Details for Patent: 7,951,130

Summary for Patent: 7,951,130

Title:	Sinus delivery of sustained release therapeutics
Abstract:	The invention provides biodegradable implants for treating sinusitis. The biodegradable implants have a size, shape, density, viscosity, and/or mucoadhesiveness that prevents them from being substantially cleared by the mucociliary lining of the sinuses during the intended treatment period. The biodegradable implants include a sustained release therapeutic, e.g., an antibiotic, a steroidal anti-inflammatory agent, or both. The biodegradable implants may take various forms, such as rods, pellets, beads, strips, or microparticles, and may be delivered into a sinus in various pharmaceutically acceptable carriers.
Inventor(s):	Donald J. Eaton, Mary L. Moran, Rodney A. Brenneman
Assignee:	Intersect ENT Inc
Application Number:	US12/883,059
Patent Claim Types: see list of patent claims	Use; Delivery; Device;

US Patent 7,951,130: Scope, Claims Map, and US Patent Landscape for Paranasal Sinus Drug-Releasing Implant Delivery

What does US 7,951,130 claim in plain scope terms?

US 7,951,130 claims a procedure for placing drug-releasing implants into a paranasal sinus cavity using an insertion conduit and visualization, then deploying the implants through an opening at the distal end (or side opening) of that conduit. The claims are written to capture a broad set of implant formats and drug modalities (including anti-inflammatory corticosteroids), and a broad set of delivery geometries (ostium vs wall access; sharp-tipped and angulated conduits; pusher and pressurized gas delivery).

The independent claim is directed to:

• a) loading one or more drug-releasing implants into a conduit with a distal portion;
• b) creating access to the paranasal sinus cavity with the loaded conduit, advancing at least part of the conduit into the cavity using a visualization technique; and
• c) delivering the implants through an opening in the distal portion into the sinus cavity; where the implants contain a therapeutic amount of an active agent for sinusitis.

Claim set theme: “implant delivery system geometry + visualization-guided access + distal deployment through an opening,” with active agent and implant formulation variations as claim-dependent scope.

Claim-by-claim scope: what is actually covered?

Below is a structured breakdown of the provided claims (1–41) into reusable claim “elements” and the added claim limitations. This is the core lens for non-infringement and design-around (what must be present in the accused process).

Core independent scope (Claim 1)

Method for delivering a drug-releasing implant into a paranasal sinus cavity with:

1. Conduit loading: load one or more drug-releasing implants into a conduit with a distal portion (Claim 1 element a).
2. Visualization-guided access and advancement: create access to the sinus cavity such that at least part of the loaded conduit is advanced into the paranasal sinus cavity using a visualization technique (Claim 1 element b).
3. Distal deployment through an opening: deliver the implants through an opening in the distal portion of the conduit (Claim 1 element c).
4. Therapeutic drug content: implants comprise a therapeutic amount of an active agent for treatment of sinusitis.

Claim 2–3: Access route variants

• Claim 2: delivered through a sinus ostium.
• Claim 3: delivered through a sinus wall.

These two dependent claims establish the patent’s coverage does not hinge on one access pathway. Both routes are explicitly claimed.

Claim 4: Conduit-carried implant diameter (format constraint)

• Claim 4: implant has diameter about 5 mm while in the conduit.

Claim 5–6: Delivery mechanism

• Claim 5: delivering the implant comprises using a pusher.
• Claim 6: delivering the implant comprises using pressurized gas.

These cover multiple mechanical deployment modes through the distal opening.

Claim 7: Biodegradable implant

• Claim 7: biodegradable polymeric implant.

Claim 8–12: Conduit distal geometry

• Claim 8: conduit is sharp-tipped.
• Claim 9: distal portion is angulated.
• Claim 10: angulated at angle between 0° and 135°.
• Claim 11: distal opening located at tip of conduit.
• Claim 12: distal opening located in side wall of conduit.

These are the main “hardware geometry” limitations; they control whether a competitor’s insertion tool with different distal architecture can avoid coverage.

Claim 13: Fracture-line implant

• Claim 13: implant has predetermined fracture lines.

Claims 14–18: Anti-inflammatory corticosteroid coverage

• Claim 14: active agent is an anti-inflammatory active agent.
• Claim 15: mometasone furoate.
• Claim 16: budesonide.
• Claim 17: fluticasone propionate.
• Claim 18: triamcinolone acetonide.

This is a direct drug-content claim subset. If an accused implant uses any of these corticosteroids as the active agent (within “therapeutic amount” in the claims’ formulation), they land squarely within these dependent claim scopes.

Claims 19–20: Visualization technique options

• Claim 19: visualization technique comprises endoscopy.
• Claim 20: visualization technique comprises computer image-guidance.

The independent claim requires visualization but does not limit which visualization method; the dependent claims show examples.

Claims 21–27: Biodegradable matrix and polymer specificity

• Claim 21: implant comprises biodegradable matrix.
• Claim 22: biodegradable polymer matrix.
• Claim 23: matrix comprises mucoadhesive polymer.
• Claim 24: matrix comprises PLGA copolymer (poly(lactic-co-glycolic) acid).
• Claims 25–26: lactic acid and glycolic acid components are recited. (These provide tighter fallback positions tied to typical implant polymers and excipients.)

Claims 27–30: Release-duration bands

• Claim 27: release period about 1 week to 3 months.
• Claim 28: about 2 weeks to 4 weeks.
• Claim 29: at least 1 week.
• Claim 30: at least 2 weeks.

These claim bands may capture “sustained-release” products across a wide window.

Claims 31–37: Active loading and implant size ranges

• Claim 31: active agent amount between 5% and 90% by weight of implant.
• Claim 32: implant is rod, pellet, bead, strip, or microparticle.
• Claim 33: implant comprises gel.
• Claim 34: implant comprises a semi-solid.
• Claim 35: implant diameter less than about 5 mm while in conduit.
• Claim 36: implant diameter about 2 mm while in conduit.
• Claim 37: implant diameter between 0.05 mm and 5 mm while in conduit.

These expand format coverage while maintaining device loading constraints.

Claim 38: Hyaluronic acid

• Claim 38: implant comprises hyaluronic acid.

This is another explicit polymer/biomaterial limitation.

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Are there multiple independent claims, and what do they change?

Yes. The patent includes additional method claims (39–41) that duplicate the procedural “conduit loading + visualization + distal delivery through opening” structure, then change the claimed indication.

Claim 39 (duplicate procedure; sinusitis treatment wording)

A method with the same delivery architecture, where implants contain therapeutic amount for treatment of sinusitis.

Claim 40 (duplicate procedure; inflammation reduction wording)

Same delivery architecture, where implants contain therapeutic amount for reduction of inflammation.

Claim 41 (duplicate procedure; inflammation reduction wording; visualization explicitly recited)

Same architecture with an explicit “while using a visualization technique” step and active agent for reduction of inflammation.

Business implication: the method scope for delivery is the same across sinusitis and inflammation reduction. Changing the claimed disease framing does not reduce the device/process limitations.

What is the patent’s “infringement-critical” claim structure?

For any accused method, the analysis should focus on these non-negotiable elements that appear across the independent method claims:

1. Conduit-based loading and advancement into sinus cavity

   • implants loaded into a conduit with a distal portion
   • conduit advanced into the paranasal sinus cavity

2. Visualization technique

   • endoscopy and computer image-guidance are claimed as examples

3. Distal opening deployment

   • implants delivered through an opening in the distal portion
   • opening is either at tip or side wall (dependent coverage)

4. Therapeutic implant drug content

   • therapeutic amount for sinusitis or reduction of inflammation

Once these are matched, many dependent claims add further scope but are not strictly necessary to fall within the broad independent method.

Where is the likely patent “center of gravity” for freedom-to-operate?

This set is built as a delivery-method patent, not a standalone “implant composition” patent. Practically, the center of gravity is:

• delivery method: conduit geometry + distal opening + visualization-guided access + deployment into sinus
• drug class and formulation: corticosteroid anti-inflammatory agents; biodegradable polymer matrices; sustained release windows; mucoadhesive polymers; PLGA; optional hyaluronic acid

A competitor can reduce risk by altering the process steps (e.g., avoid visualization-guided advancement as claimed, or avoid distal opening deployment into a sinus cavity using the claimed conduit structure). Alternatively, modifying implant composition alone is usually insufficient if the method still meets the delivery architecture.

How broad are the claim ranges that affect design and product development?

Key quantitative and structural ranges embedded in the claims:

• Conduit-deployed implant diameter:
  • “about 5 mm while in the conduit” (Claim 4)
  • “less than about 5 mm” (Claim 35)
  • “about 2 mm while in the conduit” (Claim 36)
  • “0.05 mm to 5 mm while in the conduit” (Claim 37)
• Conduit distal angle: 0° to 135° if angulated (Claim 10)
• Active loading content by weight: 5% to 90% (Claim 31)
• Release duration:
  • 1 week to 3 months (Claim 27)
  • 2 weeks to 4 weeks (Claim 28)
  • at least 1 week (Claim 29)
  • at least 2 weeks (Claim 30)

These are broad enough to cover many typical drug-eluting and sustained-release implant formulations.

What is the US patent landscape around this type of claim (method plus sinus implant delivery)?

A complete, citation-backed landscape requires reviewing the full bibliographic record, family members, prosecution history, and forward citation graph for US 7,951,130. The provided prompt includes the claims text only. Without the underlying patent metadata (assignee, filing dates, publication numbers, priority claims, and citations), a fully accurate landscape cannot be produced.

Accordingly, this analysis limits to a claim-based landscape mapping: which technical design features most often correlate with other patent clusters that competitors will also target in US filings.

Landscape clusters that overlap this claim set

1. Sinus drug-eluting implant placements
   • implant formats (rod/pellet/bead/strip/microparticle/gel/semi-solid)
   • sustained release periods from about 1 week to multiple months
2. Visualization-guided endoscopic sinus delivery
   • endoscopy and image guidance
   • ostium and/or wall access routes
3. Delivery instruments with distal openings
   • sharp-tipped and angulated distal portions
   • tip opening vs side-wall opening
   • push deployment vs gas-assisted expulsion
4. Biodegradable and mucoadhesive polymer matrices
   • PLGA copolymer, lactic/glycolic components
   • mucoadhesive polymer layer or matrix
   • optional hyaluronic acid inclusion
5. Anti-inflammatory steroid active agents
   • mometasone furoate, budesonide, fluticasone propionate, triamcinolone acetonide

Likely competitive design-around levers (claim-element level)

For a competitor trying to avoid this specific method claim architecture, the strongest levers are at the step level:

• Change distal deployment architecture: use delivery that does not require “delivering through an opening in the distal portion of the conduit into the paranasal sinus cavity” in the claimed way.
• Change the guidance method requirement: if a process avoids the claimed “visualization technique” requirement as recited in the independent claims, risk changes sharply.
• Change the implant-carried geometry constraints: while diameter ranges are broad, a design that avoids the “while in the conduit” geometry plus other limitations could help.
• Change active indication framing alone is usually not enough: claims tie to sinusitis or inflammation reduction. Switching to a non-inflammation indication does not necessarily avoid if the method still uses therapeutic anti-inflammatory delivery in practice.

Key Takeaways

• US 7,951,130 is a visualization-guided, conduit-based method for delivering drug-releasing implants into a paranasal sinus cavity, with deployment through a distal opening.
• The claim structure makes hardware/process steps more determinative than drug formulation alone: conduit loading + advancement into the sinus + distal opening deployment + therapeutic implant content.
• Dependent claims expand scope across:
  • access route (ostium vs sinus wall),
  • deployment mechanisms (pusher vs pressurized gas),
  • distal conduit geometry (sharp tip, angulated distal section, tip opening vs side opening),
  • implant formats (rod/pellet/bead/strip/microparticle/gel/semi-solid),
  • sustained release duration (about 1 week to 3 months; multiple sub-bands),
  • anti-inflammatory corticosteroids (mometasone furoate, budesonide, fluticasone propionate, triamcinolone acetonide),
  • biodegradable matrix and polymer features (PLGA, mucoadhesive polymer),
  • optional hyaluronic acid inclusion.

FAQs

1. Is US 7,951,130 limited to endoscopy only?
No. Endoscopy (Claim 19) and computer image-guidance (Claim 20) are recited as visualization techniques, but the independent method requires “a visualization technique,” not only endoscopy.

2. Does the patent require that implants be biodegradable?
No. Biodegradable polymeric implant is claimed in a dependent claim (Claim 7), not in the independent claim.

3. Can the delivery open be located at the tip or side of the conduit?
Yes. A tip opening is claimed (Claim 11) and a side wall opening is claimed (Claim 12).

4. Are ostium and sinus-wall routes both covered?
Yes. Delivering through a sinus ostium is covered (Claim 2), as is delivering through a sinus wall (Claim 3).

5. Which steroid actives are explicitly claimed as anti-inflammatory agents?
The claims list mometasone furoate (Claim 15), budesonide (Claim 16), fluticasone propionate (Claim 17), and triamcinolone acetonide (Claim 18).

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References

[1] Provided claims text for US Patent 7,951,130 (user prompt).

Drugs Protected by US Patent 7,951,130

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

International Family Members for US Patent 7,951,130

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2004222340
Canada	2518960
European Patent Office	1605863
European Patent Office	3103422
Japan	2006520786