US 12016580

Here's a concise summary of US Patent 12016580:

US Patent 12016580

• Title: Single insertion delivery system for treating embolism and associated systems and methods

• Assignee: Inari Medical Inc [cite: The "Current Assignee" and "Original Assignee" are both listed as Inari Medical Inc.]

• Inventors: Richard Quick, Benjamin Edward Merritt, John Coleman Thress, Paul Lubock, Thomas M. Tu [cite: The inventors are listed as Richard Quick, Benjamin Edward Merritt, John Coleman Thress, Paul Lubock, Thomas M. Tu.]

• Filing Date: October 11, 2021 [cite: The filing date is listed as 2021-10-11.]

• Issue Date: June 25, 2024 [cite: The publication date and application granted date are both listed as 2024-06-25.]

• Abstract: Systems and methods for the intravascular treatment of clot material within a blood vessel of a human patient are disclosed. A method can include engaging an interventional device with clot material in a blood vessel and withdrawing the interventional device and a portion of the clot material through a guide catheter. In some embodiments, the catheter system includes an attachment/valve member coupled to a proximal portion of the guide catheter, and the method can include unsealing the attachment/valve member to facilitate withdrawing the interventional device through it without significant retention of clot material. The method can further include resealing and aspirating the guide catheter before advancing another interventional device to the clot material to again engage and remove clot material from the blood vessel.

• Plain-Language Overview of Independent Claims:

  • Independent Claim 1 (Method): This claim describes a method for treating clot material in a patient's blood vessel. It involves inserting a guide catheter, advancing an interventional device through it to engage the clot, and then retracting the device and clot into the guide catheter. Crucially, the method includes an attachment member connected to the guide catheter that can be unsealed to allow the interventional device to pass through without leaving much clot material behind. After withdrawal, the attachment member is resealed, and the guide catheter is aspirated (suctioned) to remove any remaining clot or fluid. This allows for repeated deployments of the interventional device without removing the entire guide catheter from the patient.
  • Independent Claim 11 (Method): Similar to Claim 1, this method also focuses on intravascular clot treatment using a guide catheter and an interventional device. It specifies inserting a guide catheter with an attachment member, deploying an interventional device to engage clot material, and withdrawing the device with the captured clot into the guide catheter. A key aspect is actuating the attachment member to expand a lumen through which the interventional device passes, preventing clot retention. Following withdrawal, the attachment member is returned to a sealed state, and the guide catheter is aspirated to clear any residual material, enabling subsequent passes without full guide catheter removal.
  • Independent Claim 18 (System): This claim describes a system for treating clot material. The system includes a guide catheter, a delivery sheath, an interventional device, a retraction and aspiration (RA) device, and an attachment member. The attachment member is coupled to the guide catheter and designed to be actuated between a first (sealed) configuration and a second (unsealed) configuration. In the unsealed configuration, a continuous lumen of consistent diameter is formed through the attachment member and the guide catheter, allowing the interventional device to pass through without stripping clot material. The RA device is configured to retract the delivery sheath and interventional device while simultaneously aspirating through the guide catheter.

• Litigation Status: The patent is currently active. [cite: The legal status is listed as "Active".] There is a PTAB case IPR2025-01264 filed, which is pending and instituted. [cite: The patent family has litigation, specifically "PTAB case IPR2025-01264 filed (Pending - Instituted)".] As of April 26, 2026, no specific dockets directly pertaining to US Patent 12016580 have been found in the 2026 CAFC dockets.

US patent 12016580 is involved in at least one litigation case.

Here is the known litigation involving US patent 12016580:

Patent Trial and Appeal Board (PTAB) Case

• Case Number: IPR2025-01264 [cite: US12016580B2]
• Plaintiff(s): Unified Patents PTAB Data (Petitioner) [cite: US12016580B2]
• Defendant(s): Not explicitly listed as "defendant" in the provided snippet, but Inari Medical Inc. is the current assignee of the patent.
• Jurisdiction: Patent Trial and Appeal Board (PTAB) [cite: US12016580B2]
• Filing Date: Not explicitly stated in the snippet, but the case is IPR2025-01264.
• Outcome/Current Status: Pending - Instituted [cite: US12016580B2]

District Court Case

• Case Number: 5:24-cv-03117 [cite: US12016580B2]
• Plaintiff(s): Not explicitly listed in the provided snippet.
• Defendant(s): Not explicitly listed in the provided snippet.
• Jurisdiction: California Northern District Court [cite: US12016580B2]
• Filing Date: Not explicitly stated in the snippet.
• Outcome/Current Status: Litigation is ongoing. [cite: US12016580B2]

Additionally, the patent family has worldwide litigation filed. [cite: US12016580B2]

Proceedings overview

One AIA trial proceeding is on file for US patent 12016580. This proceeding is currently active with a "Trial Instituted" status, meaning a trial has been ordered but no final decision on patentability has been issued. This indicates that the patent's claims are currently being challenged, and their patentability remains undetermined by the PTAB.

IPR2025-01264 — Imperative Care, Inc. v. Inari Medical Inc.

• Type: Inter Partes Review
• Filed: 2025-07-08
• Status: Trial Instituted — A trial has been ordered by the Patent Trial and Appeal Board (PTAB), and the proceeding is currently ongoing.
• Judge panel: The specific panel of Administrative Patent Judges (APJs) assigned to conduct the trial for IPR2025-01264 is not publicly available in the provided search results. Institution decisions effective October 20, 2025, are made personally by USPTO Director John Squires in consultation with at least three PTAB judges, and routine decisions are issued without detailed explanation.
• Petition grounds: The specific claims challenged and the prior art references or statutory bases (§ 102 / § 103 / § 112) are not explicitly detailed in the public search results. Generally, IPRs challenge claims under 35 U.S.C. §§ 102 and/or 103.
• Institution decision: Instituted on 2025-12-11. Director Squires's decisions issued around this time began listing petitions that had overcome discretionary denial and were being considered on the merits, indicating institution. The reasoning for institution is not publicly detailed, as routine institution decisions under Director Squires's policy are issued as summary notices without written explanations.
• Final Written Decision (if issued): Not yet issued. The Final Written Decision is typically due one year from the institution date.
• Settlement / termination: No settlement or termination has been publicly reported for this proceeding as of 2026-05-19.
• Appeal: Not applicable, as no Final Written Decision has been issued yet.
• Defensive value: This proceeding indicates that the patentability of US12016580 is currently under review at the PTAB. While no claims have been invalidated, the active trial status means there is an ongoing challenge to the patent's validity. If a Final Written Decision ultimately cancels claims, those claims would be significantly weakened for any assertion.

Strategic summary

Currently, all claims of US12016580 are still considered active and untested by a Final Written Decision in IPR2025-01264. No claims have been CANCELED or SUSTAINED by the PTAB. The patent is actively undergoing an Inter Partes Review, with the trial having been instituted on 2025-12-11.

Regarding the estoppel landscape, if IPR2025-01264 proceeds to a Final Written Decision, the petitioner (Imperative Care, Inc.) and its privies would be estopped under 35 U.S.C. § 315(e)(2) from asserting in future civil actions or ITC proceedings any ground that was raised or reasonably could have been raised during the IPR with respect to the instituted claims. Since the specific claims challenged and prior art grounds are not publicly available, it is not possible to detail the precise scope of potential estoppel at this time.

There are no apparent pattern signals such as multiple IPRs filed by the same petitioner on this specific patent, nor any noted appeals by the patent owner yet, as no Final Written Decision has been rendered.

Recommended next steps

The IPR2025-01264 proceeding is active and currently in the trial phase. Given the institution date of 2025-12-11, the Final Written Decision for this IPR is statutorily due approximately one year from that date, which would be 2026-12-11. A defendant facing assertion of this patent should closely monitor this IPR for the issuance of the Final Written Decision, as it will determine the patentability of the challenged claims. The outcome of this proceeding will significantly impact the strength of US12016580.

Inventors

• Richard Quick
• Benjamin Edward Merritt
• John Coleman Thress
• Paul Lubock
• Thomas M. Tu

The patent does not provide information on the inventors' employers at the time of filing or their current employment status. Therefore, it is not possible to note any unusual patterns regarding their departure from an original assignee.

Original assignee

The original assignee listed is Inari Medical Inc. [cite: US12016580B2].

Inari Medical Inc. is a medical device company that develops products for treating venous diseases. They ship products embodying the claims of US12016580B2, which relates to systems and methods for the intravascular treatment of clot material, specifically for pulmonary embolism. Inari Medical Inc. is currently an operating company.

Assignment timeline

There are no recorded assignments for US12016580 found in the USPTO Assignment Center search as of 2026-05-19. The Google Patents legal events section indicates "Assigned to INCEPTUS MEDICAL, LLC" on 2022-10-07 and "Assigned to Inari Medical, Inc." on 2022-10-07, and "Assigned to Inari Medical, Inc." on 2024-01-25. However, these appear to be reassignments involving the inventors and Inceptus Medical, LLC, ultimately leading back to Inari Medical, Inc. as the current assignee. Since these events are not reflected in the USPTO Assignment Center, they are not detailed here as recorded assignments.

Timeline diagram

timeline
    title Ownership of US 12016580
    2018 : Priority date
    2021 : Application filed by Inari Medical Inc
    2022 : Publication of US20220240959A1
    2024 : Publication & Grant of US12016580B2

NPE / troll-pattern signals

1. Shell-entity transfer — not present. The patent remains with Inari Medical Inc., an operating company.
2. Known asserter in the chain — not present. Inari Medical Inc. is not identified as a known NPE.
3. Repeat correspondent across the chain — not present. There are no recorded assignments in the USPTO Assignment Center to establish a chain or identify repeat correspondents.
4. Cascading transfers — not present. No assignments are recorded in the USPTO Assignment Center.
5. Pre-litigation transfer — unclear. While there are district court and PTAB litigations noted, no assignment records are present in the USPTO Assignment Center to determine if a transfer occurred within 6 months prior to the first infringement suit.
6. Bankruptcy fire-sale — not present. There is no indication of Inari Medical Inc. undergoing bankruptcy proceedings.
7. Privateering — not present. There is no evidence of Inari Medical Inc. transferring the patent to an NPE for assertion on its behalf.
8. Defensive aggregator (anti-NPE) — not present. The patent is currently assigned to Inari Medical Inc., not a defensive aggregator.

Verdict

Operating-company assertion. The patent is currently assigned to Inari Medical Inc., an operating company in the medical device field that manufactures and sells products related to the claimed technology. The detected litigation (PTAB case IPR2025-01264 and US case 5:24-cv-03117 in California Northern District Court) suggests assertion by the operating company, likely against competitors. [cite: US12016580B2]

Verification: https://assignmentcenter.uspto.gov/ (search for patent number 12016580).

To identify the most relevant prior art for US patent 12016580 and analyze its potential impact on the claims, I will use the authoritative patent text provided. The patent itself lists prior art in its "References Cited" section. I will focus on the patent documents directly cited within the US12016580B2 text.

The provided patent text explicitly incorporates by reference U.S. Pat. No. 9,526,864. This indicates it is a highly relevant piece of prior art.

Most Relevant Prior Art for US Patent 12016580

The most directly referenced prior art within US120166580B2 is U.S. Pat. No. 9,526,864.

Full Citation: U.S. Pat. No. 9,526,864, filed Jun. 9, 2015, and titled "RETRACTION AND ASPIRATION DEVICE FOR TREATING EMBOLISM AND ASSOCIATED METHODS" [cite: The RA device 100, the catheter system 200, and the tubing system 300 can be the same as or similar to one or more of the retraction and aspiration devices, catheter systems, and tubing systems disclosed in U.S. Pat. No. 9,526,864, filed Jun. 9, 2015, and titled “RETRACTION AND ASPIRATION DEVICE FOR TREATING EMBOLISM AND ASSOCIATED METHODS,” which is incorporated herein by reference in its entirety.]
Publication/Filing Date: Filed June 9, 2015. [cite: The RA device 100, the catheter system 200, and the tubing system 300 can be the same as or similar to one or more of the retraction and aspiration devices, catheter systems, and tubing systems disclosed in U.S. Pat. No. 9,526,864, filed Jun. 9, 2015, and titled “RETRACTION AND ASPIRATION DEVICE FOR TREATING EMBOLISM AND ASSOCIATED METHODS,” which is incorporated herein by reference in its entirety.]
Brief Description: This patent describes retraction and aspiration devices, catheter systems, and tubing systems for treating embolism. The current patent (US12016580B2) states that its RA device 100, catheter system 200, and tubing system 300 can be "the same as or similar to" those disclosed in US 9,526,864. [cite: The RA device 100, the catheter system 200, and the tubing system 300 can be the same as or similar to one or more of the retraction and aspiration devices, catheter systems, and tubing systems disclosed in U.S. Pat. No. 9,526,864, filed Jun. 9, 2015, and titled “RETRACTION AND ASPIRATION DEVICE FOR TREATING EMBOLISM AND ASSOCIATED METHODS,” which is incorporated herein by reference in its entirety.] This implies that US 9,526,864 lays foundational aspects for the retraction and aspiration components of the system.
Potential Anticipation (35 U.S.C. § 102): Given that US12016580B2 explicitly states its components can be "the same as or similar to" those in US 9,526,864, it is highly probable that US 9,526,864 anticipates at least the core elements related to the RA device, catheter system, and tubing system as broadly recited in the independent claims (Claim 1, Claim 11, and Claim 18) of US12016580B2. The novelty of US12016580B2, therefore, would likely rest on the specific improvements and functionalities beyond those broadly described in US 9,526,864, particularly regarding the ability for multiple passes without full guide catheter removal and the design of the attachment member for clot retention prevention. For instance, the specific mechanisms for "unsealing" and "resealing" the attachment member (e.g., the first valve insert 650, the second valve insert 860, or the garrote valve 1108) and their cooperative function in preventing clot stripping during withdrawal, as detailed in claims, would be key differentiators. If the basic RA device, catheter, and tubing system are directly taught or rendered obvious by US 9,526,864, then any claims in US12016580B2 that do not add a novel and non-obvious improvement to these core components could be anticipated.

The patent also references U.S. Provisional Patent Application No. 62/554,931, filed Sep. 6, 2017, titled "HEMOSTASIS VALVES AND METHODS OF USE," which is reproduced in Appendix D. This provisional application relates specifically to hemostasis valves, which are a component of the attachment member 1108.

Full Citation: U.S. Provisional Patent Application No. 62/554,931, filed Sep. 6, 2017, and titled "HEMOSTASIS VALVES AND METHODS OF USE". [cite: The attachment member 1108 can be, for example, a garrote valve (e.g., a hemostasis valve) as disclosed in provisional U.S. Patent Application No. 62/554,931, filed Sep. 6, 2017, and titled “HEMOSTASIS VALVES AND METHODS OF USE,” which is reproduced in Appendix D to this application, and which is incorporated herein by reference in its entirety.]
Publication/Filing Date: Filed September 6, 2017. [cite: The attachment member 1108 can be, for example, a garrote valve (e.g., a hemostasis valve) as disclosed in provisional U.S. Patent Application No. 62/554,931, filed Sep. 6, 2017, and titled “HEMOSTASIS VALVES AND METHODS OF USE,” which is reproduced in Appendix D to this application, and which is incorporated herein by reference in its entirety.]
Brief Description: This provisional patent application describes hemostasis valves and their methods of use. Specifically, the attachment member 1108 in US12016580B2 is noted as being similar to a garrote valve disclosed in this provisional application. [cite: The attachment member 1108 can be, for example, a garrote valve (e.g., a hemostasis valve) as disclosed in provisional U.S. Patent Application No. 62/554,931, filed Sep. 6, 2017, and titled “HEMOSTASIS VALVES AND METHODS OF USE,” which is reproduced in Appendix D to this application, and which is incorporated herein by reference in its entirety.] This suggests that the garrote valve's design and function, particularly its ability to create a hemostatic seal and to be actuated between sealed and unsealed configurations, are taught by this prior art.
Potential Anticipation (35 U.S.C. § 102): The provisional application 62/554,931 likely anticipates aspects of the attachment member 1108, particularly its structure as a garrote valve and its ability to provide a hemostatic seal and to change between a collapsed/sealed state and an expanded/open state. This would impact claims (e.g., Claim 1, Claim 11, and Claim 18) that describe the attachment member's specific valve mechanisms and its ability to create a continuous lumen or to be actuated for sealing and unsealing. If the provisional application fully describes the features of the attachment member 1108 that enable the "unsealing" and "resealing" for clot material passage without significant retention, then claims relying on these features might be anticipated.

Obviousness Analysis of US Patent 12016580 Under 35 U.S.C. § 103

This analysis identifies combinations of prior art references that would render the claims of US Patent 12016580 obvious to a person having ordinary skill in the art (POSA) at the time of the invention. The core innovation of US12016580 is enabling multiple passes of an interventional device for clot removal without fully withdrawing the guide catheter, by employing an attachment member that can be unsealed to prevent clot stripping and by aspirating the guide catheter between passes.

Identified Prior Art References:

1. US Patent No. 9,526,864 ("the '864 patent"): Titled "RETRACTION AND ASPIRATION DEVICE FOR TREATING EMBOLISM AND ASSOCIATED METHODS," this patent is explicitly incorporated by reference into US12016580. US12016580 states that its retraction and aspiration (RA) device 100, catheter system 200, and tubing system 300 "can be the same as or similar to one or more of the retraction and aspiration devices, catheter systems, and tubing systems disclosed in U.S. Pat. No. 9,526,864". [cite: The RA device 100, the catheter system 200, and the tubing system 300 can be the same as or similar to one or more of the retraction and aspiration devices, catheter systems, and tubing systems disclosed in U.S. Pat. No. 9,526,864, filed Jun. 9, 2015, and titled “RETRACTION AND ASPIRATION DEVICE FOR TREATING EMBOLISM AND ASSOCIATED METHODS,” which is incorporated herein by reference in its entirety.] This reference teaches the fundamental aspects of a system and method for simultaneously retracting an interventional device and aspirating through a guide catheter to remove emboli.
2. U.S. Provisional Patent Application No. 62/554,931 ("the '931 provisional"): Titled "HEMOSTASIS VALVES AND METHODS OF USE," this provisional application is also incorporated by reference into US12016580. US12016580 specifically identifies its attachment member 1108 as being, for example, a "garrote valve (e.g., a hemostasis valve) as disclosed in provisional U.S. Patent Application No. 62/554,931". [cite: The attachment member 1108 can be, for example, a garrote valve (e.g., a hemostasis valve) as disclosed in provisional U.S. Patent Application No. 62/554,931, filed Sep. 6, 2017, and titled “HEMOSTASIS VALVES AND METHODS OF USE,” which is reproduced in Appendix D to this application, and which is incorporated herein by reference in its entirety.] This reference therefore teaches an actuatable hemostasis valve designed to address fluid flow and device passage.

Both the '864 patent (filed June 9, 2015) and the '931 provisional (filed September 6, 2017) predate the priority date of US12016580 (January 26, 2018), making them valid prior art.

Problem Addressed by US12016580:

US12016580 explicitly identifies a problem in existing thrombectomy systems: the difficulty or impossibility of making repeated attempts (multiple "passes") to remove clot material. If a first pass is incomplete, conventional systems require the entire catheter system, including the guide catheter, to be fully removed from the patient, cleaned, and then reinserted for a second pass. This process is time-consuming, traumatic for the patient, and carries a significant risk of stripping clot material from the interventional device as it is withdrawn through the hemostasis valve, potentially reintroducing it into the patient. [cite: Moreover, with many devices, it is difficult or not possible to make repeated attempts at removing clot material (e.g., to make multiple passes with a device). In particular, if a first pass with a device does not completely capture and/or collect all of the clot material, the device and an accompanying catheter system must be removed from the patient, cleaned, and subsequently reinserted into the patient in order to make a second pass and remove additional material. This can be time consuming and traumatic for the patient. Thus, there exists a need for an improved embolic extraction device.] The patent specifically notes that a conventional valve in the attachment member "may strip (e.g., break off, shear, etc.) clot material PE that held by the interventional device ID," leading to clot remaining in the attachment member and the risk of reintroduction. [cite: The valve 445 may strip (e.g., break off, shear, etc.) clot material PE that held by the interventional device ID. This can cause clot material PE to remain in the attachment member 408 after the interventional device ID is fully withdrawn from the patient, which presents a significant risk that remaining clot material PE will be reintroduced into the blood vessel BV of the patient if a second pass is made with the interventional device ID without fully removing the guide catheter 206 from the patient to enable cleaning of the guide catheter 206 and the attachment member 408.]

Obviousness Combination and Motivation:

A person of ordinary skill in the art (POSA) in the field of intravascular clot retrieval would be well aware of the limitations described in the background of US12016580 regarding multi-pass procedures and the issue of clot stripping at the hemostasis valve.

Combination of US 9,526,864 and US 62/554,931 (or similar known actuatable hemostasis valves):

• US 9,526,864 provides the core technology of a retraction and aspiration system (RA device, catheter system, tubing system) capable of simultaneously retracting an interventional device and aspirating through a guide catheter to remove clot material from a blood vessel. [cite: The RA device 100, the catheter system 200, and the tubing system 300 can be the same as or similar to one or more of the retraction and aspiration devices, catheter systems, and tubing systems disclosed in U.S. Pat. No. 9,526,864, filed Jun. 9, 2015, and titled “RETRACTION AND ASPIRATION DEVICE FOR TREATING EMBOLISM AND ASSOCIATED METHODS,” which is incorporated herein by reference in its entirety.] This reference provides the fundamental means for engaging, retracting, and aspirating clot material.
• US 62/554,931 (the garrote valve described therein, which is US12016580's attachment member 1108) teaches an actuatable hemostasis valve designed to be moved between a sealed configuration and an unsealed (open/expanded) configuration. Crucially, in its unsealed configuration, this valve can create a "continuous lumen of generally constant diameter" when a device is passed through it. [cite: The attachment member 1108 can be, for example, a garrote valve (e.g., a hemostasis valve) as disclosed in provisional U.S. Patent Application No. 62/554,931, filed Sep. 6, 2017, and titled “HEMOSTASIS VALVES AND METHODS OF USE,” which is reproduced in Appendix D to this application, and which is incorporated herein by reference in its entirety.] [cite: The actuation mechanism 1375 can be a manual actuator such as one or more buttons 1378. Depression or release of the buttons can, in some embodiments, facilitate sealing of the tubular member 1372 around tools or instruments of a wide range of sizes and/or diameters that fit through the tubular member 1372.] [cite: The central lumen 1374 of the tubular member 1372 and the first lumen 1371 of the housing 1370 can together provide a continuous lumen of generally constant diameter.] US12016580 explicitly states that this "constant diameter can prevent clot material PE associated with the interventional device ID from getting stuck in (e.g., remaining in) the attachment member 1108 as the interventional device ID is retracted through the attachment member 1108 —thus minimizing the risk of reintroducing clot material to the patient upon a second pass using the interventional device ID (or another interventional device)." [cite: Such a constant diameter can prevent clot material PE associated with the interventional device ID from getting stuck in (e.g., remaining in) the attachment member 1108 as the interventional device ID is retracted through the attachment member 1108 —thus minimizing the risk of reintroducing clot material to the patient upon a second pass using the interventional device ID (or another interventional device).]

Motivation for Combination:

A POSA, recognizing the problem of clot stripping and the inefficiencies of fully removing and reinserting the guide catheter for multiple passes in the system taught by the '864 patent, would be highly motivated to incorporate a hemostasis valve that mitigates these issues. The '931 provisional explicitly describes a garrote valve designed for such purposes, particularly its ability to create a continuous, constant-diameter lumen to facilitate device passage and prevent material retention.

Combining the effective clot removal and aspiration system of the '864 patent with the specialized hemostasis valve of the '931 provisional would be an obvious design choice for a POSA seeking to improve multi-pass thrombectomy procedures. The resulting system would allow for:

• Unsealing the attachment member: By actuating the garrote valve (or using an insert like the first valve insert 650 described in US12016580), the lumen through the attachment member could be expanded to match the guide catheter's lumen, allowing the clot-laden interventional device to pass without stripping clot material. This directly solves the problem identified by US12016580. [cite: The first valve insert 650 helps create a lumen of constant diameter through the attachment member 408 such that a diameter of the interventional device ID does not substantially change (e.g., expand and/or contract) as the interventional device ID is withdrawn proximally through the attachment member 408.] [cite: The first valve insert 650 of the present technology inhibits clot material PE engaged with the interventional device ID from being stripped by the valve 445 within the attachment member 408 and, therefore, enables a second pass with the interventional device ID to be made without removing the guide catheter 206 from the patient.]
• Resealing the attachment member: After withdrawal, the actuatable valve could be resealed to maintain hemostasis for subsequent steps. This is an inherent function of such a valve.
• Aspirating the guide catheter: The aspiration capability already taught by the '864 patent would then be employed to clear any residual blood or small clot fragments from the guide catheter before the next pass, further reducing contamination risk. [cite: Aspirating the guide catheter 206 removes any residual clot material PE remaining in the guide catheter 206.]

The combination directly addresses the stated "need for an improved embolic extraction device" that allows for "repeated attempts at removing clot material" without the need to "fully remov[e] the guide catheter 206 from the patient." [cite: Moreover, with many devices, it is difficult or not possible to make repeated attempts at removing clot material (e.g., to make multiple passes with a device). In particular, if a first pass with a device does not completely capture and/or collect all of the clot material, the device and an accompanying catheter system must be removed from the patient, cleaned, and subsequently reinserted into the patient in order to make a second pass and remove additional material. This can be time consuming and traumatic for the patient. Thus, there exists a need for an improved embolic extraction device.] [cite: The first valve insert 650 of the present technology inhibits clot material PE engaged with the interventional device ID from being stripped by the valve 445 within the attachment member 408 and, therefore, enables a second pass with the interventional device ID to be made without removing the guide catheter 206 from the patient.]

Therefore, the methods and system claimed in US12016580, specifically the features enabling multiple passes through an actuatable attachment member that prevents clot stripping, followed by resealing and aspiration, would be obvious to a POSA when combining the teachings of US 9,526,864 and US 62/554,931.

US Patent 12016580, titled "Single insertion delivery system for treating embolism and associated systems and methods," has an anticipated expiration date of January 25, 2039. This date is calculated as 20 years from its earliest priority date, which is January 26, 2018. The patent term can be adjusted by Patent Term Adjustment (PTA) or Patent Term Extension (PTE).

Patent Term Adjustment (PTA) and Patent Term Extension (PTE)
The USPTO does not publicly calculate expiration dates for patents but provides a calculator for estimation. The provided patent information indicates an "Anticipated expiration" date of 2039-01-25. [cite: The "Anticipated expiration" is listed as 2039-01-25.] This typically includes any PTA, which compensates for certain delays by the USPTO during patent prosecution. These delays include:

• Failure to issue a first Office Action or notice of allowance within 14 months of filing.
• Failure to issue an action within four months of an applicant's response.
• Failure to issue the patent within three years of the actual filing date.
• Failure to issue the patent within four months of payment of the issue fee.

The patent information does not explicitly state any awarded PTA or PTE in terms of specific days. However, the listed "Anticipated expiration" date accounts for these adjustments.

Continuation Applications, Divisional Applications, and Related Family Members
US Patent 12016580 is a continuation of U.S. patent application Ser. No. 16/258,344, filed on January 25, 2019, which itself claims the benefit of U.S. Provisional Patent Application No. 62/622,691, filed on January 26, 2018 [cite: The description states: "This application is a continuation of U.S. patent application Ser. No. 16/258,344, filed on Jan. 25, 2019, and titled “SINGLE INSERTION DELIVERY SYSTEM FOR TREATING EMBOLISM AND ASSOCIATED SYSTEMS AND METHODS,” which claims the benefit of U.S. Provisional Patent Application No. 62/622,691, filed on Jan. 26, 2018"].

The patent also lists several priority dates and other versions, indicating a family of related applications:

• Priority to US17/498,642: October 11, 2021 [cite: A priority date is listed as 2021-10-11 for US17/498,642.]
• Priority to US17/865,307: July 14, 2022 [cite: A priority date is listed as 2022-07-14 for US17/865,307.]
• Priority to US17/865,297: July 14, 2022 [cite: A priority date is listed as 2022-07-14 for US17/865,297.]
• Other Version: US20220240959A1 [cite: US20220240959A1 is listed as an "Other version".]
• Priority to US17/978,024: October 31, 2022 [cite: A priority date is listed as 2022-10-31 for US17/978,024.]
• Priority to US18/358,837: July 25, 2023 [cite: A priority date is listed as 2023-07-25 for US18/358,837.]
• Priority to US18/497,249: October 30, 2023 [cite: A priority date is listed as 2023-10-30 for US18/497,249.]
• Priority to US19/011,529: January 6, 2025 [cite: A priority date is listed as 2025-01-06 for US19/011,529.]
• Priority to US19/030,209: January 17, 2025 [cite: A priority date is listed as 2025-01-17 for US19/030,209.]
• Priority to US19/030,673: January 17, 2025 [cite: A priority date is listed as 2025-01-17 for US19/030,673.]

Continuation applications typically pursue additional or different claims from the same disclosed invention as the parent application, without adding new subject matter, and share the same priority date. Divisional applications are filed in response to a USPTO restriction requirement, claiming a distinct invention disclosed but not claimed in the parent application, and are also entitled to the parent's filing date as their priority date. The information provided does not explicitly categorize these priority applications as continuations or divisionals, beyond the initial statement that US12016580B2 is a continuation of US 16/258,344.

Defensive Disclosure: Derivatives of US12016580 - Single Insertion Delivery System

This document outlines derivative works and technical disclosures related to US Patent 12016580, "Single insertion delivery system for treating embolism and associated systems and methods," for defensive publishing purposes. The aim is to establish prior art that could render future incremental improvements by competitors as obvious or non-novel.

The derivations are based on the independent claims of US12016580, specifically focusing on the system claim (Claim 18) due to its comprehensive description of the invention's components and functionality, which inherently covers the method claims (Claims 1 and 11).

Derivatives of Independent Claim 18 (System)

Claim 18 Summary: A system for treating clot material, including a guide catheter, delivery sheath, interventional device, retraction and aspiration (RA) device, and an attachment member coupled to the guide catheter. The attachment member is actuatable between sealed and unsealed configurations, where the unsealed configuration provides a continuous, consistent-diameter lumen for interventional device passage without stripping clot. The RA device simultaneously retracts the delivery sheath/interventional device and aspirates through the guide catheter.

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1. Material & Component Substitution

Derivative 1.1: Shape Memory Alloy Actuation for Attachment Member

• Enabling Description: The attachment member (AM) housing (1370) integrates a shape memory alloy (SMA) element, such as a Nitinol coil, within or around the tubular member (1372). Instead of mechanical buttons (1378) or filaments (1376) for actuation, localized resistive heating is applied to the SMA element (e.g., via embedded micro-heaters and electrical contacts) to transition it from a martensitic (sealed/collapsed) to an austenitic (unsealed/expanded) phase. Upon cooling (e.g., active cooling via fluid circulation or passive heat dissipation), the SMA returns to its martensitic phase, sealing the lumen. The tubular member (1372) is fabricated from a medical-grade, low-friction, high-elasticity polymer, such as a silicone-polyurethane copolymer, capable of accommodating the SMA-induced diameter changes. The RA device (100) includes a control module that sends precise electrical pulses to activate the SMA, allowing for controlled, gradual opening and closing of the AM lumen. This eliminates mechanical linkages prone to wear and offers fine control over lumen diameter.

  classDiagram
      class System {
          +GuideCatheter GC
          +DeliverySheath DS
          +InterventionalDevice ID
          +RA_Device RAD
          +AttachmentMember AM
      }
      class AttachmentMember {
          +Housing 1370
          +TubularMember 1372
          +SMA_Actuator SMA
          +MicroHeaters MH
          +ControlModule CM
      }
      class SMA_Actuator {
          +NitinolCoil
          +MartensiticPhase()
          +AusteniticPhase()
      }
      class ControlModule {
          +SendElectricalPulses(target_temp)
          +MonitorTemperature(sensor_data)
      }
      System "1" -- "1" AttachmentMember : includes
      AttachmentMember "1" -- "1" SMA_Actuator : actuates
      AttachmentMember "1" -- "1" ControlModule : controls
      ControlModule -- MicroHeaters : powers
  

Derivative 1.2: Magnetorheological Fluid Seal for Attachment Member

• Enabling Description: The attachment member (AM) utilizes a magnetorheological (MR) fluid as the sealing mechanism. The tubular member (1372) is replaced with a compliant elastomer membrane (e.g., medical-grade silicone) defining the central lumen (1374). The space between this membrane and the outer housing (1370) is filled with an MR fluid. A series of electromagnets are embedded within the housing (1370) surrounding the MR fluid chamber. To seal, a magnetic field is applied, causing the MR fluid's ferromagnetic particles to align and rapidly increase the fluid's apparent viscosity and yield strength, effectively solidifying around the interventional device (ID) or guidewire. To unseal, the magnetic field is removed, and the fluid returns to a low-viscosity state, allowing the elastomer membrane to expand to its maximum diameter (1371). The RA device (100) incorporates a power supply and control unit for the electromagnets, allowing variable sealing pressure.

  flowchart TD
      A[Attachment Member] --> B{MR Fluid Chamber}
      B --> C[Elastomer Membrane (Lumen)]
      B --> D[Electromagnets]
      D -- On --> E{MR Fluid Solidifies}
      E --> F[Sealed Configuration]
      D -- Off --> G{MR Fluid Fluidizes}
      G --> H[Unsealed Configuration]
      F -- Interventional Device Passage --> I(Hemostasis Maintained)
      H -- Interventional Device Passage --> J(Unrestricted Passage)
  

Derivative 1.3: Piezoelectric-Actuated Fiber Optic Sensing for Interventional Device Deployment

• Enabling Description: The delivery sheath (204) and interventional device (ID) incorporate embedded piezoelectric micro-actuators and fiber optic sensors. The piezoelectric elements, distributed along the distal end of the delivery sheath, can generate precise, localized vibrations to help dislodge and capture clot material upon deployment. The fiber optic sensors, such as Fiber Bragg Gratings (FBGs), are embedded along the ID and delivery sheath to provide real-time, high-resolution feedback on deformation, temperature, and contact pressure during deployment and retraction. This data is transmitted to an integrated processing unit within the RA device (100). This unit uses these inputs to adjust the retraction speed, aspiration pressure, and even the vibrational frequency of the piezoelectric elements, optimizing clot capture and minimizing vessel trauma. The attachment member maintains its primary sealing function but now receives fine-tuned operational parameters from the RA device based on this advanced sensing.

  sequenceDiagram
      Operator->>RA_Device: Initiate Deployment
      RA_Device->>Delivery_Sheath: Advance DS
      RA_Device->>Interventional_Device: Deploy ID
      Interventional_Device->>+Fiber_Optic_Sensors: Sense (Deformation, Pressure, Temp)
      Fiber_Optic_Sensors->>RA_Device: Send FBG Data (Real-time)
      Interventional_Device->>+Piezo_Actuators: Apply Micro-Vibrations (Optional)
      Piezo_Actuators->>RA_Device: Send Feedback
      RA_Device->>RA_Control_Unit: Process Sensor Data
      RA_Control_Unit->>RA_Device: Adjust Retraction Speed, Aspiration Pressure, Vibration Freq.
      RA_Device->>Attachment_Member: Adjust Sealing/Unsealing Parameters (Optional)
      Note over RA_Control_Unit: AI-driven optimization
  

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2. Operational Parameter Expansion

Derivative 2.1: Micro-Thrombectomy System for Capillary-Level Occlusions

• Enabling Description: This derivative scales the system down for micro-thrombectomy in cerebral microvasculature or retinal arteries, targeting emboli smaller than 100 micrometers. The guide catheter (206) becomes a micro-catheter with an outer diameter of 0.5-1.0 mm. The delivery sheath (204) and interventional device (ID) are scaled to 100-300 micrometers. The ID utilizes a chemically functionalized surface (e.g., streptokinase- or urokinase-impregnated polymers) for localized thrombolysis, combined with a photo-activated polymeric mesh for clot capture. The RA device (100) generates ultra-low, precisely controlled negative pressures (e.g., 0-5 mmHg) via a peristaltic pump system to avoid vessel collapse in delicate microvessels. The attachment member (1108) is a miniature garrote valve, actuated by micro-solenoids, providing a hermetic seal around the micro-catheter elements while ensuring a constant micro-lumen diameter for atraumatic device withdrawal. Optical coherence tomography (OCT) or two-photon microscopy are integrated for visualization.

  classDiagram
      class MicroThrombectomySystem {
          +MicroCatheter MC
          +MicroDeliverySheath MDS
          +MicroInterventionalDevice MID
          +MicroRA_Device MRAD
          +MicroAttachmentMember MAM
      }
      class MicroCatheter {
          +OuterDiameter: 0.5-1.0mm
          +Lumen
      }
      class MicroInterventionalDevice {
          +Diameter: 100-300um
          +ChemFunctionalizedSurface: Thrombolytic
          +PhotoActivatedPolymericMesh: Clot Capture
      }
      class MicroRA_Device {
          +PeristalticPump: Ultra-low Pressure Aspiration (0-5 mmHg)
          +ControlUnit
      }
      class MicroAttachmentMember {
          +MiniatureGarroteValve
          +MicroSolenoidActuation
          +HermeticSeal
      }
      MicroThrombectomySystem "1" -- "1" MicroCatheter
      MicroCatheter "1" -- "1" MicroDeliverySheath
      MicroDeliverySheath "1" -- "1" MicroInterventionalDevice
      MicroThrombectomySystem "1" -- "1" MicroRA_Device
      MicroThrombectomySystem "1" -- "1" MicroAttachmentMember
  

Derivative 2.2: High-Flow, Pulsed Aspiration for Large Vessel De-Clotting

• Enabling Description: This system is optimized for rapid de-clotting in large vessels, such as the inferior vena cava (IVC) or aorta, handling massive thrombi. The guide catheter (206) has an internal diameter greater than 10 mm. The RA device (100) integrates a high-volume, variable-frequency pulsatile pump capable of generating negative pressures up to 500 mmHg with flow rates exceeding 5 L/min. This pulsatile aspiration creates transient pressure differentials, aiding in fragmenting and dislodging larger, adherent clot material. The interventional device (ID) features a high-tensile strength polymeric or metallic mesh with optimized pore sizes for capturing large clot fragments while minimizing flow obstruction. The attachment member (1108) utilizes a robust, pneumatically actuated garrote valve with a rapid response time (sub-second) to synchronize with the pulsatile aspiration and device retraction, ensuring quick sealing and unsealing to handle high flow volumes without leakage.

  stateDiagram-v2
      state "RA Device Idle" as RAD_IDLE
      state "Generate Negative Pressure" as ASPIRATING
      state "Retract Device" as RETRACTING
      state "Attachment Member Sealed" as AM_SEALED
      state "Attachment Member Unsealed" as AM_UNSEALED
  
      RAD_IDLE --> ASPIRATING : Lever Actuated (Pump)
      ASPIRATING --> RETRACTING : Simultaneous Operation
      RETRACTING --> ASPIRATING : Multiple Pumps
      AM_SEALED --> AM_UNSEALED : Actuate AM (Open)
      AM_UNSEALED --> AM_SEALED : Actuate AM (Close)
  
      ASPIRATING --> AM_SEALED : During Positive Pressure (Backflow Prevention)
      RETRACTING --> AM_UNSEALED : During ID Withdrawal
      AM_UNSEALED --> ASPIRATING : ID Passage with Aspiration
      AM_SEALED --> RAD_IDLE : Procedure Complete
  

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3. Cross-Domain Application

Derivative 3.1: Industrial Pipeline De-Clogging System (Oil & Gas)

• Enabling Description: The system is adapted for clearing paraffin, asphaltene, or hydrate blockages from industrial pipelines (e.g., oil and gas flowlines). The "guide catheter" becomes a rigid or flexible drilling conduit, advanced from a wellhead or access port. The "interventional device" is a modular drilling/scraping tool (e.g., a rotary cutter, brush, or solvent dispenser) designed to engage and break up blockages. The "delivery sheath" protects the drilling tool during insertion. The "RA device" is a high-pressure pumping and suction unit, circulating hot solvents or dispersants while simultaneously extracting dissolved/fragmented material. The "attachment member" functions as a configurable high-pressure isolation valve or blow-out preventer (BOP) at the wellhead or access point. It features an expandable elastomer seal reinforced with steel segments, capable of sealing around various tool diameters and maintaining pressure integrity during tool exchanges without depressurizing the entire pipeline segment.

  flowchart LR
      A[Access Port / Wellhead] -- Conduit --> B(Pipeline)
      B -- Blockage --> C(Drilling/Scraping Tool)
      C -- Delivery Sheath --> A
      A -- Configurable Isolation Valve (Attachment Member) --> D[High-Pressure Pump & Suction Unit (RA Device)]
      D -- Circulate Solvents/Dispersants --> B
      D -- Extract Blockage Material --> E(Waste Reservoir)
  

Derivative 3.2: Automated Debris Removal for HVAC Ducts

• Enabling Description: This system is used for automated cleaning and debris removal within HVAC ductwork. The "guide catheter" is a deployable conduit, such as a flexible, segmented robotic arm or a track-guided sleeve, that can be navigated through the duct. The "interventional device" is a robotic brush, vacuum nozzle, or laser ablation head, designed to dislodge and remove accumulated dust, mold, or foreign objects. The "delivery sheath" protects the robotic arm/tool during navigation. The "RA device" is a high-power industrial vacuum system, connected to the deployable conduit, providing continuous or pulsed suction for debris collection. The "attachment member" is an access port with an actuated diaphragm seal (e.g., pneumatic or electric motor-driven iris diaphragm) that creates a tight seal around the deployed conduit, preventing contaminant escape and maintaining negative pressure within the duct during cleaning cycles, while allowing seamless tool insertion and withdrawal.

  graph TD
      A[Access Port] --> B{Attachment Member: Iris Diaphragm Seal}
      B --> C[Deployable Conduit (Guide Catheter)]
      C --> D[HVAC Ductwork]
      C --> E[Robotic Tool (Interventional Device)]
      F[Industrial Vacuum (RA Device)] --> B
      E -- Dislodge Debris --> D
      D -- Suction Debris --> F
  

Derivative 3.3: Micron-Scale Contaminant Extraction in Semiconductor Manufacturing

• Enabling Description: This system is for precise, in-situ extraction of micron-scale contaminants (e.g., particles, chemical residues) from intricate fluidic channels or surfaces within semiconductor manufacturing equipment (e.g., lithography systems, wet benches). The "guide catheter" is a rigid or flexible micro-manipulator, potentially incorporating MEMS-actuators for fine positioning, delivering a cleaning fluid or gas. The "interventional device" is a micro-tool such as an acoustic transducer for cavitation, a micro-jet nozzle for localized fluidic scrubbing, or a nano-fiber "brush" for particle capture. The "delivery sheath" protects the micro-tool during insertion. The "RA device" is a precision micro-fluidic control system, providing controlled flow rates of ultra-pure cleaning fluids and high-efficiency micro-aspiration for contaminant removal. The "attachment member" is a specialized, contamination-controlled docking port with a pressure-actuated fluidic seal (e.g., a dynamic liquid O-ring or ferrofluidic seal) that creates a localized, ultra-clean environment around the micro-manipulator, preventing particle ingress/egress while allowing precise micro-tool exchange.

  flowchart LR
      A[Micro-Manipulator (Guide Catheter)]
      B[Micro-Tool (Interventional Device)]
      C[Micro-Fluidic Control (RA Device)]
      D[Contamination-Controlled Docking Port (Attachment Member)]
      E[Semiconductor Equipment Channel]
  
      A -- Delivers Cleaning Fluid/Gas --> E
      B -- Engages Contaminants --> E
      C -- Provides Aspiration/Fluid Control --> E
      D -- Seals Around A --> C
      D -- Facilitates B Insertion/Withdrawal --> A
  

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4. Integration with Emerging Tech

Derivative 4.1: AI-Driven Optimization with IoT Sensors for Predictive Embolism Treatment

• Enabling Description: The system integrates a suite of IoT micro-sensors (pressure, temperature, flow, chemical markers, ultrasound transducers) along the guide catheter (206) and interventional device (ID). These sensors continuously stream real-time physiological and procedural data to an on-board AI diagnostic and control module within the RA device (100). The AI analyzes this data to: (i) predict clot morphology and adherence, optimizing ID deployment angle and retraction force; (ii) dynamically adjust aspiration pressure and duration based on real-time flow and clot fragmentation; (iii) provide real-time feedback on vessel health and potential trauma; and (iv) suggest optimal flushing protocols. The attachment member (1108) incorporates a smart, self-calibrating seal with integrated pressure sensors, allowing the AI to fine-tune its sealing force to the exact interventional device diameter, preventing leaks while minimizing friction.

  flowchart TD
      A[IoT Micro-Sensors (GC/ID)] --> B{Data Stream}
      B --> C[AI Diagnostic & Control Module (RA Device)]
      C -- Optimize ID Deployment --> D[Interventional Device]
      C -- Adjust Aspiration Parameters --> E[RA Device Aspiration Unit]
      C -- Fine-tune Sealing Force --> F[Smart Attachment Member]
      C -- Provide Real-time Feedback --> G(Operator Interface)
      G --> H(Vessel Health/Trauma Alerts)
  

Derivative 4.2: Blockchain-Enabled Supply Chain & Procedural Logging

• Enabling Description: Each major component of the clot retrieval system (guide catheter, delivery sheath, interventional device, RA device, attachment member, and valve inserts) is tagged with a unique, cryptographically secured identifier (e.g., RFID with embedded tamper-proof chips). Upon manufacturing, packaging, sterilization, and distribution, each event is recorded on a private blockchain network accessible by manufacturers, distributors, and healthcare providers. During a medical procedure, the RA device (100) automatically logs the unique identifiers of all connected disposable components. Key procedural steps (e.g., device insertion, AM actuation, aspiration cycles, clot removal events, timestamps) are also recorded on the blockchain, creating an immutable audit trail for regulatory compliance, warranty tracking, and quality assurance. This ensures transparency, verifies component authenticity, and provides a robust, unalterable record of device usage.

  sequenceDiagram
      Manufacturer->>Blockchain: Register Component ID & Mfg Data
      Distributor->>Blockchain: Log Shipping & Receiving (Component ID)
      Hospital->>Blockchain: Log Receipt & Inventory (Component ID)
      Operator->>RA_Device: Attach Components (GC, DS, ID, AM)
      RA_Device->>RA_Device: Scan Component IDs
      RA_Device->>Blockchain: Log Component Usage (Procedure ID, Timestamp)
      Operator->>RA_Device: Perform Procedure Steps
      RA_Device->>Blockchain: Log Procedure Events (AM Actuation, Aspiration, Clot Removal)
      Blockchain->>Regulatory_Authorities: Provide Immutable Audit Trail
  

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5. The "Inverse" or Failure Mode

Derivative 5.1: Bio-Resorbable Interventional Device with Automated Safe Dissolution

• Enabling Description: The interventional device (ID) is fabricated from a bio-resorbable polymer (e.g., poly(lactic-co-glycolic acid) (PLGA) or polycaprolactone (PCL)) and designed for controlled degradation. In the event of unsuccessful retrieval or if the ID becomes irretrievably lodged, the RA device (100) can initiate an "automated safe dissolution" protocol. This involves introducing a specific, biocompatible solvent (e.g., a low-pH saline solution or enzymatic agent) through the guide catheter (206) lumen, which is recirculated by the RA device. The solvent accelerates the degradation of the ID into harmless, absorbable monomers, minimizing patient trauma from a permanently implanted or fractured device. The attachment member (1108) provides a robust, leak-proof seal during solvent circulation to prevent systemic exposure, and its internal lumen is constructed from materials resistant to the dissolution agent. The RA device monitors the degradation process via integrated sensors (e.g., pH, conductivity, turbidity).

  graph LR
      A[Interventional Device (Bio-Resorbable)] -- Lodged / Failure to Retrieve --> B{RA Device: Initiate Dissolution Protocol}
      B --> C[Introduce Biocompatible Solvent (via GC)]
      C --> D[Target ID for Degradation]
      D -- Degradation Monitored by Sensors --> B
      B -- Recirculate Solvent --> C
      D -- ID Dissolves --> E[Harmless Monomers]
      F[Attachment Member] -- Maintains Leak-Proof Seal --> C
  

Derivative 5.2: Limited-Functionality "Patency Maintenance" Mode

• Enabling Description: In situations where full clot removal is not immediately possible or desirable (e.g., patient instability, complex clot morphology requiring prolonged intervention), the system can operate in a "patency maintenance" mode. In this mode, the interventional device (ID) (e.g., a temporary expandable mesh or flow diverter) is deployed to create a minimal lumen through the clot, restoring partial blood flow. The RA device (100) reduces aspiration to a minimal, continuous flow rate (e.g., 0.1-0.5 L/min) to maintain patency without actively removing bulk clot, conserving blood and energy. The attachment member (1108) remains in a semi-sealed state, allowing a guidewire to remain in place for future re-intervention, while minimizing blood loss. The system provides continuous monitoring of distal flow and pressure, triggering alerts if patency is compromised, but refrains from full-power retraction/aspiration unless explicitly commanded by the operator.

  stateDiagram-v2
      state "Full Thrombecomy Mode" as ACTIVE_MODE
      state "Patency Maintenance Mode" as LOW_POWER_MODE
  
      ACTIVE_MODE --> LOW_POWER_MODE : Operator Command (Patient Instability, etc.)
      LOW_POWER_MODE --> ACTIVE_MODE : Operator Command (Resume Full Removal)
  
      state "ID Fully Deployed" as ID_DEPLOYED
      state "Minimal Aspiration" as MIN_ASPIRATION
      state "AM Semi-Sealed" as AM_SEMI_SEALED
      state "Continuous Monitoring" as MONITORING
  
      LOW_POWER_MODE --> ID_DEPLOYED : (Temporary Mesh/Flow Diverter)
      LOW_POWER_MODE --> MIN_ASPIRATION : (0.1-0.5 L/min)
      LOW_POWER_MODE --> AM_SEMI_SEALED : (Guidewire Access)
      LOW_POWER_MODE --> MONITORING : (Distal Flow/Pressure)
  
      MIN_ASPIRATION --> MONITORING : Provides Data
      AM_SEMI_SEALED --> MONITORING : Provides Data
      MONITORING --> Alert : If Patency Compromised
  

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Combination Prior Art Scenarios with Open-Source Standards

These scenarios combine elements of US12016580 with existing open-source standards, demonstrating how such integrations could be considered obvious to a person skilled in the art.

1. DICOM (Digital Imaging and Communications in Medicine) Integration for Imaging Guidance:

   • Scenario: The clot retrieval system (US12016580) is commonly guided by fluoroscopic imaging. Integrating the system with DICOM standards would enable the real-time transmission and archiving of all intraoperative imaging (e.g., angiograms) directly to the hospital's Picture Archiving and Communication System (PACS). This allows for immediate correlation of the interventional device's position relative to the clot material (PE) and guide catheter (206) with pre-operative diagnostic images, improving precision during deployment (block 1001, 1401) and facilitating post-procedure assessment (block 1003, 1403). The RA device (100) or an auxiliary control unit would include a DICOM-compliant interface to receive and transmit image data, overlaying device position on the live fluoroscopic feed.
   • Open-Source Standard: DICOM (ISO 12052), a widely adopted standard for handling, storing, printing, and transmitting information in medical imaging.

2. HL7 (Health Level Seven) for Electronic Health Record (EHR) Integration:

   • Scenario: Data generated by the clot retrieval system (US12016580), such as procedure start/end times, aspiration volumes, removed clot characteristics (if measured), device serial numbers, and any alerts from integrated sensors (as in Derivative 4.1), are formatted and transmitted via HL7 messaging standards to the patient's Electronic Health Record (EHR). This automated data capture streamlines documentation, enhances billing accuracy, and supports clinical research by providing a structured, interoperable data set. The RA device (100) or an associated gateway device would incorporate an HL7 interface engine to process and send relevant data to the hospital's EHR system.
   • Open-Source Standard: Health Level Seven (HL7), a set of international standards for transfer of clinical and administrative data between healthcare information systems.

3. ROS (Robot Operating System) for Robotic-Assisted Catheter Navigation and Device Manipulation:

   • Scenario: For advanced robotic-assisted interventional procedures, the mechanical retraction and aspiration functions of the RA device (100) and precise movements of the delivery sheath (204) and interventional device (ID) are controlled and coordinated using a Robot Operating System (ROS) framework. ROS nodes would manage individual robotic effectors (e.g., for guide catheter steering, delivery sheath advancement, ID articulation), integrate sensor feedback (e.g., force, torque, position, haptic feedback), and interface with imaging systems. This allows for more sophisticated, automated, or semi-automated navigation to the clot (block 1001, 1401) and precise device manipulation during clot engagement and retraction (block 1002, 1402). The attachment member's (1108) actuation mechanism would also be controlled via ROS, ensuring synchronized opening/closing with robotic tool changes.
   • Open-Source Standard: Robot Operating System (ROS), a flexible framework for writing robot software, providing libraries and tools to help software developers create robot applications.