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Patent schematic for: “Systems and methods for applying energy to ovarian tissue.”

WO2020152631-A2: “Systems and methods for applying energy to ovarian tissue.”

Assignee: AblaCare

Inventors: Gasperment, Marion; Lenihan, Tim; Osdoit, Anne

IPC Codes: A61B 34/00; A61B 17/34; A61B 17/425; A61B 18/14; A61B 8/12

Publication Date: 30-Jul-2020 (also published as US20200237437-A1)

Earliest Priority Details: US2019797191, 25-Jan-2019

Methods and systems for performing an ovarian procedure, that are disclosed as being useful in the treatment of polycystic ovary syndrome (PCOS) and infertility associated with PCOS. The systems allow for a minimally-invasive, transvaginal approach, wherein the ovary is accessed using a needle whose tip may be used to puncture through the vaginal wall and into the ovary under transvaginal ultrasound image guidance. A therapeutic portion of the needle may include one or more electrodes for emitting continuous or pulsed radiofrequency energy to ablate ovarian tissue.

The inventors say that the advantages of a transvaginal approach over surgical or laparoscopic approaches include one or more of the following: (a) conscious sedation vs general anesthesia which reduces cost and patient risk; (b) no external scars; (c) less tissue manipulation resulting in lower risk of adhesions; (d) fewer access points into the ovary resulting in lower risk of adhesions; (e) faster recovery time; (f) it is a familiar access route for obstetricians, gynecologists and fertility physicians, and fits within existing care pathways; and, (g) rebalances the ovary(ies) to effectively treat the condition(s).

While this may represent the first patenting to have been published in the name of Paris, France-based AblaCare SA, within the application’s disclosure we see the referencing of patenting in the company’s former name, Ziva Medical, that describes methods and systems for the manipulation of ovarian tissues to treat PCOS and infertility associated with PCOS, see WO2015058096 and WO2016161011.

In July 2019, AblaCare announced the raising of €10 million in series A financing from Sofinnova Partners, a leading European venture capital firm specialized in life sciences. The proceeds were earmarked for advancing AblaCare’s clinical and regulatory programs in Europe and the US. The company's technology is currently being evaluated in the ULTRA clinical trial (NCT03760926), with two sites in the UK enrolling patients, with the primary endpoint being the safety of the AblaCare procedure that uses the AblaCare Kit, which comprises two elements: a disposable device (AblaCare Device) and a radiofrequency energy generator (AblaCare System). The AblaCare Device is a short-term invasive device delivered and positioned through the vagina to deliver radiofrequency energy inside the ovary in order to ablate ovarian tissue. The study’s estimated completion date is September 2023.

 

WO2020151995-A1: “Device for the treatment of tissue calcification.”

Assignee: Aorticlab Italy Srl; Aorticlab Sàrl

Inventors: Benettin, Davide; Bonetti, Francesco; Fermi, Enrico; Osta, Franco; Osta, Stefano; Pasquino, Enrico

IPC Codes: A61B 17/22; A61N 7/00

Publication Date: 30-Jul-2020 (also published as EP3685772-A1, 29-Jul-2020)

Earliest Priority Details: EP2019153513, 24-Jan-2019

Device for treating tissue calcification, particularly aortic valve leaflets, through the combined and simultaneous use of MHz and KHz frequency ultrasound waves. When used for the treatment of an aortic valve, the device is preferably introduced by a catheter, designed for access via a femoral artery, into the seat of the aortic valve. The combined and simultaneous use of MHz and KHz frequencies is said to induce an efficient fragmentation of the calcium deposits in the aortic valve leaflets. The device preferably comprises an antiembolic filter to capture any debris resulting from the decalcification treatment.

The inventors report that their device bestows several advantages, such as: restoring the flexibility of the treated tissue, for instance valve leaflets to recover a sufficient transvalvular flow/gradient; at least partially remove calcium from the native aortic valve, in order to obtain a more regular implant site and consequently optimize the implantation of a TAVI; and, partially eliminate calcium from valvular bio-prostheses, to eliminate structural deterioration caused by progressive calcification.

Follows WO2019053538, in which three of the team (Pasquino, Bonetti, and Osta), described a transcatheter device for treating calcified heart valve leaflets.

Its patenting would to be in support of Turin, Italy-based Aorticlab’s development of a system aimed at restoring the aortic valve leaflets’ pliability in order to recover as much as possible the original hemodynamics of the native valve. As seen from its patenting the system is composed of two devices: a Transcatheter Debridement Device (TDD) that fragments calcification on valve leaflets, and which is integrated with a temporary valve that allows the treatment for some minutes; and, a Transcatheter Antiembolic Filter (TAF) to protect the patient from embolic cerebral or peripheral ischemic attacks during procedures conducted on the diseased aortic valve. Its devices can be adopted in TAVI procedures to increase their efficacy and safety, because AorticLab’s devices are compatible with all TAVI delivery systems.

 

WO2020152273-A1: “Medical chamber system, introduction system and kit.”

Assignee: Artract Medical UG

Inventors: Goetz, Wolfgang

IPC Codes: A61M 1/10; A61F 2/24

Publication Date: 30-Jul-2020

Earliest Priority Details: DE102019101771, 24-Jan-2019

Medical chamber system for implanting in the chest of a heart failure patient to support the heart’s action. Follows WO2020064922, the first patenting from the assignee, in which the same inventor previously described a cardiac support system.

In 2018, Dr Goetz, a former cardiac surgeon, founded Prima Medical Technologies GmbH as an incubator for emerging medical device companies and spun-off three technology companies: Artract Medical, Semiflow Medical and Venock Medicial. Prior to this he had set up Transcatheter Technologies GmbH to develop a transcatheter heart valve system designed to increase the safety and durability of aortic valve implantation; with the proprietary technology being acquired by Venus Medtech (Hangzhou, China) in 2016.

This series patenting would appear to be in support of Regensburg, Germany-based Artract Medical’s development of a fully implantable circulatory assist device for patients suffering from Heart Failure with preserved Ejection Fraction (HFpEF).

 

WO2020152359-A1: “System and method for neural control.”

Assignee: BIOS Health Ltd

Inventors: Armitage, Oliver; Edwards, Tristan; Gonshaw, Samuel; Hewage, Emil; Jakopec, Matjaž

IPC Codes: G16H 40/63; A61N 1/36

Publication Date: 30-Jul-2020

Earliest Priority Details: GB2019995, 24-Jan-2019

A system and method for closed-loop neural control, that may comprise implanted neural sensors and stimulators, and means for machine learning models to process the received neural data to then determine an output signal required to achieve a desired bodily state, that is then sent to an output device. For prior patenting in which Armitage, Edwards, and Hewage described a neural interface, see WO2019092456.

Formerly known as Cambridge Bio-Augmentation Systems (CBAS), BIOS Health was co-founded by Cambridge University graduates Emil Hewage, a computational neuroscientist, and Oliver Armitage, a biomechanical engineer. As evidenced from its patenting, BIOS is developing a full-stack neural interface platform that uses AI to decode and encode the signals from the brain to the body, to treat chronic health conditions. There are three parts to its technology: its implanted neural interface that connects directly with the nerves to isolate the signals that travel between the brain and the body; AI that decodes and encodes this neural information from hundreds of thousands of individual neurons, tens of thousands of times per second, and sends corrected signals back into the body; and, the use of this this neural code to build a whole digital healthcare treatment. For a person with a severe chronic condition, that means their condition could be managed via the nervous system directly by AI, giving personalized and accurate treatments, where the company says that the burden of pills and doctor visits become a second resort rather than a daily reality.

In May 2020, BIOS announced a CA$800,000 research partnership with Mila, McGill University and the Université de Montréal, to help develop an AI-controlled closed-loop neuromodulation system for chronic cardiac conditions. This partnership represents an expansion of BIOS’ involvement with Mila, a Montreal-based research institute in artificial intelligence. The BIOS team would be working closely with Dr Blake Richards, Assistant Professor, School of Computer Science, McGill University and Dr Guillaume Lajoie, Assistant Professor, Applied Mathematics, Université de Montréal in conducting this research.

 

WO2020152239-A1: “Mobile device for treatment of itching, having an interface.”

Assignee: Dermapharm AG

Inventors: Bünger Von Wurmb, Daniel

IPC Codes: G16H 40/67; A61F 7/08

Publication Date: 30-Jul-2020

Earliest Priority Details: EP2019153229, 23-Jan-2019

A device with at least two different treatment programs for the hyperthermal treatment of itching and herpes diseases, in which afflicted areas can be heated to 40-65 °C for periods of 1-12 seconds. The device has an interface for connection to a mobile device on which software may be installed to allow selection of the different treatment programs. It is seen to be discussed how data may be transferred from the device to a mobile device such as a smartphone, that may include an indication of the currently selected treatment program and its defined treatment parameters (temperature, the duration of treatment and/or a chronological sequence of treatment temperatures to be applied). Other relevant metadata can also be generated, such as treatment success, healing history, and the frequency of application, with the smartphone being able to generate still further data, such as GPS position data, time stamps, and photos of skin areas affected by itching.

Follows WO2020049070, in which the same inventor described a device for treating pruritus and/or herpetic diseases by heating areas of affected skin.

Based in Brehna, near Leipzig, Germany, Dermapharm acquired the Hyperthermic Medical Devices Business of Greifswald-Insel Riems-headquartered Riemser in September 2018. In doing so giving it access to its portfolio of OTC medical products for mosquito and insect stitches (bite away®) and herpes blisters (Herpotherm®).

 

US20200238093-A1: “Devices, systems, and methods for cardiac resynchronization therapy.”

Assignee: EBR Systems Inc

Inventors: Kim, Steven; Willis, Parker

IPC Codes: A61N 1/375; A61N 1/372

Publication Date: 30-Jul-2020

Earliest Priority Details: US2019797800, 28-Jan-2019

An implantable receiver-stimulator and an implantable controller-transmitter for leadless electrical stimulation of the left ventricle of a heart in a patient suffering from Left Bundle Branch Block (LBBB). The controller-transmitter emits acoustic energy and the receiver-stimulator converts acoustic energy received from the controller-transmitter into electrical energy. The receiver-stimulator can include one or more sensors capable of detecting the electrical conduction of the heart and the receiver-stimulator can be configured to pace the stimulation of the left ventricle based off the sensed electrical conduction to achieve synchronization of the left and right ventricles.

Comes one week after the publication of US20200230426, in which one of the inventors, Willis (EBR Systems’ CTO), described systems for optimizing acoustic energy transmission in implantable devices.

In September 2019, Sunnyvale, California-based EBR Systems announced that the US FDA had granted Breakthrough Device Designation for its WiSE™ cardiac resynchronization therapy (CRT) system for the treatment of heart failure. The WiSE™ (Wireless Stimulation Endocardially) CRT system is designed to improve the heart’s pumping ability by synchronizing the left and right ventricles to distribute blood to the lungs and body more effectively. To regulate precise pacing from within the heart, WiSE™ uses a wireless electrode the size of a grain of rice. It is implanted in the left ventricle wall during a minimally invasive procedure. This approach provides the cardiologist greater choice of pacing locations, enabling patient-specific customization of pacing site that may improve CRT response. The electrode then stimulates the left ventricle internally, working in tandem with an existing pacemaker or implantable cardioverter defibrillator (ICD) on the heart's right side to improve circulation throughout the body and reduce the symptoms of heart failure.

The WiSE™ CRT system is currently being evaluated in the IDE-approved SOLVE CRT clinical trial (NCT02922036) to assess safety and efficacy of WiSE™ pacing technology in support of US FDA approval. The study’s primary completion date is June 2021. EBR Systems won CE mark approval for the WiSE™ CRT in October 2015, however, its release has been limited to support clinical work.

 

WO2020152679-A1: “Cancer diagnosis and monitoring apparatus, systems and methods thereof.”

Assignee: GinaLife Diagnostics Ltd

Inventors: Michaely, Roni; Yehezkely-Hayon, Daniella; Yehudai-Reshef, Shlomit

IPC Codes: G01N 33/53; A61B 10/00; A61F 13/15; G01N 33/52

Publication Date: 30-Jul-2020

Earliest Priority Details: US2019795891, 23-Jan-2019

Female hygienic devices in the form of eg a sanitary pad or tampon embedded with cancer diagnostic and/or monitoring means capable of detecting physiologic markers of cancer (eg CA125 and HE4) present in vaginal discharges.

Represents the first patenting from both the inventors and Haifa, Israel-based Gina Life Diagnostics - an academic spin-off from Rambam MedTech (the technology transfer office for Rambam Health Care Campus). As evidenced from its patent application, Gina Life is developing a home-use detection test for ovarian cancer using a proprietary biomarker fingerprint of biofluid vaginal secretions. The inventor and company founder, Shlomit Yehudai-Reshef, is also Director of The Clinical Research Institute at the Rabmam Health Care Campus and co-Principal investigator of the campus’ Laboratory of Leukemia Research.

 

US20200238081-A1: “Oral drug delivery devices and methods using iontophoresis.”

Assignee: Harvard University; University of California

Inventors: Arafin, Shamsul; Banerjee, Amrita; Chen, Renwei; Mitragotri, Samir

IPC Codes: A61N 1/05; A61N 1/32

Publication Date: 30-Jul-2020

Earliest Priority Details: US2019798373, 29-Jan-2019

Methods for oral drug delivery comprising orally administering an intestinal iontophoretic device comprising at least two electrodes and an active agent (a small molecule or macromolecule, but with there being a particular focus on the delivery of insulin). The device comprises an outer enteric biocompatible protective coating that encapsulates the electrodes and active agent, and it may further comprise a mucoadhesive patch to adhere to the intestinal mucosa to deliver the active agent. Iontophoresis can be triggered in a variety of manners, such as via an environmental stimulus, such as change in pH or temperature, a timer, or a remote control, to improve transport and bioavailability of the active agent.

One of the team, Samir Mitragotri (Hiller Professor of Bioengineering and Hansjorg Wyss Professor of Biologically Inspired Engineering at the Harvard John A Paulson School of Engineering and Applied Sciences (SEAS)), can be seen to have a long held interest in the possible oral delivery of insulin, having originally claimed an intestinal mucoadhesive patch system for enhancing the bioavailability of poorly absorbed drugs such as polar molecules or bioactive peptides and proteins back in WO2003007913.

However, it is his work developing an oral insulin formulation using a choline and geranate (CAGE) ionic liquid that has received most fanfare, with CAGE having been demonstrated to have enzyme inhibitor activity, including inhibiting the degradation of insulin; see WO2019099837. This work has culminated in the reporting in April 2020, of a new startup, i2O Therapeutics, being launched to commercialize his innovations developed at Harvard University that may one day enable patients and clinicians to give up syringes in favor of pills. Using the ionic liquid technologies developed in the lab of Samir Mitragotri, biologic therapies that would normally need to be delivered via needle may be reformulated and encapsulated as pills for oral delivery. Harvard’s Office of Technology Development has granted i2O Therapeutics an exclusive license to the technology, to develop safe and effective oral formulations for a range of biologics, large molecules, and peptide-based pharmaceuticals. The company has raised $4 million in seed funding from Sanofi Ventures and the JDRF T1D Fund to advance its mission that will initially focus on developing formulations for GLP1 analogs, glucagon-like peptides that help balance glucose levels to treat diabetes.

 

WO2020154638-A1: “Method and apparatus for assessing cardiac output in veno-venous extracorporeal blood oxygenation.”

Assignee: Transonic Systems Inc

Inventors: Galyanov, Gregory; Krivitski, Nikolai M.

IPC Codes: A61M 1/36; A61B 5/1455; A61M 1/16; A61B 5/029; A61B 5/145

Publication Date: 30-Jul-2020 (also published as US20200237989-A1)

Earliest Priority Details: US2019796800, 25-Jan-2019

Method and apparatus for assessing cardiac output (CO) of a patient operably connected to a veno-venous (VV) extracorporeal circuit, and particularly to a VV extracorporeal blood oxygenation circuit such as but not limited to a VV extracorporeal membrane oxygenation (ECMO) circuit. It is discussed how VV ECMO is a medical procedure employed in patients who are experiencing life-threatening respiratory failure, typically acute respiratory distress syndrome (ARDS).

The invention would appear to describe a new noninvasive methodology to measure cardiac output in VV ECMO patients that the inventors detailed in a paper published in the journal Perfusion in May 2020. The procedure included measurement of recirculation, using Ithaca, New York-based Transonic Systems’ ELSA (Extracorporeal Life Support Assurance) Monitor, and arterial saturation at two extracorporeal membrane oxygenation flows after temporary pump flow decrease. Mathematic modeling that utilized a crude Monte Carlo method was used to analyze theoretical errors in CO calculations from unknown behavior of venous saturation. The developed concept was retrospectively applied to clinical data archive of 17 adult patients on VV ECMO that included 52 measurement sessions. They reported that the mathematical model and clinical retrospective analysis demonstrated that their new methodology had the potential to accurately measure CO in VV ECMO patients, and that their next step was to undertake validation in animal and clinical settings.

During the Covid-19 pandemic Transonic has seen increased demand for its ELSA Monitor systems, with ARDS being a known complication of Covid-19. The ELSA Monitor reports the exact amount of blood flow that is being delivered to the patient and how much is being recirculated. ELSA can also quantify clotting in the oxygenator, and Covid-19 patients are being found to have very severe inflammatory responses throughout their bodies and that this is causing serious clotting issues, which is especially a concern during ECMO. ECMO performed with the ELSA monitor has been found useful in providing information on when to change out the oxygenators to help provide the most optimal oxygenation for critical patients.

 

WO2020154398-A1: “Noninvasive real-time patient-specific assessment of stroke severity.”

Assignee: University of Arizona; University of Pittsburgh

Inventors: Babaee, Hessam; Laksari, Kaveh

IPC Codes: A61B 34/10; G16H 50/50; G16H 30/00; A61B 5/02; G06G 7/48; G16H 50/00

Publication Date: 30-Jul-2020

Earliest Priority Details: US2019795170, 22-Jan-2019

Method for obtaining information for use in determining stroke severity that includes simulating, with a processor executing instructions stored on a compute readable medium, cerebral blood flow (CBF) using as inputs information extracted from an angiography scan of the stroke patient and information concerning blood flow in cranial arteries. Cerebral tissue viability of the stroke patient is assessed based at least in part on the simulated CBF.

The invention would appear to feature as Case ID: UA18-140 on the website of University of Arizona’s technology transfer office, Tech Launch Arizona. The inventors’ hybrid computational model utilizes high-performance computing and machine learning to simulate the entire brain vasculature, as well as provide real time measurements of regional CBF. Their invention uses mathematical methods to determine the vascular geometry of each subject using existing imaging database that includes computed tomography angiography (CTA) and CBF images from stroke patients, and machine learning algorithms to extract patterns in stroke patients' blood flow and give estimates for stroke severity predictors based on patient-specific measurements.

Of the inventors, only Kaveh Laksari (an Assistant Professor at the University of Arizona) has any history of patenting, with his only other patent application having described systems, devices, and methods to detect a concussive event; see WO2020123875 assigned to Stanford University where he has been working as a post-doctoral researcher focusing on understanding how sudden motions of the head, in the absence of direct contact, could lead to “mild” traumatic brain injury.

 

WO2020154287-A1: “Microcatheter for therapeutic and/or diagnostic interventions in the subarachnoid space.”

Assignee: University of Pennsylvania

Inventors: Pukenas, Bryan

IPC Codes: A61B 17/34; A61M 25/06; A61B 5/03; A61M 25/01; A61M 25/14; A61M 25/09

Publication Date: 30-Jul-2020

Earliest Priority Details: US2019795350, 22-Jan-2019

Minimally-invasive access and delivery medical device for therapeutic and/or diagnostic interventions within the subarachnoid space, comprising a microcatheter, a guidewire, a fiber-optic lighting element, and a fiber-optic probe or other micro-camera that enables the contents of the subarachnoid space within cerebrospinal fluid (CSF), which is typically clear, to be viewed in real-time as the microcatheter is navigated within the subarachnoid space. It is claimed that the device may provide a path of delivery to the subarachnoid space for delivering a gene therapy, drug, probe, medical tool, laser ablation, electrode, or a lasso to the distal end of the microcatheter.

Represents the first patenting from the inventor, whose invention can be seen to be listed on the Penn Center for Innovation’s website as Docket # 18-8675, where it is described as a patent-pending minimally invasive micro-catheter with an integrated camera (MIMIC) to reach suboccipital space of the cisterna magna via lumbar puncture for drug and gene-therapy delivery to the brain. The device has been tested in bench top spine models and a human cadaver. The technology is said to be being further developed for additional applications such as the treatment of aneurysms, chemotherapy for brain tumors, epilepsy, and laser ablation for brain tumors.

 

US20200237315-A1: “Pulse oximetry system.”

Assignee: Vios Medical Inc

Inventors: Kovtun, Vladimir V.; Mazar, Scott Thomas; Ricci, Carlos A.

IPC Codes: A61B 5/00; A61B 5/024; A61B 5/1455

Publication Date: 30-Jul-2020

Earliest Priority Details: US2019260631, 29-Jan-2019

Pulse oximetry system comprising an optical sensor (that may be affixed to a patient's fingertip or earlobe) that is configured to detect light and generate photoplethysmogram (PPG) signals, a display apparatus, one or more data processing apparatus coupled with the optical sensor and the display apparatus, and a non-transitory computer readable storage medium encoded with a computer program. It is disclosed that the system may be included in a patient monitoring device that can continuously collect physiological vital signs data, such as electrocardiogram (ECG), heart rate, respiratory rate, oxygen saturation, blood pressure, temperature, and pulse rate.

Follows US20200163563 in which one of the team, Mazar, described systems employing patient worn sensors that may be used for tracking and monitoring information associated with a patient, such for monitoring patient vital signs, tracking patient activity and movement, recording information associated with a patient, coordinating patient care, and providing up-to-date information to health care providers.

In June 2019, St Paul, Minnesota-based Vios Medical announced it had received US FDA clearance for two 510(k) submissions for its second-generation wireless patient monitoring platform, the Vios Monitoring System (VMS). The approved suite of products provides a platform designed to reduce the cost of patient-monitoring equipment while simultaneously striving to improve the quality of care and the patient experience. The wireless, internet of things VMS enables clinicians to continuously monitor a patient’s 7-lead ECG, heart rate, respiratory rate, SpO2, blood pressure, temperature, pulse rate, patient posture and activity data to conveniently and cost-effectively monitor patients throughout their various care settings.

 

US20200237252-A1: “Vital sign detection and measurement.”

Assignee: Welch Allyn Inc

Inventors: Baker, Steven D.; Goldfain, Ervin; Guo, Lei; Lane, John A.; Lia, Raymond A.; Moons, Brian T.; Sun, Zhengguo; Vivenzio, Robert L.

IPC Codes: A61B 5/00; A61B 5/024; A61B 5/05; A61B 5/08; G01S 13/88

Publication Date: 30-Jul-2020

Earliest Priority Details: US2019798124, 29-Jan-2019

Patient monitoring device and method for vital sign measurement without physically contacting a patient. The monitoring device comprises a signal transmission device to transmit signals (eg radar), receive reflected signals, and determine a non-contact vital sign measurement based on data from the reflected signals.

Within the invention’s disclosure we see US20190053707 to be incorporated by reference in its entirety. In said application, the inventors Baker and Lane described a patient monitoring system that employed the use of radar transmitted to a subject to determine eg their position, an incontinence condition or their physiological condition.

It would appear that Skaneateles Falls, New York-headquartered Welch Allyn has yet to have commercially developed such a radar-based contact-free patient monitoring system, however, it does offer the Connex® Clinical Surveillance System (CSS) with contact-free monitoring that it says helps hospitals to proactively monitor patient vitals such as heart rate, respiratory rate and patient movement on all beds on medical/surgical floors to help decrease the rate of adverse events such as falls, pressure ulcers and patient deterioration. Rather than using radar, the Connex® CSS integrates Ramat Gan, Israel-headquartered Earlysense’s contact-free monitoring sensor that takes the form of a thin sensor placed under a mattress, that then uses piezoelectric technology to detect heart rate, breathing, sleep quality, and body movements, and alert caregivers when an abnormal situation occurs.

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