Scope and Claim-Chart Analysis of U.S. Patent 8,562,564 (Jet Injector with Glass Prefilled Syringe, Flange Support Cushion, and 80–1000 psi Pressure Window)
Executive summary. U.S. Patent 8,562,564 is directed to a one-use, prefilled glass syringe used with a hand-injected jet device, where the syringe is supported primarily via a radial flange and a resilient cushion that (i) accommodates flange irregularities and (ii) absorbs shock to prevent flange breakage during jetting. The independent claims center on an energy source producing an injecting pressure maintained between about 80 psi and 1000 psi (with narrower dependent claim pressure windows), and a jet-injection mechanism that drives medicament through a needle at a controlled penetration depth (about 0.5 mm to 5 mm). Claim scope is structurally tethered to (a) glass syringe/flange/hub configuration and (b) how the syringe is supported axially during injection (distal portion “substantially unsupported axially”). The likely competitive design-around surface is high: alternative support architectures, non-glass syringe materials, different pressure ranges, different penetration depth strategies, and different cushioning interfaces can fall outside key claim limitations.
Note: This analysis is limited to the claim text provided and the patent number requested; it does not include external registry verification of the patent family, prosecution history, or Orange Book/device listings because those inputs were not provided.
What does U.S. Patent 8,562,564 claim for jet injectors using glass prefilled syringes and flange cushions?
Short answer (independent claim core). The patent claims a jet injector comprising:
- a syringe support that supports a syringe by a radial flange,
- a syringe that is a glass prefilled syringe with a hand-graspable flange and a needle defining a fluid pathway,
- an energy source that biases a plunger to maintain injecting pressure between about 80 psi and 1000 psi during jet injection, and
- a resilient cushion associated with the syringe support that compensates for flange shape irregularities and absorbs shock to protect the flange from breaking.
How the claims define the syringe: structure, materials, and needle interface
The claim set repeatedly requires or implies a specific syringe architecture:
Syringe body and chamber
- Syringe wall defines container portion and fluid chamber holding the medicament.
- Plunger movable within the chamber to expel the medicament.
Flange
- Flange extends radially from the syringe wall.
- Shaped for grasping for injection by hand when used independently.
- Dependent limitations narrow flange location and support geometry (proximal portion vs unitary flange with wall).
Needle
- Needle disposed at the distal end.
- Needle includes injection tip that pierces an insertion location.
- Needle defines a fluid pathway in fluid communication with the chamber.
Glass constraints
- Claims explicitly recite unitary glass construction for:
- the syringe body (“unitary construction made of glass”),
- optionally flange and wall being unitary,
- optional “blown glass” specificity.
- Claim 7 adds a needle hub adhered to the needle with unitary construction with the wall.
Material/design-around pressure point.
- Any syringe that is not “made of glass” (or not “blown glass” where required by dependent claims) can avoid at least those dependent claim limitations. For independent claim 1, glass is not explicitly required in the base text you provided; however, the dependent claim chain makes “glass” a major enforcement target.
How the claims define the jet injection: pressure window, penetration depth, and “injection-assisting needle”
Injecting pressure (key numeric limitation)
- Independent claim 1: injecting pressure maintained between ~80 psi and 1000 psi during injection.
- Dependent claims provide narrower windows:
- Claim 14: above ~90 psi and below ~500 psi.
- Claim 15: between ~100 psi and 350 psi.
Penetration depth (key numeric limitation)
- Claim 16 adds a housing/ram configuration and defines insertion/penetration:
- needle penetration depth between ~0.5 mm and 5 mm below the insertion surface.
- The claim ties this to a remote delivery concept:
- energy source and ram produce injecting pressure sufficient for ejecting medicament with sufficient velocity for delivery remote from the penetration depth by jet injection.
“Injection-assisting needle” strategy
- Claim 13 and Claim 27 both frame the needle as enabling jetting rather than deep mechanical delivery:
- needle is used in the device as an injection-assisting needle where depth is small and delivery is achieved via the jet.
Design-around pressure surface
- Devices using a pressure outside 80–1000 psi (or outside the asserted narrower windows in dependent-claim land) can be non-infringing against those claims.
- Systems that use substantially greater needle penetration depths (or deliver primarily by needle-bore aspiration rather than “remote from penetration depth” jetting) can avoid the penetration-depth and “injection-assisting needle” limitations.
What role does the flange-based syringe support and resilient cushion play in patent scope?
Short answer. The cushion is a claim differentiator: it is “sufficiently resilient,” compensates for shape irregularities of the flange, and absorbs shock to protect the flange from breaking during jet injection.
Support geometry: distal portion “substantially unsupported axially”
Claims 3–5 and 8 tightly constrain how the syringe is held during injection:
- Claim 3: injector supports syringe only from the proximal portion such that the distal portion is substantially unsupported axially.
- Claim 4: injector supports syringe substantially only from the flange via support and cushion so the distal portion is substantially unsupported axially.
- Claim 5: support and cushion configured for supporting substantially only the flange such that distal portion is substantially unsupported axially.
- Claim 8: support and cushion entirely supporting the syringe from the flange with distal portion substantially unsupported axially.
Enforcement leverage.
- If an accused device supports the syringe axially elsewhere (for example, via a distal barrel clamp, sleeve contact along the syringe wall, or a multi-point axial support), it can argue non-infringement of flange-only support claims.
Cushion interface: sleeve, flange portion, and axial abutment
- Claim 9: syringe support comprises a sleeve receiving syringe wall axially, while cushion has a flange portion extending radially interfacing axially between flange and sleeve to compensate irregularities and absorb shock.
- Claim 11: cushion comprises axially elevated portions for abutting the flange.
- Claim 12: cushion resilient material is elastomeric.
Design-around surface.
- Cushion material type (non-elastomeric), cushion geometry (no axially elevated portions, no radial flange-interfacing portion as claimed), or support interface changes can avoid dependent claim limitations.
- Independent claim coverage (from your text) is broad enough to capture non-elastomeric resilient materials only if they still meet the “sufficiently resilient” function described, but the dependent claim ladder narrows to elastomerics and specific structures.
When does the patent require 80–1000 psi injecting pressure, and how do the narrower windows change risk?
Short answer. The pressure window is an absolute numeric boundary in the independent claim (80–1000 psi) and a key narrowing element in dependent claims (above 90 and below 500; 100–350).
Pressure windows embedded in claim text
| Claim |
Injecting pressure limitation (maintained during injection) |
Risk implication |
| 1 |
about 80 psi to 1000 psi |
Primary infringement anchor for core jetting energy |
| 14 |
above about 90 psi and below about 500 psi |
Narrower “middle-range” target; design choices outside this may avoid |
| 15 |
about 100 psi to 350 psi |
Smaller numeric zone; easier to design around by moving pressure higher or lower |
Interpretive note tied to your provided language. The claims state the injecting pressure is “maintained” within the window “during injection.” A device that spikes above the range briefly without sustained “maintained” pressure can argue non-infringement against those claims, but the literal outcome depends on pressure-time profiles.
How pressure interacts with jetting velocity and remote delivery
Claim 16 further links pressure and velocity to delivery “remote from the penetration depth” using a jet.
What about needle penetration depth (0.5 mm to 5 mm): how strong is that limitation for jet injection exclusivity?
Short answer. Penetration depth is a specific numeric limitation tied to a housing/ram configuration and remote delivery outcome.
Where penetration depth appears
- Claim 16: penetration depth between 0.5 mm and 5 mm below the surface, with housing enabling needle insertion and ram-driven plunger expelling medicament.
- Claim 27 repeats the same concept in the prefilled-syringe jet injector claim.
Design-around surfaces
- Devices using a needle that penetrates substantially deeper can reduce the chance of meeting this limitation.
- Devices achieving jet delivery without this small penetration-depth strategy can also avoid the claim pathway.
Which dependent claims add manufacturing and product-form constraints, and which are easiest to design around?
Glass unitary constructions and needle hub adhesion
Key dependent claims:
- Claim 6: flange is of unitary construction with the body; made of glass.
- Claim 7: needle hub is unitary with the wall; needle adhered to hub.
- Claim 10: syringe body is blown glass.
Easiest design-arounds (relative)
- Non-glass syringes.
- Non-unitary flange-body designs.
- Different needle hub construction or needle attachment method not matching “unitary construction” with wall and “adhered” relationship (depending on how a court interprets “adhered,” literal application may be contested).
Energy source embodiments: spring and bell portion geometry
- Claim 19: energy source comprises a spring; ram biased by spring; ram includes a bell portion seating spring; bell portion defines a hollow interior configured to receive prefilled syringe and syringe support when fired so the spring surrounds the prefilled syringe after firing.
Design-around surfaces
- Use of pneumatic, gas-actuated, or other energy sources not meeting “spring” limitation avoids those claims.
- Ram/spring geometry not surrounding the syringe after firing can reduce exposure.
Safety and guard mechanics
- Claim 18: retractable guard movable between protecting position (needle disposed within guard) and injecting position (tip exposed), with trigger mechanism activating energy source on guard retraction.
Design-around surfaces
- Fixed needle guard or different actuation sequence can avoid claim 18.
How does the independent claim set split between “jet injector” and “jet injector with a prefilled syringe”?
Short answer. Your text includes two independent structures:
- Claim 1: jet injector defined by syringe support, syringe (as described), energy source and pressure window, and cushion.
- Claim 21: a second independent claim where the syringe is explicitly a prefilled glass syringe with unitary glass syringe body, proximal flange, energy source pressure window, and cushion.
Key structural differences
| Feature |
Claim 1 (jet injector) |
Claim 21 (prefilled syringe variant) |
| Syringe material “glass” |
Not explicit in independent claim text you provided |
Explicit: syringe body of unitary construction made of glass |
| Flange location |
General radial flange extending from syringe wall |
Flange extends from proximal portion of syringe wall |
| Syringe support |
Supports syringe by radial flange |
Supports syringe body by flange (more explicit) |
| Cushion |
Compensate flange irregularities and absorb shock |
Same function, but tied to prefilled glass syringe |
Practical exposure conclusion.
- A commercial product that uses glass prefilled syringes with proximal hand-grasp flange and flange-based cushion support is exposed to both independent claim lines.
- A product using non-glass or different flange placement may avoid Claim 21 but still be at risk under Claim 1 depending on how “glass” is treated in that independent scope.
What is the patent’s likely competitive claim coverage against modern jet injectors and auto-injector designs?
Short answer. The patent is most aligned to the niche where jet injection is executed using a hand-graspable flange-mounted prefilled glass syringe held in a device sleeve with a shock-absorbing resilient cushion, while maintaining 80–1000 psi injecting pressure and sub-5 mm needle penetration.
Most exposed product architecture (from claim language)
- Prefilled glass syringe with integrated needle structure.
- Device clamps the syringe primarily via flange, leaving distal axial portion substantially unsupported.
- Cushion at flange interface absorbs shock and compensates for flange irregularities.
- Injection uses a ram/spring or similar energy source to maintain injecting pressure within the defined range.
Lower exposure architecture
- Needle-bore delivery where penetration depth is deeper and jetting remote delivery is not the mechanism.
- Non-glass syringes.
- Multi-point axial support of the syringe during injection.
Patent landscape framing for U.S. Patent 8,562,564: what claim categories will competitors target to avoid it?
This patent’s claim set is unusually organized around device mechanics (pressure window, penetration depth, flange-only support, shock-absorbing cushion) rather than drug-specific content. That shifts the landscape from “drug formulation” to platform device engineering.
High-probability design-around categories
- Pressure window: operate outside 80–1000 psi or avoid sustained maintenance within narrower dependent claim bands.
- Penetration depth: move beyond 0.5–5 mm “below surface” insertion depth.
- Support scheme: keep distal portion axially supported, or support syringe via wall/fixture beyond flange.
- Cushion interface: change cushion geometry/material to not meet resilient function as claimed or eliminate axial flange abutment features.
- Syringe material and construction: use polymer syringes, non-unitary flange-body designs, or avoid “blown glass” construction.
- Energy source mechanism: replace spring/ram configurations with gas or electromagnetic actuators, particularly where dependent claims require bell portion geometry and spring surrounding.
High-probability infringement categories
- Any product that literally uses a flange-mounted syringe supported by a shock-absorbing cushion and operates within the pressure and penetration depth windows.
Key Takeaways
- U.S. Patent 8,562,564 is a device-architecture patent anchored by injecting pressure maintained at 80–1000 psi and jet delivery with shallow needle penetration (0.5–5 mm).
- The most distinctive claim scope is flange-based syringe support plus a resilient cushion that absorbs jet shock and compensates for flange shape irregularities to prevent flange breakage.
- The claim ladder narrows strongly with glass prefilled syringe construction, unitary flange-body, and needle hub adhered to a unitary hub/wall, plus specific energy source geometry (spring/ram bell portion) and safety guard mechanics.
- The most likely competitive design-arounds are straightforward in principle: alter pressure profile, penetration depth, axial support scheme, syringe material, and/or cushion geometry/material.
FAQs
-
What pressure range in U.S. Patent 8,562,564 must be “maintained” for infringement?
80–1000 psi in independent claim 1; 90–500 psi (claim 14) and 100–350 psi (claim 15) in dependent claims, per the provided claim language.
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Does the patent require the needle to penetrate less than 5 mm into tissue?
Yes where the housing/ram and remote delivery limitations of claim 16 (and the parallel claim 27) are asserted: penetration depth is between 0.5 mm and 5 mm below the surface.
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Is flange-only support critical to the claim scope?
Yes for claims 3–5 and 8: they require the distal portion to be “substantially unsupported axially,” with support via proximal portion and/or substantially only the flange.
-
Is glass mandatory for infringement?
Glass is explicit in the prefilled-syringe independent claim 21 and in several dependent claims (claims 6, 7, 10, 24). Independent claim 1 in the text you provided does not explicitly require glass, but the claim set strongly targets glass syringe platforms.
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What components are most likely to drive non-infringement arguments?
The combination of (i) sustained pressure window, (ii) shallow penetration depth, (iii) flange-only axial support architecture, and (iv) glass/unitary construction plus cushion interface geometry.
References (APA)
No external sources were cited because the prompt did not include bibliographic or registry data beyond the requested patent number and claim text.
