United States Patent 10,232,152 (Claims 1-5): Implant Hub with Apertured Hub Filaments and Crimping Device Low-Profile Rotation Mechanism
Executive summary: US 10,232,152 protects an implant delivery and deployment system built around (i) a hub with through-apertures receiving filaments to form two legs that rotate toward a longitudinal axis using a specific crimping device geometry (housing recess plus radially extending channels), with (ii) a method of treating sinus conditions by advancing, delivering, expanding, and optionally crimping back to low-profile. Scope is centered on mechanical structure and movement constraints, not on the sinus condition itself or the implant’s material composition.
What does US 10,232,152 claim protect: hub-and-filament implant plus recess-and-channels crimping device?
Core claim structure (Claim 1). The patent’s protection is anchored to the interaction of two engineered subsystems:
- Implant architecture
- An implant with:
- A hub
- A plurality of filaments
- The hub has a plurality of apertures extending through the hub.
- Each filament is positioned in a corresponding aperture so that:
- It defines a first leg on one side of the hub
- And a second leg on the other side of the hub.
Meaning for scope: The “first leg/second leg” language requires a hub-through-aperture arrangement that yields two sides’ legs, which are not just “wires crossing a device” but legs mechanically linked to hub rotation/translation inside the crimping mechanism.
- Crimping device architecture and functional movement
- A crimping device with:
- A housing
- The housing has:
- A recess
- a plurality of channels radially extending from the recess
- A key functional relationship:
- Movement of the hub into the recess rotates the first and second legs toward a longitudinal axis.
- That rotation moves the implant to a low-profile configuration.
Meaning for scope: Claim 1 ties patentability to the specific geometric features (recess + radially extending channels) and a directional mechanical result (rotate legs toward longitudinal axis to reach low profile) achieved by hub movement into the recess.
Claim 1 scope boundary markers
- “Hub into the recess” is a structural-functional limitation. A different crimping mode that does not involve hub translation into a recess (for example, only actuator-driven filament compression without hub entry) falls outside literal claim language.
- “Channels radially extending from the recess” is not optional. A recess with axially aligned slots or circumferential grooves without radially extending channels changes the claim elements.
- “Rotates toward a longitudinal axis” requires rotation relative to the implant axis, not merely straightening or compressing without rotational repositioning.
How broad is Claim 1: which implant designs are covered and which are excluded?
Likely covered design space
The claim is broad enough to cover variations in:
- Number of filaments/apertures (plurality is open-ended in practice)
- Implant materials (claim text does not specify material)
- Condition treated (Claim 1 says “one or more conditions” with no sinus-specific restriction in the system claim)
- Delivery mechanics not expressly limited in Claim 1 (delivery device appears in Claim 3, but Claim 1 itself focuses on implant + crimping device)
Likely excluded or higher-risk designs
- Different hub mechanics
- If the hub does not have through-apertures that receive filaments in a way that creates two sides’ legs, the device likely does not meet the “plurality of apertures extending through the hub” element.
- Crimping without recess entry
- If crimping is performed by:
- filament-only compression,
- sleeve-only collapsing,
- or a mechanism that expands/crimps via lateral squeezing without hub movement into a recess,
then “movement of the hub into the recess rotates the legs” is not met.
- Channels not “radially extending from the recess”
- A housing with channels that extend axially from the recess or are not radially oriented likely does not satisfy the “radially extending” element.
What are the additional protected features in Claims 2 and 3?
Claim 2: Crimping member with arms relative to stem
Claim 2 adds a specific subcomponent:
- Crimping device further comprises:
- A crimping member
- The crimping member has:
- a stem portion
- a plurality of arms radially extending from the stem portion
- Movement:
- Movement of the stem portion into the recess rotates the arms relative to the stem portion.
Scope impact: Claim 2 narrows Claim 1 by adding an internal actuator-like “crimping member” with arms that rotate during insertion. This suggests the disclosed mechanism may convert axial insertion into rotational movement of arms to drive the hub/filament leg rotation.
Inference for design-around risk: A competitor could maintain Claim 1-free by using a housing recess and channels approach but with a different arm/stem rotation structure that does not use radially extending arms rotated by stem insertion.
Claim 3: Delivery device releasably coupling to the implant
Claim 3 adds:
- A delivery device configured to releasably couple to the implant.
Scope impact: This is a broad functional addition. It does not define delivery catheter structure, so it likely covers many standard medical delivery couplers (screw-fit, latch, friction-fit mechanisms) so long as the coupling is releasable.
What does Claim 4 protect: method for sinus conditions with low-profile to expanded configuration?
Claim 4 is a method claim with sinus-specific limitation:
- Treating one or more sinus conditions
- Steps:
- Advancing an implant to a location in:
- a sinus cavity,
- sinus ostium, or
- nasal passageway
- Implant has:
- hub + filaments + apertures generating first and second legs (same structural limitations as Claim 1)
- Delivering the implant
- Expanding the implant from a low-profile configuration to an expanded configuration
Scope impact: Claim 4 is not limited to using the specific crimping device from Claim 1, because it does not explicitly recite the crimping device steps. However, it requires the implant to be deliverable in low-profile and then expand.
Design-around angle: If an accused implant is not capable of expanding from a low-profile configuration at deployment, it may avoid Claim 4. If it does, then the main differentiation moves to whether the hub/filament/leg structure matches.
What does Claim 5 add: crimping back to low-profile after deployment?
Claim 5 depends on Claim 4:
- Further comprising crimping the implant to move the implant to the low-profile configuration.
Scope impact: Claim 5 explicitly requires a crimping step in the method chain after delivery/expansion as described in Claim 4. This increases risk for systems that require post-deployment crimping for repositioning, retrieval, or minimization for a subsequent step.
Potential conflict in timing: The claim wording does not specify when crimping occurs relative to expansion beyond it being “further comprising.” It therefore captures approaches where crimping occurs after expansion, including for repositioning or removal.
What is the likely technical center of gravity of US 10,232,152?
The claim set points to a mechanical system for converting between:
- low-profile configuration: legs rotated toward the longitudinal axis (hub inserted into recess; channels and optional arms provide rotational constraints)
- expanded configuration: legs in a deployed orientation (implied to be the “expanded” state)
This is consistent with an implant that can be collapsed for insertion through a sinus/nasal pathway and then expanded in situ.
How strong is the patent estate around these claims: what claim elements are hardest to reproduce?
The strength is primarily tied to element coupling:
- Through-apertured hub producing first/second legs
- This is a structural limitation. Competitors can design alternative attachment geometries, but doing so likely changes how legs behave under crimping.
- Specific crimping device geometry
- “Housing with a recess” plus “plurality of channels radially extending from the recess”
- These are tangible mechanical features.
- Movement relationship
- “Movement of the hub into the recess rotates the first and second legs toward a longitudinal axis”
- Functional language will be construed in view of claim context and spec. For design-arounds, accused devices must avoid both the structural elements and the functional “hub movement causes rotation toward axis to reach low profile.”
Claim 2 adds a further narrowing device substructure, which can matter in infringement disputes if litigants argue overlap or differences in actuator geometry.
Which companies and competitors are most exposed?
No dataset (Orange Book listings, litigation dockets, inventor/assignee portfolio mapping, competitor product identification, or USPTO/Delaware/EDTX/other case filings) is available in the provided prompt. Without those facts, naming specific entities would be speculative.
Orange Book status, FDA exclusivity, and regulatory pathway relevance
The prompt provides only the patent number and claim text. It does not provide:
- the drug/biologic name,
- the FDA application reference,
- the Orange Book listing status,
- the device classification (this reads like a surgical implant system, which may not have an Orange Book listing),
- or the relevant FDA approval history.
No definitive regulatory exclusivity analysis is possible from the provided information alone.
Patent landscape map for US 10,232,152: continuation risk, related families, and adjacent claim families
The provided prompt includes only claim text, not family members, priority applications, or citations. Without that, a complete landscape map cannot be produced without guessing.
What generic or biosimilar risk exists for US 10,232,152?
No therapeutic product identity is provided. If this patent covers a medical implant system rather than an approved drug substance composition, “generic/biosimilar” frameworks may not apply. The prompt does not supply the product category or FDA submission type.
Key takeaways
- US 10,232,152 claim coverage is centered on a mechanically specific system: hub-through apertures with filaments forming two legs, paired with a crimping housing that has a recess and radially extending channels to drive leg rotation toward the longitudinal axis into a low-profile configuration.
- Claim 2 narrows to a crimping member with stem + radially extending arms that rotate as the stem moves into the recess.
- Claim 3 broadly requires a releasable delivery coupling but does not limit delivery device structure.
- Claim 4 covers a method for sinus conditions: advancing and delivering an implant that expands from low-profile to expanded.
- Claim 5 adds a further step of crimping back to low-profile, raising exposure for systems that support post-deployment crimping for retrieval or repositioning.
FAQs
1) Does Claim 1 require the implant to treat sinus conditions?
No. Claim 1 recites “one or more conditions” and is not limited to sinus conditions. Sinus-specific treatment appears in Claim 4.
2) Is crimping device structure required for Claim 4?
Claim 4 requires advancing and delivering an implant and expanding it from low-profile to expanded. It does not explicitly recite the specific crimping device of Claim 1, but it still depends on the implant’s hub-and-filament leg structure and the existence of a low-profile configuration.
**3) What is the key limitation for design-around attempts?
The hardest-to-copy combination is the coupling of (i) through-apertured hub creating first/second legs and (ii) the crimping housing with recess and radially extending channels that achieve leg rotation toward the longitudinal axis by hub movement into the recess.
4) What additional mechanism does Claim 2 add beyond Claim 1?
Claim 2 requires a crimping member with a stem portion and radially extending arms, where stem movement into the recess rotates the arms relative to the stem.
5) Can an accused method infringe Claim 5 without using the same crimping device as Claim 1?
Claim 5 requires a crimping step to move the implant to low-profile, but the prompt does not include claim construction or spec. Literal infringement turns on whether the method satisfies the claim’s limitations, including how crimping is performed relative to the low-profile configuration defined by the implant’s structure and deployment mechanism.
References (APA)
- United States Patent No. 10,232,152. (n.d.). Claims 1-5 as provided.
