Ablative Solutions, Inc.

Angel Medical Systems Inc.

Neuropace, Inc.

Other

Cordis Corporation

Cathco, Inc.

Isostent, Inc.

Svelte Medical Systems, Inc.

Eneura, Inc.

Arrow International Investment Corp.

Fischell Innovations, LLC

At&t Bell Laboratories

Bell Telephone Laboratories

The United States of America As Represented by the Administrator of the

American Telephone and Telegraph, Co.

David R Fischell

Robert E Fischell

Tim A Fischell

Michael Sasha John

Jonathan Harwood

Andy Edward Denison

Darrin James Kent

Eric Thomas Johnson

Robert Ryan Ragland

Jeff Alan Burke

Christopher Scott Hayden

Adrian R M Upton

Steven R Johnson

Steven Almany

Benjamin D Pless

Vartan E Ghazarossian

Bruce Hopenfeld

David Keenan

Barbara Gibb

Scott J S Fischell

Janet Burpee

Stanley P Woods

Joseph P Fredrick

Lisa Guzzo

Gregg Turi

Adrian R Upton

Steve Johnson

David Christopher Majercak

Fernando DiCaprio

Robert Burgermeister

Nicholas A Green

Dieter Stockel

Emily Ma

Neal Arthur Siegel

Dave Vondle

Mark L Pomeranz

Kuen Chang

Sean Salmon

Nicole Haratani

Leopold Rolih

Michael Graves

Richard Barthel

Adrian Rm Upton

Hikmat Hojeibane

Stephen T Archer

James H Snyder

Chao C Chen

Dennis Potts

Robert L Wallace, Jr

Mark Zyzelewski

Alexander J Travis

Richard L Harding

John A Dispenza

Philip B Fleck

Cecil H Coker

I John Khan

Gihyun Cho

Christopher D Stockbridge

William A Easterbrook, Iii

Martha J Morell

Roy Cohen

John Mcguire Jaicks

Furkat Mukhtarov

Noel A Smith

Mary Carol Day

Rajesh Kalavalapally

Victor Fei

Jeffrey C Mazique

Janet W Burpee

Todd H Turnland

Priyanka Venkatesh

James J Thompson

Qi Rui

Rachel Hyder

Abirvab Deb

Scott Js Fischell

Scott Sj Fischell

Chao Chen

Systems and Methods are disclosed for detecting acute coronary syndrome (ACS) events, arrythmias, heart rate abnormalities, medication problems such as non-compliance or ineffective amount or type of medication, and demand/supply related cardiac ischemia. The system may have both implanted and external components that communicate with a Physicians's programmer, and smart-devices for monitoring and alerting to detected medically relevant events or states. At least one processor provides event detection using statistical threshold criteria calculated upon at least a portion of a patient's data/distributions and set for a patient or based upon what a doctor determines as abnormal for a patient. A power management system provides at least 2 strategies of evaluating power level including at least obtaining a voltage measure and measuring and calculating a cumulative capacity measure and comparing these two measure to their respective thresholds.

Cardiac alerting system with power monitoring and management

A rapid exchange guide wire system for rapid delivery of a guide wire to a blood vessel. The system has a main guide wire and rapid a rapid exchange tube attached to the main guide wire near a distal end of the main guide wire. The rapid exchange tube has a lumen which extends in a longitudinal direction and is configured to permit the rapid exchange tube to be reversibly displaceable in the longitudinal direction over a medical device having a cylindrical portion The medical device may be a guide wire, balloon angioplasty catheter, stent delivery catheter, atherectomy catheter, intravascular ultrasound catheter, blood flow measurement wire, optical coherence tomography catheter, or a stent-on-wire catheter.

Rapid exchange (monorail) guide wire system for rapid delivery of guide wire to a blood vessel

An intravascular catheter for nerve activity ablation and/or sensing includes one or more needles advanced through supported guide tubes (needle guiding elements) which expand to contact the interior surface of the wall of the renal artery or other vessel of a human body allowing the needles to be advanced though the vessel wall into the extra-luminal tissue including the media, adventitia and periadvential space. The catheter also includes structures which provide radial and lateral support to the guide tubes so that the guide tubes open uniformly and maintain their position against the interior surface of the vessel wall as the sharpened needles are advanced to penetrate into the vessel wall. Electrodes near the distal ends of the needles allow sensing of nerve activity before and after attempted renal denervation. In a combination embodiment ablative energy or fluid is delivered from the needles in or near the adventitia to ablate nerves outside of the media while sparing nerves within the media.

Apparatus for effective ablation and nerve sensing associated with denervation

An intravascular catheter for peri-vascular nerve activity sensing or measurement includes multiple needles advanced through supported guide tubes (needle guiding elements) which expand with open ends around a central axis to contact the interior surface of the wall of the renal artery or other vessel of a human body allowing the needles to be advanced though the vessel wall into the perivascular space. The system also may include means to limit and/or adjust the depth of penetration of the needles. The catheter also includes structures which provide radial and lateral support to the guide tubes so that the guide tubes open uniformly and maintain their position against the interior surface of the vessel wall as the sharpened needles are advanced to penetrate into the vessel wall. The addition of an injection lumen at the proximal end of the catheter and openings in the needles adds the functionality of ablative fluid injection into the perivascular space for an integrated nerve sending and ablation capability.

Intravascular catheter with peri-vascular nerve activity sensors

A coupled enzyme reaction point of care assay system detects and measures an active enzyme biomarker from a patient's blood sample. The assay system has a point of care blood collector for collecting blood into a blood collection vial. A biomarker detection mechanism has at least three fluid flow entities. Each fluid flow entity has a fluid input zone and a corresponding reaction zone. The fluid flow entities include a test strip, a negative control strip and a positive control strip. The reaction zones include components from a multiplicity of substrates, co-factors, buffers and cryoprotectants, and a multiplicity of tethered enzymes. At least one of the tethered enzymes is an enzyme that produces luminescence. The tethered enzymes are adapted to react to a constituent which may be a biomarker. A photonic luminescence reader measures light emitted from an active enzyme biomarker present in the patient's blood.

Apparatus and methods using tethered enzymes for the detection of the enzymatic activity of biomarkers

An intravascular catheter for peri-vascular or peri-urethral tissue ablation includes multiple needles advanced through supported guide tubes which expand around a central axis to engage the interior surface of the wall of the renal artery or other vessel of a human body allowing the injection an ablative fluid for ablating tissue, or nerve fibers in the outer layer or deep to the outer layer of the vessel, or in prostatic tissue. A method can involve injection/infusion of the ablative fluid over an extended time period of at least 10 seconds or with two injections at two different penetration depths to reduce or eliminate patient pain during ablation.

Method for painless renal denervation using a peri-vascular tissue ablation catheter with support structures

An intravascular catheter for nerve activity ablation and/or sensing includes one or more needles advanced through supported guide tubes (needle guiding elements) which expand to contact the interior surface of the wall of the renal artery or other vessel of a human body allowing the needles to be advanced though the vessel wall into the extra-luminal tissue including the media, adventitia and periadvential space. The catheter also includes structures which provide radial and lateral support to the guide tubes so that the guide tubes open uniformly and maintain their position against the interior surface of the vessel wall as the sharpened needles are advanced to penetrate into the vessel wall. Electrodes at the distal ends of the guide tubes allow sensing of nerve activity before and after attempted renal denervation. In a combination embodiment ablative energy or fluid is delivered to ablate nerves outside of the media.

Method for denervation with reduced pain

An intravascular catheter for peri-vascular and/or peri-urethral tissue ablation includes multiple needles advanced through supported guide tubes which expand around a central axis to engage the interior surface of the wall of the renal artery or other vessel of a human body allowing the injection an ablative fluid for ablating tissue, and/or nerve fibers in the outer layer or deep to the outer layer of the vessel, or in prostatic tissue. The system may also include a means to limit and/or adjust the depth of penetration of the ablative fluid into and beyond the tissue of the vessel wall. The catheter may also include structures which provide radial and/or lateral support to the guide tubes so that the guide tubes expand uniformly and maintain their position against the interior surface of the vessel wall as the sharpened injection needles are advanced to penetrate into the vessel wall.

Peri-vascular tissue ablation catheter with support structures

An intravascular catheter for peri-vascular and/or peri-urethral tissue ablation includes multiple penetrators advanced through supported guide tubes which expand around a central axis to engage the interior surface of the wall of the renal artery or other vessel of a human body allowing the injection an ablative fluid for ablating tissue, nerve sensing, nerve stimulation, or ablation by application of energy. The catheter can include a proximal handle for the advancement of guide tubes and penetrators.

Peri-vascular tissue access catheter with locking handle

An intravascular catheter for peri-vascular and/or peri-urethral tissue ablation includes multiple needles advanced through supported guide tubes which expand around a central axis to engage the interior surface of the wall of the renal artery or other vessel of a human body allowing the injection an ablative fluid for ablating tissue, and/or nerve fibers in the outer layer or deep to the outer layer of the vessel, or in prostatic tissue. The system may also include a means to limit and/or adjust the depth of penetration of the ablative fluid into and beyond the tissue of the vessel wall. The catheter may also include structures which provide radial and/or lateral support to the guide tubes so that the guide tubes expand uniformly and maintain their position against the interior surface of the vessel wall as the sharpened injection needles are advanced to penetrate into the vessel wall. A method can involve injection/infusion of the ablative fluid over an extended time period of at least 10 seconds or with two injections at two different penetration depths to reduce or eliminate patient pain during ablation.

Peri-vascular tissue ablation catheters

Systems and Methods are disclosed for detecting acute coronary syndrome (ACS) events, arrythmias, heart rate abnormalities, medication problems such as non-compliance or ineffective amount or type of medication, and demand/supply related cardiac ischemia. The system may have both implanted and external components that communicate with a Physicians's programmer, and smart-devices for monitoring and alerting to detected medically relevant events or states. At least one processor provides event detection using statistical threshold criteria calculated upon at least a portion of a patient's data/distributions and set for a patient or based upon what a doctor determines as abnormal for a patient. Cardiovascular condition is tracked using histogram, trend, and summary information related to heart rate and/or cardiac features such as S-T segment measures of heartbeats. Heartbeats with elevated rates, and below a 'high' range, provide medically relevant detections including medication non-compliance where the patient is alerted through a patient alerting mechanism of an abnormality in the heart rate or ST shifts of the patient.

Advanced cardiovascular monitoring system with normal, elevated, and high heartrate thresholds

An intravascular catheter for peri-vascular and/or peri-urethral tissue ablation includes multiple needles advanced through supported guide tubes which expand with open ends around a central axis to engage the interior surface of the wall of the renal artery or other vessel of a human body allowing the injection an ablative fluid for ablating tissue, and/or nerve fibers in the outer layer or deep to the outer layer of the vessel, or in prostatic tissue. The system also includes means to limit and/or adjust the depth of penetration of the ablative fluid into and beyond the tissue of the vessel wall. The preferred embodiment of the catheter includes structures which provide radial and lateral support to the guide tubes so that the guide tubes open uniformly and maintain their position against the interior surface of the vessel wall as the sharpened injection needles are advanced to penetrate into the vessel wall.

Transvascular methods of treating extravascular tissue

At the present time, physicians often treat patients with atrial fibrillation (AF) using radiofrequency (RF) catheter systems to ablate conducting tissue in the wall of the Left Atrium of the heart around the ostium of the pulmonary veins. These systems are expensive and take time consuming to use. The present invention circular ablation system CAS includes a multiplicity of expandable needles that can be expanded around a central axis and positioned to inject a fluid like ethanol to ablate conductive tissue in a ring around the ostium of a pulmonary vein quickly and without the need for expensive capital equipment. The expansion of the needles is accomplished by self-expanding or balloon expandable structures. The invention includes centering means so that the needles will be situated in a pattern surrounding the outside of the ostium of a vein. Also included are members that limit the distance of penetration of the needles into the wall of the left atrium, or the aortic wall. The present invention also has an important application to ablate tissue around the ostium of one or both renal arteries, for the ablation of the sympathetic nerve fibers and/or other afferent or efferent nerves going to or from each kidney in order to treat hypertension.

Expandable catheter system for peri-ostial injection and muscle and nerve fiber ablation

Growing community of inventors

Fair Haven, NJ, United States of America

David R Fischell