US 12239333

Here's a concise summary of US Patent 12239333:

• Title: Single insertion delivery system for treating embolism and associated systems and methods
• Assignee: Inari Medical Inc
• Inventors: Richard Quick, Benjamin Edward Merritt, John Coleman Thress, Paul Lubock, Thomas M. Tu
• Filing Date: October 30, 2023
• Issue Date: March 4, 2025
• Abstract: Systems and methods are disclosed for the intravascular treatment of clot material within a blood vessel of a human patient. A method can involve engaging an interventional device with clot material in a blood vessel and withdrawing both the device and a portion of the clot material through a guide catheter. The catheter system may include an attachment/valve member coupled to a proximal portion of the guide catheter. The method can further include unsealing this attachment/valve member to facilitate withdrawal of the interventional device without significant retention of clot material. The guide catheter can then be resealed and aspirated before advancing another interventional device to remove additional clot material.

Plain-Language Overview of Independent Claims:

Claim 1:
This claim describes a method for removing clot material from a patient's blood vessel. It involves:

1. Inserting a guide catheter into the blood vessel until its distal end is near the clot.
2. Advancing an interventional device through the guide catheter to engage the clot.
3. Connecting an attachment member to the guide catheter, where the attachment member has a hemostasis valve and a branch lumen for aspiration.
4. Retracting the interventional device and clot into the guide catheter while simultaneously aspirating through the guide catheter.
5. Opening the hemostasis valve of the attachment member by inserting a first valve insert into it.
6. Withdrawing the interventional device out of the patient through the attachment member and the inserted first valve, thereby creating a continuous lumen to prevent clot material from being stripped.
7. Removing the first valve insert and replacing it with a second valve insert.
8. Tightening the second valve insert to seal around a component (like a guidewire) that remains in the guide catheter.
9. Aspirating the guide catheter again, through the branch lumen of the attachment member, to remove any remaining clot material before the interventional device is re-advanced.

Claim 9:
This claim describes a method for intravascular treatment of clot material that focuses on an attachment member with an actuated valve. It involves:

1. Inserting a guide catheter into a blood vessel and advancing an interventional device to engage clot material.
2. Coupling an attachment member to the guide catheter. This attachment member contains a tubular member forming a central lumen and an actuation mechanism to collapse and seal the tubular member.
3. Retracting the interventional device and captured clot into the guide catheter while simultaneously aspirating through the guide catheter.
4. Determining if more clot removal passes are needed. If so:
5. Actuating the attachment member (e.g., pressing buttons) to open the tubular member, ensuring a continuous lumen of generally constant diameter through the attachment member.
6. Withdrawing the interventional device through this opened attachment member.
7. Returning the attachment member to its sealed state (collapsing the tubular member).
8. Aspirating the guide catheter through a branch lumen of the attachment member to clear residual clot.

Claim 16:
This claim details a specific type of attachment member for a catheter system. It comprises:

1. A housing with a first lumen designed to receive a component of the catheter system (like a guide catheter).
2. A branch portion with a second lumen that connects to the first lumen and is configured for aspiration.
3. A valve located within the first lumen, which includes a tubular member defining a central lumen and an actuation mechanism. This actuation mechanism is designed to collapse the tubular member to seal the central lumen and to expand it to unseal the central lumen, allowing for the passage of an interventional device without significant change in diameter or stripping of clot material.

Legal Status and Litigation:

US Patent 12239333 is currently Active and was granted on March 4, 2025.

As of April 26, 2026, there is a PTAB case IPR2026-00215 filed (Pending) litigation related to this patent.

A search of the CAFC 2026 dockets did not reveal any specific cases directly involving patent 12239333. The search provided general information about scheduled cases for May, June, and July 2026, but no mention of this specific patent.

Known litigation involving US patent 12239333 includes the following:

• Case Number: IPR2026-00215
• Plaintiff(s): Unified Patents
• Defendant(s): Inari Medical Inc
• Jurisdiction: Patent Trial and Appeal Board (PTAB)
• Filing Date: 2026 (specific date not provided, but inferred from case number)
• Outcome or Current Status: Pending

Proceedings overview

US patent 12239333 is currently involved in one pending Inter Partes Review (IPR) proceeding. As the IPR is in its early stages and an institution decision has not yet been rendered, all claims of the patent remain untested through an AIA trial. This means that, from a defensive posture, the patent claims currently hold their original strength, but their patentability is actively being challenged.

IPR2026-00215 — Imperative Care, Inc. v. Inari Medical Inc.

• Type: Inter Partes Review
• Filed: 2026-01-16
• Status: Pending. This IPR is currently in the pre-institution phase, awaiting a decision from the PTAB on whether to institute a trial.
• Judge panel: Information regarding the specific Administrative Patent Judges assigned to this case is not publicly available at this early stage of the proceeding.
• Petition grounds: Details regarding which claims are challenged, the prior art cited, and the statutory basis (§ 102 / § 103 / § 112) are not yet publicly released by the USPTO, as the institution decision is pending.
• Institution decision: Not yet issued. The statutory deadline for the PTAB to issue an institution decision is typically six months from the filing date of the petition, which would be around July 16, 2026.
• Final Written Decision: Not applicable; the proceeding has not reached this stage.
• Settlement / termination: No settlement or termination has been publicly reported.
• Appeal: Not applicable; the proceeding has not reached this stage.
• Defensive value: This IPR is in its initial phase, meaning no claims have been challenged or validated by a PTAB decision. For a defendant, this proceeding introduces uncertainty regarding the patent's enforceability. If the IPR is instituted, it could lead to claim cancellation, but until then, the patent remains intact.

Strategic summary

Currently, all claims of US patent 12239333 are UNTESTED in the context of an AIA trial, as the sole IPR proceeding (IPR2026-00215) is still pending an institution decision. No claims have been canceled or sustained by the PTAB.

Regarding the estoppel landscape, since IPR2026-00215 has not been instituted or reached a final written decision, no statutory estoppel under 35 U.S.C. § 315(e)(2) has yet applied to the petitioner, Imperative Care, Inc., or its privies. This means that, at this moment, the prior-art grounds raised in the petition are still "available" in the sense that they haven't been finally adjudicated by the PTAB.

There is a clear pattern signal here: IPR2026-00215 was filed by Imperative Care, Inc., indicating an active challenge against Inari Medical Inc.'s patent. While Google Patents listed "Unified Patents PTAB Data" as a petitioner in its legal status timeline, the canonical "PTAB proceedings on file" block in the prompt clearly states "petitioner: Imperative Care, Inc." for IPR2026-00215, which takes precedence. This signifies a direct dispute between operating companies rather than a defensive aggregator. The patent owner, Inari Medical Inc., is actively defending its patent against this challenge.

Recommended next steps

• Monitor IPR2026-00215: As a defendant, closely track the institution decision for IPR2026-00215. The decision is anticipated around July 16, 2026. This decision will be crucial as it determines whether a trial on the patentability of the challenged claims will proceed. You can monitor the status on the USPTO PTAB End-to-End system (E2E) by searching for IPR2026-00215.
• Analyze Petition if Public: If the petition for IPR2026-00215 becomes publicly available, review the specific claims challenged and the prior art asserted. This can provide insight into potential invalidity arguments.
• Assess Remaining Claims: Since no claims have been invalidated or sustained, all claims of US12239333 are currently considered valid. Any infringement theories should be evaluated against the full scope of the granted claims.

https://patents.google.com/patent/US12239333/en

Inventors

• Richard Quick (Inari Medical Inc)
• Benjamin Edward Merritt (Inari Medical Inc)
• John Coleman Thress (Inari Medical Inc)
• Paul Lubock (Inari Medical Inc)
• Thomas M. Tu (Inari Medical Inc)

All inventors appear to be associated with Inari Medical Inc. There is no immediate indication of all inventors departing the original assignee within 12 months of filing.

Original assignee

Inari Medical Inc is the original assignee. Inari Medical Inc is an operating company focused on developing products for the treatment of venous diseases, including pulmonary embolism and deep vein thrombosis. They ship products embodying the claims, such as the FlowTriever and ClotTriever systems, which align with the patent's description of devices for intravascular clot removal. The company is currently operating.

Assignment timeline

• 2024-01-11 (executed) / recorded 2024-01-11 — Reel 063380/0556
  • Conveyance: Assignment
  • Assignor: QUICK, RICHARD; LUBOCK, PAUL; MERRITT, BENJAMIN EDWARD; THRESS, JOHN COLEMAN; TU, THOMAS M.
  • Assignee: Inari Medical, Inc.
  • Correspondent: Matthew J. Van Eman, Knobbe, Martens, Olson & Bear, LLP, 2040 Main Street, 14th Floor, Irvine, CA 92614.
  • Context: Internal reorg (assignment from inventors to company)

Timeline diagram

timeline
    title Ownership of US 12239333
    2023 : Filed by Inari Medical Inc
    2024 : Assigned from inventors to Inari Medical Inc
    2025 : Issued to Inari Medical Inc

NPE / troll-pattern signals

1. Shell-entity transfer — not present. The sole assignment on record is from the individual inventors to Inari Medical Inc., which is an operating company.
2. Known asserter in the chain — not present. Inari Medical Inc. is not identified as a known asserter.
3. Repeat correspondent across the chain — unclear. Matthew J. Van Eman of Knobbe, Martens, Olson & Bear, LLP is listed as the correspondent for the inventor assignment. Without further assignment records or a broader database of correspondent activity, it's not possible to determine if this correspondent recurs across multiple chains indicative of an NPE pattern.
4. Cascading transfers — not present. There is only one recorded assignment for this patent.
5. Pre-litigation transfer — not present. The assignment from the inventors to Inari Medical Inc. occurred on January 11, 2024, and the patent was granted on March 4, 2025. While there is a PTAB case IPR2026-00215 filed (Pending) as of April 26, 2026, this is not an infringement suit, and the assignment date does not fall within 6 months before the PTAB filing.
6. Bankruptcy fire-sale — not present. There is no indication of Inari Medical Inc. having filed for bankruptcy.
7. Privateering — not present. There is no evidence of Inari Medical Inc. transferring the patent to an NPE to assert on their behalf.
8. Defensive aggregator (anti-NPE) — not present. The patent is currently assigned to Inari Medical Inc., an operating company.

Verdict

Operating-company assertion The sole assignment on record is from the individual inventors to Inari Medical Inc. on 2024-01-11 (Reel 063380/0556), which is an operating company that manufactures and sells products embodying the claims. There are no other signals indicative of NPE activity.

USPTO Assignment Center search page for US12239333: https://assignmentcenter.uspto.gov/patent/index.html?query=[12239333](/patent/12239333)

I will now search the USPTO database for patent 12239333 and then analyze its cited prior art.

Prior art is crucial in patent examination to assess the novelty and non-obviousness of an invention. It encompasses any information publicly available before the patent application's filing date, including other patents, publications, products, and public knowledge. Patent examiners use prior art to determine if an invention is already known or obvious, and a thorough search considers various data sources beyond just patent documents.

USPTO Patent 12239333 Search Results:

As of May 28, 2026, searching the USPTO database for patent number 12239333 directly should yield information about "Single insertion delivery system for treating embolism and associated systems and methods" assigned to Inari Medical Inc.. The patent was granted on March 4, 2025.

To identify the most relevant prior art, I will examine the citations listed within US patent 12239333. The full patent text indicates that it incorporates by reference U.S. Pat. No. 9,526,864, filed Jun. 9, 2015, and titled "RETRACTION AND ASPIRATION DEVICE FOR TREATING EMBOLISM AND ASSOCIATED METHODS." This is a primary piece of prior art.

Most Relevant Prior Art for US Patent 12239333:

Based on the provided patent text, the most explicitly referenced prior art is:

1. Full Citation: U.S. Patent No. 9,526,864, titled "RETRACTION AND ASPIRATION DEVICE FOR TREATING EMBOLISM AND ASSOCIATED METHODS."
2. Publication/Filing Date: Filed June 9, 2015.
3. Brief Description: This patent describes retraction and aspiration devices, catheter systems, and tubing systems that are "the same as or similar to" those used in the clot retrieval system 1 of US12239333B2. Specifically, it covers components like the RA device 100, catheter system 200, and tubing system 300, which are designed to simultaneously retract a portion of the catheter system and aspirate through it to remove material like blood and clot.
4. Potential Anticipation (35 U.S.C. § 102):
   • Claims 1, 9, and 16 (in part): U.S. Patent 9,526,864 potentially anticipates aspects of claims 1, 9, and 16 of US12239333B2 related to the fundamental components of a retraction and aspiration system, specifically the RA device, catheter system, and tubing system for treating embolisms via simultaneous retraction and aspiration. The new patent (US12239333B2) builds upon this foundation by introducing specific advancements related to single insertion and managing multiple passes, particularly concerning the attachment/valve member and valve inserts to prevent clot stripping and allow for redeployment of the interventional device without fully removing the guide catheter. The "single insertion" and "repeated deployment" aspects, along with the detailed mechanisms for preventing clot stripping during withdrawal and re-advancement, appear to be the distinguishing features of 12239333 over 9,526,864, according to the description. Without a detailed claim comparison to 9,526,864, it's difficult to pinpoint exact claim elements that are directly anticipated, but the core functionality of a retraction and aspiration system for embolism treatment is clearly present in the earlier patent.

Obviousness (35 U.S.C. § 103)

To assess obviousness under 35 U.S.C. § 103, one must consider whether the differences between the claimed invention and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art (PHOSITA). This involves identifying the scope and content of the prior art, ascertaining the differences between the prior art and the claims at issue, and resolving the level of ordinary skill in the pertinent art. Additionally, secondary considerations of non-obviousness, such as commercial success, long-felt but unsolved needs, and failure of others, can be considered.

The priority date for US12239333 is January 26, 2018.

Obviousness Arguments

Combination 1: U.S. Pat. No. 9,526,864 in view of US20220347455A1 (or other hemostasis valve prior art)

• U.S. Pat. No. 9,526,864: This patent, titled "RETRACTION AND ASPIRATION DEVICE FOR TREATING EMBOLISM AND ASSOCIATED METHODS," is explicitly incorporated by reference into US12239333. It discloses a retraction and aspiration device, catheter systems, and tubing systems for treating embolisms. The patent describes an RA device coupleable to a catheter system to simultaneously retract a portion of the catheter system and aspirate through it. The tubing system fluidly couples the pressure source of the RA device to the aspiration lumen of the catheter system, enabling material (e.g., blood and clot) to flow into the tubing system.
• US20220347455A1 (and related): This application, and its underlying provisional application (U.S. Provisional Application No. 62/554,931, filed Sep. 6, 2017), detail hemostasis valves and methods of use for sealing medical devices during intravascular access. These valves are designed to minimize blood loss, prevent air delivery into the vasculature, and maintain sterility. They can seal the lumen of a catheter when a tool extends through it or when no tool is present. The patent describes methods of advancing a tool through a delivery device with a hemostatic valve, and the tubular member of the valve collapsing on the shaft of the tool to seal around it. Other prior art such as WO2019055411A1 also describes hemostasis valves with seal members and plungers to open and close the seal. The Guardian Haemostasis Valve is another example of a hemostasis valve designed to minimize blood loss by maintaining a continuous seal during wire or microcatheter positioning.

Motivation for Combination:
A PHOSITA, seeking to improve the efficiency and safety of repeated interventional device passes for clot removal, would have been motivated to combine the retraction and aspiration system of U.S. Pat. No. 9,526,864 with the hemostasis valve technology known in the art, such as that described in US20220347455A1 (and related disclosures).

The U.S. Pat. No. 9,526,864 system aims to remove clot material and enable multiple passes. However, the background of US12239333 itself highlights a problem with existing devices: "if the once-deployed interventional device is reintroduced without fully removing and cleaning the catheter system, there is a significant risk that clot material and/or other contaminants from the catheter system will be reintroduced into the blood vessel of the patient during a second pass." This clearly identifies a problem that a PHOSITA would want to solve to facilitate safe, multiple passes without fully removing the guide catheter.

Hemostasis valves, as taught by US20220347455A1 and other references, are specifically designed to minimize blood loss and maintain sterility during catheter procedures, especially when devices are inserted or removed. A PHOSITA would recognize that incorporating a sophisticated hemostasis valve into the attachment member of the guide catheter in the U.S. Pat. No. 9,526,864 system would address the problem of preventing clot material from being stripped by the valve and subsequently reintroduced.

Specifically, the concept of a valve that can be unsealed (or opened) to facilitate withdrawal of the interventional device without stripping clot material (as in claims 1 and 9 of US12239333) and then resealed for subsequent aspiration is a logical evolution. U.S. Pat. No. 9,526,864 already discusses aspiration during retraction of the interventional device. Integrating a hemostasis valve that can be selectively opened (e.g., by an insert or actuation mechanism as taught by US12239333) to create a continuous lumen of consistent diameter for device withdrawal, and then resealed for effective aspiration, would be an obvious design choice to prevent clot stripping and reintroduction. The prior art on hemostasis valves already describes tubular members that collapse to seal and can be adjusted (e.g., via a tensioning mechanism or plunger) to allow passage of tools.

Therefore, a PHOSITA would be motivated to combine these references to create a system that allows for multiple, safe passes of an interventional device without requiring full removal of the guide catheter, by utilizing a hemostasis valve in the attachment member that can be manipulated to prevent clot stripping during device withdrawal and ensure effective aspiration.

Combination 2: U.S. Pat. No. 9,526,864 in view of US7018401B1 and general knowledge of aspiration thrombectomy.

• U.S. Pat. No. 9,526,864: As above, this patent describes a system for retraction and aspiration of clot material.
• US7018401B1: This patent discloses woven intravascular devices, including filters, and delivery systems for them. The delivery systems often involve two coaxial hollow tubes, where a device is secured between them. This patent also discusses a device being delivered over a guidewire using two coaxial tubes, where one end of the body is secured to the inner tube and the other to the outer tube.
• General Knowledge of Aspiration Thrombectomy: The field of thrombectomy, including aspiration techniques, was well-established prior to the priority date of US12239333. For example, the Penumbra's Indigo Aspiration system, launched in 2014, was marketed for thrombus removal from peripheral arteries and veins and for the treatment of PE. Devices such as the FlowTriever® Retrieval/Aspiration system (from the assignee Inari Medical Inc. itself) are indicated for non-surgical removal of emboli and thrombi from blood vessels through aspiration. The use of vacuum-assisted systems to treat pulmonary embolism was also known. WO2020036809A1 describes methods for intravascular treatment of clot material including positioning a catheter, coupling a pressure source via a valve, charging a vacuum while the valve is closed, and then opening the valve to apply the vacuum to aspirate clot.

Motivation for Combination:
A PHOSITA would readily combine the general principles of aspiration thrombectomy with the specific retraction and aspiration device described in U.S. Pat. No. 9,526,864. The need for efficient clot removal and the desire to minimize passes or improve the efficacy of each pass would motivate the PHOSITA to enhance the aspiration capabilities. The concept of using a "continuous lumen of generally constant diameter" through the attachment member (as claimed in US12239333 claim 16) to facilitate clot removal without stripping is a logical improvement given the known issues with clot fragmentation and re-embolization. US7018401B1, while not directly addressing hemostasis valves for multiple passes, highlights the use of coaxial tubes for device delivery and retrieval, which inherently suggests controlling the interaction between the device and the catheter lumen during withdrawal.

The idea of pre-charging a vacuum (as described in WO2020036809A1), then applying it instantaneously to generate greater suction forces (as described in US12239333, e.g., in block 1007 and 1406 of the methods), would be an obvious optimization to improve aspiration efficiency. This pre-charging technique, when combined with a system like U.S. Pat. No. 9,526,864 which already provides aspiration functionality, would lead to more effective removal of residual clot material, as highlighted as a benefit in US12239333.

The described benefits in US12239333 of preventing clot stripping and reintroduction by maintaining a constant diameter lumen during interventional device withdrawal are problems a PHOSITA would strive to solve, and the combination of existing aspiration techniques with well-understood catheter and valve designs would lead to the claimed inventions.

US Patent 12239333, titled "Single insertion delivery system for treating embolism and associated systems and methods," was granted on March 4, 2025, and filed on October 30, 2023.

Patent Term Adjustments (PTA)

Patent Term Adjustment (PTA) is granted to compensate patent applicants for delays caused by the USPTO during the prosecution of a patent application. This can extend the 20-year lifespan of a patent. Delays can include the USPTO failing to:

• Issue a first office action or notice of allowance within 14 months of filing.
• Respond to an applicant's reply to an office action within four months.
• Issue the patent within four months of paying the issue fee.
• Issue a patent within three years of the actual filing date.

The total PTA is the sum of these delays, minus any delays caused by the applicant. The patent text for US12239333 does not explicitly state the amount of PTA awarded. To determine the exact PTA, one would typically need to consult the patent's file history on the USPTO Patent Center.

Patent Term Extensions (PTE)

Patent Term Extensions (PTE) are available for patents claiming certain human drug products, medical devices, animal drugs, veterinary biological products, and food or color additive products. This extension aims to restore some of the patent term lost while awaiting premarket government approval from a regulatory agency like the FDA.

The patent text for US12239333 does not indicate that a Patent Term Extension (PTE) has been applied for or granted. Given that the patent relates to medical devices for treating embolisms, it could be eligible for PTE if it underwent a regulatory review period with a government agency prior to commercial marketing. However, without specific information within the patent document or its associated legal status on the USPTO, no PTE can be confirmed.

Continuation and Divisional Applications

The patent states in its "CROSS-REFERENCE TO RELATED APPLICATION" section that it is a continuation of:

• U.S. patent application Ser. No. 17/865,307, filed on Jul. 14, 2022.
• U.S. patent application Ser. No. 17/498,642, filed on Oct. 11, 2021.
• U.S. patent application Ser. No. 16/258,344, filed on Jan. 25, 2019, which is now issued as U.S. Pat. No. 11,154,314.

It also claims the benefit of:

• U.S. Provisional Patent Application No. 62/622,691, filed on Jan. 26, 2018.

This indicates that US12239333 is a continuation application, building upon previous applications. The document does not mention any divisional applications.

Related Family Members

Based on the continuation chain provided in the patent text, the related family members include:

• U.S. patent application Ser. No. 17/865,307
• U.S. patent application Ser. No. 17/498,642
• U.S. Pat. No. 11,154,314 (from U.S. patent application Ser. No. 16/258,344)
• U.S. Provisional Patent Application No. 62/622,691

The Google Patents page also lists other versions: US20240074771A1. Additionally, it shows priority to US19/011,529 (patent/US20250213259A1/en), US19/030,673 (patent/US20250325291A1/en), and US19/030,209 (patent/US20250281192A1/en).

Projected Expiration Date

The standard term for a U.S. utility patent is 20 years from its earliest filing date. Since US12239333 claims priority to U.S. Provisional Patent Application No. 62/622,691, filed on January 26, 2018, this date would typically be the starting point for calculating the 20-year term.

Therefore, without any Patent Term Adjustment (PTA) or Patent Term Extension (PTE), the patent would expire on January 26, 2038.

However, the Google Patents information page for US12239333 lists an "Anticipated expiration" date of 2039-01-25. This suggests that there has been a Patent Term Adjustment (PTA) of approximately one year. This adjustment accounts for delays by the USPTO during the examination process. This "Anticipated expiration" date of 2039-01-25 takes precedence as the current ground truth. [cite: Patents.google.com]

Defensive Disclosure Document for US Patent 12239333

This document outlines derivative variations of the core claims of US Patent 12239333, "Single insertion delivery system for treating embolism and associated systems and methods," for defensive publishing purposes. The aim is to create readily available prior art to render future incremental improvements by competitors as obvious or non-novel.

Independent Claim 1 Derivatives (Method for clot removal with two valve inserts)

Claim 1 (Recap): A method for removing clot material from a patient's blood vessel, involving: (1) inserting a guide catheter, (2) advancing an interventional device, (3) connecting an attachment member with a hemostasis valve and branch lumen, (4) retracting device/clot with aspiration, (5) inserting a first valve insert to open the hemostasis valve, (6) withdrawing the interventional device through the first valve insert (continuous lumen), (7) removing the first valve insert and replacing with a second valve insert, (8) tightening the second valve insert to seal around a component, and (9) aspirating the guide catheter again through the branch lumen.

---

1.1 Material & Component Substitution: Bioresorbable Polymer Inserts with Magnetic Retention

Enabling Description:
A method wherein the first and second valve inserts (650, 860) are fabricated from a bioresorbable polymer, such as polylactic-co-glycolic acid (PLGA) or polycaprolactone (PCL), designed to degrade within a specified timeframe (e.g., 24-72 hours) post-procedure. The engagement features (652, 862) on these inserts, instead of mechanical snap-fits, incorporate small, biocompatible ferromagnetic particles or a thin ferromagnetic layer. Corresponding magnetic elements (e.g., neodymium iron boron micro-magnets) are embedded within the attachment member (408) to provide a reversible, secure magnetic coupling, thereby retaining the inserts. The tensioning mechanism of the second valve insert (860) utilizes a shape memory alloy (e.g., Nitinol) collar that constricts upon an external thermal or electrical signal, replacing traditional screw-thread tightening for sealing around the guidewire.

graph TD
    A[Insert Guide Catheter] --> B[Advance Interventional Device]
    B --> C[Attach Attachment Member (Magnetic)]
    C --> D{Retract Device & Aspirate}
    D --> E[Insert First Bioresorbable Insert (Magnetic Retention)]
    E --> F[Withdraw Interventional Device]
    F --> G[Remove First Insert]
    G --> H[Insert Second Bioresorbable Insert (Magnetic Retention & Nitinol Seal)]
    H --> I[Activate Nitinol Seal]
    I --> J[Aspirate Guide Catheter]
    J --> K{Additional Pass?}
    K -- Yes --> B
    K -- No --> L[Remove Catheter System]

---

1.2 Operational Parameter Expansion: Cryo-Aspiration with Dynamic Lumen Control

Enabling Description:
A method for large-volume, high-viscosity clot removal, potentially in pulmonary arteries up to 50mm in diameter, utilizing cryo-aspiration. The guide catheter (206) and attachment member (408) are constructed from cryogenically compatible polymers (e.g., PTFE with reinforced braiding). The aspiration system is enhanced with a closed-loop cryocooler (e.g., Stirling cycle cooler) positioned proximally, delivering a cryo-agent (e.g., supercooled saline or inert gas) to the distal lumen of the guide catheter (206). This creates a localized hypothermic zone (e.g., 0-4°C) around the clot material (PE) to increase its viscosity and structural integrity, reducing fragmentation during retraction. The first valve insert (650) is designed with active lumen dilation capabilities, using miniature inflatable micro-balloons or radially expanding Nitinol stents integrated into its structure, actuated pneumatically or electrically, to dynamically match the expanding clot diameter (up to 30% larger than the guide catheter's relaxed internal diameter) during withdrawal, preventing stripping. The aspiration pressure can reach -700 mmHg (relative to atmospheric).

stateDiagram
    state "Deployment" {
        [*] --> Insert_Catheter
        Insert_Catheter --> Advance_Device
        Advance_Device --> Engage_Clot
    }
    state "Clot Retrieval Pass" {
        Engage_Clot --> Retract_Device_Cryo_Aspirate: Apply Cryo-agent, -700mmHg
        Retract_Device_Cryo_Aspirate --> Insert_First_Insert_Dynamic: Actively Dilate Lumen
        Insert_First_Insert_Dynamic --> Withdraw_Device_No_Stripping
        Withdraw_Device_No_Stripping --> Remove_First_Insert
        Remove_First_Insert --> Insert_Second_Insert_Sealed
        Insert_Second_Insert_Sealed --> Re_Aspirate_Cryo_Guide: Clear Residual
    }
    state "Procedure End" {
        Re_Aspirate_Cryo_Guide --> Check_Clot_Removal
        Check_Clot_Removal -- More Clot --> Engage_Clot
        Check_Clot_Removal -- No More Clot --> Remove_Catheter
        Remove_Catheter --> [*]
    }

---

1.3 Cross-Domain Application: Industrial Sediment Retrieval in Submersible Piping

Enabling Description:
A method for removing sediment and particulate build-up from submerged industrial piping systems (e.g., wastewater treatment plant intake pipes, chemical process lines) up to 200mm in diameter. The "guide catheter" is a robust, chemically resistant polymer conduit (e.g., HDPE or PVDF) temporarily installed upstream of the blockage. The "interventional device" is a mechanical grabber or auger tool, powered by a subsea hydraulic motor, advanced through this conduit. The "attachment member" is a high-pressure valve assembly, integrated with a large-diameter branch lumen for aspiration, attached to the conduit. During retraction of the grabber tool with collected sediment, a first valve insert, made of hardened ceramic or abrasion-resistant steel, is inserted to create a smooth, continuous flow path, preventing damage to the primary valve seals from abrasive particulates. After removing the grabber tool, a second valve insert with an adjustable elastomeric seal is inserted and tightened around a residual guidewire or cleaning brush, enabling high-flow aspiration (up to 10 m³/hr) to remove residual fine sediments from the conduit.

flowchart TD
    A[Install Industrial Conduit] --> B[Advance Hydraulic Grabber]
    B --> C[Attach High-Pressure Valve Assembly]
    C --> D{Retract Grabber & Aspirate Sediment}
    D --> E[Insert Ceramic Valve Insert]
    E --> F[Withdraw Grabber/Sediment]
    F --> G[Remove Ceramic Insert]
    G --> H[Insert Elastomeric Seal Insert]
    H --> I[Tighten Seal Insert around Cleaning Brush]
    I --> J[Aspirate Conduit (High Flow)]
    J --> K{More Sediment?}
    K -- Yes --> B
    K -- No --> L[Remove Conduit System]

---

1.4 Integration with Emerging Tech: AI-Optimized, IoT-Monitored Thrombectomy with Blockchain Provenance

Enabling Description:
A method for AI-optimized thrombectomy where the catheter system (200), attachment member (408), and valve inserts (650, 860) are equipped with embedded IoT sensors. Micro-electromechanical systems (MEMS) pressure sensors, optical spectroscopy clot composition sensors, and miniature accelerometers are integrated along the guide catheter (206) and interventional device (ID). The attachment member (408) includes flow rate and temperature sensors in its branch lumen (444). Data from these sensors is transmitted via a low-power wireless module (e.g., Bluetooth Low Energy 5.0) to a local edge computing unit. An AI algorithm (e.g., a deep reinforcement learning model) running on this unit analyzes real-time sensor data to dynamically optimize aspiration pressure, retraction speed, and first valve insert lumen diameter for maximal clot removal and minimal vessel trauma. The AI also determines the optimal timing for switching between valve inserts. All procedural parameters, sensor readings, and clot removal events (including before/after images) are securely logged onto a private blockchain (e.g., Hyperledger Fabric), ensuring an immutable record for regulatory compliance, supply chain verification of device components, and patient outcome analysis.

sequenceDiagram
    participant ID as Interventional Device
    participant GC as Guide Catheter
    participant AM as Attachment Member
    participant S as IoT Sensors
    participant ECU as Edge Computing Unit (AI)
    participant BC as Blockchain Network
    participant OP as Operator Console

    OP->GC: Insert Guide Catheter
    OP->ID: Advance Interventional Device
    ID->AM: Attach to Attachment Member
    loop Clot Removal Passes
        OP->ECU: Request Clot Retrieval
        ECU->AM: Control Aspiration & Retraction (AI-Optimized)
        S->ECU: Stream Real-time Data (Pressure, Flow, Clot Comp.)
        AM->OP: Display Live Metrics
        OP->AM: Insert First Valve Insert (AI-Guided)
        OP->ID: Withdraw Interventional Device
        OP->AM: Remove First Insert & Replace Second (AI-Guided)
        AM->ECU: Adjust Seal (AI-Optimized)
        AM->ECU: Re-Aspirate Guide Catheter
        ECU->BC: Log Procedure Data (Timestamp, Sensor Data, AI Actions)
        BC->BC: Verify & Immutable Record
        OP->ECU: Determine Next Step (AI-Assisted)
    end
    OP->GC: Remove Catheter System

---

1.5 The "Inverse" or Failure Mode: Controlled Defragmentation and Drug Delivery System

Enabling Description:
A method where the system is primarily designed for controlled defragmentation of large, intractable clots and targeted thrombolytic drug delivery, rather than complete mechanical extraction in a single piece. If a clot (PE) is too large or adherent, the interventional device (ID) features an ultrasonic fragmentation tip. During initial retraction, the aspiration pressure is intentionally kept low (e.g., -50 mmHg) to minimize distal embolization, and a first valve insert (650) is used that has a perforated inner lumen lined with a thrombolytic agent (e.g., tPA). This insert is activated to slowly release the drug as the fragmented clot passes through, initiating chemical dissolution. If the primary hemostasis valve (445) in the attachment member (408) experiences excessive pressure buildup or is compromised, an integrated pressure relief mechanism (e.g., a burst disk or spring-loaded valve) automatically vents the aspiration lumen to an external sterile collection bag, preventing proximal backflow into the patient and ensuring safe operation. The second valve insert (860) is designed with a porous membrane that allows continuous low-flow irrigation/drug infusion (e.g., heparinized saline) while maintaining a partial hemostasis, preventing total vessel occlusion even in failure scenarios.

stateDiagram
    state "Initial Engagement" {
        [*] --> Insert_Catheter_LowFlow
        Insert_Catheter_LowFlow --> Advance_Device_Fragmentation
        Advance_Device_Fragmentation --> Engage_Intractable_Clot
    }
    state "Controlled Defragmentation & Drug Delivery Pass" {
        Engage_Intractable_Clot --> Retract_Device_LowAspirate: Ultrasonic Fragmentation, -50mmHg
        Retract_Device_LowAspirate --> Insert_First_Insert_Perforated: Thrombolytic Release
        Insert_First_Insert_Perforated --> Process_Clot_Fragments
        Process_Clot_Fragments --> Check_Pressure_Relief: If > Threshold, Vent Safely
        Process_Clot_Fragments --> Remove_First_Insert
        Remove_First_Insert --> Insert_Second_Insert_Porous: Continuous Low-Flow Irrigation
        Insert_Second_Insert_Porous --> Monitor_Vessel_Condition
    }
    state "Termination" {
        Monitor_Vessel_Condition -- Clot Resolved --> Remove_Catheter_Safe
        Monitor_Vessel_Condition -- Persistence --> Engage_Intractable_Clot
        Remove_Catheter_Safe --> [*]
    }

---

Independent Claim 9 Derivatives (Method for clot removal with actuated attachment member)

Claim 9 (Recap): A method for intravascular treatment of clot material, involving: (1) inserting a guide catheter and advancing an interventional device, (2) coupling an attachment member with a tubular member (central lumen) and actuation mechanism, (3) retracting device/clot with aspiration, (4) determining if more passes are needed, (5) if so, actuating the attachment member to open the tubular member (continuous lumen), (6) withdrawing the interventional device, (7) returning the attachment member to its sealed state, and (8) aspirating the guide catheter through a branch lumen.

---

2.1 Material & Component Substitution: Self-Healing Elastomer Tubular Member with Piezoelectric Actuation

Enabling Description:
A method wherein the tubular member (1372) of the attachment member (1108) is constructed from a self-healing, biocompatible elastomer (e.g., a polyurethane-urea with embedded microcapsules of healing agent). This material can autonomously repair minor punctures or tears that might occur during device insertion/withdrawal, enhancing durability and hemostatic integrity over multiple passes. The actuation mechanism (1375) for collapsing and expanding the tubular member (1372) is replaced by an array of annular piezoelectric transducers (e.g., PZT ceramic rings) embedded within the housing (1370) of the attachment member (1108). These transducers are controlled by an external electrical signal to generate radial compression or expansion forces, precisely controlling the diameter of the tubular member's central lumen (1374) to maintain hemostasis or open for interventional device passage. The buttons (1378) are replaced by capacitive touch sensors that activate the piezoelectric array.

classDiagram
    class GuideCatheter {
        +lumen: channel
        +distal_end: position
    }
    class InterventionalDevice {
        +engage_clot()
        +withdraw()
    }
    class AttachmentMember {
        +tubular_member: SelfHealingElastomer
        +actuation_mechanism: PiezoelectricArray
        +branch_lumen: channel
        +seal()
        +unseal()
        +aspirate()
    }
    class PiezoelectricArray {
        +apply_radial_force(signal: electrical)
    }
    class CapacitiveSensor {
        +detect_touch(): boolean
    }

    GuideCatheter --o AttachmentMember
    InterventionalDevice --o GuideCatheter
    AttachmentMember --o PiezoelectricArray
    CapacitiveSensor --> AttachmentMember: controls

---

2.2 Operational Parameter Expansion: Ultra-High Frequency Pulsatile Aspiration with Real-time Pressure Feedback

Enabling Description:
A method for thrombectomy in highly tortuous or fragile vessels (e.g., intracranial or renal arteries) using ultra-high frequency pulsatile aspiration. The RA device (100) incorporates a micro-reciprocating pump capable of generating aspiration pulses at frequencies ranging from 500 Hz to 2 kHz, with peak negative pressures reaching -400 mmHg and rapid pressure cycling. The attachment member (1108) is equipped with a MEMS pressure sensor directly embedded within the wall of the tubular member (1372) to provide real-time intra-lumen pressure feedback. This feedback is used by a proportional-integral-derivative (PID) control algorithm to dynamically adjust the actuation mechanism (1375) and the pulsatile aspiration parameters. The tubular member (1372) is expanded to its maximal diameter (matching the guide catheter lumen) to allow frictionless passage of the interventional device (ID) during withdrawal, then precisely sealed (e.g., to within 0.1mm of the guidewire diameter) during pulsatile aspiration, optimizing clot capture and minimizing vessel wall trauma from high-frequency pressure fluctuations.

sequenceDiagram
    participant ID as Interventional Device
    participant GC as Guide Catheter
    participant AM as Attachment Member
    participant PS as Pressure Sensor (MEMS)
    participant RP as Reciprocating Pump (RA Device)
    participant PID as PID Controller
    participant OP as Operator

    OP->GC: Insert Guide Catheter
    OP->ID: Advance Interventional Device
    ID->AM: Couple Attachment Member
    loop Multiple Passes
        OP->RP: Initiate Pulsatile Aspiration (500Hz-2kHz)
        RP->AM: Generate Aspiration
        AM->PS: Measure Intra-lumen Pressure
        PS->PID: Send Pressure Feedback
        PID->RP: Adjust Pump Parameters
        PID->AM: Adjust Actuation Mechanism (for sealing)
        OP->AM: Actuate (Open) Tubular Member
        AM->ID: Withdraw Interventional Device
        OP->AM: Release Actuation (Seal Tubular Member)
        AM->RP: Resume Pulsatile Aspiration (Guide Catheter)
        OP->OP: Assess Need for More Passes
    end
    OP->GC: Remove Catheter

---

2.3 Cross-Domain Application: Precision Filtration and Recovery in Pharmaceutical Synthesis

Enabling Description:
A method for precision filtration and recovery of fine particulate catalysts or sensitive biological precipitates from fluid streams in pharmaceutical synthesis processes. The "guide catheter" is a sterile, electropolished stainless steel conduit in a closed-loop reactor system. The "interventional device" is a retractable micro-filter or a harvesting probe. The "attachment member" is an aseptic valve assembly coupled to the conduit. This assembly includes a tubular member made from a chemically inert, autoclavable polymer (e.g., PEEK or reinforced silicone) forming a central lumen. An automated actuation mechanism (e.g., pneumatic piston or servo-motor driven cam) precisely collapses the tubular member to seal around the harvesting probe during aspiration, preventing cross-contamination or loss of material. To withdraw the harvesting probe, the actuation mechanism is commanded to fully open the tubular member, creating a smooth, unobstructed flow path to avoid damaging the delicate filter membrane or disturbing collected precipitates, ensuring high yield and purity.

flowchart TD
    A[Connect Sterile Conduit] --> B[Advance Harvesting Probe]
    B --> C[Couple Aseptic Valve Assembly]
    C --> D{Retract Probe & Filter/Harvest}
    D --> E[Automate Actuation (Open Valve)]
    E --> F[Withdraw Probe with Material]
    F --> G[Automate Actuation (Seal Valve)]
    G --> H[Aspirate Conduit (Residue Removal)]
    H --> I{More Filtration?}
    I -- Yes --> B
    I -- No --> J[Disconnect System]

---

2.4 Integration with Emerging Tech: Predictive Maintenance & Automated Actuation with Digital Twin

Enabling Description:
A method leveraging a digital twin for predictive maintenance and automated actuation. A digital twin of the entire clot retrieval system (1), including the attachment member (1108) and interventional device (ID), is continuously updated with real-time operational data (e.g., number of passes, clot material characteristics, actuation cycles, filament stress) streamed from embedded IoT sensors via a secure 5G connection. The digital twin predicts potential component wear (e.g., fatigue in the tubular member, degradation of the actuation mechanism) and suggests optimal replacement intervals or proactive maintenance actions. The actuation mechanism (1375) of the attachment member (1108) is automated using a high-precision servo motor, controlled by a local microcontroller. An AI model, trained on historical procedure data and the digital twin's simulations, dynamically adjusts the tubular member's opening and closing sequences and sealing pressure based on the predicted clot morphology and vessel characteristics to minimize stripping and optimize aspiration, overriding manual button presses (1378) for improved consistency and safety.

stateDiagram
    state "Initialization" {
        [*] --> System_Online
        System_Online --> Digital_Twin_Created
        Digital_Twin_Created --> Sensors_Streaming_Data
    }
    state "Operational Phase" {
        Sensors_Streaming_Data --> AI_Model_Predicting_Optimal_Actions
        AI_Model_Predicting_Optimal_Actions --> Auto_Actuate_Attachment_Member
        Auto_Actuate_Attachment_Member --> Retract_Device_Aspirate
        Retract_Device_Aspirate --> DT_Updates_State: Update Digital Twin
        DT_Updates_State --> AI_Model_Predicting_Optimal_Actions
    }
    state "Predictive Maintenance" {
        DT_Updates_State --> Monitor_Component_Health
        Monitor_Component_Health -- Wear Detected --> Suggest_Maintenance
        Suggest_Maintenance --> Operator_Action
    }
    state "End of Procedure" {
        Retract_Device_Aspirate --> Procedure_Complete
        Procedure_Complete --> System_Offline
        System_Offline --> [*]
    }

---

2.5 The "Inverse" or Failure Mode: Fail-Open Co-Aspiration for Distal Embolus Protection

Enabling Description:
A method wherein the attachment member (1108) is designed to default to a "fail-open" state to facilitate continuous co-aspiration and provide distal embolus protection in case of primary system failure or a highly friable clot. The actuation mechanism (1375) includes a default spring-biased configuration that holds the tubular member (1372) in a continuously expanded (unsealed) state, maintaining a constant diameter lumen equal to the guide catheter's inner diameter. Sealing (collapsing the tubular member) only occurs when a positive external force is applied (e.g., holding down buttons 1378 against the spring bias). If the operator releases the buttons or if there is a power failure to an electronic actuation system, the tubular member immediately reverts to its open state. This ensures a pathway for constant, albeit lower, aspiration through the guide catheter (206) even during interventional device (ID) withdrawal, continuously removing small emboli generated by a friable clot and minimizing distal embolization. A passive filter integrated into the branch lumen (444) captures any inadvertently aspirated large fragments.

graph TD
    A[Insert Guide Catheter] --> B[Advance Interventional Device]
    B --> C[Couple Attachment Member (Fail-Open Bias)]
    C --> D{Retract Device & Aspirate (Continuous Low Flow)}
    D -- Operator applies force --> E[Seal Tubular Member (Active)]
    E -- Operator releases force / Power failure --> F[Unseal Tubular Member (Fail-Open)]
    F --> G[Withdraw Interventional Device (Continuous Aspiration)]
    G --> H[Return to Sealed State (Manual Override)]
    H --> I[Aspirate Guide Catheter (Full Flow)]
    I --> J{Additional Pass?}
    J -- Yes --> B
    J -- No --> K[Remove Catheter System]

---

Independent Claim 16 Derivatives (Attachment member apparatus)

Claim 16 (Recap): An attachment member for a catheter system, comprising: (1) a housing with a first lumen, (2) a branch portion with a second lumen for aspiration, and (3) a valve within the first lumen including a tubular member (central lumen) and an actuation mechanism (to collapse/seal and expand/unseal).

---

3.1 Material & Component Substitution: Smart Composite Housing with Electroactive Polymer Valve

Enabling Description:
An attachment member (1108) featuring a housing (1370) constructed from a smart composite material (e.g., carbon fiber reinforced polymer with embedded strain gauges and optical fibers). This housing provides structural integrity and allows real-time monitoring of stress and deformation. The valve within the first lumen (1371) utilizes a tubular member (1372) made of an electroactive polymer (EAP), such as a dielectric elastomer actuator (DEA) or ionic polymer-metal composite (IPMC). The actuation mechanism (1375) is an integrated micro-electrode array that applies voltage across the EAP tubular member, causing it to radially contract (seal) or expand (unseal) without mechanical moving parts like filaments (1376) or buttons (1378). The magnitude and polarity of the applied voltage directly control the lumen diameter (1374), allowing for precise, continuous adjustment of the hemostatic seal or full opening, and eliminating potential mechanical wear points.

classDiagram
    class AttachmentMember_SmartComposite {
        +housing: SmartComposite
        +first_lumen: Channel
        +branch_portion: Branch
        +second_lumen: Channel
        +valve: EAPValve
    }
    class SmartComposite {
        +material: CarbonFiberRP
        +embedded_sensors: StrainGauges, OpticalFibers
    }
    class EAPValve {
        +tubular_member: ElectroactivePolymer (DEA/IPMC)
        +actuation_mechanism: MicroElectrodeArray
        +collapse_seal(voltage: float)
        +expand_unseal(voltage: float)
        -central_lumen: Channel
    }
    class MicroElectrodeArray {
        +apply_voltage(target_EAP: ElectroactivePolymer, voltage: float)
    }

    AttachmentMember_SmartComposite "1" -- "1" SmartComposite : includes
    AttachmentMember_SmartComposite "1" -- "1" EAPValve : includes
    EAPValve "1" -- "1" MicroElectrodeArray : controls
    AttachmentMember_SmartComposite "1" -- "1" Branch : has

---

3.2 Operational Parameter Expansion: Variable-Stiffness Tubular Member for Extreme Pressure Gradients

Enabling Description:
An attachment member (1108) engineered for deployment in medical scenarios involving extreme pressure gradients (e.g., veno-venous extracorporeal membrane oxygenation (VV-ECMO) circuits with high-flow pumps, or arterial access under severe hypertension). The tubular member (1372) is fabricated from a novel, variable-stiffness polymer composite, such as a magnetorheological elastomer (MRE) or electrorheological fluid-filled membrane. An integrated electromagnetic coil or electrostatic field generator serves as the actuation mechanism (1375). By altering the magnetic or electric field strength, the stiffness and compliance of the tubular member (1372) can be rapidly and reversibly modulated. This allows the valve to dynamically adapt its sealing force and resistance to collapse, ensuring a robust hemostatic seal (e.g., against pressure differentials exceeding 500 mmHg) when required, while offering minimal resistance to interventional device (ID) passage (e.g., reducing friction coefficient by 80%) when the tubular member is in its expanded state.

stateDiagram
    state "Default: Low Stiffness" {
        direction LR
        Low_Stiffness --> Apply_Field : Increase Field
        Apply_Field --> High_Stiffness : Modulate Stiffness
        High_Stiffness --> Remove_Field : Decrease Field
        Remove_Field --> Low_Stiffness
    }
    state "Functionality" {
        Low_Stiffness : Device Passage, Minimal Resistance
        High_Stiffness : Robust Seal, High Pressure Differential
    }

---

3.3 Cross-Domain Application: High-Purity Fluid Interface for Semiconductor Manufacturing

Enabling Description:
An attachment member (1108) configured as a high-purity fluid interface for introducing and withdrawing processing tools (e.g., microscopic inspection probes, chemical injectors) into ultra-clean fluidic channels within semiconductor manufacturing equipment (e.g., for wafer cleaning or etching). The housing (1370) is machined from a high-grade, passivated stainless steel or optical-grade quartz. The first lumen (1371) connects to the process fluid line. The branch portion (444) is designed for vacuum-assisted contaminant removal, connected to a high-purity nitrogen purge or dedicated vacuum pump. The valve comprises a tubular member (1372) made of ultra-high molecular weight polyethylene (UHMWPE) or a fluoropolymer (e.g., PFA) for chemical inertness and particle shedding resistance. The actuation mechanism (1375) is a pneumatic cylinder that precisely compresses or relaxes the tubular member (1372). This allows a hermetic seal (leak rate <10⁻⁹ mbar·l/s) around the inserted tool, preventing airborne particulate contamination, and ensures a smooth, particle-free path during tool withdrawal, critical for maintaining wafer yield.

flowchart TD
    A[Process Fluid Line] --> B[AttachmentMember_Semiconductor]
    B --> C{Tool Insertion/Withdrawal}
    C -- Insert Tool --> D[Pneumatic Actuator (Seal UHMWPE Valve)]
    D --> E[Process Fluid Flow]
    C -- Withdraw Tool --> F[Pneumatic Actuator (Open UHMWPE Valve)]
    F --> G[Vacuum-Assisted Purge (Branch Lumen)]
    G --> H[Tool Removed]
    H --> I[Process Completion]

---

3.4 Integration with Emerging Tech: AI-Driven Self-Calibrating Valve with Embedded Microfluidic Diagnostics

Enabling Description:
An attachment member (1108) with an AI-driven, self-calibrating valve and embedded microfluidic diagnostics. The housing (1370) incorporates a microfluidic channel network with optical sensors (e.g., micro-spectrometers, particle counters) at the junction of the first (1371) and second (442) lumens. These sensors perform real-time diagnostic analysis of aspirated fluid for residual clot material, blood cell lysis, or presence of infection markers. An integrated microcontroller runs an AI algorithm (e.g., a neural network) that uses this diagnostic data, along with pressure and flow sensor readings, to self-calibrate the actuation mechanism (1375) of the tubular member (1372). This AI-driven calibration optimizes the sealing pressure to minimize both leakage and frictional drag on the interventional device (ID), extending valve lifespan and ensuring consistent performance over multiple passes. The system can alert the operator to abnormal fluid composition or compromised valve integrity.

graph TD
    A[Catheter System Component] --> B[First Lumen (Housing)]
    B --> C[Valve (Tubular Member & Actuation)]
    C --> D[Second Lumen (Branch Portion)]
    D --> E[Aspiration System]

    C -- Control --> F[AI Controller (Microcontroller)]
    D -- Fluid Sample --> G[Microfluidic Diagnostics (Optical Sensors)]
    G -- Data --> F
    F -- Calibration Signal --> C
    F -- Alerts --> H[Operator Interface]
    B -- Pressure/Flow --> F

---

3.5 The "Inverse" or Failure Mode: Modular Sacrificial Liner with Bypass Port

Enabling Description:
An attachment member (1108) designed with a modular, sacrificial liner system and an emergency bypass port, to safely manage severe clot stripping events or valve failures. The tubular member (1372) is a disposable, replaceable cartridge featuring multiple, independently segmented, thin-walled polymer liners (e.g., silicone or polyurethane). The actuation mechanism (1375) is configured to only compress the outermost intact liner segment. If clot material (PE) strips and damages a liner, the system automatically detects a breach (e.g., via embedded conductive traces or differential pressure sensors) and the operator can mechanically rotate the cartridge to engage a new, undamaged liner segment. Furthermore, the housing (1370) includes a spring-loaded, normally-closed emergency bypass port connected directly from the first lumen (1371) to an external waste collection system. In the event of catastrophic valve failure (e.g., complete inability to seal) or an acute high-pressure event, this bypass port automatically opens at a predefined pressure threshold (e.g., 200 mmHg above normal operating pressure), diverting fluid and potentially stripped clot material away from the aspiration system and preventing backflow into the patient, ensuring patient safety as the primary goal.

stateDiagram
    state "Operational" {
        [*] --> Intact_Liner
        Intact_Liner --> Seal_Device : Actuation Mechanism
        Intact_Liner --> Pass_Device : Actuation Mechanism
        Seal_Device --> Intact_Liner
        Pass_Device --> Intact_Liner
    }
    state "Failure Management" {
        Intact_Liner -- Liner Damaged --> Breached_Liner_Detected
        Breached_Liner_Detected --> Rotate_Cartridge : New Liner
        Breached_Liner_Detected --> Emergency_Bypass_Open : Pressure Threshold Exceeded
        Rotate_Cartridge --> Intact_Liner
        Emergency_Bypass_Open --> External_Waste : Divert Fluid
        Emergency_Bypass_Open --> System_Alert
        System_Alert --> Operator_Intervention
    }

---

Combination Prior Art Scenarios with Open-Source Standards

These scenarios combine elements of US Patent 12239333 with existing open-source standards to demonstrate obviousness or lack of novelty for potential future advancements.

1. US12239333 + DICOM (Digital Imaging and Communications in Medicine) + OpenCV (Open Source Computer Vision Library):

   • Scenario: A clot retrieval system as described in US12239333, where the determination of whether it is necessary or desirable to redeploy the interventional device (Claim 1, block 1003; Claim 9, block 1403) is augmented by real-time fluoroscopic imaging. The fluoroscopic images, acquired in DICOM format (an open-source standard for medical imaging), are fed into a computer vision system utilizing the OpenCV library. This system performs automated image analysis (e.g., blob detection, edge detection, optical flow) to quantify residual clot burden, measure vessel patency, and track interventional device position. The visual data, processed by OpenCV, provides objective feedback to the operator or an AI system (as in derivative 1.4 or 2.4) to guide subsequent passes, eliminating subjective visual assessment via the clot reservoir.
   • Obviousness Argument: The combination of a known medical procedure device (US12239333) with widely adopted medical imaging standards (DICOM) and common open-source image processing tools (OpenCV) to enhance visualization and decision-making for a medical practitioner would be an obvious step for a person having ordinary skill in the art seeking to improve diagnostic accuracy and procedural efficiency.

2. US12239333 + FHIR (Fast Healthcare Interoperability Resources) + SMART on FHIR (Substitutable Medical Applications and Reusable Technologies):

   • Scenario: A clot retrieval system as described in US12239333, where all procedural data, including device serial numbers, operator actions (e.g., pump cycles, valve insert changes), aspiration volumes, estimated clot sizes, and patient vital signs, are automatically captured and securely transmitted to an Electronic Health Record (EHR) system. This data is formatted according to FHIR standards (an open-source standard for exchanging healthcare information) and made accessible to third-party applications (e.g., a post-procedure analytics tool or a remote consultation platform) via the SMART on FHIR framework. This enables real-time clinical decision support, retrospective outcome analysis, and automated billing, all integrated seamlessly into the existing healthcare IT infrastructure.
   • Obviousness Argument: Given the push for interoperability and data-driven healthcare, it would be obvious for a PHOSITA to integrate a medical device (US12239333) with established open-source healthcare data exchange standards like FHIR and SMART on FHIR to improve data capture, facilitate clinical research, and enhance patient care coordination.

3. US12239333 + ROS (Robot Operating System) + Gazebo (Robot Simulator):

   • Scenario: A semi-autonomous robotic system built upon the principles of US12239333, particularly for precise catheter and interventional device navigation (e.g., guide catheter 206, delivery sheath 204, pull member 202). The robotic components (e.g., motorized stages for catheter advancement, force-feedback manipulators) are controlled by software developed using ROS (an open-source framework for robot software development). The entire procedure, including simulated clot engagement, valve insert manipulation, and aspiration, is first simulated in a Gazebo environment (an open-source 3D robotics simulator) to optimize control algorithms and train AI models for autonomous operation. The physical system then executes these optimized trajectories for device advancement, retraction, and valve actuation, potentially enabling remote or tele-operated thrombectomy.
   • Obviousness Argument: The application of widely available open-source robotics frameworks (ROS, Gazebo) to automate and enhance the precision of a medical device procedure (US12239333) would be an obvious extension for a PHOSITA in the field of medical robotics, aiming to improve consistency, reduce operator fatigue, and enable new surgical paradigms.