge/pincher/spring/teeth) |
Adds specific string retention/release mechanics |
| Distal sheath tip and diameter ranges |
Not in 1 |
18–22 |
Enables narrower product differentiation |
| Optional audible/visible/tactile feedback |
Not in 1 |
23 |
Adds additional device feature dependence |
| Active-agent/hormone IUD construction |
Not in 1 |
24–26 |
Limits expanded coverage to hormone-releasing IUD constructs |
What is the patent landscape context for this concept?
US 10,028,858 sits in a crowded space: IUD insertion systems have long-standing mechanical control patents (sheath/rod mechanisms, removal of strings from the insertion path, atraumatic tips, and user-actuated release). The distinctive focus here is the channelized proximal interface driving coupled sheath and string movement with tactile “soft motion” events.
Landscape “design-around” levers implied by claim structure
Because claim 1 is combination-based, competitive designs can target gaps in one or more of these required features:
- Remove the “proximally positioned user interface” channel/guides architecture
- Eliminate the “moveable sheath slider” in channels controlling axial sheath movement
- Avoid tactile “soft motion control features” that provide feedback at a defined first-to-second position corresponding to a soft motion location
- Change string control so it does not use the claimed string control slider with the curved abutting relationship
- Use a fundamentally different string locking release concept (if dependent claims 15–17 are asserted)
Landscape “risk concentration”
Risk concentrates where competitors already use:
- channel-and-slider motion transfer,
- step-like tactile events,
- coupled string control during sheath withdrawal,
- and atraumatic tapered/rounded distal ends.
The addition of specific dependent features (cavities, alignment surfaces, telescoping overlap, combined slider width limits, and slits/flaps) further concentrates infringement exposure when designs share the same manufacturing/geometry choices.
Potential claim construction focal points (litigation posture)
Without relying on extrinsic facts, several claim terms are likely to be central to scope:
- “one or more elongated guides” and whether “channels formed in an exterior surface of the user interface” is mandatory for claim 1 or merely a structural expression of the guide.
- “soft motion control features … provides tactile feedback” which can become a functional limitation:
- the structure must correspond to tactile “feedback” during the slider travel from first to second position.
- “controls axial movement of the elongated sheath along the axis”
- this is a mechanism requirement tied to the slider motion and the sheath’s axial movement.
- Curved surface abutment:
- infringement will likely turn on whether “curved distal surface” abuts “curved surface” under adjacent conditions as claimed.
- “one or more alignment surfaces … mechanically complement”
- mechanical complement suggests fit or mating geometry rather than simply “close proximity.”
Commercial implications of the claim set
US 10,028,858 is not a broad “any IUD insertion device” claim. It is an apparatus claim that locks onto a particular control path: proximal channel guides + coupled slider motion + tactile soft motion events + string control linkage, with dependent constraints covering string locking, sheath geometry, and optionally hormone-releasing IUD structures.
If a competitor’s insertion device already includes tactile “steps” during insertion or withdrawal, and uses slider-driven sheath movement through recessed guides, this patent is likely to be a high-read-risk.
Key Takeaways
- US 10,028,858 claims a specific mechanical IUD insertion architecture: a distal-loaded IUD in an elongated sheath actuated by a moveable sheath slider traveling in channels/elongated guides on a proximal user interface.
- Claim 1 requires tactile “soft motion” control features in the guide system that provide feedback at defined first-to-second slider positions tied to soft-motion locations.
- The patent’s strongest infringement hooks are the channelized slider control of sheath axial movement and the curved abutting relationship between the sheath slider and string control slider.
- Dependent claims add narrowing features for guide geometry, alignment surfaces, telescopic overlap, string locking mechanisms, and distal sheath tip/dimensions, plus optional audible/visible/tactile feedback.
- Claims 24–26 extend coverage to hormone-releasing IUD constructions with a polymeric reservoir around a core, framing potential additional risk when the product includes the hormone reservoir design.
FAQs
1) Is the tactile “soft motion” feedback required for infringement of claim 1?
Yes. Claim 1 includes “soft motion control features” in the elongated guides that provide tactile feedback when the moveable sheath slider moves between two positions corresponding to a soft motion location.
2) What is the single most differentiating feature in claim 1 versus generic IUD inserters?
The combination of proximal user interface channels, a moveable sheath slider traveling in those channels to control axial sheath movement, coupled with tactile soft motion events tied to slider travel positions.
3) Does the patent require a specific string locking mechanism?
Claim 1 does not specify locking types. Dependent claims 15–17 introduce string locking features such as cleft/clamp/wedge/pincher/spring/teeth, with an example movable-member cleft unlock embodiment.
4) Do claims cover hormone-releasing IUDs?
Yes, through dependent claims 24–26, which recite a polymeric reservoir around an IUD core containing a hormone used for menopausal troubles treatment or contraception.
5) What design-around options are most consistent with the claim structure?
The most direct design-around is to change one or more required claim-1 elements: remove the channelized guide/slider axial drive structure, eliminate the soft motion tactile feedback features, or redesign the string control coupling so it does not meet the curved abutting slider interaction.
References
[1] US Patent 10,028,858.
