Silicone Elastomer Compliance Patents: Leaders & Trends 2026
- Device claims dominate the corpus. A61B and A61M together account for over 800 of the 1,299 records, meaning most compliance activity is filed around device integration, not raw material formulation.
- Filing growth is flat, not rising. Activity moved from 43 filings in 2017 to a 2025 peak of 99, but the 2022 midpoint of 35 shows the growth was uneven rather than steady.
- Informatics and testing are barely claimed. G16H (healthcare informatics) sits at just 49 records and G01N (material testing) at 102, the two thinnest branches in an otherwise dense field.
Filing growth compares 2021 (40 records) with 2024 (73) — a three-year span. 2024 is the most recent year we treat as complete: publication lags filing by roughly 18 months, so 2025 onwards are still filling in and any growth rate that ends there would understate the field. Top-5 share is the combined record count of the five largest assignees divided by all 1,299 records in scope (CR5), not by the ranked leaders only.
A device-centric compliance landscape
Silicone elastomer safety and compliance patents in this corpus sit overwhelmingly inside device claims rather than material-formulation claims. Records classified under A61B (diagnosis and surgery) and A61M (devices for body fluids) together make up the largest share of the 1,299 tracked families, and the most-cited records in the dataset are catheter, electrode-array and vessel-patch patents rather than raw silicone composition patents.
That concentration matters for anyone drafting new claims: occupied device space means differentiation has to come from a specific compliance step, manufacturing process, or integration detail, not from the base material alone. The thinner branches — healthcare informatics and material testing — show where compliance-adjacent claim space has not yet been fully staked out.
Let an AI agent run this analysis on your own technology
Pick a task. Every answer cites the patents behind it.
Filing trends and technology composition
The filing curve and IPC spread below chart where silicone elastomer compliance activity has concentrated since 2017, and which device classes are absorbing the bulk of new claims.
Filing activity, 2017-2026
Filings rose from 43 in 2017 to a peak of 99 in 2025, with 2022 sitting at 35 as a rough midpoint. The 2026 figure of 19 is a partial year and understates true activity, since publication typically lags filing by around 18 months.
Technology composition by IPC subclass
A61B (diagnosis and surgery) and A61M (devices for body fluids) dominate the corpus at 503 and 315 records respectively, with A61F (implants and prostheses) close behind at 296. Healthcare informatics (G16H, 49) and material testing (G01N, 102) sit far smaller, marking the least-claimed corners of this technology space.
Shares are the percentage of the 1,299 records in scope. A patent can carry several IPC classes, so the shares add up to more than 100%.
Go deeper on Silicone Elastomer Safety and Compliance with Eureka
This page is one run against one query. Ask Eureka your own question about silicone elastomer safety and compliance and every answer comes back with the patent numbers behind it.
Try EurekaA representative filing and the citation leaders
Elastomeric Tube and Method of Making Same
Two medical-grade silicone rubber compositions with differing physical properties but similar curing conditions are coaxially coextruded to form a tube. The compositions blend at a shared interface during coextrusion, forming a gradient covering between 1 and 99 percent of the tube, which is then cured.Filed by ST. JUDE MEDICAL AB, published 2008-07-31.
| # | Publication no. | Patent title | Citations |
|---|---|---|---|
| 1 | US6482217B1 | Neuro thrombectomy catheter | 1,593 |
| 2 | US4573481A | Implantable electrode array | 1,431 |
| 3 | US5104400A | Blood vessel patch | 1,156 |
| 4 | US5100422A | Blood vessel patch | 965 |
| 5 | US7479147B2 | Rotational atherectomy device | 802 |
| 6 | US5011469A | Peripheral cardiopulmonary bypass and coronary reperfusion system | 712 |
| 7 | US6402689B1 | Methods, systems, and associated implantable devices for dynamic monitoring of physiological and biological p… | 608 |
| 8 | US4559951A | Catheter assembly | 551 |
| 9 | US4920979A | Bidirectional helical electrode for nerve stimulation | 546 |
| 10 | US3727616A | Electronic system for the stimulation of biological systems | 526 |
Citation counts reflect age as much as importance; older device patents accumulate citations simply by being in the corpus longer.
Each row carries its publication number; clicking a row searches Eureka by that number.
Put your own technology through the same analysis
Eureka on the web
When you want the answer in the next five minutes.
The agent works the prompt against patents and technical literature, citing every source.
Run your analysis now →MCP server & REST API
When it has to run inside your own pipeline.
Patent search, landscape analysis and assignee resolution as MCP tools. Drop them into any agent framework, or call REST directly.
Browse MCP servers →What the filing pattern signals
Reading the IPC spread and citation data together shows a field where device integration has absorbed most of the claim space, leaving formulation and compliance-verification work comparatively open.
Growth is episodic, not sustained
The climb from 43 filings in 2017 to a 2025 peak of 99 was not linear; the 2022 midpoint of 35 shows a plateau in the middle of the period. That pattern is more consistent with periodic product-cycle filing surges than with a technology in continuous expansion.
Device classes carry the claim density
A61B and A61M together hold well over half the corpus, meaning most new entrants will be filing directly into diagnosis, surgery, and body-fluid device space rather than open material-composition territory.
Old catheter patents still set the boundaries
The most-cited records in this dataset are catheter and electrode-array patents from well before the current filing window, meaning today's claim drafting still has to work around foundational device geometry patents rather than recent material claims.
Informatics-linked silicone is thin
Healthcare informatics tied to silicone devices is the smallest IPC branch in the dataset, well behind even material testing at 102 records, pointing to a genuine gap rather than a saturated niche.
Eureka can read the same corpus for gaps instead of for coverage: under-claimed branches adjacent to silicone elastomer safety and compliance, with the prior art for and against each one.
| Assignee | Co-assignee | Shared families |
|---|---|---|
| North Carolina State University | Cizzle Technologies, Inc. | 39 |
| Massachusetts Institute of Technology | Children's Medical Center Corporation | 18 |
| Massachusetts Institute of Technology | Mayo Foundation for Medical Education and Research | 14 |
| Northwestern University | Rehabilitation Institute of Chicago | 7 |
| Northwestern University | The Board of Trustees of the University of Illinois | 7 |
| Gauss Surgical, Inc. | ZHAO CHARLES | 2 |
| Gauss Surgical, Inc. | ZANDIFAR ALI | 2 |
| Gauss Surgical, Inc. | SATISH SIDDARTH | 2 |
The dataset records 10 co-assignee pairs, with the strongest pairing appearing 39 times, well ahead of the next two pairings at 18 and 14 — a sign that a small number of university-industry partnerships account for a disproportionate share of joint filings.
Who is filing, and where the activity has gone quiet
Citation depth and co-assignee clustering point to a small set of university and device-company pairings that dominate historical filing, but recent-year momentum data shows most named holders with no new filings in the latest year.
Historical device patents still anchor the field
The highest-cited records in this corpus — a thrombectomy catheter and an implantable electrode array — predate most of the current filing window, meaning current claim drafting still has to account for foundational geometry and material-interface patents rather than recent filings.
A small set of partnerships drive joint filing
Of 10 recorded co-assignee pairs, the strongest appears 39 times, well ahead of the next two pairings at 18 and 14, showing that joint university-industry filing in this space is concentrated rather than broadly distributed.
Named leaders show no recent filings
Several institutions with strong historical presence in this corpus recorded zero filings in the most recent year tracked, suggesting their influence sits in past citation weight rather than active current claiming.
| Assignee | Recent year | YoY |
|---|---|---|
| Gauss Surgical, Inc. | 0 | — |
| InnoMed One, LLC | 0 | — |
| Rutgers University | 0 | — |
| North Carolina State University | 0 | — |
| Cizzle Technologies, Inc. | 0 | — |
| Massachusetts Institute of Technology | 0 | — |
| Ossur Iceland ehf | 0 | -100% |
| iCu Medical, Inc. | 0 | — |
Where to take this analysis
The filing data points to specific next steps depending on whether the goal is freedom-to-operate, whitespace filing, or competitor tracking.
Check claim conflicts before filing
With A61B and A61M carrying the bulk of this corpus, a new device-integration filing should be checked against the highest-cited records first, since those set the boundaries other filers already draft around.
Run a claim-conflict searchTrack the quiet historical leaders
Several institutions with strong citation weight show zero filings in the latest year; confirming whether that reflects assignment changes, licensing, or genuine inactivity affects any competitive read of this space.
Monitor assignee activityScope a filing in the thin branches
Healthcare informatics and material-testing classes remain the least-claimed parts of this corpus, making them a reasonable starting point for a first-claim search before committing to a filing strategy.
Explore white space in EurekaFrequently asked questions
In this dataset, medical-grade and food-grade silicone claims are defined by compliance-oriented language tied to biocompatibility, sterilisation compatibility, or contact-safety testing rather than by a single formulation standard. Filings under A61L (sterilising and disinfecting, 129 records) and A61K (medicinal preparations, 168 records) typically specify a compliance pathway alongside the material composition. Practically, a claim in this space needs to tie the elastomer to a specific compliance step or test method to be defensible, since generic silicone rubber composition claims alone face dense prior art.
The corpus shows filing activity concentrated among a mix of universities and specialty medical device firms, several of which appear in strong co-assignee pairs such as a materials-focused university paired with a device company. However, recent-year momentum data shows multiple previously active holders recording zero filings in the latest year, which suggests the field's historical leaders are not necessarily its current filers. A freedom-to-operate check should look at both citation depth and recent filing activity separately, since they tell different stories here.
Filing activity peaked in 2025 at 99 records after rising from 43 in 2017, but the trend between those points was flat rather than steadily climbing, with 2022 sitting at only 35. The 2026 figure of 19 looks like a sharp drop, but that year is only partially captured in this dataset and publication lag of roughly 18 months means recent filings are undercounted. Overall the pattern reads as a mature field with periodic filing surges rather than sustained exponential growth.
The smallest IPC branches in this corpus are healthcare informatics (G16H, 49 records) and material analysis and testing (G01N, 102 records), both far behind the device-heavy classes like A61B and A61M. This suggests compliance-verification technology and sensor-integrated silicone applications are comparatively under-claimed. A first filing there would be strongest if it ties a specific silicone construction to a defined monitoring or verification function, rather than claiming the material or the sensing concept separately.
This ST. JUDE MEDICAL AB filing claims a coextrusion method for producing gradient silicone tubing from two medical-grade compositions, with a blend zone covering between 1 and 99 percent of the tube. That range is wide enough to cover most practical multi-durometer tube designs made by coextrusion, so it functions as a real checkpoint for anyone developing similar catheter or tubing products. New entrants building comparable structures should look closely at curing-condition compatibility and non-coextrusion manufacturing routes as potential design-around paths.
Research Silicone Elastomer Safety and Compliance in depth with Eureka
Go past this page: query the whole silicone elastomer safety and compliance corpus yourself, in your own scope.
Every answer comes back with patent numbers you can open.
Disclaimer. This page is generated from Patsnap Eureka data drawn from a limited snapshot of global patent and scientific-literature records, and is provided for general information and reference only.
Patent data carries inherent limitations: recent filings (typically the most recent 18–24 months) are under-counted due to standard publication lag; counts may be reported at either a patent-family or a patent-record basis and are not always directly comparable; classification, applicant-name, and citation data may contain errors, duplicates, or omissions; and the underlying search query defines and constrains the scope shown. As a result, the analysis may be incomplete or inaccurate and may not reflect the full technology landscape.
Nothing on this page constitutes an exhaustive prior-art, novelty, freedom-to-operate, or validity search, nor does it constitute legal, financial, investment, or professional advice, and it should not be relied upon as such. Any patent, commercial, or strategic decision should be verified independently and reviewed with qualified patent, legal, and domain professionals. Patsnap makes no warranties, express or implied, as to the accuracy, completeness, or fitness for any particular purpose of the information presented.
Machine translation. Assignee and organisation names originally recorded in Chinese, Japanese or Korean have been rendered into English by an AI translation step so that the tables stay readable. These renderings are best-effort and may not match a company’s registered English name; the original name is what the underlying patent record carries, and it is what any Eureka query launched from this page uses.