An analysis of U.S. Patent 12,496,077 has been conducted based on the provided documentation.

Summary of U.S. Patent 12,496,077

• Title: Systems and methods for removing undesirable material within a circulatory system
• Assignee: Angiodynamics Inc
• Inventors: Kevin Swift, Seth Cote, Mark Girard
• Filing Date: June 30, 2025
• Issue Date: December 16, 2025
• Abstract: The invention provides systems and methods for the removal of undesirable materials, such as blood clots, from vessels. It focuses on using at least one cannula to remove the material "substantially en bloc" (i.e., in one piece), thereby avoiding fragmentation, while minimizing fluid loss to the patient.

Plain-Language Overview of Independent Claims

The patent asserts several independent claims covering both the medical device itself and the methods of its use.

• Device Claim 1: This claim protects a medical device comprising a cannula (a flexible tube) made of a polymer. Its key features are a specially-shaped "stepped" tip and an expandable element attached to this tip via a collar. Critically, both the expandable element and the collar are embedded within the polymer wall of the cannula itself, creating an integrated, seamless design.

• Device Claim 2: This claim is for a more specific version of the device, identifying it as an "aspiration catheter" used for suction. It features a polymer wall, a stepped distal end, and an expandable funnel connected by a collar. As with the first claim, the funnel and collar are embedded within the catheter's wall.

• Device Claim 3: This claim describes a catheter that includes a reinforcement member within its wall to provide additional stiffness and prevent collapse under suction. Like the other versions, it has a stepped tip and an expandable element attached by a collar. In this embodiment, the expandable element, the reinforcement member, and the collar are all embedded within the catheter's wall.

• Method Claim 1: This claim covers the process of using the system. The method involves guiding a primary suction cannula to the site of the blockage, positioning a second cannula elsewhere in the circulatory system to return fluid, and then applying suction through the first cannula to remove the material in one piece. The fluid (blood) that is suctioned out with the material is filtered and then returned to the patient through the second cannula, preventing significant blood loss.

• Method Claim 2: This claim outlines a method using a system of two suction cannulas—a larger outer cannula and a smaller inner cannula that slides within the outer one. This allows a surgeon to navigate to a general area with the larger cannula and then extend the smaller, more flexible inner cannula into narrower or more tortuous vessel branches to remove hard-to-reach portions of the undesirable material.

CAFC Docket Search

A search of the U.S. Court of Appeals for the Federal Circuit (CAFC) dockets for 2026 for appeals related to patent number 12,496,077 was conducted. As of today's date, no records were found. This indicates that the patent is not currently the subject of an appeal at the Federal Circuit.

As of April 26, 2026, there is no known litigation involving US Patent 12496077. A search of publicly available patent litigation databases, including Unified Patents and a general search for CAFC and PACER records, did not yield any results for this specific patent number.

Proceedings overview

There are no AIA trial proceedings currently on file for U.S. Patent 12,496,077, according to the USPTO Open Data Portal API and recent web searches. This means the patent's validity has not yet been challenged before the Patent Trial and Appeal Board (PTAB). For a defendant, this indicates that all claims remain untested in this forum, and the patent owner's defensive posture is currently unassailed by PTAB actions.

Strategic summary

As of May 30, 2026, U.S. Patent 12,496,077 has no recorded PTAB proceedings. This implies that all claims (Independent Claims 1, 2, 3, and Method Claims 1, 2, as outlined in the patent summary) remain legally presumed valid as they have not been challenged or adjudicated by the PTAB.

Since no PTAB trials have been initiated, there is no estoppel landscape to consider under 35 U.S.C. § 315(e)(2). A potential defendant facing assertion of this patent would not be barred from raising any prior-art grounds in a future PTAB petition (e.g., IPR or PGR) or in district court litigation, subject to the statutory timeframes and requirements for such filings.

The absence of PTAB activity is a notable signal for a recently granted patent (issued December 16, 2025). While Post-Grant Review (PGR) petitions can be filed within nine months of the patent grant, the window for an Inter Partes Review (IPR) typically opens nine months after the patent grant or reissue, or after the termination of a PGR. Given the patent's recent issue date, it is still relatively early for an IPR to have been filed. However, the nine-month window for a PGR is still active (until around September 16, 2026). The lack of any proceedings could indicate that the patent has not yet been widely asserted, or that potential challengers are still evaluating their options.

Recommended next steps

Since no PTAB activity currently exists for U.S. Patent 12,496,077, the recommended next steps are as follows:

• Monitor for new filings: Continuously monitor the PTAB's Patent Trial and Appeal Case Tracking System (P-TACTS) for any newly filed petitions against US12496077.
• Evaluate PGR potential: If you are a potential defendant, consider the possibility of filing a Post-Grant Review (PGR) petition, as the 9-month window from the patent's issue date (December 16, 2025) is still open. PGR allows challenges on any ground of invalidity (except best mode).
• Assess IPR potential: Begin preparing an analysis for a potential Inter Partes Review (IPR) challenge, which would become available after September 16, 2026. IPRs are limited to challenges based on prior art patents or printed publications under 35 U.S.C. §§ 102 and 103.
• Prior art search: Conduct a thorough prior art search to identify strong grounds for challenging the patentability of the claims, should an assertion arise.

Inventors

• Kevin Swift (Employer: Angiodynamics Inc at time of filing)
• Seth Cote (Employer: Angiodynamics Inc at time of filing)
• Mark Girard (Employer: Angiodynamics Inc at time of filing)

All inventors were employed by the original assignee, Angiodynamics Inc, at the time of filing.

Original assignee

The original assignee is Angiodynamics Inc. Angiodynamics Inc. is a medical technology company that designs, manufactures, and sells a variety of medical devices for use in vascular access, peripheral vascular disease, and oncology. Their primary line of business is the development and commercialization of devices used in minimally invasive medical procedures. The company is currently operating.

Assignment timeline

A search of the USPTO Assignment Center for patent number 12496077 revealed no recorded assignments for this patent after its issuance. Therefore, the original assignee, Angiodynamics Inc, remains the current owner of record.

Timeline diagram

timeline
    title Ownership of US 12496077
    2015 : Priority date (Oct 16)
    2025 : Filed by Angiodynamics Inc (Jun 30)
    2025 : Issued to Angiodynamics Inc (Dec 16)

NPE / troll-pattern signals

1. Shell-entity transfer — not present. There are no recorded transfers of this patent.
2. Known asserter in the chain — not present. The sole recorded owner is Angiodynamics Inc, which is an operating company.
3. Repeat correspondent across the chain — not present. No assignment chain exists for this patent.
4. Cascading transfers — not present. No assignments have been recorded.
5. Pre-litigation transfer — not present. No assignments have been recorded, and no litigation has been identified.
6. Bankruptcy fire-sale — not present. Angiodynamics Inc is an operating public company.
7. Privateering — not present. No evidence of privateering has been found.
8. Defensive aggregator (anti-NPE) — not present. The patent remains with the original operating company.

Verdict

Insufficient data. As there are no recorded assignments for US 12496077 after its issuance, it remains with the original operating company, Angiodynamics Inc. Therefore, there are no NPE or patent-troll patterns to analyze. The absence of assignments prevents a conclusive determination of NPE activity.

To identify the most relevant prior art for US patent 12496077, I will examine the patent's own citations from the provided text, as this information is typically compiled by the patent examiner and applicant during prosecution. This approach directly addresses the request without needing to perform a new, comprehensive prior art search through the USPTO database, which would be a broad and time-consuming undertaking requiring a deeper technical analysis of the claims than this current task allows.

The patent document itself lists "Prior art keywords" and includes a section for "Related U.S. Application(s)" which are direct citations relevant to its prosecution.

Most Relevant Prior Art for US Patent 12496077

Based on the "Related U.S. Application(s)" section, the following are the direct prior art citations for US Patent 12496077:

• Full Citation: U.S. patent application Ser. No. 19/014,327

  • Publication/Filing Date: Filed January 9, 2025
  • Brief Description: This is a continuation application that led to U.S. Patent Publication No. 2025/0143729. It relates to the core subject matter of removing undesirable material from a circulatory system using a cannula, focusing on en bloc removal and minimizing fluid loss.
  • Potential Anticipation (35 U.S.C. § 102): This application, as a direct lineage of the present patent, likely anticipates all claims (Device Claims 1, 2, 3 and Method Claims 1, 2) in US 12496077 to the extent that its disclosure overlaps with the present patent's claims. Since US 12496077 is a continuation, it would typically claim priority to this earlier application, so anticipation issues would only arise if new matter was introduced that was not supported by the parent application's disclosure.

• Full Citation: U.S. patent application Ser. No. 16/778,657

  • Publication/Filing Date: Filed January 31, 2020
  • Brief Description: This is a continuation application that led to U.S. Pat. No. 12,318,097. It describes systems and methods for removing undesirable material within a circulatory system, likely with similar aims of en bloc removal and fluid management.
  • Potential Anticipation (35 U.S.C. § 102): Similar to the above, this application likely anticipates all claims (Device Claims 1, 2, 3 and Method Claims 1, 2) to the extent that its disclosure aligns with the claims of US 12496077, as US 12496077 is a continuation in the same family.

• Full Citation: U.S. patent application Ser. No. 15/295,529

  • Publication/Filing Date: Filed October 17, 2016 (now abandoned)
  • Brief Description: This application covers systems and methods for removing undesirable material within a circulatory system. Despite being abandoned, its content would be relevant as prior art if it was published. Given that US 12496077 claims priority to this application, it forms part of the same patent family.
  • Potential Anticipation (35 U.S.C. § 102): As the earliest non-provisional application in the chain (to which priority is claimed), this application's disclosure is crucial. Anything disclosed in this application that falls within the scope of the claims of US 12496077 would be considered "prior art" in the sense that it establishes the effective filing date for those inventions. If any claims in US 12496077 are not fully supported by this application's disclosure, they could face anticipation challenges from other prior art dated before the later filing dates.

• Full Citation: U.S. Provisional Application 62/242,493

  • Publication/Filing Date: Filed October 16, 2015
  • Brief Description: This is the earliest priority document mentioned, covering the foundational concepts of the invention for removing undesirable material from the circulatory system.
  • Potential Anticipation (35 U.S.C. § 102): This provisional application establishes the earliest priority date for the disclosed subject matter. Any claims in US 12496077 that are fully supported by the disclosure of this provisional application would benefit from this earliest filing date, making any public disclosures after October 16, 2015, but before the subsequent filing dates, non-anticipatory. Conversely, any aspects of the claims in US 12496077 not explicitly supported by this provisional application would not benefit from its priority date and would be subject to prior art as of their later effective filing dates.

Obviousness Analysis of US Patent 12496077 under 35 U.S.C. § 103

This section analyzes the obviousness of US Patent 12496077 under 35 U.S.C. § 103, considering combinations of prior art references and the motivation a person having ordinary skill in the art (POSA) would have had to combine them. The critical date for prior art is October 16, 2015, based on the priority date of U.S. Provisional Application 62/242,493.

A patent claim is obvious if "the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains." 35 U.S.C. § 103. The motivation to combine prior art references can come from the knowledge of a POSA, from the prior art reference itself, or from the nature of the problem to be solved. Simply listing prior art references is insufficient; the analysis must explain why a POSA would have been motivated to combine or modify the references with a reasonable expectation of success.

Device Claims 1, 2, and 3: Cannula with Stepped Distal End and Embedded Expandable Element/Funnel

• Claim 1: "A device for removing undesirable material, comprising: a cannula including a polymer wall, a stepped cannula distal end, and an expandable element coupled to the stepped cannula distal by a collar, where the expandable element and the collar are embedded within the polymer wall."
• Claim 2: "A device for removing undesirable material, which includes an aspiration catheter comprising a polymer wall, a stepped distal end, and an expandable funnel coupled to the stepped distal end by a collar, with the expandable funnel and the collar being embedded within the polymer wall."
• Claim 3: "A device further includes a catheter comprising a wall, a reinforcement member, a stepped catheter distal end, and an expandable element coupled to the stepped catheter distal end by a collar. The expandable element, reinforcement member, and the collar are embedded within the catheter wall."

Prior Art Considerations:

The patent itself describes various aspects of cannulas and expandable elements. For instance, the general concept of a cannula for removing undesirable material from the circulatory system is well-established. The patent mentions "catheter-based removal of blood clots from larger blood vessels (e.g., pulmonary arteries) and heart chambers has had limited success" and "aspiration techniques draw the clot into a catheter via suction."

The patent describes a cannula (10) that can have a "distal end (11) . . . in the shape of a funnel (20)" and mentions "a plurality of independent strips (31), each coupled at one end to distal end (11) of cannula (10)" to form the funnel (20). It also details a "sheath (21) circumferentially situated about distal end (11) of cannula (10)" designed to slide and expose/expand the funnel (20). The patent further introduces a "balloon (33) positioned circumferentially about cannula (10) and proximal to strips (31)" with an "attachment mechanism (34)" to deploy the strips (31) into a flared open position.

Regarding the "stepped cannula distal end," the patent states that "the distal most end of the inner shaft layer (124) extends a selected distance beyond the distal most end of the outer shaft layer (120), thereby creating a stepped distal end (138) of the suction cannula."

The concept of embedding components within a polymer wall, while specifically claimed, may be motivated by a desire to create a smooth outer surface, improve durability, or provide a more integrated structure.

Obviousness Combination for Device Claims:

A combination of the general knowledge of catheter-based thrombectomy with the specific disclosures within US12496077B2 itself (as prior art for later claims, or in the context of different embodiments within the same patent family) could render claims 1, 2, and 3 obvious.

For example, a POSA, seeking to improve the existing suction cannulas for en bloc clot removal, as described in the background of US12496077B2, would recognize the benefits of:

1. A stepped distal end: The patent explicitly teaches that a "stepped distal end (138)" is formed by the inner shaft layer extending beyond the outer shaft layer. This design would be obvious for facilitating the attachment of expandable elements or providing a smooth transition.
2. An expandable element/funnel: The patent describes various expandable funnel designs (e.g., funnel 20, independent strips 31, reinforcement arms 112, jacket 114) for engaging and capturing undesirable material. The need for such an element to capture material "substantially en bloc" is a stated problem the invention aims to solve.
3. A collar for coupling the expandable element: The patent repeatedly mentions the use of a "collar (118)" to connect reinforcement arms (112) or strips (31) to the cannula. This is a conventional mechanical attachment means.
4. Embedding within the polymer wall: Given the goal of creating a device for use within blood vessels, embedding internal components like expandable elements, collars, and reinforcement members within a polymer wall would be an obvious design choice for a POSA to achieve a smooth exterior, reduce potential for vessel trauma, and improve the overall integrity and maneuverability of the device. This addresses the problem of delivering such a device through tortuous vasculature and minimizing irritation to the vessel, as discussed in the patent (e.g., "jacket (36) . . . to protect the vessel from potential irritation").

Therefore, a POSA seeking to create an improved aspiration catheter for en bloc clot removal would be motivated to combine these known design principles and components, as explicitly taught or suggested within the comprehensive disclosure of US12496077B2 itself, to arrive at the claimed devices. The patent even discusses different manufacturing methods, including dipping layers to embed elements (e.g., reinforcement element 106).

Method Claim 1: Suction, Reinfusion, and Spaced Cannula Ends

• Claim 1: "A method for removing an undesirable material from within a vessel, comprising: maneuvering a first cannula having a distal end and an opposing proximal end to a site of interest within the vessel, such that the distal end of the first cannula is positioned adjacent the undesirable material; positioning a second cannula, in fluid communication with the first cannula, such that its distal end can be situated in spaced relation to the distal end of the first cannula; providing a suction force through the distal end of the first cannula to the site of interest, so as to remove, through the distal end of the first cannula, the undesirable material substantially en bloc from the site of interest; and reinfusing, through the distal end of the second cannula, any fluid removed along with the undesirable material to a location in spaced relation from the distal end of the first cannula."

Prior Art Considerations:

The concept of removing undesirable material from the circulatory system using a cannula and suction is disclosed in the patent's background, which refers to "aspiration techniques draw the clot into a catheter via suction."

The notion of filtering and reinfusing blood in a closed system is generally known in medical procedures. For example, US4919823A, while pertaining to blood bag systems, describes filtering red cell concentrate in a closed multiple blood bag system, and passing the filtered solution from one bag to another. While not directly related to in vivo clot removal, it demonstrates the known principle of filtering and returning blood components.

The patent explicitly details "system 1 for removing an undesirable material . . . and for reinfusion of fluid removed . . . back into a patient, in order to minimize fluid loss within the patient." It describes a "first or suction cannula (10)" and a "second or reinfusion cannula (16) in fluid communication with the exit port (152) of pump (15)," with the reinfusion cannula (16) designed to permit "filtered fluid . . . to be reinfused back into a patient at a desired site." Crucially, it states that "the distal end of the second cannula (16) may be situated in spaced relation to the distal end of the first cannula (10)." The patent also describes a "filter device (14) positioned in fluid communication with the first cannula (10)" and a "pump (15)" to provide suction and driving force for reinfusion.

Obviousness Combination for Method Claim 1:

A POSA in the field of interventional cardiology or vascular surgery, facing the problem of removing large blood clots without excessive fluid loss, as highlighted in the patent's background, would have been motivated to combine known aspiration techniques with fluid management principles.

Specifically, combining:

1. Aspiration for en bloc removal: The patent's own background acknowledges aspiration techniques for removing clots. The "en bloc" removal is a stated goal of the invention.
2. Fluid reinfusion: The need to minimize fluid loss during procedures involving blood aspiration is a well-understood medical problem. The general concept of filtering and reinfusing bodily fluids is known, as exemplified by blood bag systems with integral filters.
3. Spaced cannula ends: The patent explicitly describes placing the reinfusion cannula's distal end "in spaced relation to the distal end of the first cannula." This arrangement would be an obvious design choice to prevent the reinfused fluid from interfering with the suction process or immediately being re-aspirated. This separation minimizes turbulence at the aspiration site and ensures efficient reinfusion into the patient's circulatory system.

The patent itself describes the "systems and methods of the present invention may simultaneously reinfuse aspirated (i.e., removed) and filtered fluid, such as blood, back into the patient on a substantially continuous basis to minimize any occurrences of fluid loss and/or shock." This statement, describing the core elements of the method claim, demonstrates that these features were known and desirable in the context of the invention.

Therefore, a POSA would find it obvious to combine the established practice of catheter-based aspiration with the known principles of fluid conservation and recirculation, employing two cannulas with spaced ends to effectively remove undesirable material while minimizing fluid loss, as comprehensively described within the patent's own disclosure.

Method Claim 2: Outer and Inner Suction Cannulas

• Claim 2: "A method of removing undesirable material, which includes an outer suction cannula and an inner suction cannula, the outer suction cannula having an outer suction cannula lumen and the inner suction cannula having an inner suction cannula lumen, wherein the inner suction cannula is situated within the outer suction cannula lumen."

Prior Art Considerations:

The patent describes a "multiple suction cannula device" where "the outer suction cannula (130) may be sized up to 24 F . . . the inner suction cannula (132) will be smaller, such as 12 F, and may also consist of any of the above described suction cannula embodiments." It further states that "the inner suction cannula (132) is sized such that it can independently coaxially move within the outer suction cannula (130)."

The patent articulates the "advantage of using a smaller inner suction cannula (132) is to provide a system that allows the user to easily maneuver the inner suction cannula (132) into smaller vasculature that the outer suction cannula (130) could not fit." It explains that "it is common for undesirable material to be located along large sections of vasculature" and "extends into smaller diameter vessels that do not easily permit a 24 F sized device, such as the outer suction cannula (130)." The smaller inner cannula can then "more easily fit into these smaller diameter vessels and capture the undesirable material."

Obviousness Combination for Method Claim 2:

A POSA facing the problem of removing widespread undesirable material that extends into smaller, more tortuous vessels, as explicitly outlined in the patent, would find the combination of an outer and inner suction cannula obvious. The motivation to combine these elements comes directly from the nature of the problem to be solved.

1. Outer suction cannula: Provides the primary means of aspiration for larger vessels, as described throughout the patent.
2. Inner suction cannula coaxially movable within the outer cannula: This configuration would be an obvious solution to access smaller, more distal vasculature. The inherent problem of a single large cannula being unable to reach smaller vessels would lead a POSA to consider a smaller, more maneuverable cannula that can be deployed through the larger one. The "smaller inner suction cannula (132) is sized such as it can more easily fit into these smaller diameter vessels and capture the undesirable material."

The patent itself provides the clear motivation and solution for this combination, stating that the inner cannula allows the user to "easily maneuver the inner suction cannula (132) into smaller vasculature that the outer suction cannula (130) could not fit." This directly addresses the limitation of single, larger cannulas and proposes a straightforward, incremental improvement that a POSA would readily conceive. The operation of advancing the inner cannula beyond the outer one and activating suction is also detailed in the patent.

Patent Term Adjustments (PTA) and Patent Term Extensions (PTE) for US Patent 12496077

Patent Term Adjustments (PTA)

Patent Term Adjustment (PTA) extends the term of a U.S. patent to compensate for delays by the USPTO during patent prosecution. These delays are categorized into specific timeframes, such as issuing an office action within 14 months of filing, responding to replies within four months, and issuing a patent within 36 months from the filing date.

To accurately determine any PTA for US Patent 12496077, access to the official USPTO Patent Center or the patent's prosecution history (Image File Wrapper) is required. This information is not directly available in the provided patent text or general search results. The issue date of the patent is December 16, 2025, and the filing date is June 30, 2025. Without detailed prosecution history, the exact PTA cannot be calculated. However, the patent's filing-to-issue timeframe (less than a year) suggests that significant USPTO delays, which would trigger large PTA, are less likely.

Patent Term Extensions (PTE)

Patent Term Extensions (PTE) are typically granted for delays incurred during regulatory review processes, most commonly by the FDA for pharmaceutical patents, under 35 U.S.C. § 156. There is no indication within the provided patent information that US Patent 12496077, related to systems and methods for removing undesirable material within a circulatory system, has undergone any such regulatory review that would qualify for a PTE. Therefore, it is unlikely to have any PTE.

Continuation and Divisional Applications, and Related Family Members

US Patent 12496077 is explicitly identified as a continuation application. The "RELATED U.S. APPLICATION(S)" section states:
"This Application is a continuation of U.S. patent application Ser. No. 19/014,327, filed Jan. 9, 2025, now U.S. Patent Publication No. 2025/0143729, which is a continuation of U.S. patent application Ser. No. 16/778,657, filed Jan. 31, 2020, now U.S. Pat. No. 12,318,097, which is a continuation of U.S. patent application Ser. No. 15/295,529, filed Oct. 17, 2016, now abandoned, which claims the benefit of U.S. Provisional Application 62/242,493, filed Oct. 16, 2015, each of which is hereby incorporated herein by reference in its entirety."

Based on this, the related family members and application lineage are:

• Provisional Application: U.S. Provisional Application 62/242,493, filed October 16, 2015. This is the earliest priority document.
• Parent Application 1: U.S. patent application Ser. No. 15/295,529, filed October 17, 2016 (now abandoned). This is a non-provisional application claiming benefit of the provisional.
• Parent Application 2 (Continuation): U.S. patent application Ser. No. 16/778,657, filed January 31, 2020, which issued as U.S. Pat. No. 12,318,097. This is a continuation of Ser. No. 15/295,529.
• Parent Application 3 (Continuation): U.S. patent application Ser. No. 19/014,327, filed January 9, 2025, which published as U.S. Patent Publication No. 2025/0143729. This is a continuation of Ser. No. 16/778,657.
• Current Patent: US 12496077, filed June 30, 2025. This is a continuation of Ser. No. 19/014,327.

There is no information explicitly identifying any divisional applications within the provided text. Divisional applications arise when an applicant carves out subject matter from a parent application into a new application, maintaining the parent's filing date. While continuations are explicitly mentioned, divisionals are not.

Projected Expiration Date

The standard term for U.S. utility patents issued from applications filed on or after June 8, 1995, is 20 years from the filing date of the earliest application for which a benefit is claimed. This rule applies to continuation and divisional applications as well, where the term ends 20 years from the filing date of the earliest application for which a benefit is claimed.

In this case, the earliest priority date claimed is October 16, 2015, from U.S. Provisional Application 62/242,493. Therefore, the base expiration date for US 12496077 would be 20 years from this priority date.

Base Expiration Date: October 16, 2015 + 20 years = October 16, 2035.

However, the Google Patents information for US12496077B2 explicitly states an "Anticipated expiration" date of 2036-10-17. This discrepancy suggests that there is a Patent Term Adjustment (PTA) that has been applied to the patent. The difference of approximately one year (October 16, 2035, vs. October 17, 2036) would account for PTA awarded due to delays during the prosecution of the applications in the patent family.

Therefore, the projected expiration date, including any calculated PTA, is October 17, 2036. It is important to note that this date is subject to the timely payment of maintenance fees. Terminal disclaimers, if any were filed in the patent family, could also impact the expiration date, but none are mentioned in the provided text.

Defensive Disclosure for US Patent 12496077

This document details derivative variations and extensions of the technology described in US Patent 12496077, focusing on generating prior art to render future incremental improvements obvious or non-novel. The derivations are organized by the patent's core claims and explored across five axes: Material & Component Substitution, Operational Parameter Expansion, Cross-Domain Application, Integration with Emerging Tech, and The "Inverse" or Failure Mode.

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II. Derivative Works for Device Claims (Generalized from Claims 1, 2, and 3)

This section covers derivatives for a device comprising a cannula with a polymer wall, a stepped distal end, an expandable element (e.g., funnel), and a collar, where these components (and potentially a reinforcement member) are embedded within the polymer wall.

A. Material & Component Substitution

1. Shape Memory Polymer Expandable Element with Bioresorbable Polymer Wall

Enabling Description: The expandable element (e.g., funnel 108) and its coupling collar (e.g., collar 118) are fabricated from a bioresorbable shape memory polymer, such as polylactic acid (PLA) or polycaprolactone (PCL) copolymers. The polymer wall of the cannula (e.g., 100) is also composed of a bioresorbable polymer, like poly-dioxanone (PDO) or polyglycolic acid (PGA), chosen for its controlled degradation rate and mechanical properties. The shape memory polymer is pre-programmed to expand upon reaching body temperature or after a specific chemical activation (e.g., exposure to a pH-sensitive buffer delivered via an auxiliary lumen). The collar and expandable element are embedded during the cannula's manufacturing via co-extrusion or multi-layer dip-coating processes where the outer polymer layer encapsulates the pre-formed shape-memory structure. The reinforcement member (e.g., 106) in the main shaft could be a braided bioresorbable fiber (e.g., PCL-based braid) rather than a metallic coil, offering temporary rigidity. This design is suitable for temporary interventions where the device is not intended for long-term implantation, allowing for complete absorption post-procedure.

classDiagram
    class Cannula {
        +BioR_PolymerWall polymerWall
        +SteppedDistalEnd steppedDistalEnd
        +BioR_SM_ExpandableElement expandableElement
        +BioR_Collar collar
        +BioR_FiberReinforcement reinforcementMember
        +Lumen lumen
    }
    class BioR_PolymerWall {
        +material: PDO/PGA
        +degradationRate: float
    }
    class SteppedDistalEnd {
        +geometry: Stepped
    }
    class BioR_SM_ExpandableElement {
        +material: PLA/PCL_copolymer
        +shapeMemoryActivation: Temp/Chem
    }
    class BioR_Collar {
        +material: PLA/PCL_copolymer
    }
    class BioR_FiberReinforcement {
        +material: PCL_braid
        +rigidity: Temporary
    }
    Cannula "1" -- "1" BioR_PolymerWall : encapsulates
    Cannula "1" -- "1" SteppedDistalEnd
    Cannula "1" -- "1" BioR_SM_ExpandableElement : embedded
    Cannula "1" -- "1" BioR_Collar : embedded
    Cannula "1" -- "1" BioR_FiberReinforcement : embedded

2. Magnetic Actuation with Ferrofluid-Filled Expandable Element

Enabling Description: The expandable element (e.g., funnel 20, 108) consists of a non-ferromagnetic polymer shell (e.g., PEBAX) filled with a biocompatible ferrofluid (e.g., magnetite nanoparticles suspended in a carrier fluid like perfluorodecalin). Instead of mechanical strips or shape-memory alloys, the expansion is controlled by an external electromagnetic field generator. The collar (e.g., 118) contains small, embedded permanent magnets (e.g., NdFeB micro-magnets) or coils. When the external field is applied, the ferrofluid within the expandable element is manipulated, causing the polymer shell to deform and expand into its desired shape, forming the funnel. Retraction occurs upon reversal or removal of the field, with the polymer's elastic memory returning it to a collapsed state. The polymer wall (e.g., 100) of the cannula is standard polyurethane, chosen for flexibility and biocompatibility.

graph TD
    A[External Electromagnetic Field Generator] --> B{Cannula Distal End};
    B --> C[Polymer Wall (Polyurethane)];
    C --> D[Embedded Collar with Micro-Magnets];
    D --> E[Ferrofluid-Filled Expandable Element (PEBAX shell)];
    E -- Actuation --> F[Expand/Collapse Funnel];
    F --> G[Capture/Remove Undesirable Material];

3. Piezoelectric Polymer Actuators for Expandable Funnel

Enabling Description: The expandable funnel (e.g., 20, 108) is constructed from a piezoelectric polymer material, such as polyvinylidene fluoride (PVDF), instead of traditional strips or shape-memory alloys. The funnel structure is segmented into multiple PVDF elements, each capable of shape change upon application of an electrical potential. Thin, flexible electrodes are integrated within the polymer wall (e.g., 100) and connect to a proximal control unit. When an electrical pulse is delivered, the piezoelectric elements deform, causing the funnel to radially expand. Reversing the polarity or removing the charge causes the funnel to collapse. The collar (e.g., 118) serves as a stable anchor point for these piezoelectric segments, and both the collar and the PVDF funnel are embedded within the cannula's outer polymer wall through lamination or overmolding techniques, ensuring a smooth profile.

graph TD
    A[Proximal Control Unit] --> B[Integrated Electrodes in Polymer Wall];
    B --> C{Piezoelectric Polymer Funnel Segments (PVDF)};
    C -- Electrical Pulse --> D[Funnel Expands];
    C -- Reverse Polarity/Remove Charge --> E[Funnel Collapses];
    E --> F[Embedded Collar Anchors Segments];
    F --> G[Polymer Wall (e.g., Urethane) encapsulates all];
    G --> H[Capture/Remove Material];

4. Carbon Nanotube Composite for Reinforcement and Flexibility

Enabling Description: The reinforcement member (e.g., 106) is a woven lattice or braided structure made from a carbon nanotube (CNT) composite fiber. This composite offers significantly higher tensile strength and stiffness-to-weight ratio compared to traditional metallic coils (e.g., stainless steel, nitinol) while maintaining flexibility. The outer and inner shaft layers (e.g., 120, 124) of the cannula are co-extruded with a multi-walled carbon nanotube (MWCNT)-enhanced polymer (e.g., medical-grade PEEK or ultra-high molecular weight polyethylene - UHMWPE), increasing the overall shaft's burst pressure resistance and radial strength. The expandable element (e.g., 108) itself could also incorporate fine CNT composite strands for enhanced structural integrity during expansion and suction, embedded within a standard polymer (e.g., urethane) via injection molding or heat-fusing. The collar (e.g., 118) could similarly be a CNT-reinforced polymer component.

classDiagram
    class Cannula {
        +MWCNT_PolymerWall polymerWall
        +SteppedDistalEnd steppedDistalEnd
        +CNT_ExpandableElement expandableElement
        +CNT_Collar collar
        +CNT_Reinforcement reinforcementMember
        +Lumen lumen
    }
    class MWCNT_PolymerWall {
        +material: PEEK/UHMWPE_MWCNT_composite
        +properties: HighTensileStrength, BurstResistant
    }
    class CNT_ExpandableElement {
        +material: Urethane_CNT_composite
    }
    class CNT_Collar {
        +material: Polymer_CNT_composite
    }
    class CNT_Reinforcement {
        +material: CNT_braid/lattice
        +properties: HighStiffnessToWeight, Flexible
    }
    Cannula "1" -- "1" MWCNT_PolymerWall
    Cannula "1" -- "1" SteppedDistalEnd
    Cannula "1" -- "1" CNT_ExpandableElement : embedded
    Cannula "1" -- "1" CNT_Collar : embedded
    Cannula "1" -- "1" CNT_Reinforcement : embedded

5. Ionic Polymer-Metal Composite (IPMC) Expandable Element

Enabling Description: The expandable element (e.g., funnel 108) is constructed from an Ionic Polymer-Metal Composite (IPMC) material. IPMCs are smart materials that bend or deform significantly when a low voltage is applied across their surfaces, acting as soft actuators. The funnel consists of thin IPMC strips (e.g., Nafion membrane plated with noble metals like gold or platinum) that are pivotally coupled to the stepped distal end (e.g., 138). Electrical leads run through an auxiliary lumen within the cannula's polymer wall (e.g., 100) to connect to the IPMC strips. Applying a specific voltage across the IPMC strips causes them to bend, deploying the funnel into an open position. Reversing the voltage or releasing it collapses the funnel. The collar (e.g., 118) can be a rigid, electrically insulating polymer component providing the foundational connection point, with the IPMC elements and collar embedded within the outer polymer wall (e.g., urethane) for smooth vessel interaction.

sequenceDiagram
    participant ControlUnit
    participant Cannula
    participant IPMCFunnel
    ControlUnit->>Cannula: Apply Low Voltage
    Cannula->>IPMCFunnel: Transmit Electrical Signal
    IPMCFunnel->>IPMCFunnel: Ionic movement causes bending
    IPMCFunnel-->>Cannula: Funnel Deploys (Expands)
    ControlUnit->>Cannula: Reverse/Release Voltage
    Cannula->>IPMCFunnel: Transmit Electrical Signal
    IPMCFunnel->>IPMCFunnel: Ionic movement causes reverse bending
    IPMCFunnel-->>Cannula: Funnel Collapses

B. Operational Parameter Expansion

1. Micro-scale System for Capillary Thrombectomy

Enabling Description: The entire cannula system, including the polymer wall, stepped distal end, expandable element (e.g., micro-funnel), and collar, is scaled down to a micro-electromechanical system (MEMS) device. The outer diameter of the cannula shaft is reduced to approximately 100-500 micrometers (e.g., 1-5 French), suitable for navigation within cerebral capillaries or other microvasculature. The expandable element uses micro-actuators (e.g., micro-Nitinol springs or electroactive polymer micro-flaps) to create a funnel with an expanded diameter of 200-800 micrometers. The polymer wall is a biocompatible Parylene C or SU-8 photoresist, deposited layer-by-layer. Suction is generated by micro-peristaltic pumps integrated into a proximal MEMS chip or by external micro-fluidic vacuum systems. This system operates at extremely low flow rates (nanoliters/minute) and pressures (e.g., -5 mmHg) to avoid damage to delicate micro-vessels, with enhanced real-time optical coherence tomography (OCT) or photoacoustic imaging guidance due to the small scale.

graph TD
    A[External Micro-Fluidic Vacuum System] --> B[Micro-Cannula (100-500µm OD)];
    B --> C[Parylene/SU-8 Polymer Wall];
    C --> D[MEMS Stepped Distal End];
    D --> E[Micro-Actuator Expandable Micro-Funnel (200-800µm)];
    E -- NanoL/min Suction --> F[Remove Micro-Clot];
    G[OCT/Photoacoustic Imaging] --> B;

2. High-Pressure, High-Volume System for Industrial Pipeline Debris Removal

Enabling Description: The system is scaled up significantly for industrial applications, specifically for removing aggregated debris (e.g., paraffin wax, scale, sludge) from large-diameter oil or gas pipelines (e.g., 12-48 inch diameter). The cannula (e.g., 100) is constructed from high-strength, corrosion-resistant composites (e.g., fiberglass-reinforced epoxy or carbon-fiber PEEK) with an outer diameter up to 10 inches. The stepped distal end (e.g., 138) and expandable funnel (e.g., 20, 108) are made from high-tensile stainless steel or titanium alloys, with the funnel actuated by hydraulic pistons and able to expand to diameters of 20 inches or more. These metallic components are encased in a robust, abrasion-resistant polymer jacket (e.g., high-density polyethylene or polyurethane with ceramic fillers) via overmolding, protecting the pipeline wall. The suction force is generated by industrial-grade centrifugal pumps capable of creating pressures exceeding 500 PSI negative pressure and handling fluid volumes of thousands of gallons per minute (GPM) at elevated temperatures (e.g., 80-150°C) to maintain fluidity of viscous debris.

flowchart TD
    A[Industrial-Grade Centrifugal Pump] --> B{High Pressure/Volume Suction};
    B --> C[Composite Cannula (10 inch OD)];
    C --> D[Abrasion-Resistant Polymer Jacket];
    D --> E[Stepped Distal End (SS/Ti Alloy)];
    E --> F[Hydraulically Actuated Expandable Funnel (SS/Ti Alloy)];
    F -- 500+ PSI Neg. Pressure, 1000s GPM --> G[Remove Pipeline Debris (Paraffin, Scale)];
    G --> H[Filtration & Separation System];

3. Cryogenic Aspiration for Tissue Cryopreservation

Enabling Description: The system is adapted for handling biological material (e.g., oocytes, embryos, or delicate cell aggregates) at cryogenic temperatures (e.g., -196°C in liquid nitrogen). The cannula (e.g., 100) is fabricated from cryo-compatible polymers like PFA (perfluoroalkoxy) or specially formulated silicone, maintaining flexibility at ultra-low temperatures. The stepped distal end (e.g., 138) and expandable element (e.g., funnel 108) are made from a cryo-compatible shape memory alloy (e.g., specific Nitinol grades or Copper-Aluminum-Nickel alloys) that expands reliably upon controlled temperature cycling (e.g., from room temperature to liquid nitrogen, or via localized micro-heating elements for deployment). These components are embedded within the cryo-polymer wall. Suction is precisely controlled via a cryo-pump or by precisely managed inert gas pressure differentials, operating with cryoprotective agents (CPAs) as the working fluid. The system ensures minimal thermal shock and mechanical shear force during aspiration to preserve cell viability.

stateDiagram-V2
    [*] --> Collapsed_Ambient_Temp : Init
    Collapsed_Ambient_Temp --> Cooled_LN2 : Insert to Cryo-bath
    Cooled_LN2 --> Deployed_LN2 : Activate Micro-Heater (for SM expansion)
    Deployed_LN2 --> Aspiration_LN2 : Apply Cryo-Pump Suction
    Aspiration_LN2 --> Retracted_LN2 : Turn off Micro-Heater (for SM collapse)
    Retracted_LN2 --> Removed_LN2 : Withdraw from Cryo-bath
    Removed_LN2 --> [*] : End Procedure

4. High-Frequency Pulsed Suction for Particulate Suspension

Enabling Description: The aspiration system incorporates a high-frequency pulsatile suction mechanism for removing finely dispersed particulate matter (e.g., microplastics, heavy metal sludge) from liquid suspensions. The pump (e.g., 15) is a high-speed diaphragm or piezoelectric pump capable of generating suction pulses at frequencies ranging from 1 kHz to 100 kHz. The cannula (e.g., 100) is designed with acoustic impedance matching layers in its polymer wall to minimize energy loss from the high-frequency pulses. The expandable element (e.g., funnel 108) is a micro-perforated membrane or a fine mesh filter (e.g., woven stainless steel or polymer with <10 micron pore size) that vibrates sympathetically with the suction pulses, preventing clogging and assisting in fluidizing aggregated particulates at the capture site. The stepped distal end (e.g., 138) includes an integrated ultrasonic transducer array for localized acoustic agitation of the target material, further aiding its suspension and capture.

flowchart TD
    A[High-Frequency Pulsatile Pump (1-100 kHz)] --> B{Pulsed Suction};
    B --> C[Cannula with Acoustic Impedance Layers];
    C --> D[Ultrasonic Transducer Array (Stepped Distal End)];
    D --> E[Micro-Perforated/Mesh Vibrating Funnel];
    E -- High-Freq Pulsed Suction + Acoustic Agitation --> F[Capture Dispersed Particulates];
    F --> G[Micro-Filtration System];

C. Cross-Domain Application

1. Oceanography: Deep-Sea Sediment Core Sampling

Enabling Description: The device is adapted for precise, minimally disruptive collection of unconsolidated sediment cores or fragile biological samples (ee.g., vent fauna) from deep-sea environments. The cannula (e.g., 100) is constructed from high-strength, pressure-resistant composites (e.g., carbon fiber-reinforced PEEK) with an operational depth rating of 10,000 meters. The stepped distal end (e.g., 138) is equipped with a blunted, penetrative tip. The expandable element (e.g., funnel 108) is a robust, self-actuating claw or flexible mesh basket made of corrosion-resistant titanium alloy or shape-memory polymers, embedded within the composite wall and actuated hydraulically or by pressure differential. This allows for controlled deployment to encapsulate a sediment plug or delicate organism. A specialized low-shear suction pump (e.g., bellows pump) operating with ambient seawater or a buffered solution as the reinfusion medium is used to draw the sample into the cannula's lumen without fragmentation, maintaining original stratification.

graph TD
    A[ROV/AUV Platform] --> B[Deployment Arm];
    B --> C[Deep-Sea Cannula (CF-PEEK)];
    C --> D[Pressure-Resistant Polymer Wall];
    D --> E[Stepped Penetrative Distal End];
    E --> F[Hydraulic/Pressure-Actuated Ti/SMP Claw/Basket (Embedded)];
    F -- Low-Shear Suction (Bellows Pump) --> G[Collect Sediment Core/Fragile Organism];
    G --> H[Sealed Sample Chamber];

2. Aerospace: In-Orbit Debris Removal from Satellite Components

Enabling Description: This system is designed for autonomous or remotely operated removal of micro-meteoroid and orbital debris (MMOD) impacts, or dislodged components from critical satellite surfaces in low Earth orbit. The cannula is constructed from ultra-lightweight, high-stiffness carbon-carbon composite or beryllium alloys, designed for vacuum and extreme thermal cycling. The stepped distal end incorporates a soft-capture mechanism (e.g., a compliant polymer interface with micro-suction cups) that temporarily adheres to the satellite surface adjacent to the debris. The expandable element (e.g., funnel 108) is a deployable, fine-mesh capture net (e.g., Vectran or high-modulus polymer fibers) actuated by miniature electro-mechanical motors, allowing it to conform to the satellite's geometry and encapsulate the debris. This net and its actuation mechanism are embedded within the composite cannula wall. Suction is generated by a cold gas thruster system that evacuates the cannula lumen, creating a vacuum differential to draw the debris into a containment chamber without generating secondary debris.

flowchart TD
    A[Satellite Servicing Robot (ROV)] --> B[Mounted Debris Removal Cannula];
    B --> C[Carbon-Carbon Composite Wall];
    C --> D[Stepped Distal End with Compliant Interface];
    D --> E[Micro-Suction Cups for Adhesion];
    E --> F[Electro-Mechanical Motors Actuating Embedded Capture Net (Vectran)];
    F -- Cold Gas Thruster Suction --> G[Encapsulate & Collect Orbital Debris];
    G --> H[Internal Debris Containment Chamber];

3. Food Processing: Foreign Object Removal from Fluidized Beds

Enabling Description: The system is engineered for continuous, automated removal of foreign objects (e.g., metal fragments, plastic pieces, insect contaminants) from dry particulate food products (e.g., grains, coffee beans, nuts) within industrial fluidized bed processes. The cannula is fabricated from food-grade stainless steel or FDA-approved polymers (e.g., UHMWPE), designed to withstand abrasive particulate flow and hygienic cleaning protocols. The stepped distal end is a wide-mouthed scoop or shovel-like appendage. The expandable element (e.g., funnel 108) is a dynamically adjustable grate or sieve made of food-grade stainless steel wire mesh, actuated by pneumatic cylinders, capable of expanding to create a larger capture area or closing to isolate a captured object. These components are embedded within a robust, cleanable outer polymer layer (e.g., silicone rubber overmolding). High-volume, low-pressure pneumatic suction (e.g., Venturi effect or industrial vacuum blower) is used to draw the identified foreign object along with a minimal amount of product into the cannula, and then separated downstream.

graph TD
    A[Fluidized Bed Containing Food Product] --> B[Integrated Cannula System];
    B --> C[Food-Grade Stainless Steel/UHMWPE Cannula];
    C --> D[Robust Polymer Overmolding (Silicone)];
    D --> E[Stepped Wide-Mouthed Scoop Distal End];
    E --> F[Pneumatic Cylinders Actuating Dynamically Adjustable Sieve/Grate (SS Mesh)];
    F -- High-Volume Pneumatic Suction --> G[Capture Foreign Object];
    G --> H[Downstream Separation & Collection];

D. Integration with Emerging Tech

1. AI-Driven Trajectory Optimization & Suction Control

Enabling Description: The cannula system integrates an onboard AI module for real-time trajectory optimization and adaptive suction control. High-resolution intravascular imaging (e.g., OCT, IVUS, or micro-CT) provides a continuous data stream of vessel anatomy, blood flow dynamics, and undesirable material characteristics (e.g., density, adherence, size). An embedded neural network, trained on a vast dataset of anatomical variations and successful thrombectomy procedures, analyzes this data to autonomously adjust the cannula's tip orientation (via miniature steerable wires or electroactive polymer segments), funnel expansion parameters (e.g., angle, deployment speed), and suction pressure/flow rate (e.g., via a proportional-integral-derivative (PID) controller linked to a variable-speed pump). The AI module continuously refines its strategy to achieve optimal en bloc removal, minimize vessel trauma, and prevent distal embolization. The system includes haptic feedback to the operator for manual override.

flowchart TD
    A[Intravascular Imaging (OCT/IVUS/Micro-CT)] --> B{Data Acquisition};
    B --> C[Onboard AI Module (Neural Network)];
    C -- Real-time Analysis --> D{Control Decisions};
    D --> E[Cannula Tip Orientation Control];
    D --> F[Funnel Expansion Actuators];
    D --> G[Variable-Speed Suction Pump];
    H[Haptic Feedback Interface] --> I{Operator Input};
    I --> C;
    E & F & G --> J[Adaptive Cannula Operation];
    J --> K[Optimal En Bloc Removal];

2. IoT Sensor Network for Real-time Hemodynamic & Material Characterization

Enabling Description: The cannula incorporates a dense array of micro-IoT sensors embedded within its polymer wall (e.g., 100) and expandable element (e.g., 108). These sensors include pressure transducers, flow sensors, temperature sensors, chemical sensors (e.g., for thrombin, fibrinogen), and impedance sensors for real-time material characterization. Data from these sensors is continuously transmitted wirelessly (e.g., via near-field communication or miniaturized radio-frequency modules) to an external processing unit. The external unit correlates these data points with location information (e.g., from electromagnetic tracking coils also embedded in the cannula) to construct a comprehensive 3D hemodynamic map and real-time compositional analysis of the undesirable material. This allows for predictive modeling of clot adherence, fragmentation risk, and optimal suction parameters. Alerts are triggered for potential vessel perforation, excessive fluid loss, or incomplete material removal, with all data logged to a secure cloud platform.

graph TD
    A[Cannula (Polymer Wall)] --> B[Embedded Micro-IoT Sensors];
    B --> C[Pressure Transducers];
    B --> D[Flow Sensors];
    B --> E[Chemical Sensors];
    B --> F[Impedance Sensors];
    G[Electromagnetic Tracking Coils] --> B;
    B -- Wireless Data Transmission --> H[External Processing Unit];
    H -- Correlate & Analyze --> I[Real-time Hemodynamic & Material Map];
    I --> J[Predictive Modeling];
    I --> K[Alert System];
    I -- Secure Data Logging --> L[Cloud Platform];

3. Blockchain for Supply Chain Verification & Device History Logging

Enabling Description: Each individual cannula device (e.g., 100) and its critical components (e.g., expandable element 108, collar 118, reinforcement member 106) are assigned a unique, cryptographically secure digital identity (e.g., a QR code linking to a hash on a blockchain). Throughout the manufacturing, sterilization, and distribution process, every key event—material sourcing, assembly date, sterilization batch, quality control checks, shipping logs—is immutably recorded as a transaction on a private or consortium blockchain (e.g., Hyperledger Fabric). Upon use in a medical procedure, the device's usage parameters (e.g., deployment duration, suction pressure profiles, number of expansion/retraction cycles, operator ID, patient ID) are also logged to the blockchain, securely and pseudonymously. This creates an unalterable audit trail from raw material to patient use, ensuring device authenticity, tracking potential failures or recalls, and providing transparent data for regulatory compliance and post-market surveillance.

sequenceDiagram
    participant RawMaterialSupplier
    participant Manufacturer
    participant Distributor
    participant Hospital
    participant Patient
    RawMaterialSupplier->>Manufacturer: Ship Materials
    Manufacturer->>Manufacturer: Record Material Lot # (Blockchain Tx)
    Manufacturer->>Manufacturer: Assemble Device, QC (Blockchain Tx)
    Manufacturer->>Distributor: Ship Device (Blockchain Tx)
    Distributor->>Hospital: Deliver Device (Blockchain Tx)
    Hospital->>Patient: Device Used in Procedure (Blockchain Tx - Pseudonymized)
    Patient->>Hospital: Post-Procedure Monitoring
    Hospital->>Blockchain: Log Usage Data & Outcomes

E. The "Inverse" or Failure Mode

1. Self-Retracting Funnel for Safe Disengagement

Enabling Description: The expandable element (e.g., funnel 20, 108) is designed with an inherent bias towards a collapsed state, utilizing opposing forces. For example, the shape memory alloy reinforcement arms (e.g., 112) are pre-shaped to be collapsed at body temperature, requiring continuous active deployment (e.g., via a pull-wire or miniature pneumatic bladder for constant outward pressure) for the funnel to remain open. In the event of power loss, system malfunction, or intentional disengagement, this active deployment mechanism immediately ceases. The inherent shape memory of the arms, coupled with the elastic recoil of the polymer jacket (e.g., 114) and polymer wall (e.g., 100), then causes the funnel to passively and safely retract to its collapsed profile within milliseconds. This prevents unintended vessel wall engagement, minimizing trauma during an abrupt system failure or if the device becomes entangled.

stateDiagram-V2
    state "Funnel_Deployed (Active)" as Deployed
    state "Funnel_Collapsed (Passive)" as Collapsed

    [*] --> Collapsed : Init
    Collapsed --> Deployed : Activate_Deployment_Mechanism (e.g., pull-wire)
    Deployed --> Collapsed : Deactivation_of_Mechanism OR Power_Failure OR Malfunction
    Deployed --> Collapsed : Operator_Command_Retract

2. Limited-Functionality "Bypass" Mode with Perfusion Lumen

Enabling Description: The cannula (e.g., 100) includes a dedicated, independent perfusion lumen running parallel to the main aspiration lumen, terminating proximal to the stepped distal end (e.g., 138) and expandable element (e.g., 108). In a "limited-functionality" or "bypass" mode, if the primary aspiration lumen becomes completely occluded by the undesirable material, or if prolonged aspiration leads to unacceptable ischemic risk, the suction pump (e.g., 15) automatically deactivates. Simultaneously, an auxiliary pump activates, drawing blood from a peripheral site (e.g., a reinfusion cannula, as in Method Claim 1) and perfusing it through the dedicated bypass lumen. This ensures continuous, albeit reduced, blood flow past the obstructed site, mitigating the risk of downstream ischemia during prolonged or complicated clot removal procedures. The expandable funnel can remain collapsed or partially deployed, but suction is disabled.

graph TD
    A[Primary Suction Pump] --> B{Aspiration Lumen};
    C[Auxiliary Perfusion Pump] --> D{Bypass Perfusion Lumen};
    B -- Occlusion / Ischemic Risk --> E[System Monitor];
    E -- Detect Failure / Ischemia --> F[Activate Bypass Mode];
    F --> A[Deactivate];
    F --> C[Activate];
    B --> G[Cannula Distal End];
    D --> G;
    G --> H[Vessel Distal to Obstruction];

3. Low-Power "Idle" Mode with Flow Sensing

Enabling Description: The device incorporates an intelligent "idle" mode for energy conservation and reduced shear stress during periods of no or low material capture. The suction pump (e.g., 15) is equipped with a variable-speed drive and integrates a flow sensor (e.g., Doppler ultrasound or thermal mass flow sensor) at the distal end of the cannula (e.g., 11). When the flow sensor detects a persistent lack of undesirable material entering the funnel (e.g., below a set threshold for a specified duration), the system automatically transitions to a low-power "idle" state. In this state, the pump reduces its rotational speed, maintaining only a minimal suction pressure (e.g., 10% of full power) sufficient to clear minor debris and maintain patency, but significantly reducing energy consumption and shear forces on blood. The expandable funnel (e.g., 108) may partially retract to reduce drag. The system can instantly revert to full power upon detection of new material or operator command.

stateDiagram-V2
    state "Full_Suction_Active" as Active
    state "Low_Power_Idle" as Idle

    [*] --> Active : Init
    Active --> Idle : Flow_Sensor_Detects_No_Material (Threshold Met)
    Idle --> Active : Flow_Sensor_Detects_Material OR Operator_Command
    Idle --> [*] : System_Shutdown

---

III. Derivative Works for Method Claim 1 (Suction, Reinfusion, Spaced Cannula Ends)

This section focuses on methods involving a first (suction) cannula and a second (reinfusion) cannula with spaced distal ends, coupled with a pump for en bloc removal and continuous reinfusion.

A. Operational Parameter Expansion

1. Ultra-High Volume, Rapid Extracorporeal Clearance for Toxin Removal

Enabling Description: The method is applied to rapid, ultra-high volume extracorporeal removal of circulating toxins (e.g., overdose drugs, septic inflammatory mediators) or large volumes of abnormal cellular components (e.g., leukapheresis for hyperleukocytosis). A first, large-bore suction cannula (e.g., 28-36 Fr) is maneuvered into a large central vein (e.g., inferior vena cava). A second, equally large-bore reinfusion cannula is positioned in a different central vein (e.g., superior vena cava or femoral vein, spaced from the first). A high-flow, low-shear centrifugal pump operates to withdraw blood at rates of 5-10 liters per minute. The system includes an inline, high-capacity filtration or adsorption module capable of selectively removing target toxins/cells while returning plasma and other blood components. The continuous reinfusion ensures hemodynamic stability despite the rapid turnover of blood volume. This method operates at significantly higher flow rates and total blood volumes than typical thrombectomy, demanding robust cannulae and pump systems.

graph TD
    A[Patient Circulatory System] --> B{Large-Bore Suction Cannula (IVC)};
    B --> C[High-Flow Centrifugal Pump];
    C --> D[High-Capacity Filtration/Adsorption Module];
    D --> E[High-Flow Centrifugal Pump];
    E --> F{Large-Bore Reinfusion Cannula (SVC/Femoral)};
    F --> A;
    G[Real-time Toxin/Cell Count Monitor] --> D;

2. Micro-Flow, Targeted Biopsy & Perfusion for Organoids/Tissue Engineering

Enabling Description: This method is adapted for extremely delicate procedures involving micro-scale biological constructs, such as targeted biopsy of specific cell clusters within an organoid or isolated tissue perfusion in tissue engineering. The first cannula is a micro-cannula (e.g., 50-200 µm diameter) with a blunt, aspiration-compatible tip, guided by robotic micro-manipulators to extract a single cell cluster (en bloc biopsy). The second cannula is an equally fine micro-perfusion cannula, situated in extremely close (but spaced) proximity, delivering precisely controlled, oxygenated nutrient media. Suction is achieved by a micro-fluidic peristaltic pump generating picoliter to nanoliter per minute flow rates and very low negative pressures (e.g., -1 mmHg to -5 mmHg) to minimize mechanical stress on the delicate tissue. The reinfusion of culture medium occurs simultaneously at similar low rates, maintaining a stable local microenvironment during the biopsy or material transfer.

flowchart TD
    A[Robotic Micro-Manipulator] --> B[Micro-Cannula (50-200µm)];
    B --> C[Micro-Funnel/Blunt Aspiration Tip];
    C -- Picoliter/min Suction --> D[Extract Single Cell Cluster (En Bloc)];
    E[Micro-Perfusion Cannula] --> F[Deliver Nutrient Media];
    G[Micro-Fluidic Peristaltic Pump] --> C;
    G --> F;
    C -- Spaced Relation --> F;

B. Cross-Domain Application

1. Environmental Remediation: Targeted Micro-Pollutant Removal from Waterways

Enabling Description: The method is employed for the highly localized removal of aggregated micro-pollutants (e.g., oil globules, algal blooms, plastic micro-particles) from sensitive aquatic environments (e.g., coral reefs, protected wetlands). A first, remotely operated suction cannula (e.g., 5-10 cm diameter) with an expandable, fine-mesh funnel is deployed near the pollutant cluster via an underwater ROV. A second, co-located reinfusion cannula, positioned downstream, returns filtered water. A low-shear, variable-speed axial flow pump generates suction to draw the pollutant material and surrounding water into the first cannula, capturing the aggregate en bloc. The water is then passed through an on-board, multi-stage filtration system (e.g., reverse osmosis, activated carbon, micro-filtration) to remove the targeted pollutants. The cleansed water is continuously reinfused to minimize localized ecological disruption from water removal.

graph TD
    A[Underwater ROV] --> B[Remote Operated Suction Cannula];
    B --> C[Expandable Fine-Mesh Funnel];
    C -- Low-Shear Suction --> D[Capture Micro-Pollutant Aggregate (En Bloc)];
    D --> E[Multi-Stage Filtration System (RO/Activated Carbon)];
    E --> F[Reinfusion Cannula (Spaced from Suction)];
    F --> G[Aquatic Environment (Clean Water)];
    H[Variable-Speed Axial Flow Pump] --> B;

2. Precision Manufacturing: Removal of Machining Swarf/Debris in Micro-Assembly

Enabling Description: This method is applied in precision manufacturing, specifically for removing microscopic machining swarf, adhesive residue, or foreign particles from intricate components during micro-assembly processes (e.g., in optics, micro-robotics, or semiconductor fabrication). A first, finely tipped suction micro-nozzle (acting as a cannula), mounted on a robotic arm, is positioned precisely adjacent to the undesirable particulate. A second, inert gas micro-jet (acting as a reinfusion cannula), also robotically controlled and precisely spaced, directs filtered clean air/nitrogen to prevent re-deposition of airborne particles or to assist in dislodging loosely adhered debris. A miniature vacuum pump provides pulsed micro-suction through the nozzle to remove the particulate en bloc. The "reinfused fluid" is essentially the filtered gas, continuously flowing to maintain a clean work environment and provide a directed airstream.

flowchart TD
    A[Robotic Arm] --> B[Micro-Nozzle (Suction Cannula)];
    A --> C[Inert Gas Micro-Jet (Reinfusion Cannula)];
    B -- Pulsed Micro-Suction --> D[Remove Machining Swarf/Particulate (En Bloc)];
    C -- Filtered Clean Gas --> E[Prevent Re-deposition / Aid Dislodgement];
    B -- Spaced Relation --> C;
    F[Miniature Vacuum Pump] --> B;
    G[Filtered Gas Supply] --> C;

C. Integration with Emerging Tech

1. Haptic Feedback & Augmented Reality Guided Intervention

Enabling Description: The medical procedure (Method Claim 1) is enhanced by integrating haptic feedback and augmented reality (AR) for the operating clinician. The first cannula is equipped with force/torque sensors at its distal end, providing real-time tactile feedback to the operator's control interface, simulating the feel of vessel wall interaction, clot adherence, and suction forces. An AR overlay system projects 3D anatomical models (derived from pre-operative imaging like CT/MRI) and real-time intravascular ultrasound (IVUS) or optical coherence tomography (OCT) data onto the patient or a digital display. This AR interface guides the clinician in maneuvering both the suction and reinfusion cannulas, visualizing the undesirable material in 3D, predicting potential vessel damage, and optimizing the spaced relationship between the two cannula tips for efficient removal and reinfusion. AI algorithms can analyze the haptic and imaging data to suggest optimal maneuvering paths and suction parameters.

sequenceDiagram
    participant Clinician
    participant ControlInterface
    participant CannulaSensors
    participant ImagingSystem
    participant ARDisplay
    participant AIModule
    Clinician->>ControlInterface: Manipulate Cannula
    ControlInterface->>CannulaSensors: Send Control Signals
    CannulaSensors->>ControlInterface: Haptic Feedback Data
    ImagingSystem->>ARDisplay: Real-time 3D Imaging Data (IVUS/OCT)
    ARDisplay->>Clinician: Augmented Reality Guidance
    AIModule->>ControlInterface: Optimal Path/Suction Suggestions
    AIModule->>ARDisplay: Real-time Predictive Visuals
    CannulaSensors->>AIModule: Sensor Data for Analysis
    ControlInterface->>Clinician: Haptic Feedback + AR Guidance

2. Blockchain for Automated Regulatory Compliance & Auditable Procedure Logs

Enabling Description: The entire procedure, from device deployment to material removal and reinfusion, is automatically logged onto a blockchain-based platform for unalterable regulatory compliance and auditing. Each step (cannula insertion, navigation, suction activation, reinfusion rates, material capture events, removal time) is recorded as a cryptographically signed transaction, timestamped and linked to anonymized patient data, device serial numbers, and operator credentials. Smart contracts automatically verify adherence to established clinical protocols (e.g., max suction duration, reinfusion volume limits) and flag any deviations. This creates a transparent, immutable, and auditable record for post-market surveillance, quality assurance, and demonstrating compliance with medical device regulations (e.g., FDA, CE mark). The distributed ledger prevents tampering and provides a single source of truth for all stakeholders.

flowchart LR
    A[Cannula Insertion Event] --> B{Smart Contract Verification};
    B -- Protocol Adherence --> C[Log to Blockchain];
    D[Navigation Data] --> B;
    E[Suction Activation/Rate] --> B;
    F[Reinfusion Volume/Rate] --> B;
    G[Material Capture Event] --> B;
    H[Operator ID/Timestamp] --> B;
    C --> I[Immutable Procedure Log];
    I --> J[Regulatory Compliance Audit];
    I --> K[Quality Assurance Analysis];

D. The "Inverse" or Failure Mode

1. Automated Pressure Relief & Fluid Diversion for Vessel Protection

Enabling Description: The system incorporates an automated pressure relief mechanism and fluid diversion pathway to protect the vessel from excessive negative pressure or inadvertent vessel wall adherence by the first cannula. Pressure sensors (e.g., strain gauges) are integrated into the distal tip of the first (suction) cannula. If the detected negative pressure exceeds a predefined safe threshold (e.g., indicative of full vessel occlusion or wall suction), a high-speed solenoid valve immediately opens. This valve connects the aspiration lumen to an atmospheric vent or a dedicated, lower-pressure overflow reservoir, instantly relieving the suction force at the tip. Concurrently, the fluid flow from the reinfusion cannula can be temporarily diverted to the overflow reservoir, preventing uncontrolled reinfusion into a compromised vessel. This allows for safe repositioning of the suction cannula without causing barotrauma or wall damage.

graph TD
    A[First (Suction) Cannula Distal Tip] --> B[Integrated Pressure Sensor];
    B -- Pressure > Threshold --> C{High-Speed Solenoid Valve};
    C --> D[Aspiration Lumen];
    D --> E[Atmospheric Vent / Overflow Reservoir];
    E --> F[Suction Force Relieved];
    G[Second (Reinfusion) Cannula] --> H[Reinfusion Flow];
    H -- Pressure Exceeded --> I[Divert Flow to Overflow Reservoir];
    F & I --> J[Safe Repositioning];

---

IV. Derivative Works for Method Claim 2 (Outer and Inner Suction Cannulas)

This section focuses on methods involving a larger outer suction cannula with an inner suction cannula situated within its lumen.

A. Operational Parameter Expansion

1. Multi-Stage Differential Pressure Aspiration for Fragmented Debris

Enabling Description: This method optimizes the two-cannula system for removing highly friable or fragmented undesirable material (e.g., calcified emboli, atherosclerotic plaque fragments). The outer suction cannula (e.g., 130) provides an initial, moderate suction force (e.g., -50 mmHg) and acts as a "capture net" or primary conduit for larger fragments. The inner suction cannula (e.g., 132), once advanced into smaller vessels, applies a significantly higher, pulsed suction force (e.g., -200 mmHg at 10 Hz pulse rate) through its smaller lumen. This differential pressure strategy is dynamically adjusted: the outer cannula maintains a continuous, lower vacuum to stabilize the overall flow and capture large pieces, while the inner cannula's pulsed, higher vacuum specifically targets and aspirates smaller, more distal fragments that might otherwise escape. The inner cannula's distal tip incorporates a miniature rotating brush or vibrating mesh to actively dislodge and fluidize fragmented material before aspiration.

flowchart TD
    A[Outer Suction Cannula (Moderate, Continuous Suction)] --> B{Primary Capture / Large Fragments};
    C[Inner Suction Cannula (High, Pulsed Suction)] --> D{Target Smaller / Distal Fragments};
    C -- Advance into Smaller Vessels --> E[Miniature Rotating Brush / Vibrating Mesh];
    E --> D;
    A & D --> F[Combined Debris Collection];
    G[Variable-Pressure Suction Pumps] --> A;
    G --> C;

2. Thermo-Mechanical Softening & Aspiration for Dense Calcifications

Enabling Description: This method combines localized heating with the dual-cannula aspiration system to remove dense, calcified undesirable material (e.g., heavily calcified arterial plaques). The inner suction cannula (e.g., 132) is modified to incorporate a miniature resistive heating element or focused ultrasound transducer at its distal tip. Upon deployment adjacent to the calcified material, this element delivers controlled thermal energy (e.g., 45-60°C) for a precise duration, softening the calcification without damaging the vessel wall. Immediately after the softening phase, the inner cannula applies high-power suction to aspirate the now-pliable material en bloc or in larger softened pieces. The outer cannula (e.g., 130) maintains a continuous, lower suction field to capture any detached fragments during the softening and aspiration. Thermal feedback sensors are integrated to prevent overheating of the vessel wall.

graph TD
    A[Inner Suction Cannula] --> B[Miniature Heating Element / Ultrasound Transducer];
    B --> C{Apply Controlled Heat to Calcification};
    C -- Softened Calcification --> D[High-Power Suction (Inner Cannula)];
    D --> E[Aspirate Softened Material (En Bloc)];
    F[Outer Suction Cannula] --> G[Maintain Lower Suction Field];
    G --> H[Capture Detached Fragments];
    I[Thermal Feedback Sensors] --> B;

B. Cross-Domain Application

1. Mining & Geotechnical: Subsurface Micro-Exploration & Sample Collection

Enabling Description: This method is adapted for geotechnical and mining applications, specifically for micro-exploration and sample collection in unstable or delicate subsurface formations (e.g., fault zones, lunar regolith simulant). The outer suction cannula is a larger-diameter (e.g., 5-10 cm) drilling/coring tool that creates a primary access borehole and stabilizes the surrounding material. The inner suction cannula is a smaller-diameter (e.g., 1-2 cm), flexible probe with an expandable core-sampling mechanism (e.g., a coring barrel with a flexible sheath) that is deployed through the outer casing. It collects undisturbed micro-cores or granular samples from specific geological layers identified by integrated sensors (e.g., spectroscopic, resistivity). Suction is provided by a heavy-duty vacuum pump using a specialized drilling mud or inert gas as the reinfusion medium, preventing borehole collapse and ensuring sample integrity. The ability to advance the inner probe beyond the outer allows for targeted sampling in complex geological structures.

flowchart TD
    A[Larger-Diameter Outer Drilling/Coring Cannula] --> B{Create Primary Borehole / Stabilize};
    C[Smaller-Diameter Inner Flexible Probe] --> D{Deploy Through Outer Cannula};
    D --> E[Expandable Core-Sampling Mechanism];
    E -- Targeted Suction (Heavy-Duty Vacuum Pump) --> F[Collect Undisturbed Micro-Cores];
    B & E --> G[Geological Formation];
    H[Integrated Sensors (Spectroscopic/Resistivity)] --> C;

2. Pharmaceutical Production: Targeted Powder Recirculation & Agglomerate Removal

Enabling Description: In pharmaceutical manufacturing, this method is used for targeted recirculation of fine powders and removal of unwanted agglomerates or foreign particles within enclosed, sterile powder processing lines (e.g., tablet compression feeds, lyophilization chambers). The outer suction cannula is a larger-diameter conduit (e.g., 2-4 inches) that establishes a bulk flow path for the powder. The inner suction cannula is a narrower, articulating probe with a variable-geometry suction tip, deployed through the outer conduit. It is precisely positioned via robotic control to aspirate specific agglomerates or dislodged contaminants without disrupting the main powder flow. A pharmaceutical-grade vacuum conveying system generates the suction, recirculating filtered, inert gas as the "reinfusion" medium to maintain a controlled atmosphere. The system allows for pinpoint removal of defects in real-time, improving product quality and reducing waste in sensitive manufacturing environments.

graph TD
    A[Larger Outer Powder Conveying Cannula] --> B{Bulk Powder Flow Path};
    C[Narrower Inner Articulating Probe] --> D{Deployed Through Outer Cannula};
    D --> E[Variable-Geometry Suction Tip];
    E -- Targeted Suction (Vacuum Conveying) --> F[Remove Agglomerates/Contaminants];
    F --> G[Downstream Filtration/Separation];
    B & E --> H[Powder Processing Line];
    I[Robotic Control] --> C;

C. Integration with Emerging Tech

1. Swarm Robotics for Distributed Multi-Cannula Operation

Enabling Description: This method extends the dual-cannula concept to a swarm of independently navigating, smaller inner cannulas operating within a single, larger outer cannula lumen or multiple outer cannulas. Each inner cannula is a micro-robot (e.g., micrometer-scale, autonomously swimming/crawling) equipped with its own micro-actuators for funnel deployment, micro-sensors for local environmental sensing (e.g., flow, pH), and a micro-suction port. A central AI control system orchestrates the swarm, assigning individual inner cannulas to specific tasks (e.g., targeting different fragments of undesirable material simultaneously, or creating a distributed suction field). The outer cannula acts as a central docking and data relay station. Communication between the swarm and the central system occurs wirelessly (e.g., acoustic or optical signals). This allows for highly efficient, parallelized removal of distributed undesirable material, far exceeding the capabilities of a single inner cannula.

flowchart TD
    A[Central AI Control System] --> B{Orchestrate Swarm};
    B --> C[Larger Outer Cannula (Docking/Relay)];
    C --> D[Swarm of Autonomous Micro-Robotic Inner Cannulas];
    D --> E[Micro-Actuators (Funnel)];
    D --> F[Micro-Sensors (Local Env.)];
    D --> G[Micro-Suction Port];
    D -- Wireless Communication --> C;
    E & F & G --> H[Distributed Material Removal];
    H --> I[Central Collection Chamber];

D. The "Inverse" or Failure Mode

1. Redundant Inner Cannula for Aspiration Lumen Occlusion

Enabling Description: The outer suction cannula (e.g., 130) is designed to accommodate not just one, but multiple (e.g., two or three) smaller inner suction cannulas (e.g., 132), each with its own independent suction lumen and expandable funnel. In the event that a primary inner cannula's lumen becomes completely occluded by captured material or kinks during navigation, the system automatically detects this failure (e.g., via pressure sensor data in the lumen). The failed inner cannula is then either partially retracted or simply left in place, and a redundant, pre-loaded inner cannula is immediately advanced and deployed to continue the aspiration procedure without interruption. This provides a robust "fail-safe" mechanism, significantly reducing procedure time and improving safety by ensuring continuous aspiration capability even if a single inner cannula fails. The outer cannula's lumen is appropriately sized to allow for the passage and deployment of multiple inner cannulas sequentially or in parallel.

stateDiagram-V2
    state "Primary_Inner_Cannula_Active" as PrimaryActive
    state "Primary_Inner_Cannula_Occluded" as PrimaryOccluded
    state "Redundant_Inner_Cannula_Active" as RedundantActive

    [*] --> PrimaryActive : Init
    PrimaryActive --> PrimaryOccluded : Lumen_Occlusion_Detected
    PrimaryOccluded --> RedundantActive : Deploy_Redundant_Cannula
    RedundantActive --> [*] : Procedure_Complete OR Other_Failure
    PrimaryOccluded --> [*] : Retract_Failed_Cannula

---

V. Combination Prior Art Scenarios

Here are three combination prior art scenarios where the technology described in US 12496077 is combined with existing open-source standards. These combinations aim to demonstrate obviousness for certain aspects of the invention to a Person Having Ordinary Skill in the Art (POSA).

1. US 12496077 (Method Claim 1) + DICOM Standard for Medical Imaging

Scenario: A POSA in medical imaging and interventional procedures, seeking to improve the guidance and documentation of embolectomy procedures, would find it obvious to combine the method of US 12496077 with the DICOM (Digital Imaging and Communications in Medicine) standard.

Enabling Description: The method outlined in Method Claim 1 involves maneuvering a first suction cannula and a second reinfusion cannula, applying suction for en bloc removal, and reinfusing fluid. To enhance the precision and reproducibility of this method, particularly during the "maneuvering" step, a POSA would integrate real-time fluoroscopic or echocardiographic imaging data (as suggested in the patent's own disclosure for "image guidance") with DICOM-compliant systems. Specifically, the imaging data, enriched with metadata about cannula position, orientation, and even the detected material (e.g., clot burden quantified via image analysis), would be captured, stored, and transmitted using the DICOM standard. This allows for standardized data exchange between imaging modalities, navigation systems, and electronic health records. Furthermore, a DICOM-compliant structured report (SR) could be generated to document critical procedural parameters, such as the exact final position of the cannula tips relative to anatomical landmarks, the volume of material removed, and the reinfusion rates. This combination provides a standardized framework for image-guided navigation and comprehensive procedural documentation.

Obviousness Rationale: DICOM is a widely adopted open-source standard (ISO 12052) for handling, storing, printing, and transmitting information in medical imaging. The patent itself mentions the use of "image guidance, for example, using fluoroscopy or echocardiography." Combining these established imaging techniques with the open DICOM standard for data management, storage, and exchange for any image-guided medical procedure, including catheter-based interventions, would be a routine engineering and clinical practice for a POSA seeking to improve documentation, interoperability, and planning. It is an obvious application of an existing standard to a known medical procedure.

2. US 12496077 (Device Claim 3) + IEC 60601-1 Standard for Medical Electrical Equipment

Scenario: A POSA designing medical devices would find it obvious to ensure the device of Device Claim 3 (catheter with polymer wall, reinforcement member, stepped distal end, embedded expandable element/collar) complies with the IEC 60601-1 standard for basic safety and essential performance of medical electrical equipment.

Enabling Description: The device described in Device Claim 3, being an intravascular catheter for surgical intervention, is inherently an electrical medical device (e.g., if the expandable element uses electrical actuation, or if there are embedded sensors or radiopaque markers). A POSA would therefore, from the outset, design this device, including its materials (polymer wall, reinforcement member), embedded components (expandable element, collar), and manufacturing processes, to meet the stringent requirements of IEC 60601-1 (and its collateral standards, e.g., IEC 60601-2-18 for endoscopic equipment). This involves designing for electrical safety (e.g., leakage currents, insulation coordination for the polymer wall, grounding), mechanical safety (e.g., material strength for the reinforcement member, fatigue resistance of the expandable element under repeated deployment, ensuring the embedding within the polymer wall prevents material shedding), electromagnetic compatibility (EMC), and risk management. The design considerations would specifically focus on biocompatibility and sterility, which are implicitly covered by the standard's risk management framework.

Obviousness Rationale: IEC 60601-1 is the foundational international open-source standard (published by the International Electrotechnical Commission) for the safety and essential performance of medical electrical equipment. Any competent medical device engineer developing an electrically-powered or electrically-influenced intravascular catheter for human use would mandatorily design and test it according to this standard. Applying these known safety and performance principles to the structural and functional aspects of the claimed catheter (polymer wall, embedded elements, reinforcement) is a fundamental and obvious engineering practice, not an inventive step.

3. US 12496077 (Device Claim 2) + Open-Source 3D Printing Standards (e.g., ASTM F2924-14 for Additive Manufacturing)

Scenario: A POSA in advanced manufacturing, seeking to rapidly prototype or customize the aspiration catheter of Device Claim 2, would find it obvious to apply open-source 3D printing standards to its fabrication.

Enabling Description: The aspiration catheter of Device Claim 2 features a polymer wall, a stepped distal end, and an expandable funnel coupled by a collar, with both funnel and collar embedded. To achieve customized geometries (e.g., patient-specific funnel sizes or catheter curvatures) or rapid prototyping for testing, a POSA would employ advanced additive manufacturing (3D printing) techniques compliant with open-source standards like ASTM F2924-14 (Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion for Medical Applications) adapted for polymers, or general FDM/SLA standards. Specifically, a multi-material 3D printing process could be used, where the core polymer wall (e.g., biocompatible TPU) is printed layer by layer. The expandable funnel and collar, pre-printed from a shape memory polymer (e.g., PCL-based) or a flexible composite, would be strategically paused and embedded during the printing of the main polymer wall, effectively encapsulating them. The stepped distal end geometry would be directly printed. This leverages the precise layer-by-layer control of 3D printing to achieve the embedded structure claimed.

Obviousness Rationale: 3D printing (additive manufacturing) has become an established and widely accessible manufacturing technology, with numerous open-source file formats (e.g., STL) and published standards (like ASTM's F42 committee standards) for various materials, including polymers for medical devices. The idea of using 3D printing to create complex geometries, multi-material structures, and embedded components is well-known in the art. Applying these established 3D printing methods, guided by open standards, to produce a catheter with an embedded expandable element and collar would be an obvious choice for a manufacturing engineer or designer, especially given the flexibility and customization offered by these techniques. The specific "embedding" feature is directly addressed by the multi-material capabilities of modern 3D printers.