Abstract: The present disclosure describes a replacement valve that can remove or lacerate the anterior mitral leaflet (or other portion of the heart) to reduce the obstruction of the left ventricular outflow tract (LVOT). The replacement valve can include integrated cutting features to lacerate a leaflet of a heart valve. For example, the cutting features can include blades or electrosurgical features that can cut the leaflets to reduce obstruction of the LVOT. As the cutting features are integrated components of the replacement valve, the laceration of the leaflet can follow implantation of the replacement valve and enables for clinical decisions to be made based on the degree of obstruction to the LVOT following the implantation procedure.

Abstract: The present disclosure describes a replacement valve that can remove or lacerate the anterior mitral leaflet (or other portion of the heart) to reduce the obstruction of the left ventricular outflow tract (LVOT). The replacement valve can include integrated cutting features to lacerate a leaflet of a heart valve. For example, the cutting features can include blades or electrosurgical features that can cut the leaflets to reduce obstruction of the LVOT. As the cutting features are integrated components of the replacement valve, the laceration of the leaflet can follow implantation of the replacement valve and enables for clinical decisions to be made based on the degree of obstruction to the LVOT following the implantation procedure.

Abstract: Systems, methods, and devices having improved conformal properties for biomedical signal measurement are disclosed. A device can have a first polymer substrate coupled to a conductive layer forming a conductive trace electrically coupled to a conductive pad exposed via an opening. The device can have a second polymer substrate forming a first cavity between the first polymer substrate and the second polymer substrate. The device can have a first inlet portion that receives a fluid that expands the first cavity causing the device to conform to an anatomical structure. The structure can be an atrium, such as the left atrium, of the heart of a patient. The device can conform to the walls of the tissue structure, and the conductive pad exposed via the opening can detect a signal from the wall of the tissue structure. The signal can be provided to an external measurement device for processing.

Abstract: Methods for fabricating flexible/stretchable circuits can include identifying one or more regions of a printed circuit board (PCB) for selectively removing insulation material. The PCB can include one or more electrically conductive structures arranged on an insulation layer. The method can include applying, within each region of the one or more regions, thermal energy via a heat source to a surface of the PCB within the region such that insulation material of the insulation layer is removed from the region while a portion of the insulation layer beneath the one or more electrically conductive structures is maintained. The flexible/stretchable circuit can be laminated on a soft actuator to form a soft robotic device.

Abstract: Implanted medical devices need a mechanism of immobilization to surrounding tissues, which minimizes tissue damage while providing reliable long-term anchoring. This disclosure relates to techniques for patterning arbitrarily shaped 3D objects and to patterned balloon devices having micro- or nano-patterning on an outer surface of an inflatable balloon. The external pattern can provide enhanced friction and anchoring in an aqueous environment. Examples of these types of patterns are hexagonal arrays inspired by tree frogs, corrugated patterns, and microneedle patterns. The patterned balloon devices can be disposed between an implant and surrounding tissues to facilitate anchoring of the implant.

Abstract: Implanted medical devices need a mechanism of immobilization to surrounding tissues, which minimizes tissue damage while providing reliable long-term anchoring. This disclosure relates to techniques for patterning arbitrarily shaped 3D objects and to patterned balloon devices having micro-or nano-patterning on an outer surface of an inflatable balloon. The external pattern can provide enhanced friction and anchoring in an aqueous environment. Examples of these types of patterns are hexagonal arrays inspired by tree frogs, corrugated patterns, and microneedle patterns. The patterned balloon devices can be disposed between an implant and surrounding tissues to facilitate anchoring of the implant.

Abstract: A catheter system is provided that reduces the risk of catheter-associated urinary tract infections by preventing bacteria near the urethral opening from being carried by the catheter during insertion, and by allowing cycling (filling and emptying) of the bladder. The system includes a main lumen, and a balloon near a distal end thereof that is inflatable, after insertion, to open an eyelet to the main lumen that allows urine to flow from the bladder into the main lumen. A catheter system with two balloons, e.g., a retention and an actuation balloon, is also provided herein. An access port at a proximal end has a resting configuration that closes the proximal end of main lumen to prevent drainage of urine through the main lumen. An access cap is provided that, when installed in the access port, opens the access port to allow urine to flow therethrough.

Abstract: Embodiments described herein provide systems and methods for improving diagnosis, screening, and treatment of patients. The disclosed systems and methods generally relate to artificial intelligence (AI) based deep learning models that can help with decision making, for example, in gynecological procedures. In various embodiments, a method of generating a model for performing gynecologic procedures is described. In various embodiments, a method of determining a success rate of a minimally invasive procedure for a patient is described. In various embodiments, a method of enhancing a diagnosis of an ovarian tumor is described. In various embodiments, a method of providing a mixed reality guidance for performing gynecological procedures is described.

Abstract: Systems, methods, and devices having improved conformal properties for biomedical signal measurement are disclosed. A device can have a first polymer substrate coupled to a conductive layer forming a conductive trace electrically coupled to a conductive pad exposed via an opening. The device can have a second polymer substrate forming a first cavity between the first polymer substrate and the second polymer substrate. The device can have a first inlet portion that receives a fluid that expands the first cavity causing the device to conform to an anatomical structure. The structure can be an atrium, such as the left atrium, of the heart of a patient. The device can conform to the walls of the tissue structure, and the conductive pad exposed via the opening can detect a signal from the wall of the tissue structure. The signal can be provided to an external measurement device for processing.

Abstract: Systems and method to measure pressure are described herein. The system can include a force sensor can that be implanted into a patient to measure, for example, cardiac pressure. The force sensor can include first and second film layers that can define a plurality of pressure cells. An external pressure can deform the pressure cells and change their resonant frequency. When exposed to an acoustic signal, the pressure cells can resonant at a pressure-dependent resonant frequency. The system can detect reflected acoustic waves generated by the resonance of the pressure cells. The system can convert the frequency readings into pressure values.

Abstract: Disclosed are approaches that may provide image-guidance to interventionalists by providing true 3D visualization and quantitative feedback in real-time. A guidance system may allow a physician to manipulate a medical device and see a 3D rendering with quantitative feedback floating in mixed reality, next to standard monitors. Image tracking may detect and co-register the medical device's 3D position using, for example, bi-plane C-arm X-ray fluoroscopy and provide a 3D trajectory as quantitative feedback. Patterns in a fluoroscopic image may be used to accurately determine an object's z-position from a single angle projection.

Abstract: Implanted medical devices need a mechanism of immobilization to surrounding tissues, which minimizes tissue damage while providing reliable long-term anchoring. This disclosure relates to techniques for patterning arbitrarily shaped 3D objects and to patterned balloon devices having micro- or nano-patterning on an outer surface of an inflatable balloon. The external pattern can provide enhanced friction and anchoring in an aqueous environment. Examples of these types of patterns are hexagonal arrays inspired by tree frogs, corrugated patterns, and microneedle patterns. The patterned balloon devices can be disposed between an implant and surrounding tissues to facilitate anchoring of the implant.

Abstract: The present disclosure describes a device that can be implanted into the left atrial appendage for occlusion. The device can prevent or reduce thrombus formation in this anatomic region for patients with atrial fibrillation. This device includes a patient-specific inflatable device that represents a patient's anatomy or morphological class. The inflatable device can be designed by imaging (e.g., computed tomography, magnetic resonance imaging) the patient's anatomy. Through a catheter (or surgically), the inflatable device can be filled with an inflation fluid to occlude the appendage in a patient-specific fashion.

Abstract: Methods for fabricating flexible/stretchable circuits can include identifying one or more regions of a printed circuit board (PCB) for selectively removing insulation material. The PCB can include one or more electrically conductive structures arranged on an insulation layer. The method can include applying, within each region of the one or more regions, thermal energy via a heat source to a surface of the PCB within the region such that insulation material of the insulation layer is removed from the region while a portion of the insulation layer beneath the one or more electrically conductive structures is maintained. The flexible/stretchable circuit can be laminated on a soft actuator to form a soft robotic device.

Abstract: Systems, methods, and devices having improved conformal properties for biomedical signal measurement are disclosed. A device can have a first polymer substrate coupled to a conductive layer forming a conductive trace electrically coupled to a conductive pad exposed via an opening. The device can have a second polymer substrate forming a first cavity between the first polymer substrate and the second polymer substrate. The device can have a first inlet portion that receives a fluid that expands the first cavity causing the device to conform to an anatomical structure. The structure can be an atrium, such as the left atrium, of the heart of a patient. The device can conform to the walls of the tissue structure, and the conductive pad exposed via the opening can detect a signal from the wall of the tissue structure. The signal can be provided to an external measurement device for processing.

Abstract: A catheter system is provided that reduces the risk of catheter-associated urinary tract infections by preventing bacteria near the urethral opening from being carried by the catheter during insertion, and by allowing cycling (filling and emptying) of the bladder. The system includes a main lumen, and a balloon near a distal end thereof that is inflatable, after insertion, to open an eyelet to the main lumen that allows urine to flow from the bladder into the main lumen. A catheter system with two balloons, e.g., a retention and an actuation balloon, is also provided herein. An access port at a proximal end has a resting configuration that closes the proximal end of main lumen to prevent drainage of urine through the main lumen. An access cap is provided that, when installed in the access port, opens the access port to allow urine to flow therethrough.

Abstract: The present disclosure describes a device that can be implanted into the left atrial appendage for occlusion. The device can prevent or reduce thrombus formation in this anatomic region for patients with atrial fibrillation. This device includes a patient-specific inflatable device that represents a patient's anatomy or morphological class. The inflatable device can be designed by imaging (e.g., computed tomography, magnetic resonance imaging) the patient's anatomy. Through a catheter (or surgically), the inflatable device can be filled with an inflation fluid to occlude the appendage in a patient-specific fashion.

Abstract: The present disclosure describes a system and a method for producing patient-specific small diameter vascular grafts (SDVG) for coronary artery bypass graft (CABG) surgery. In some embodiments, the method for producing SDVGs includes non-invasive quantification of patient-specific coronary and vascular physiology by applying computational fluid dynamics (CFD), rapid prototyping, and in vitro techniques to medical images and coupling the quantified patient-specific coronary and vascular physiology from the CFD to computational fluid-structure interactions and SDVG structural factors to design a patient-specific SDVG.

Abstract: The present disclosure describes a system that can enable the prediction of coronary flow without invasive medical procedure. The system can generate physical models that can provide an accurate assessment of coronary mechanics and enable realistic simulation of coronary procedures. The models can enable the hemodynamic measurement of flow through the model and the study of flow dynamics through the model and the biomechanics of the model.

Abstract: The present disclosure describes a replacement valve that can remove or lacerate the anterior mitral leaflet (or other portion of the heart) to reduce the obstruction of the left ventricular outflow tract (LVOT). The replacement valve can include integrated cutting features to lacerate a leaflet of a heart valve. For example, the cutting features can include blades or electrosurgical features that can cut the leaflets to reduce obstruction of the LVOT. As the cutting features are integrated components of the replacement valve, the laceration of the leaflet can follow implantation of the replacement valve and enables for clinical decisions to be made based on the degree of obstruction to the LVOT following the implantation procedure.