SYSTEM AND METHODS FOR TREATING MVO

MVO is treated by introducing injectate into blood vessels affected by MVO at precise flow rates, while blocking retrograde flow, such that the natural pumping of the heart aids in forcing the injectate into the affected microvessels. Monitoring pressure distal of an occlusion balloon is used to determine treatment effectiveness and heart health. 1. A system for treating myocardial microvascular obstruction (MVO) , the system comprising:a catheter comprising a distal region, a proximal region, and a balloon disposed at the distal region, the distal region of the catheter sized and shaped to be positioned in a myocardial vessel supplying blood to a patient's myocardium;at least one pressure sensor configured to generate sensor data corresponding to at least one of pressure inside the catheter or pressure outside the catheter distal to the balloon; anda pump assembly coupled to the proximal region of the catheter, the pump assembly comprising at least one reservoir containing injectate, the pump assembly configured to pump injectate from the at least one reservoir through the catheter at a flow rate and responsive to the sensor data,wherein the pump assembly further is configured to reduce the flow rate to zero to allow compression of microvasculature caused by natural myocardial contraction to draw the injectate into occluded myocardial vessels to promote mixing of the injectate with obstructing matter causing MVO.2. The system of claim 1 , wherein the balloon is either manually or automatically inflated and deflated.3. The system of claim 1 , further comprising at least one temperature sensor configured to sense temperature at the distal region.4. The system of claim 1 , further comprising a user interface electronically associated with the pressure sensor to display a graph of calculated values of vascular resistance over time based on the sensor data.5. The system of claim 4 , wherein the user interface displays tau claim 4 , wherein tau is defined as the ...

COMBINED STENT REPERFUSION SYSTEM

Devices and methods for preventing reperfusion injuries when an occlusion balloon is deflated. A catheter having an infusion lumen exiting the catheter distal of a stent balloon and/or occlusion balloon allows a therapeutic agent to be introduced to a target location to establish desired temperatures and pressures prior to deflation of the balloon such that negative effects of reperfusion are minimized. 1. A combined stent delivery and occlusion device comprising: an infusion port; and', 'a stent balloon inflation port;, 'a proximal manifold includinga catheter extending distally from the manifold and defining an infusion lumen in fluid communication with the infusion port, and an inflation lumen in fluid communication with the stent balloon inflation port;a therapeutic agent port in fluid communication with a therapeutic agent lumen further defined by the catheter and leading to a distal end of the catheter;a stent balloon near the distal end of the catheter and surrounding the catheter, the stent balloon in fluid communication with the inflation lumen; anda stent surrounding the stent balloon.2. The combined stent delivery and occlusion device of claim 1 , wherein the stent balloon claim 1 , when inflated claim 1 , serves as an occlusion balloon claim 1 , blocking blood flow through a vessel in which the stent balloon is inflated.3. The combined stent delivery and occlusion device of claim 1 , wherein the therapeutic agent port is located distal of the manifold.4. The combined stent delivery and occlusion device of claim 1 , further comprising an occlusion balloon.5. The combined stent delivery and occlusion device of claim 4 , wherein the occlusion balloon is located distal of the stent balloon.6. The combined stent delivery and occlusion device of claim 4 , wherein the proximal manifold further includes an occlusion balloon inflation port.7. The combined stent delivery and occlusion device of claim 6 , wherein the catheter further defines an occlusion balloon ...

METHOD AND APPARATUS FOR DIAGNOSIS AND TREATMENT OF MICROVASCULAR DYSFUNCTION

Methods and devices for the diagnosis and treatment of microvascular dysfunction, such as microvascular obstruction (MVO) and other dysfunctional diseases of the microvasculature of many organs, including the heart. The present subject matter provides novel devices and methods to successfully diagnose, restore patency, open and preserve flow, and limit reperfusion injury in organs and cases with microvascular dysfunction. The present subject matter provides apparatus and method to detect, measure and treat microvascular dysfunction in real time during scenarios such as invasive angiographic/therapeutic procedures. Such procedures include therapy for organ systems including the heart (acute myocardial infarction—primary percutaneous coronary intervention (PPCI)), brain stroke (CVA), bowel ischemia/infarction, pulmonary emboli/infarction, critical limb ischemia/infarction, renal ischemia/infarction, and others. The present subject matter provides various systems including an infusion and sensing catheter, diagnostic agents, therapeutic agents, and a control console with specialized algorithms to diagnose and treat microvascular dysfunction, such as MVO, in real-time with real-time operator feedback for interventional procedures.

APPARATUS AND METHOD FOR DETERMINING AND/OR TREATING MICROVASCULAR OBSTRUCTION

Methods and systems are provided for diagnosis and/or treatment of microvascular dysfunction, such as microvascular obstruction (MVO) by injecting volumetric flows into a vessel using an infusion system to arrest or reverse native antegrade flow, such that an equipoise value of volumetric flow rate and corresponding pressure may be determined, which in turn enables calculation of MVO, absolute hydrodynamic resistance, fractional flow reserve, coronary flow reserve, and other physiologic parameters in real-time or near real time.

Removable mechanical circulatory support for short term use

Mechanical circulatory supports configured to operate in series with the native heart are disclosed. In an embodiment, an intravascular propeller is installed into the descending aorta and anchored within via an expandable anchoring mechanism. The propeller and anchoring mechanism may be foldable so as to be percutaneously deliverable to the aorta. The propeller may have foldable blades. The blades may be magnetic and may be driven by a concentric electromagnetic stator circumferentially outside the magnetic blades. The stator may be intravascular or may be configured to be installed around the outer circumference of the blood vessel. The support may create a pressure rise between about 20-50 mmHg, and maintain a flow rate of about 5 L/min. The support may have one or more pairs of contra-rotating propellers to modulate the tangential velocity of the blood flow. The support may have static pre-swirlers and or de-swirlers. The support may be optimized to replicate naturally occurring vortex formation within the descending aorta.

INTRACORONARY CHARACTERIZATION OF MICROVASCULAR OBSTRUCTION (MVO) AND MYOCARDIAL INFARCTION

Systems and apparatus are included that are configured to determine the effectiveness of apparatus and methods used to diagnose and unblock microvascular obstruction (MVO). An infusion system blocks antegrade flow for a short time and measures vascular pressure response as an infusate is infused in stepwise fashion at increasingly higher flowrates. During the antegrade flow occlusion, calculations of the real-time vascular resistance can be obtained using the formula R(t)=(t)/Q(t) where: Q(t) is the flow mean values generated by the infusion system; P(t) is the distal pressure response in the vessel generated from the flow infusion; and R(t) is the calculated vascular resistance using the two other known parameters. 1. A method for analyzing microvascular obstruction (MVO) , comprising:receiving a first plurality of pressure measurements sensed distal of a blocking position in a vessel where antegrade blood flow in the vessel is substantially blocked and at least after a crystalloid solution is infused at one or more different flow infusion rates to the vessel distal of the blocking position;receiving a second plurality of pressure measurements configured to be taken after the infusion to the vessel is stopped and the antegrade blood flow in the vessel remains substantially blocked; andperforming calculations at different times relating the one or more different flow infusion rates to the pressure measurements to determine a plurality of measurements related to vascular resistance at the different times.2. The method of claim 1 , further comprising:measuring changes in the measurements related to vascular resistance associated with an infusion of a therapeutic solution.3. The method of claim 2 , further comprising:determining a waterfall pressure at a plurality of the different times based on the pressure measurements; andmeasuring changes in the waterfall pressure at the different times.4. The method of claim 3 , further comprising:using an initial measurement of ...

METHOD AND APPARATUS FOR DIAGNOSIS AND TREATMENT OF MICROVASCULAR DYSFUNCTION

Methods and devices for the diagnosis and treatment of microvascular dysfunction, such as microvascular obstruction (MVO) and other dysfunctional diseases of the microvasculature of many organs, including the heart. The present subject matter provides novel devices and methods to successfully diagnose, restore patency, open and preserve flow, and limit reperfusion injury in organs and cases with microvascular dysfunction. The present subject matter provides apparatus and method to detect, measure and treat microvascular dysfunction in real time during scenarios such as invasive angiographic/therapeutic procedures. Such procedures include therapy for organ systems including the heart (acute myocardial infarction—primary percutaneous coronary intervention (PPCI)), brain stroke (CVA), bowel ischemia/infarction, pulmonary emboli/infarction, critical limb ischemia/infarction, renal ischemia/infarction, and others. The present subject matter provides various systems including an infusion and sensing catheter, diagnostic agents, therapeutic agents, and a control console with specialized algorithms to diagnose and treat microvascular dysfunction, such as MVO, in real-time with real-time operator feedback for interventional procedures. 1. A method for measuring microvascular dysfunction in an organ or limb using apparatus for providing controlled flow infusion of at least a first solution to a portion of a vessel for assessment of microvascular function and for providing a second solution to the vessel for therapeutic benefit of the microvascular function , wherein the first solution is different than the second solution.2. The method of claim 1 , wherein the first solution is a Newtonian fluid chosen to enhance linearity of the flow to better assess microvascular parameters.3. The method of claim 1 , wherein the first solution lacks oxygenation to control hypoxia.4. The method of claim 1 , wherein the first solution lacks oxygenation to vasodilate the microvasculature.5. ...

MECHANICAL CIRCULATORY SUPPORT DEVICE WITH CENTRIFUGAL IMPELLER DESIGNED FOR IMPLANTATION IN THE DESCENDING AORTA

Mechanical circulatory supports configured to operate in series with the native heart are disclosed. In an embodiment, a centrifugal pump is used. In an embodiment, inlet and outlet ports are connected into the aorta and blood flow is diverted through a lumen and a centrifugal pump between the inlet and outlet ports. The supports may create a pressure rise between about 40-80 mmHg, and maintain a flow rate of about 5 L/min. The support may be configured to be inserted in a collinear manner with the descending aorta. The support may be optimized to replicate naturally occurring vortex formation within the aorta. Diffusers of different dimensions and configurations, such as helical configuration, and/or the orientation of installation may be used to optimize vortex formation. The support may use an impeller which is electromagnetically suspended, stabilized, and rotated to pump blood. 128.-. (canceled)29. A method of treating cardiovascular function in a patient , the patient having a native aorta comprising an ascending aorta , an aortic arch , and a descending aorta , the method comprising:installing a mechanical circulation support within the descending aorta of the patient, wherein the mechanical circulation support comprises an impeller positioned within an internal volume of a mechanical body, wherein the impeller comprises a plurality of blades for pumping blood, the blades being arranged around a longitudinal axis and defining an outer circumference, wherein the mechanical circulation support is configured to provide a pressure rise between 20 mmHg and 50 mmHg in blood flow.30. The method of claim 29 , wherein the mechanical circulation support is configured to maintain a flow rate of 5 L/min.31. The method of claim 29 , wherein the mechanical circulation support is configured to maintain a continuous flow rate.32. The method of claim 29 , wherein the mechanical circulation support does not mimic the pulsatile flow imparted by the native heart.33. The method ...

DEVICES AND METHODS FOR PREPARING A VALVE FOR A TRANSCATHETER VALVE REPLACEMENT PROCEDURE

Aspects of the disclosure include methods, systems and devices for severing and optionally removing at least a portion of heart valve leaflets. Leaflets can be partially removed or entirely removed or otherwise, the leaflets can be severed or splayed in such a way as to avoid coronary blockage, LVOT obstruction, or access challenges in procedures where a prosthetic valve is to be implanted within a previously implanted prosthetic valve. Aspects of the disclosure also relate to numerous devices for and methods of disabling one or more valve ligating devices to provide an unobstructed valve opening so that a prosthetic heart valve can be implanted within the opening. The ligation device(s) is disabled either by removing the ligation device(s) or severing one leaflet so that ligated leaflets can be separated. In some embodiments, the ligation device(s) are severed to disable the ligation device(s). 1. A valve preparation device comprising:an outer catheter;an inner catheter coaxially slidable within the outer catheter;a balloon secured to the inner catheter; andan electrode extending along a length of the balloon.2. The valve preparation device of claim 1 , further comprising a plurality of electrodes extending along a length of the balloon.3. The valve preparation device of claim 1 , wherein the electrode is segmented.4. The valve preparation device of claim 1 , further comprising a first attachment ring interconnecting the electrode to the inner catheter and a second attachment ring interconnecting the electrode to the inner catheter.5. The valve preparation device of claim 4 , wherein one of the first and second attachment rings are slidable along the inner catheter.6. The valve preparation device of claim 1 , wherein the valve preparation device further includes a positioning device configured to align a puncturing element in front of a coronary ostium.7. The valve preparation device of claim 6 , wherein the positioning device includes a positioning catheter and a ...

SYSTEM AND METHODS FOR TREATING MVO

MVO is treated by introducing injectate into blood vessels affected by MVO at precise flow rates, while blocking retrograde flow, such that the natural pumping of the heart aids in forcing the injectate into the affected microvessels. Monitoring pressure distal of an occlusion balloon is used to determine treatment effectiveness and heart health. 1. A method for treating Microvascular Obstruction (MVO) comprising:navigating a catheter into a myocardial vessel supplying blood to a patient's myocardium with MVO;blocking antegrade and retrograde blood flow within the vessel around said catheter using a balloon;measuring a fluid pressure of the myocardial vessel occurring distal of the balloon;introducing infusate through a lumen of said catheter at predetermined flow rates;allowing natural myocardial contraction and compression of the microvasculature to pump the infusate antegrade into occluded myocardial vessels and to promote mixing of the infusate with obstructing matter causing MVO;collecting data pertinent to pressure parameters in the myocardial vessel;analyzing the collected data to determine a change resulting from said treating the MVO.2. The method of further comprising measuring temperature of the fluid in the myocardial vessel.3. The method of further comprising collecting data pertinent to temperature parameters in the myocardial vessel.4. The method of wherein introducing infusate through a lumen of the catheter comprises repeating an inject-stop-hold pattern until total elapsed occlusion time nears that of physiologic myocardial or organ injury due to ischemia.5. The method of wherein introducing infusate through a lumen of the catheter comprises introducing infusate through an arterial or venous lumen at at least one predetermined flow rate.6. The method of further comprising varying said predetermined flow rate to match a waveform.7. The method of wherein said waveform is selected from the group steady claim 6 , square claim 6 , triangle claim 6 , ...

Mechanical circulatory support device with axial flow turbomachine optimized for heart failure and cardio-renal syndrome by implantation in the descending aorta

Mechanical circulatory supports configured to operate in series with the native heart are disclosed. In an embodiment, an intravascular propeller is installed into the descending aorta and anchored within via an expandable anchoring mechanism. The propeller and anchoring mechanism may be foldable so as to be percutaneously deliverable to the aorta. The propeller may have foldable blades. The blades may be magnetic and may be driven by a concentric electromagnetic stator circumferentially outside the magnetic blades. The stator may be intravascular or may be configured to be installed around the outer circumference of the blood vessel. The support may create a pressure rise between about 20-50 mmHg, and maintain a flow rate of about 5 L/min. The support may have one or more pairs of contra-rotating propellers to modulate the tangential velocity of the blood flow. The support may have static pre-swirlers and or de-swirlers. The support may be optimized to replicate naturally occurring vortex formation within the descending aorta.

Combined Stent Reperfusion System

Devices and methods for preventing reperfusion injuries when an occlusion balloon is deflated. A catheter having an infusion lumen exiting the catheter distal of a stent balloon and/or occlusion balloon allows a therapeutic agent to be introduced to a target location to establish desired temperatures and pressures prior to deflation of the balloon such that negative effects of reperfusion are minimized. 1. A combined stent delivery and occlusion device comprising: an infusion port;', 'a stent balloon inflation port;, 'a proximal manifold includinga catheter extending distally from the manifold and defining an infusion lumen in fluid communication with the infusion port, and an inflation lumen in fluid communication with the stent balloon inflation port;a therapeutic agent port in fluid communication with a therapeutic agent lumen further defined by the catheter and leading to a distal end thereof;a stent balloon near a distal end of the catheter and surrounding the catheter, the stent balloon in fluid communication with the inflation lumen;a stent surrounding the stent balloon.2. The combined stent delivery and occlusion device of wherein said stent balloon claim 1 , when inflated claim 1 , serves as an occlusion balloon claim 1 , blocking blood flow through a vessel in which the stent balloon is inflated.3. The combined stent delivery and occlusion device of wherein said therapeutic agent port is located distal of said manifold.4. The combined stent delivery and occlusion device of further comprising an occlusion balloon.5. The combined stent delivery and occlusion device of wherein said occlusion balloon is located distal of the stent delivery balloon.6. The combined stent delivery and occlusion device of wherein said proximal manifold further includes an occlusion balloon inflation port.7. The combined stent delivery and occlusion device of wherein said catheter further defines an occlusion balloon inflation lumen.8. A method of delivery a stent while preventing ...

System for diagnosing and treating microvascular obstructions

Devices for the diagnosis and treatment of microvascular obstruction (MVO) and other dysfunctional diseases of the microvasculature of many organs, including the heart. The present subject matter provides novel devices and methods to detect and measure or treat MVO in real time during scenarios such as invasive angiographic/therapeutic procedures. Such procedures include therapy for organ systems including the heart (acute myocardial infarction-primary percutaneous coronary intervention (PPCI)), brain stroke (CVA), bowel ischemia/infarction, pulmonary emboli/infarction, critical limb ischemia/infarction, renal ischemia/infarction, and others. Using methods of the invention, a system comprising specialized infusion and sensing catheter, diagnostic agents, therapeutic agents, and control console with specialized algorithms can both diagnose and treat MVO by eliminating the microvascular clot and debris causing the obstruction. The techniques involve a combination of novel devices, methods, and software to simultaneously diagnose and treat MVO.

Removable mechanical circulatory support for short term use

Mechanical circulatory supports configured to operate in series with the native heart are disclosed. In an embodiment, an intravascular propeller is installed into the descending aorta and anchored within via an expandable anchoring mechanism. The propeller and anchoring mechanism may be foldable so as to be percutaneously deliverable to the aorta. The propeller may have foldable blades. The blades may be magnetic and may be driven by a concentric electromagnetic stator circumferentially outside the magnetic blades. The stator may be intravascular or may be configured to be installed around the outer circumference of the blood vessel. The support may create a pressure rise between about 20-50 mmHg, and maintain a flow rate of about 5 L/min. The support may have one or more pairs of contra-rotating propellers to modulate the tangential velocity of the blood flow. The support may have static pre-swirlers and or de-swirlers. The support may be optimized to replicate naturally occurring vortex formation within the descending aorta.

MECHANICAL CIRCULATORY SUPPORT DEVICE WITH CENTRIFUGAL IMPELLER DESIGNED FOR IMPLANTATION IN THE DESCENDING AORTA

Mechanical circulatory supports configured to operate in series with the native heart are disclosed. In an embodiment, a centrifugal pump is used. In an embodiment, inlet and outlet ports are connected into the aorta and blood flow is diverted through a lumen and a centrifugal pump between the inlet and outlet ports. The supports may create a pressure rise between about 40-80 mmHg, and maintain a flow rate of about 5 L/min. The support may be configured to be inserted in a collinear manner with the descending aorta. The support may be optimized to replicate naturally occurring vortex formation within the aorta. Diffusers of different dimensions and configurations, such as helical configuration, and/or the orientation of installation may be used to optimize vortex formation. The support may use an impeller which is electromagnetically suspended, stabilized, and rotated to pump blood. 1. A mechanical circulatory support for assisting the heart , the support comprising:a casing comprising a main body, an inlet configured to introduce blood flow from an upstream portion of a human aorta into the main body, and an outlet configured to return the blood flow from the main body to a downstream portion of the human aorta; wherein the impeller comprises a plurality of blades for pumping blood, the blades being arranged around the longitudinal axis so as to define an outer circumference, and', 'wherein the impeller is configured to rotate around the longitudinal axis to pump the blood in a centrifugal manner toward the outer circumference; and, 'an impeller positioned within an internal volume of the main body of the casing so as to receive blood flow from the inlet, the direction of the received blood flow defining a longitudinal axis,'} 'wherein the diffuser is at least partially open the internal volume of the main body of the casing along at least a portion of the outer circumference of the impeller.', 'a diffuser integral with or joined to the casing, the diffuser ...

System And Methods For Treating MVO

MVO is treated by introducing injectate into blood vessels affected by MVO at precise flow rates, while blocking retrograde flow, such that the natural pumping of the heart aids in forcing the injectate into the affected microvessels. Monitoring pressure distal of an occlusion balloon is used to determine treatment effectiveness and heart health.

REMOVABLE MECHANICAL CIRCULATORY SUPPORT FOR SHORT TERM USE

A temporary, removable mechanical circulatory support heart-assist device has at least two propellers or impellers. Each propeller or impeller has a number of blades arranged around an axis of rotation. The blades are configured to pump blood. The two propellers or impellers rotate in opposite directions from each other. The device can be configured to be implanted and removed with minimally invasive surgery. 184-. (canceled)85. A mechanical circulatory support device , comprising:a pump head comprising at least one impeller positioned within a central waist section of an hourglass-shaped cage, such that an inlet of an inlet section and an outlet of an outlet section of the hourglass shaped cage are of varying diameter and the inlet and the outlet are configured to be secured within blood vessels of various diameter sizes, thus configured to accommodating one size of waist section and turbomachine pump head for various blood vessel sizes.86. The device of claim 85 , wherein the waist section of the hourglass shaped cage is a memory-alloy frame cage covered with biocompatible material claim 85 , so that the inlet of the inlet section and outlet of the outlet section of the hourglass shaped cage are configured to be secured against an inside of blood vessels of various sizes claim 85 , so that the whole length of the hourglass shaped cage is collapsible along its axis claim 85 , and the inlet and the outlet accommodate one size of waist section and turbomachine pump head for all sizes of blood vessels.87. The device of claim 85 , wherein the inlet section of the hourglass shaped cage comprises perforations allowing blood permeability through the perforations and perfuse the region between the outside of the hourglass shaped cage and the inside of blood vessel claim 85 , wherein the waist of the hourglass shaped cage and a diffuser of the hourglass shaped cage are non-permeable to blood.88. The device of claim 85 , wherein the pump head has at least one rotating blade ...

Mechanical circulatory support device with centrifugal impeller designed for implantation in the descending aorta

Mechanical circulatory supports configured to operate in series with the native heart are disclosed. In an embodiment, a centrifugal pump is used. In an embodiment, inlet and outlet ports are connected into the aorta and blood flow is diverted through a lumen and a centrifugal pump between the inlet and outlet ports. The supports may create a pressure rise between about 40-80 mmHg, and maintain a flow rate of about 5 L/min. The support may be configured to be inserted in a collinear manner with the descending aorta. The support may be optimized to replicate naturally occurring vortex formation within the aorta. Diffusers of different dimensions and configurations, such as helical configuration, and/or the orientation of installation may be used to optimize vortex formation. The support may use an impeller which is electromagnetically suspended, stabilized, and rotated to pump blood.

Method and device for examining viscus and therapy

(57)【要約】 【課題】 臓器の明瞭な３次元の内部像を与える小型で 空間解像度に優れた装置を提供する。 【解決手段】(a)人体内に挿入するカテーテル、(b)カテ ーテル上に取り付けられている超音波変換装置集合、 (c)変換装置を励起させて超音波信号を発生する手段、 (d)得られた超音波エコー信号を受信し、それらをデジ タル信号に変換する手段、(e)デジタル信号が供給され るデジタルコンピュータ、(f)コンピュータ内で、臓器 が３次元で表示できるようにデジタル信号を処理し、表 示そのものが処理されて、表示が異なる局面から観察で きるように、又組織の構造的な構成が視覚的に表示でき るようにする手段、並びに(g)３次元表示を視覚的に表 示する、コンピュータに接続されている手段を備えた、 ヒトの臓器内部の画像を提供する装置。

Combined stent reperfusion system

Devices and methods for preventing reperfusion injuries when an occlusion balloon is deflated. A catheter having an infusion lumen exiting the catheter distal of a stent balloon and/or occlusion balloon allows a therapeutic agent to be introduced to a target location to establish desired temperatures and pressures prior to deflation of the balloon such that negative effects of reperfusion are minimized.

Mechanical circulatory support device with axial flow turbomachine optimized for heart failure and cardio-renal syndrome

Mechanical circulatory supports configured to operate in series with the native heart are disclosed. In an embodiment, an intravascular propeller is installed into the descending aorta and anchored within via an expandable anchoring mechanism. The propeller and anchoring mechanism may be foldable so as to be percutaneously deliverable to the aorta. The propeller may have foldable blades. The blades may be magnetic and may be driven by a concentric electromagnetic stator circumferentially outside the magnetic blades. The stator may be intravascular or may be configured to be installed around the outer circumference of the blood vessel. The support may create a pressure rise between about 20-50 mmHg, and maintain a flow rate of about 5 L/min. The support may have one or more pairs of contra- rotating propellers to modulate the tangential velocity of the blood flow. The support may have static pre-swirlers and or de-swirlers. The support may be optimized to replicate naturally occurring vortex formation within the descending aorta.

Combined stent reperfusion system

Devices and methods for preventing reperfusion injuries when an occlusion balloon is deflated. A catheter having an infusion lumen exiting the catheter distal of a stent balloon and/or occlusion balloon allows a therapeutic agent to be introduced to a target location to establish desired temperatures and pressures prior to deflation of the balloon such that negative effects of reperfusion are minimized.

System for diagnosing and treating microvascular obstructions

Devices for the diagnosis and treatment of microvascular obstruction (MVO) and other dysfunctional diseases of the microvasculature of many organs, including the heart. The present subject matter provides novel devices and methods to detect and measure or treat MVO in real time during scenarios such as invasive angiographic/therapeutic procedures. Such procedures include therapy for organ systems including the heart (acute myocardial infarction-primary percutaneous coronary intervention (PPCI)), brain stroke (CVA), bowel ischemia/infarction, pulmonary emboli/infarction, critical limb ischemia/infarction, renal ischemia/infarction, and others. Using methods of the invention, a system comprising specialized infusion and sensing catheter, diagnostic agents, therapeutic agents, and control console with specialized algorithms can both diagnose and treat MVO by eliminating the microvascular clot and debris causing the obstruction. The techniques involve a combination of novel devices, methods, and software to simultaneously diagnose and treat MVO.

Mechanical circulatory support device with centrifugal impeller designed for implantation in the descending aorta

Mechanical circulatory supports configured to operate in series with the native heart are disclosed. In an embodiment, a centrifugal pump is used. In an embodiment, inlet and outlet ports are connected into the aorta and blood flow is diverted through a lumen and a centrifugal pump between the inlet and outlet ports. The supports may create a pressure rise between about 40-80 mmHg, and maintain a flow rate of about 5 L/min. The support may be configured to be inserted in a collinear manner with the descending aorta. The support may be optimized to replicate naturally occurring vortex formation within the aorta. Diffusers of different dimensions and configurations, such as helical configuration, and/or the orientation of installation may be used to optimize vortex formation. The support may use an impeller which is electromagnetically suspended, stabilized, and rotated to pump blood.

Removable mechanical circulatory support for short term use

A temporary, removable mechanical circulatory support heart-assist device has at least two propellers or impellers. Each propeller or impeller has a number of blades arranged around an axis of rotation. The blades are configured to pump blood. The two propellers or impellers rotate in opposite directions from each other. The device can be configured to be implanted and removed with minimally invasive surgery.

Apparatus for assessment of microvascular dysfunction

Methods and devices for assessment of microvascular dysfunction, such as microvascular obstruction (MVO) and other dysfunctional diseases of the microvasculature of many organs, including the heart. The present subject matter provides novel devices and methods to successfully diagnose, restore patency, open and preserve flow, and limit reperfusion injury in organs and cases with microvascular dysfunction. The present subject matter provides apparatus and method to detect, measure and treat microvascular dysfunction in real time during scenarios such as invasive angiographic/therapeutic procedures. Such procedures include therapy for organ systems including the heart (acute myocardial infarction - primary percutaneous coronary intervention (PPCI)), brain stroke (CVA), bowel ischemia/infarction, pulmonary emboli/infarction, critical limb ischemia/infarction, renal ischemia/infarction, and others. The present subject matter provides various systems including an infusion and sensing catheter, diagnostic agents, therapeutic agents, and a control console with specialized algorithms to diagnose and treat microvascular dysfunction, such as MVO, in real-time with real-time operator feedback for intervention al procedures.

Apparatus and method for determining and/or treating microvascular obstruction

Methods and systems are provided for diagnosis and/or treatment of microvascular dysfunction, such as microvascular obstruction (MVO) by injecting volumetric flows into a vessel using an infusion system to arrest or reverse native antegrade flow, such that an equipoise value of volumetric flow rate and corresponding pressure may be determined, which in turn enables calculation of MVO, absolute hydrodynamic resistance, fractional flow reserve, coronary flow reserve, and other physiologic parameters in real-time or near real time.

System and methods for treating MVO

MVO is treated by introducing injectate into blood vessels affected by MVO at precise flow rates, while blocking retrograde flow, such that the natural pumping of the heart aids in forcing the injectate into the affected microvessels. Monitoring pressure distal of an occlusion balloon is used to determine treatment effectiveness and heart health.

Removable mechanical circulatory support for short term use

A temporary, removable mechanical circulatory support heart-assist device has at least two propellers or impellers. Each propeller or impeller has a number of blades arranged around an axis of rotation. The blades are configured to pump blood. The two propellers or impellers rotate in opposite directions from each other. The device can be configured to be implanted and removed with minimally invasive surgery.

Apparatus for assessment of microvascular dysfunction

Methods and devices for assessment of microvascular dysfunction, such as microvascular obstruction (MVO) and other dysfunctional diseases of the microvasculature of many organs, including the heart. The present subject matter provides novel devices and methods to successfully diagnose, restore patency, open and preserve flow, and limit reperfusion injury in organs and cases with microvascular dysfunction. The present subject matter provides apparatus and method to detect, measure and treat microvascular dysfunction in real time during scenarios such as invasive angiographic/therapeutic procedures. Such procedures include therapy for organ systems including the heart (acute myocardial infarction - primary percutaneous coronary intervention (PPCI)), brain stroke (CVA), bowel ischemia/infarction, pulmonary emboli/infarction, critical limb ischemia/infarction, renal ischemia/infarction, and others. The present subject matter provides various systems including an infusion and sensing catheter, diagnostic agents, therapeutic agents, and a control console with specialized algorithms to diagnose and treat microvascular dysfunction, such as MVO, in real-time with real-time operator feedback for intervention al procedures.

Apparatus and method for determining and/or treating microvascular obstruction

Methods and systems are provided for diagnosis and/or treatment of microvascular dysfunction, such as microvascular obstruction (MVO) by injecting volumetric flows into a vessel using an infusion system to arrest or reverse native antegrade flow, such that an equipoise value of volumetric flow rate and corresponding pressure may be determined, which in turn enables calculation of MVO, absolute hydrodynamic resistance, fractional flow reserve, coronary flow reserve, and other physiologic parameters in real-time or near real time.

Mechanical circulatory support device with centrifugal impeller designed for implantation in the descending aorta

Mechanical circulatory supports configured to operate in series with the native heart are disclosed. In an embodiment, a centrifugal pump is used. In an embodiment, inlet and outlet ports are connected into the aorta and blood flow is diverted through a lumen and a centrifugal pump between the inlet and outlet ports. The supports may create a pressure rise between about 40-80 mmHg, and maintain a flow rate of about 5 L/min. The support may be configured to be inserted in a collinear manner with the descending aorta. The support may be optimized to replicate naturally occurring vortex formation within the aorta. Diffusers of different dimensions and configurations, such as helical configuration, and/or the orientation of installation may be used to optimize vortex formation. The support may use an impeller which is electromagnetically suspended, stabilized, and rotated to pump blood.

Mechanical circulatory support device with centrifugal impeller designed for implantation in the descending aorta

Mechanical circulatory supports configured to operate in series with the native heart are disclosed. In an embodiment, a centrifugal pump is used. In an embodiment, inlet and outlet ports are connected into the aorta and blood flow is diverted through a lumen and a centrifugal pump between the inlet and outlet ports. The supports may create a pressure rise between about 40-80 mmHg, and maintain a flow rate of about 5 L/min. The support may be configured to be inserted in a collinear manner with the descending aorta. The support may be optimized to replicate naturally occurring vortex formation within the aorta. Diffusers of different dimensions and configurations, such as helical configuration, and/or the orientation of installation may be used to optimize vortex formation. The support may use an impeller which is electromagnetically suspended, stabilized, and rotated to pump blood.

Collapsing mechanical circulatory support device for temporary use

A temporary, removable mechanical circulatory support heart-assist device has at least two propellers or impellers. Each propeller or impeller has a number of blades arranged around an axis of rotation. The blades are configured to pump blood. The two propellers or impellers rotate in opposite directions from each other. The device can be configured to be implanted and removed with minimally invasive surgery.

System and methods for treating MVO

MVO is treated by introducing injectate into blood vessels affected by MVO at precise flow rates, while blocking retrograde flow, such that the natural pumping of the heart aids in forcing the injectate into the affected microvessels. Monitoring pressure distal of an occlusion balloon is used to determine treatment effectiveness and heart health.

Apparatus for assessment of microvascular dysfunction

Intracoronary characterization of microvascular obstruction (MVO) and myocardial infarction

Systems and apparatus are included that are configured to determine the effectiveness of apparatus and methods used to diagnose and unblock microvascular obstruction (MVO). An infusion system blocks antegrade flow for a short time and measures vascular pressure response as an infusate is infused in stepwise fashion at increasingly higher flowrates. During the antegrade flow occlusion, calculations of the real-time vascular resistance can be obtained using the formula R(t)= P(t)/Q

Aparato para la evaluación de la disfunción microvascular

Métodos y dispositivos para la evaluación de la disfunción microvascular, como la obstrucción microvascular (OMV) y otras enfermedades disfuncionales de la microvasculatura de muchos órganos, incluido el corazón. El presente tema proporciona dispositivos y métodos novedosos para diagnosticar con éxito, restaurar la permeabilidad, abrir y preservar el flujo y limitar la lesión por reperfusión en órganos y casos con disfunción microvascular. El presente tema proporciona aparatos y métodos para detectar, medir y tratar la disfunción microvascular en tiempo real durante escenarios tales como procedimientos angiográficos/terapéuticos invasivos. Dichos procedimientos incluyen terapia para sistemas de órganos, incluido el corazón (infarto agudo de miocardio - intervención coronaria percutánea primaria (ICPP)), accidente cerebrovascular (ACV), isquemia/infarto intestinal, embolia/infarto pulmonar, isquemia/infarto de extremidades críticas, isquemia/infarto renal , y otros. El presente tema proporciona varios sistemas que incluyen un catéter de infusión y detección, agentes de diagnóstico, agentes terapéuticos y una consola de control con algoritmos especializados para diagnosticar y tratar la disfunción microvascular, como la OMV, en tiempo real con retroalimentación del operador en tiempo real para la intervención. todos los procedimientos. (Traducción automática con Google Translate, sin valor legal)

Apparatus for assessment of microvascular dysfunction

Collapsing and expanding structures with shape memory materials at multiple temperatures

Shape memory alloys are used in aerospace structures, orthodontics, cardiovascular prosthetic devices, sensors and controllers, and many other engineering, technology, science, and other fields. The methods are described in the case of a temporary heart assist pump to illustrate the concepts, but the method applies to many other fields. The properties of shape memory alloys are used to fold or collapse and implant in the human body a device without breaking the device as it reaches body temperature or without reaching permanent plastic deformation. The properties of nitinol are also used to describe intended explantation of the device, at body temperature, from the body without breaking it. Such planned explantation may be needed in cases where the device is designed for temporary use, such as mechanical circulatory support devices intended for temporary use and then removal of all components of the device from the body. The same method can be used for devices that have not been initially designed for removal, such as stents or valves, that must later be explanted for reasons unanticipated.

System for diagnosing and treating microvascular obstructions

System for treating microvascular obstruction

Removable mechanical circulatory support for short term use

Mechanical circulatory supports configured to operate in series with the native heart are disclosed. In an embodiment, an intravascular propeller is installed into the descending aorta and anchored within via an expandable anchoring mechanism. The propeller and anchoring mechanism may be foldable so as to be percutaneously deliverable to the aorta. The propeller may have foldable blades. The blades may be magnetic and may be driven by a concentric electromagnetic stator circumferentially outside the magnetic blades. The stator may be intravascular or may be configured to be installed around the outer circumference of the blood vessel. The support may create a pressure rise between about 20-50 mmHg, and maintain a flow rate of about 5 L/min. The support may have one or more pairs of contra-rotating propellers to modulate the tangential velocity of the blood flow. The support may have static pre-swirlers and or de-swirlers. The support may be optimized to replicate naturally occurring vortex formation within the descending aorta.

Collapsing and expanding structures with shape memory materials at multiple temperatures

Shape memory alloys are used in aerospace structures, orthodontics, cardiovascular prosthetic devices, sensors and controllers, and many other engineering, technology, science, and other fields. The methods are described in the case of a temporary heart assist pump to illustrate the concepts, but the method applies to many other fields. The properties of shape memory alloys are used to fold or collapse and implant in the human body a device without breaking the device as it reaches body temperature or without reaching permanent plastic deformation. The properties of nitinol are also used to describe intended explantation of the device, at body temperature, from the body without breaking it. Such planned explantation may be needed in cases where the device is designed for temporary use, such as mechanical circulatory support devices intended for temporary use and then removal of all components of the device from the body. The same method can be used for devices that have not been initially designed for removal, such as stents or valves, that must later be explanted for reasons unanticipated when they were installed. The methods ensure that the devices stay within stress-strain-temperature conditions so they remain elastic, or under the upper stress plateau, or remain plastic, but always under the breaking strain, of shape memory alloys at: room or environmental conditions; cooler than environmental conditions; and at a higher temperature, or body temperature. The methods described may also be applied to other industrial applications, where shape memory alloys may be installed and removed at different temperatures. Applications in other industries, include aerospace, civil structures, mechanical structures are contemplated.

Collapsing and expanding structures with shape memory materials at multiple temperatures

Shape memory alloys are used in aerospace structures, orthodontics, cardiovascular prosthetic devices, sensors and controllers, and many other engineering, technology, science, and other fields. The methods are described in the case of a temporary heart assist pump to illustrate the concepts, but the method applies to many other fields. The properties of shape memory alloys are used to fold or collapse and implant in the human body a device without breaking the device as it reaches body temperature or without reaching permanent plastic deformation. The properties of nitinol are also used to describe intended explantation of the device, at body temperature, from the body without breaking it. Such planned explantation may be needed in cases where the device is designed for temporary use, such as mechanical circulatory support devices intended for temporary use and then removal of all components of the device from the body. The same method can be used for devices that have not been initially designed for removal, such as stents or valves, that must later be explanted for reasons unanticipated.

Combined stent reperfusion system

Apparatus and method for determining and/or treating microvascular obstruction

Methods and systems are provided for diagnosis and/or treatment of microvascular dysfunction, such as microvascular obstruction (MVO) by injecting volumetric flows into a vessel using an infusion system to arrest or reverse native antegrade flow, such that an equipoise value of volumetric flow rate and corresponding pressure may be determined, which in turn enables calculation of MVO, absolute hydrodynamic resistance, fractional flow reserve, coronary flow reserve, and other physiologic parameters in real-time or near real time.

Apparatus and method for determining and/or treating microvascular obstruction

Methods and systems are provided for diagnosis and/or treatment of microvascular dysfunction, such as microvascular obstruction (MVO) by injecting volumetric flows into a vessel using an infusion system to arrest or reverse native antegrade flow, such that an equipoise value of volumetric flow rate and corresponding pressure may be determined, which in turn enables calculation of MVO, absolute hydrodynamic resistance, fractional flow reserve, coronary flow reserve, and other physiologic parameters in real-time or near real time.

Collapsing mechanical circulatory support device for temporary use

A temporary, removable mechanical circulatory support heart-assist device has at least two propellers or impellers. Each propeller or impeller has a number of blades arranged around an axis of rotation. The blades are configured to pump blood. The two propellers or impellers rotate in opposite directions from each other. The device can be configured to be implanted and removed with minimally invasive surgery.

System and methods for treating mvo

MVO is treated by introducing injectate into blood vessels affected by MVO at precise flow rates, while blocking retrograde flow, such that the natural pumping of the heart aids in forcing the injectate into the affected microvessels. Monitoring pressure distal of an occlusion balloon is used to determine treatment effectiveness and heart health.

Removable mechanical circulatory support for short term use

A temporary, removable mechanical circulatory support heart-assist device has at least two propellers or impellers. Each propeller or impeller has a number of blades arranged around an axis of rotation. The blades are configured to pump blood. The two propellers or impellers rotate in opposite directions from each other. The device can be configured to be implanted and removed with minimally invasive surgery.

Mechanical circulatory support device with axial flow turbomachine optimized for heart failure and cardio-renal syndrome by implantation in the descending aorta

Mechanical circulatory supports configured to operate in series with the native heart are disclosed. In an embodiment, an intravascular propeller is installed into the descending aorta and anchored within via an expandable anchoring mechanism. The propeller and anchoring mechanism may be foldable so as to be percutaneously deliverable to the aorta. The propeller may have foldable blades. The blades may be magnetic and may be driven by a concentric electromagnetic stator circumferentially outside the magnetic blades. The stator may be intravascular or may be configured to be installed around the outer circumference of the blood vessel. The support may create a pressure rise between about 20-50 mmHg, and maintain a flow rate of about 5 L/min. The support may have one or more pairs of contra-rotating propellers to modulate the tangential velocity of the blood flow. The support may have static pre-swirlers and or de-swirlers. The support may be optimized to replicate naturally occurring vortex formation within the descending aorta.

System for treating microvascular obstruction

Removable mechanical circulatory support for short term use

A temporary, removable mechanical circulatory support heart-assist device has at least two propellers or impellers. Each propeller or impeller has a number of blades arranged around an axis of rotation. The blades are configured to pump blood. The two propellers or impellers rotate in opposite directions from each other. The device can be configured to be implanted and removed with minimally invasive surgery.