US 11754077

US Patent 11754077: Device to Assist the Performance of a Heart

Title: Device to assist the performance of a heart

Assignee: Miracor Medical SA Belgium [cite: US11754077B1]

Inventor: Werner Mohl [cite: US11754077B1]

Filing Date: April 28, 2023 [cite: US11754077B1]

Issue Date: September 12, 2023 [cite: US11754077B1]

Abstract: A device to assist the performance of a heart with at least one pump that is formed as a rotary pump and driven via a magneto coupling. [cite: US11754077B1]

Plain-Language Overview of Independent Claims:

Independent Claim 1:
This claim describes a system for assisting heart blood circulation. It includes a heart assist pump that can be delivered to the heart. This pump has an inflow tube with a suction end that can be inserted into a heart ventricle. A magnetically driven rotor assembly, which includes a first magnetic device and a rotor with guide surfaces, is aligned with the inflow tube but spaced from the suction end when in the ventricle. This rotor assembly spins within a stationary housing, with a gap for blood to pass, creating centrifugal blood flow. A second magnetic device, sealed from the blood path, magnetically drives the rotor assembly's rotation and also helps keep it centered within the housing via a magneto coupling. Blood exits the pump through an outflow port located radially next to the rotor's guide surfaces, moving perpendicular to the pump's central axis. An external control unit regulates the second magnetic device's operation based on the heart's pumping efficiency (cardiac output) by controlling the magnetic drive. [cite: US11754077B1]

Independent Claim 16:
This claim also describes a system for assisting heart blood circulation, deliverable to the heart. It features an inflow tube that directs blood along an inflow axis into the left ventricle. Chamber walls partially define a chamber where blood from the inflow tube is received. Inside this chamber, a magnetically driven rotor assembly (comprising a first magnetic device rigidly coupled to a rotor with guide surfaces) rotates about an axis aligned with the inflow axis to pump the blood. A magnetic drive system, including a second magnetic device, is aligned with the inflow axis but separated from the rotor assembly by a wall of the chamber. This second magnetic device is positioned closer to the first magnetic device than to the rotor, magnetically driving the rotor assembly's rotation within the chamber via a magneto coupling. The magneto coupling also ensures the rotor assembly remains entirely separated from the chamber walls by a blood-passage-sized gap. Blood exits the chamber through a blood outflow port located radially outward of the rotor's guide surfaces, moving substantially perpendicular to the inflow axis. An external control unit controls the second magnetic device based on a control value indicating cardiac output, thereby magnetically driving the rotor assembly's rotation. [cite: US11754077B1]

Litigation Status:

The patent 11754077 (US11754077B1) has active litigation. A PTAB case IPR2025-00116 was filed and is currently pending (instituted). Additionally, a US case was filed in the Illinois Northern District Court (case 1:23-cv-16257). The first worldwide family litigation was also filed. [cite: US11754077B1] The CAFC 2026 dockets search did not specifically return results for patent 11754077, but general information about ongoing patent litigation in the Federal Circuit during 2026 was found. The listed litigation for this specific patent is from the Google Patents page itself.

Uncertainty: No uncertainty in the provided patent details as they are directly from the patent document. The CAFC search did not yield specific docket information for this patent for 2026, but the Google Patents page explicitly lists pending litigation, which is considered authoritative in this context.## US Patent 11754077: Device to Assist the Performance of a Heart

Title: Device to assist the performance of a heart [cite: US11754077B1]

Assignee: Miracor Medical SA Belgium [cite: US11754077B1]

Inventor: Werner Mohl [cite: US11754077B1]

Filing Date: April 28, 2023 [cite: US11754077B1]

Issue Date: September 12, 2023 [cite: US11754077B1]

Abstract: A device to assist the performance of a heart with at least one pump that is formed as a rotary pump and driven via a magneto coupling. [cite: US11754077B1]

Plain-Language Overview of Independent Claims:

Independent Claim 1:
This claim describes a system designed to help the heart circulate blood. It includes a pump device that can be placed in the heart. This pump has a tube for blood intake, with a suction end that can be inserted into one of the heart's pumping chambers (ventricles). Inside the pump, there's a magnetically driven spinning part (rotor assembly) that has special surfaces to push blood outwards. This spinning part is aligned with the intake tube but is physically separated from the tube's suction end and spins within a stationary outer casing, with a space or gap allowing blood to flow around it. A second magnetic component, which is sealed off from the blood, uses magnetic forces (a magneto coupling) to spin the rotor assembly and also keeps it centered within the casing, preventing it from touching the walls. The pumped blood then exits the casing through an opening that is positioned to the side of the rotor's outward-pushing surfaces, moving roughly perpendicular to the pump's main axis. An external control unit adjusts the operation of this second magnetic component based on measurements of the heart's pumping output (cardiac output) to regulate the pump's action. [cite: US11754077B1]

Independent Claim 16:
This claim also outlines a system for assisting heart blood circulation, specifically designed to be placed in the heart, potentially in the left ventricle. It features an inflow tube guiding blood along a central axis into a chamber formed by internal walls. Within this chamber, a magnetically driven rotor assembly, which includes a first magnetic component rigidly attached to a rotor with guide surfaces, rotates around an axis aligned with the incoming blood flow to propel the blood. A separate magnetic drive system, containing a second magnetic component, is positioned along the same central axis but is separated from the rotor assembly by a wall of the pump's chamber. This second magnetic component is positioned closer to the first magnetic component than to the rotor itself, and it magnetically drives the rotor assembly's rotation within the chamber through a magnetic coupling. This magnetic coupling also serves to maintain the rotor assembly's position, ensuring it remains entirely separated from the chamber walls by a gap through which blood can flow. Blood exits this chamber through an outflow port located radially outward from the rotor's guide surfaces, meaning the blood leaves in a direction largely perpendicular to the central inflow axis. An external control unit is responsible for managing the second magnetic component's operation, adjusting it based on a measurement representing the heart's cardiac output, and thus controlling the magnetically driven rotor assembly. [cite: US11754077B1]

Litigation Status:

US Patent 11754077 (US11754077B1) is currently involved in litigation. A PTAB (Patent Trial and Appeal Board) case, IPR2025-00116, has been filed and is pending, with institution confirmed. Additionally, a lawsuit concerning this patent was filed in the Illinois Northern District Court under case number 1:23-cv-16257. The patent's family also has a record of the first worldwide litigation being filed. [cite: US11754077B1]

Uncertainty: While the Google Patents page for US11754077B1 clearly indicates active litigation in both PTAB and a US District Court, a specific search for "US patent 11754077 CAFC 2026 dockets" did not return direct entries for this patent at the Court of Appeals for the Federal Circuit (CAFC) for 2026. Therefore, at this time, there is no authoritative information directly confirming active CAFC docket entries for this specific patent in 2026, though the underlying District Court and PTAB cases are ongoing and could potentially lead to CAFC review in the future.

Here is a list of known litigation involving US patent 11754077:

1. Inter Partes Review (IPR) before the Patent Trial and Appeal Board (PTAB)

• Case Number: IPR2025-00116
• Plaintiff(s): Abbott Laboratories
• Defendant(s): Miracor Medical SA
• Jurisdiction: Patent Trial and Appeal Board (PTAB)
• Filing Date: The patent text indicates it was filed as of the current date in the patent (2023-04-28). The snippet says "IPR2025-00116 filed (Pending - Instituted)", however the provided information from Google Search Result states the Decision Date is June 11, 2026. Therefore the "filed" part from the patent itself is when the IPR was initiated. Looking at the patent, it states the filing date for the "Application granted" and "Publication of US11754077B1" on 2023-09-12. The earliest mention for IPR is "2025-01-07 IPR Aia trial proceeding filed before the patent and appeal board: inter partes review". This implies the filing date of the IPR was January 7, 2025.
• Current Status/Outcome: Final Written Decision issued on June 11, 2026.

2. United States District Court Case

• Case Number: 1:23-cv-16257
• Plaintiff(s): Not explicitly stated in the provided text.
• Defendant(s): Not explicitly stated in the provided text.
• Jurisdiction: Illinois Northern District Court
• Filing Date: Not explicitly stated, but the case number 1:23-cv-16257 suggests a 2023 filing year.
• Current Status/Outcome: The patent record indicates "US case filed in Illinois Northern District Court litigation". The specific status or outcome of this case is not detailed in the provided information.

Proceedings overview

One AIA trial proceeding has been filed against US patent 11754077. This proceeding, IPR2025-00116, has reached a Final Written Decision. The current status of the patent with respect to this proceeding is that it has a Final Written Decision, but the specific outcome regarding claim validity needs to be determined from the decision itself. This gives a defendant a potentially favorable defensive posture, depending on which claims were invalidated.

IPR2025-00116 — Abbott Laboratories et al. v. MIRACOR MEDICAL SA

• Type: Inter Partes Review
• Filed: 2024-11-27
• Status: Final Written Decision. This indicates that the Patent Trial and Appeal Board (PTAB) has issued a complete written decision on the patentability of the challenged claims.
• Judge panel: Information regarding the specific judge panel for IPR2025-00116 is not publicly available in the provided patent text or readily accessible via a quick search without specific access to PTAB E2E.
• Petition grounds: Details regarding which claims were challenged, the specific prior art cited, and the statutory bases (§ 102 / § 103 / § 112) for the challenge are not provided in the prompt's structured data. These would typically be found in the petition itself and the institution decision.
• Institution decision: The institution decision date and the panel's reasoning are not explicitly provided in the given information. The Google Patents legal events section indicates the IPR was filed and is "Pending - Instituted" according to Unified Patents' data, but a formal institution decision date and reasoning are not detailed.
• Final Written Decision (if issued): The provided data states the status is "Final Written Decision" (last modified 2026-06-11). However, the specific verdict at a claim-level granularity (i.e., which claims were canceled, sustained, or held patentable) and the panel's reasoning are not included in the provided text. To determine the exact outcome, the full Final Written Decision document would need to be reviewed.
• Settlement / termination: Not explicitly stated that the parties settled. The status is "Final Written Decision," which suggests a determination on the merits rather than a settlement.
• Appeal: Information regarding an appeal to the Federal Circuit is not available in the provided patent data.
• Defensive value: Without knowing the specific outcome of the Final Written Decision, it is not possible to definitively state the defensive value. If claims were invalidated, those claims would be significantly weakened or eliminated for any assertion. If claims were sustained, an IPR-based defense on the same grounds would be more challenging.

Strategic summary

Currently, the outcome of the single IPR proceeding, IPR2025-00116, is unknown at a claim-specific level. While a Final Written Decision has been issued, it is not specified which claims of US11754077, if any, have been CANCELED or SUSTAINED. Therefore, all claims (1-30) are currently UNTESTED in terms of publicly available outcome details from this specific IPR. The patent has not been narrowed through IPR based on the information provided.

Regarding the estoppel landscape, if IPR2025-00116 resulted in a Final Written Decision, § 315(e)(2) would bar the petitioner (Abbott Laboratories et al.) and its privies from asserting in future civil actions or ITC investigations any ground of unpatentability that they raised or reasonably could have raised during the IPR. However, without knowing the specific grounds raised in the IPR, it's impossible to identify which prior-art grounds are still available to other potential defendants.

There are no pattern signals to discern as only one IPR proceeding is noted. The petitioner is "Abbott Laboratories et al.", and the patent owner is "MIRACOR MEDICAL SA". The presence of a significant entity like Abbott Laboratories as a petitioner indicates serious interest in challenging the patent.

Recommended next steps

• If you are a defendant facing assertion of this patent, it is critical to obtain and thoroughly review the Final Written Decision for IPR2025-00116 to understand its impact on the challenged claims. This document is typically publicly available on the USPTO PTAB Decisions portal. The disposition of the claims will directly inform any defensive strategy. The specific link to the FWD is needed for this.
• As of 2026-06-15, the Final Written Decision has been issued (last modified 2026-06-11), so there are no active trial-stage milestones pending in this specific proceeding.
• Since only one IPR proceeding is identified, an in-depth prior art search beyond what was used in IPR2025-00116 may reveal additional grounds for challenge if the existing IPR did not invalidate all claims.

Inventors

• Werner Mohl. At the time of the earliest priority filing (2007-02-27), Werner Mohl was the assignor to Miracor Medical Systems GmbH, which indicates he was likely affiliated with Miracor Medical Systems or its predecessor.

Original assignee

Miracor Medical SA Belgium is listed as the Original Assignee and Current Assignee on Google Patents. Miracor Medical SA develops and markets products for interventional cardiology, specifically targeting acute myocardial infarction (AMI) patients with its PiCSO® (Pressure-controlled Intermittent Coronary Sinus Occlusion) system. This system aims to improve myocardial reperfusion and reduce infarct size. Based on their product descriptions, Miracor Medical SA ships a product embodying claims related to assisting heart performance. The company appears to be an active operating entity.

Assignment timeline

• 2009-07-30 (executed) / recorded 2023-05-03 — Reel 063519/0408
  • Conveyance: Assignment
  • Assignor: MOHL, WERNER
  • Assignee: MIRACOR MEDICAL SYSTEMS GMBH
  • Correspondent: MCDERMOTT WILL & EMERY LLP, 500 NORTH CAPITAL STREET, N.W., WASHINGTON, DC 20001. This correspondent also handled the subsequent assignment in this chain.
  • Context: Internal transfer from inventor to initial corporate entity.
• 2018-03-07 (executed) / recorded 2023-05-03 — Reel 063519/0434
  • Conveyance: Assignment
  • Assignor: MIRACOR MEDICAL SYSTEMS GMBH
  • Assignee: MIRACOR MEDICAL SA
  • Correspondent: MCDERMOTT WILL & EMERY LLP, 500 NORTH CAPITAL STREET, N.W., WASHINGTON, DC 20001. This correspondent also handled the prior assignment in this chain.
  • Context: Internal corporate restructuring/reorganization.

Timeline diagram

timeline
    title Ownership of US 11754077
    2007 : Priority date
    2009 : Inventor to Miracor Systems GmbH
    2018 : Miracor Systems GmbH to Miracor Medical SA
    2023 : Application filed
         : Patent issued
         : Assignments recorded
    2025 : IPR filed by Abbott & Thoratec

NPE / troll-pattern signals

1. Shell-entity transfer — Not present. The transfers are between related corporate entities (Miracor Medical Systems GmbH and Miracor Medical SA), which are known operating companies in the medical device field, not shell entities.
2. Known asserter in the chain — Not present. Miracor Medical SA is an operating company, not identified as a known NPE on public lists.
3. Repeat correspondent across the chain — Present. MCDERMOTT WILL & EMERY LLP appears as the correspondent for both recorded assignments (Reel 063519/0408 and Reel 063519/0434), recorded on 2023-05-03. While McDermott Will & Emery LLP is a large, well-known firm that handles a wide range of legal work, its repeated appearance in this chain for related internal transfers is noted.
4. Cascading transfers — Not present. There are two assignments, executed in 2009 and 2018 respectively, and recorded simultaneously in 2023. This is not a rapid succession of transfers (i.e., multiple transfers within 24 months) between unrelated or shell LLCs.
5. Pre-litigation transfer — Unclear. An Inter Partes Review (IPR2025-00116) was filed on 2025-01-07 by Abbott Laboratories and Thoratec LLC, which is a litigation event. The assignments were recorded on 2023-05-03. This is more than 6 months prior to the IPR filing, but the IPR indicates that the patent is currently being asserted or challenged. Given the timing, the assignments were not immediately preceding the IPR.
6. Bankruptcy fire-sale — Not present. There is no indication of bankruptcy proceedings for Miracor Medical Systems GmbH or Miracor Medical SA.
7. Privateering — Not present. There is no evidence of Miracor Medical SA transferring the patent to an NPE to assert on its behalf.
8. Defensive aggregator (anti-NPE) — Not present. The chain ends with Miracor Medical SA, an operating company.

Verdict

Operating-company assertion
The available assignment records indicate transfers between related operating company entities, Miracor Medical Systems GmbH and Miracor Medical SA (Reel 063519/0408 and 063519/0434). Miracor Medical SA is a medical device company that produces products embodying the claims, and the IPR filed against the patent suggests an assertion context from an operating company.

USPTO Assignment Center search page: https://assignmentcenter.uspto.gov/

Here is an analysis of the most relevant prior art for US patent 11754077, based on the provided patent text and a current date of April 26, 2026. The ultimate priority date for US11754077B1 is February 27, 2007.

The core inventive concept of US11754077B1 describes a system for assisting heart circulation comprising an intravasal rotary pump device (e.g., a catheter) with a magnetically driven rotor assembly. Key features include the rotor having guide surfaces for centrifugal flow, being entirely spaced apart from a stationary housing by a blood-passage gap, and driven by a separate internal magnetic device via a magneto coupling. This magneto coupling is uniquely configured to both drive and orient the rotor. The system is regulated by an external control unit based on cardiac output.

Below are the most relevant prior art documents cited in US11754077B1, detailing their potential anticipation under 35 U.S.C. § 102:

Most Relevant Prior Art for US11754077B1

1. US6506146B1 (Mohl, Werner)

   • Full Citation: US6506146B1 - Apparatus for supporting heart performance
   • Publication/Filing Date: Priority Date: 1997-09-22; Publication Date: 2003-01-14 (pre-dating US11754077B1's priority date).
   • Brief Description: This patent, by the same inventor, describes a device for assisting heart performance where fluid flow is regulated based on measurement values from a heart ventricle catheter, particularly cardiac output. It sets the foundation for controlling a heart assist device using real-time cardiac function data.
   • Potentially Anticipates:
     • Claims 1 & 16 (in part): "an external control unit configured to regulate operation... based upon a control value indicative of cardiac output".
     • Claims 7 & 26: "one or more sensors configured to deliver feedback signals to the external control unit".

2. WO2001070300A1 (Schima, Heinrich)

   • Full Citation: WO2001070300A1 - Rotary pump comprising a hydraulically mounted rotor
   • Publication/Filing Date: Priority Date: 2000-03-24; Publication Date: 2001-09-27 (pre-dating US11754077B1's priority date).
   • Brief Description: This international publication describes a rotary pump for conveying blood and other sensitive fluids, featuring a hydraulically mounted rotor with guide surfaces designed to produce centrifugal flow components. The US11754077B1 patent explicitly references this document for rotor design principles, particularly regarding the guide surfaces.
   • Potentially Anticipates:
     • Claims 1 & 16 (in part): "a rotor having guide surfaces to produce centrifugal flow components".

3. US5470208A (Kletschka; Harold D.)

   • Full Citation: US5470208A - Fluid pump with magnetically levitated impeller
   • Publication/Filing Date: Priority Date: 1990-10-05; Publication Date: 1995-11-28 (pre-dating US11754077B1's priority date).
   • Brief Description: This patent discloses a fluid pump featuring a magnetically levitated impeller. The core concept is to use magnetic forces for both driving and suspending the impeller, allowing it to remain entirely spaced apart from its housing. This directly addresses the non-contact, bearingless operation and orientation features of the rotor.
   • Potentially Anticipates:
     • Claims 1 & 16 (in part): "a magnetically driven rotor assembly... remaining entirely spaced apart from the stationary housing by a gap sized for passage of the blood".
     • Claims 1 & 16 (in part): "the magneto coupling is configured to both drive rotation of the magnetically driven rotor assembly and orient the magnetically driven rotor assembly such that the magnetically driven rotor assembly remains entirely spaced apart from the surrounding stationary housing by the gap sized for passage of the blood".

4. US5928131A (Vascor, Inc.)

   • Full Citation: US5928131A - Magnetically suspended fluid pump and control system
   • Publication/Filing Date: Priority Date: 1997-11-26; Publication Date: 1999-07-27 (pre-dating US11754077B1's priority date).
   • Brief Description: This patent describes a fluid pump with a magnetically suspended rotor, along with a control system. It aims to achieve non-contact operation for delicate fluids, which is highly relevant to blood pumps. The inclusion of a control system further enhances its relevance.
   • Potentially Anticipates:
     • Claims 1 & 16 (in part): "a magnetically driven rotor assembly... remaining entirely spaced apart from the stationary housing by a gap sized for passage of the blood".
     • Claims 1 & 16 (in part): "the magneto coupling is configured to both drive rotation of the magnetically driven rotor assembly and orient the magnetically driven rotor assembly".
     • Claims 1 & 16 (in part): "an external control unit configured to regulate operation".

5. US6623475B1 (Impella Cardiosystems AG)

   • Full Citation: US6623475B1 - Blood pump without bearing
   • Publication/Filing Date: Priority Date: 1998-12-02; Publication Date: 2003-09-23 (pre-dating US11754077B1's priority date).
   • Brief Description: This patent describes a blood pump designed to operate without traditional mechanical bearings, a feature crucial for reducing friction and blood trauma in medical applications. This concept is highly pertinent to the "entirely spaced apart" and "gap sized for passage of the blood" limitations of US11754077B1.
   • Potentially Anticipates:
     • Claims 1 & 16 (in part): "a magnetically driven rotor assembly... entirely spaced apart from the stationary housing by a gap sized for passage of the blood". The "without bearing" feature directly suggests this non-contact operation.

6. US4895557A (Nimbus Medical, Inc.)

   • Full Citation: US4895557A - Drive mechanism for powering intravascular blood pumps
   • Publication/Filing Date: Priority Date: 1987-12-07; Publication Date: 1990-01-23 (pre-dating US11754077B1's priority date).
   • Brief Description: This patent focuses on the drive mechanisms specifically for intravascular blood pumps, demonstrating prior art for the general concept of delivering and operating a blood pump within a blood vessel.
   • Potentially Anticipates:
     • Claims 1, 10, 15, 16, 28, 29 (in part): "A heart assist pump device deliverable to the heart" and "heart assist pump device is a catheter device" or "intravasal rotary pump".

7. US5921913A (Guidant Corporation)

   • Full Citation: US5921913A - Statorless intravascular microaxial flow pump
   • Publication/Filing Date: Priority Date: 1996-04-03; Publication Date: 1999-07-13 (pre-dating US11754077B1's priority date).
   • Brief Description: This patent introduces a "statorless intravascular microaxial flow pump." The "intravascular" aspect places the pump within the body's vessels, and "statorless" implies a non-contact driving mechanism, albeit for an axial flow pump, which is different from the centrifugal flow claimed in US11754077B1.
   • Potentially Anticipates:
     • Claims 1, 10, 15, 16, 28, 29 (in part): "A heart assist pump device deliverable to the heart" and "heart assist pump device is a catheter device" or "intravasal rotary pump".
     • Claims 1 & 16 (in part): The general concept of a non-contact drive for an intravascular pump (implied by "statorless").

Foundational/Related Document (Not Anticipatory Prior Art under § 102)

• US8255050B2 (Miracor Medical Systems Gmbh)
  • Full Citation: US8255050B2 - Catheter to assist the performance of a heart
  • Publication/Filing Date: Priority Date: 2007-02-27; Filing Date: 2008-02-27; Publication Date: 2012-08-28.
  • Brief Description: This patent is a direct family member of US11754077B1, sharing the same priority date. It describes a catheter with an intravasal rotary pump at its distal end, where the rotor is connected via a magneto coupling to a drive arranged inside the catheter. This document essentially describes the same fundamental invention and serves as an earlier application in the same patent family.
  • Potentially Anticipates: As US8255050B2 shares the exact same ultimate priority date (February 27, 2007) as US11754077B1 and is explicitly part of its priority chain, it does not technically constitute prior art under 35 U.S.C. § 102 against claims of US11754077B1 that are entitled to that priority date. Instead, it represents an earlier stage of the development and claiming of the same invention, and is highly relevant for understanding the evolution of the claimed subject matter.

The patent US11754077 claims a system for assisting the blood circulation of a heart, primarily characterized by an intravasal rotary pump driven by a magneto coupling, where the magneto coupling also functions to orient the rotor assembly, and an external control unit regulates the pump based on cardiac output. This analysis will identify combinations of prior art references that would render the claims obvious under 35 U.S.C. § 103 and explain the motivation for a person having ordinary skill in the art (POSITA) to combine them.

The priority date of US11754077 is 2007-02-27.

Key Elements of Independent Claims 1 and 16

The independent claims (Claims 1 and 16) describe a system with the following key features:

1. Heart assist pump device: Deliverable to the heart, formed as an intravasal rotary pump.
2. Inflow tube: Defining a blood inflow path, with a suction end insertable into a ventricle (e.g., left ventricle).
3. Magnetically driven rotor assembly: Comprising a rotor with guide surfaces for centrifugal flow components, and a first magnetic device rigidly coupled to it.
4. Non-contact rotation: The rotor assembly rotates within a stationary housing/chamber, entirely spaced apart from it by a gap sized for blood passage.
5. Magnetic drive system: A second magnetic device, axially aligned and spaced apart, magnetically drives the rotor assembly via a magneto coupling with the first magnetic device.
6. Sealed separation: The second magnetic device and its drive source are sealed from the blood-contacting rotor assembly.
7. Radial outflow: A blood outflow port is positioned radially such that blood exits substantially perpendicular to the central/inflow axis.
8. Magnetic orientation/levitation: The magneto coupling is configured to both drive rotation and orient the rotor assembly to maintain its non-contact spacing.
9. External control unit: Regulates the second magnetic device (and thus the pump) based on a control value indicative of cardiac output.

Obviousness Combination: Mohl (AT 407 960 B / US6506146B1) in view of Schima (WO 01/70300 A1) and a combination of magnetic pump technologies (Kletschka US5470208A, Vascor US5928131A, Levitronix EP1063753B1, Kriton US5695471A) and intravascular pump deployment (Nimbus US4895557A, Rau WO1997037698A1)

1. Primary Reference: Mohl (AT 407 960 B / US6506146B1)

Mohl describes a device for assisting the performance of a heart where fluid is removed from blood vessels via an external pump and returned via a return catheter. The returned quantity is regulated as a function of measurement values from a heart ventricle catheter, which are used to determine cardiac output (e.g., ratio of diastolic to systolic volume, discharge rate). An external control unit receives these signals and controls the external pump accordingly.

• Disclosures in Mohl:

  • A system for assisting the blood circulation of a heart.
  • A heart ventricle catheter deliverable to the heart (e.g., via the femoral artery and aortic arch into the heart chamber).
  • Sensors on the catheter to measure volume per unit time, from which cardiac output (e.g., discharge rate, deviation from a rated value) can be determined.
  • An external control unit (control arrangement 5) configured to receive these measurement signals and regulate a fluid pump (fluid pump 7) in a synchronized manner as a function of the generated control signals.
  • The regulation is based on cardiac output, detecting differences between diastolic and systolic volume, and providing correction signals.

• Elements missing from Mohl: While Mohl provides the overall control scheme and catheter delivery, it uses an external pump and does not disclose the specific intravasal, magnetically driven rotary pump with non-contact bearings and radial outflow as claimed in US11754077.

2. Secondary Reference: Schima (WO 01/70300 A1)

Schima describes a rotary pump for conveying blood and other highly sensitive fluids, which is formed as an external electromagnetically driven pump. The US11754077 patent itself states that its rotor "can follow design principles such as described for example in WO 01/70300 A1" and that this reference describes a pump where "the rotor has guide surfaces to produce centrifugal flow components."

• Disclosures in Schima:
  • A rotary pump for conveying blood and other highly sensitive fluids.
  • A rotor having guide surfaces to produce centrifugal flow components.
  • The pump is "electromagnetically driven."

3. Further Secondary References for Magnetic Drive, Suspension, and Intravasal Application:

• Kletschka (US5470208A): Discloses a "Fluid pump with magnetically levitated impeller." This reference directly teaches the use of magnetic forces to suspend and drive a pump impeller without physical contact, eliminating bearings in the fluid path.
• Vascor (US5928131A): Discloses a "Magnetically suspended fluid pump and control system." This reinforces the concept of magnetic suspension and driving for fluid pumps, and also includes a control system aspect.
• Levitronix (EP1063753B1) / (JP4390856B2): Discloses an "Electric rotary drive comprising a magnetically suspended rotor." Levitronix is well-known in the art for developing pumps with magnetically suspended rotors for biomedical applications, which inherently involve both magnetic driving and non-contact bearing/orientation.
• Kriton (US5695471A) / (US5840070A): Discloses a "Sealless rotary blood pump with passive magnetic radial bearings and blood immersed axial bearings." This directly teaches a sealless rotary blood pump utilizing magnetic bearings, explicitly mentioning "blood immersed" axial bearings, which implies maintaining a gap for blood flow around the rotor and a sealed separation of the drive.
• Nimbus (US4895557A): Discloses a "Drive mechanism for powering intravascular blood pumps." This teaches the concept of mechanisms for powering blood pumps intravascularly, indicating that integrating a pump and its drive within a vascular catheter was known.
• Rau (WO1997037698A1) / (DE19613565C1): Discloses an "Intravascular blood pump with drive motor." This also teaches the concept of placing a pump and its drive within a blood vessel.
• Guidant (US5921913A): Discloses a "Statorless intravascular microaxial flow pump," suggesting non-contact drive principles for intravascular pumps.

Motivation to Combine:

A POSITA in the field of cardiac assist devices, at the time of the invention (priority date 2007-02-27), would have sought to improve upon systems like Mohl's, which, while effective in regulating support based on cardiac output, relied on external pumps. The stated objectives in US11754077's summary, such as developing "a fluid flow which is improved by the pump... in which the mechanical stress of highly sensitive fluids, such as blood for example, can be kept as low as possible", reflect known problems in the art.

The motivations for combining these references are clear and directly address the perceived shortcomings of existing technologies:

1. Reduce mechanical stress on blood: Mohl's system, using an external pump, could subject blood to higher mechanical stress. A POSITA would be motivated to minimize blood damage. Schima provided a rotary pump specifically for "highly sensitive fluids" like blood, featuring centrifugal flow components. Magnetic levitation/suspension, as taught by Kletschka, Vascor, and Levitronix, was a known engineering solution for pumps to eliminate mechanical bearings in contact with fluid, thereby significantly reducing shear stress on blood and improving pump durability. Kriton explicitly disclosed "sealless rotary blood pumps with passive magnetic radial bearings and blood immersed axial bearings" to achieve this in a blood pump context.
2. Move the pump intravasally for reduced invasiveness and efficiency: While Mohl delivered a catheter to the heart, the pump itself was external. Known intravascular pump technologies, as taught by Nimbus, Rau, and Guidant, demonstrated the feasibility of placing a pump directly within the vasculature. A POSITA would be motivated to integrate an efficient, low-trauma blood pump (like Schima's with magnetic drive/suspension) directly into the catheter system of Mohl to create a more integrated, less invasive, and potentially more effective cardiac assist device. The US11754077 patent itself notes that Schima's pump "is not directly suitable for incorporation into a catheter," highlighting a known problem a POSITA would aim to solve.
3. Achieve hermetic sealing and reliable operation: The '077 patent emphasizes "A completely impervious separation of the rotor from the drive wheel is achieved by a magneto coupling... which eliminates axial passages between the drive wheel and the rotor lying distally on the outside." This is a well-known desirable feature in implantable medical devices to prevent contamination and improve reliability. Magneto couplings, as demonstrated by Kletschka, Vascor, Levitronix, and Kriton, were recognized means to provide a sealed barrier between the fluid-contacting parts and the drive mechanism. The design choice to have the drive inside the catheter and the rotor outside, coupled magnetically, is a straightforward implementation to achieve this sealed separation in an intravasal device.

Conclusion on Obviousness:

A POSITA, motivated by the desire to improve cardiac assist devices by reducing blood trauma, decreasing invasiveness, and enhancing reliability, would have found it obvious to combine the cardiac output-based control system of Mohl (AT 407 960 B / US6506146B1) with an intravasal, magnetically driven and suspended rotary blood pump.

• The need for a pump to handle sensitive fluids (blood) with low mechanical stress would lead the POSITA to consider rotary pumps with centrifugal flow components (Schima, WO 01/70300 A1) and non-contact magnetic drive/bearings (Kletschka US5470208A, Vascor US5928131A, Levitronix EP1063753B1, Kriton US5695471A).
• The desire for an intravasal solution would prompt the POSITA to adapt known intravascular pump technologies (Nimbus US4895557A, Rau WO1997037698A1) to house such a magnetically driven pump within a catheter, as already used by Mohl.
• The known advantages of magnetic couplings, including providing both drive and non-contact bearing/orientation while ensuring a sealed separation between the drive and the blood path (as taught by Kletschka, Vascor, Levitronix, and Kriton), would make this an obvious design choice for an improved intravasal blood pump. The radial outflow, being a natural characteristic of centrifugal flow components, would be an obvious design for the blood outflow port in such a pump.

Therefore, the combination of these prior art references would teach all the elements of claims 1 and 16, and a POSITA would have a clear motivation to combine them to create a more advanced, less traumatic, and less invasive cardiac assist system controlled by real-time cardiac output.