WO2023275122A1 - Systems, apparatuses, and methods for image-guided valvuloplasty catheter procedures to treat stenotic valves, incorporating valvuloplasty balloon and pressure sensors - Google Patents
Systems, apparatuses, and methods for image-guided valvuloplasty catheter procedures to treat stenotic valves, incorporating valvuloplasty balloon and pressure sensors Download PDFInfo
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- WO2023275122A1 WO2023275122A1 PCT/EP2022/067848 EP2022067848W WO2023275122A1 WO 2023275122 A1 WO2023275122 A1 WO 2023275122A1 EP 2022067848 W EP2022067848 W EP 2022067848W WO 2023275122 A1 WO2023275122 A1 WO 2023275122A1
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Definitions
- Embodiments of the subject matter described herein relate generally to medical devices, and more particularly, embodiments of the subject matter relate to systems, apparatuses, and methods to treat stenoses in the vascular system by balloon valvuloplasty via placing a balloon catheter across the stenosed valve, to expand the opening of the valve leaflets by laser-induced pressure waves, and to monitor pressures by a set of sensors to quantify the valve functionality.
- the openings to heart valves can become narrowed due to anatomical abnormalities or degenerative diseases, a situation called stenosis.
- the narrow openings to the heart valves limit the amount of blood flow through the heart, which can cause either decreased circulatory volumes or increased back pressure to the heart. Both of these conditions can lead to patient morbidity and can eventually result in heart failure.
- the use of balloon valvuloplasty is a treatment procedure to prevent heart failure and to improve quality of life because of decreased blood circulations by combating the effects caused by the narrow or narrowing of heart openings.
- the balloon valvuloplasty is performed by a medical provider placing a transvenous balloon catheter across the stenosed valve, then expanding the balloon of the transvenous balloon catheter to increase the opening of the valve leaflets.
- the balloon catheter is guided only by fluoroscopy.
- the stenosed valve condition may be diagnosed using either echocardiogram (ultrasound of the heart) or x-ray with contrast. Both diagnostic methods have drawbacks as the mechanism causing the stenosis of the heart valve may not be clearly shown. Also, while valvuloplasty is deemed a beneficial procedure to alleviating symptoms experienced by the valve stenosis, it does not treat or address directly the underlying causes of the valve stenosis.
- the inflation lumen is configured to both inflate the balloon and to receive an accessory catheter lumen which can be implemented to insert an imaging catheter to image through the balloon catheter and to view a valve situs.
- the balloon catheter it is desirable for the balloon catheter to be configured with a set of pressure sensors to monitor pressure differences across the valve to assess the functionality of the valve during and after the valvuloplasty procedure and to provide metrics for confirming treatment results.
- a valvuloplasty system configured with a balloon and an inflation lumen wherein the inflation lumen is configured to both inflate the balloon and to receive an accessory catheter lumen for enabling imaging through the balloon catheter of a valve to perform a valvuloplasty procedure, and a set of pressure sensors including a first pressure sensor coupled to a proximate end of the balloon catheter, and a second pressure sensor coupled to a distal end of the balloon catheter to monitor pressure differences across the valve to assess the functionality of the valve while during the valvuloplasty procedure.
- the valvuloplasty system includes a third pressure sensor configured within the balloon of the catheter balloon to provide measurements to monitor the pressure of the balloon during the valvuloplasty procedure.
- the valvuloplasty system includes a laser catheter that is inserted through the accessory catheter lumen and positioned at a location within the balloon of the balloon catheter to treat tissue about a situs of the valve.
- the valvuloplasty system includes a control device to monitor the pressure measured by at least one pressure sensor of the first, second, and third pressure sensors.
- the valvuloplasty system includes an inflation mechanism coupled to the balloon catheter to inflate the balloon and to introduce a contrast agent into the balloon to provide visibility of an outline of the balloon under fluoroscopy.
- the valvuloplasty system includes the laser catheter that is at least a deflectable type of laser.
- the valvuloplasty system includes the balloon of a material that is transparent to infrared light and sufficiently rigid to enable treatment of calcific valve leaflets at the valve situs.
- the valvuloplasty system includes prior to inflation of the balloon, the control system is configured to collect the set of measurements sensed by at least one pressure value to assess the functionality of a valve before commencing treatment of the tissue about the situs of the valve; wherein the balloon is inflated with contrast-infused saline to compress the valve leaflets against an anatomical vascular wall; wherein the contrast agent is infused into the balloon to enable viewing under fluoroscopy and to assist in the treatment to the tissue at the situs of the valve; wherein the pressure within the balloon is measured with time-response to determine amounts of valvular insufficiency; and wherein after the balloon is expanded within the valve, an imaging catheter is inserted through the accessory lumen of the balloon catheter to image the valve.
- the valvuloplasty system includes in response to completion of an imaging action and removal of the imaging catheter in the valvuloplasty procedure, the laser catheter is inserted into the accessory lumen and positioned in a manner to direct multiple laser-induced pressure waves (LIPWs) at the situs to treat the calcified leaflets.
- LIPWs laser-induced pressure waves
- the valvuloplasty system includes wherein fluid in the balloon filled with the contrast agent enables absorption of laser light and for the LIPWs by the laser catheter to apply pressure at the situs to expand the calcified leaflets.
- the valvuloplasty system includes in response to the completion of a treatment action including the multiple LIPWs by the laser catheter, the laser catheter is removed, and the imaging catheter is reinserted to re-image the valve leaflets to view the situs of the treatment action; and in response to a deflation action of the balloon, the control device is configured to collect the measurements from the set of pressure sensors to quantify functionality of the valve.
- a valvuloplasty apparatus in another exemplary embodiment, includes a balloon catheter configured with a balloon and an inflation lumen wherein the inflation lumen is configured to both inflate the balloon and to receive an accessory catheter lumen for enabling imaging through the balloon catheter of a valve to perform a valvuloplasty procedure; and a set of pressure sensors including a proximal sensor coupled to a proximate end of the balloon catheter, a distal sensor coupled to a distal end of the balloon catheter to monitor pressure differences across the valve to assess the functionality of the valve while during the valvuloplasty procedure; an internal sensor configured within the balloon of the catheter balloon to provide measurements to monitor the pressure of the balloon during the valvuloplasty procedure.
- the apparatus includes a laser catheter inserted through the accessory catheter lumen and positioned at a location within the balloon of the balloon catheter to treat tissue about a situs of the valve.
- the apparatus includes a control device coupled to the balloon catheter to monitor the pressure measured by at least one pressure sensor of the set of pressure sensors.
- the apparatus includes an inflation mechanism coupled to the balloon catheter to inflate the balloon and to introduce a contrast agent into the balloon to provide visibility of an outline of the balloon under fluoroscopy.
- the apparatus includes the laser catheter that is at least a deflectable configured laser; and the balloon that is a material that is transparent to infrared light and sufficiently rigid to enable treatment of calcific valve leaflets at a valve situs.
- a valvuloplasty system that includes a balloon catheter configured with an accessory catheter lumen for insertion of a laser catheter and coupled to a control device that monitors pressure measurements sensed by a set of multiple pressure sensors configured with the balloon catheter during a valvuloplasty procedure is provided.
- the valvuloplasty system includes the balloon catheter configured with at least one balloon and at least one an inflation lumen wherein the inflation lumen is configured to both inflate the at least one balloon and to receive the accessory catheter lumen for enabling imaging through the balloon catheter of a valve to perform the valvuloplasty procedure; and the set of multiple pressure sensors includes a proximal sensor coupled to a proximate end of the balloon catheter, a distal sensor coupled to a distal end of the balloon catheter to monitor pressure differences across the valve to assess the functionality of the valve while during the valvuloplasty procedure, and an internal sensor configured within the at least one balloon of the catheter balloon to provide the measurements to monitor the pressure of the at least one balloon during the valvuloplasty procedure.
- the valvuloplasty system includes an inflation mechanism coupled to the balloon catheter to inflate at least one balloon and to introduce a contrast agent into at least one balloon to provide visibility of an outline of at least one balloon under fluoroscopy.
- the valvuloplasty system includes the laser catheter that is at least a deflectable type of laser; and at least one balloon that is a material that is transparent to infrared light and sufficiently rigid to enable treatment of calcific valve leaflets at a valve situs.
- the valvuloplasty system includes in response to completion of an imaging action and removal of an imaging catheter in the valvuloplasty procedure, the laser catheter is inserted into the accessory lumen and positioned in a manner to direct multiple laser-induced pressure waves (LIPWs) at the situs to treat calcified leaflets; and wherein prior to inflation of the balloon, the control system is configured to collect the set of measurements sensed by multiple pressure values to assess functionality of a valve before commencing treatment of the tissue about the situs of the valve; wherein the balloon is inflated with contrast-infused saline to compress the valve leaflets against an anatomical vascular wall; wherein the contrast agent is infused into the balloon to enable viewing under fluoroscopy and to assist in the treatment to the tissue at the situs of the valve; wherein the pressure within the at least one balloon is measured with time- response to determine amounts of valvular insufficiency; and wherein after the at least one balloon is expanded within the valve, the imaging catheter is inserted through the accessory lume
- LIPWs laser-induced pressure waves
- FIG. 1 depicts an exemplary balloon catheter device incorporating a valvuloplasty balloon and pressure sensors of the image-guided valvuloplasty catheter system to treat stenotic valves in accordance with one or more exemplary embodiments;
- FIG. 2 depicts a snapshot image of a simulated calcification post FIPW treatment from OCT imaging balloon of the image-guided valvuloplasty catheter system to treat stenotic valves in accordance with one or more exemplary embodiments;
- FIGS. 3A, 3B, and 3C depict exemplary valvuloplasty balloons for use in an exemplary balloon catheter device incorporating a valvuloplasty balloon and pressure sensors of the image-guided valvuloplasty catheter system to treat stenotic valves in accordance with one or more exemplary embodiments;
- FIG. 4 depicts an exemplary diagram of the exemplary balloon catheter device placed at a situs across the valve wherein the exemplary balloon catheter device incorporates a valvuloplasty balloon and pressure sensors of the image-guided valvuloplasty catheter system to treat stenotic valves in accordance with one or more exemplary embodiments; and
- FIG. 5 is an exemplary flowchart of the endoscopic procedure for operating the exemplary balloon catheter device incorporating a valvuloplasty balloon and pressure sensors of the image-guided valvuloplasty catheter system to treat stenotic valves in accordance with one or more exemplary embodiments.
- Balloon valvuloplasty or balloon valvuloplasty is a procedure to repair a heart valve that has a narrowed opening.
- the valve flaps may become thick or stiff and fuse together (stenosis). This reduces blood flow through the valve.
- the valvuloplasty treatment may improve blood flow through the heart valve and improve the subject's symptoms.
- Balloon valvuloplasty is an endoscopic treatment that relies on a catheter (thin, flexible tube) inserted into a vein or artery in your groin to repair your heart valve. A balloon is guided with the catheter to the heart and expanded in the narrowed valve to split the leaflets apart.
- the balloon valvuloplasty is used to treat mitral valve stenosis in the case when the valvuloplasty has been deemed a treatment of choice for patients with rheumatic mitral valve stenosis whose anatomy is suitable for the procedure. It is used to treat pulmonary stenosis which is often a congenital disease and pulmonary stenosis can be treated in childhood.
- TAVR transcatheter aortic valve replacement
- BAV balloon aortic valvuloplasty
- TAVR transcatheter aortic valve replacement
- the present disclosure describes various exemplary embodiments that provide systems and processes for improving difficulties experienced in characterizing the amount and location of calcification on aortic valves by clearer imaging of valve situses, and calcification to treat the calcification, and providing metrics to monitor for confirming the appropriate treatment for the calcification.
- the present disclosure describes systems, apparatuses and methods of a balloon catheter device that can include elements as follows: a balloon catheter equipped with pressure sensors, a guidewire lumen, and inflation lumen large enough to insert accessory catheters, or a separate accessory catheter lumen, an imaging catheter that can pass through the catheter lumen to image through balloon catheter, a laser catheter to treat surrounding tissue through balloon catheter, 4) laser source to connect to laser catheter, an inflation mechanism to inflate the balloon and introduce contrast into the balloon, and a control system to monitor inflation pressures and analyze pressure sensors on the balloon.
- the present disclosure describes systems, apparatuses, and methods that start with a valvuloplasty balloon inserted into the subject via femoral, carotid, or apical access, guided to the valve in question over a guidewire placed previously.
- the balloon material is transparent to infrared light and stiff enough to expand calcific valve leaflets.
- the catheter material within the balloon is transparent to light.
- the balloon catheter has two pressure sensors, one distal and one proximal to the balloon, to measure pressure differences across the valve. The pressure measurements are used to assess valve functions. Before the balloon inflation, readings are collected from the pressure sensors to assess valve functions before treatment.
- this assessment equates to a Fractional Flow Reserve (FFR), or the PHILIPS® Instant Wave-free Ratio Philips (iFR) assessment.
- FFR Fractional Flow Reserve
- iFR PHILIPS® Instant Wave-free Ratio Philips
- the balloon is then inflated with contrast-infused saline to press the valve leaflets against the valvular apparatus wall. Contrast is included to see the balloon under fluoroscopy and to assist in the treatment phase of this system.
- the pressure within the balloon and time-response can be measured to know the compliance of the valve leaflets.
- an imaging catheter is inserted through the accessory lumen of the balloon catheter to image the valve.
- FIG. 1 depicts an exemplary balloon catheter device 100 incorporating a valvuloplasty balloon 5 and pressure sensors of the image-guided valvuloplasty catheter system to treat stenotic valves in accordance with one or more exemplary embodiments.
- the exemplary balloon catheter device 100 includes a valvuloplasty balloon 5, an internal sensor 10, a distal sensor 20, an accessory catheter lumen 15 for imaging or treatment, and a laser catheter 30.
- the accessory catheter lumen 15 can be configured with an imaging catheter.
- the accessory catheter lumen 15 can also be configured with a laser catheter for treatment.
- the deflectable laser can be implemented as a type of laser catheter.
- the balloon catheter 100 device is equipped with the multiple pressure sensors of the distal sensor 20, the proximal sensor 40, and the internal sensor 10.
- the balloon catheter 100 device is configured with guidewire lumen 35, and inflation lumen 25 that is large enough to allow a user to insert a series of accessory catheters or a separate accessory catheter lumen.
- an imaging catheter can be inserted or pass through the catheter lumens such as the inflation lumen 25 (i.e., an input port for the balloon catheter 100) or the accessory catheter lumen 15.
- the imaging catheter once passed through an image through the balloon catheter lumen or at an output port of the accessory catheter lumen 15 which can position at the situs for the valvuloplasty procedure.
- the laser catheter can also be inserted once the imaging catheter is removed from a catheter lumen to treat the surrounding tissue through the balloon catheter (inflation lumen 25).
- a laser source 45 can connect to the laser catheter inserted into the balloon catheter 100 or accessory catheter lumen.
- an inflation mechanism 50 is connected to the balloon catheter 100 to inflate the valvuloplasty balloon 5 and introduce the contrast agent to the valvuloplasty balloon 5.
- a monitor system 55 may be connected to the balloon catheter 100
- the monitor system 55 can monitor the pressures sensed by the balloon catheter with two pressure sensors, the distal sensor 20 and the proximal sensor 40 to measure the pressure differences across the valve.
- the pressure measurements which are monitored in the procedure can be used to assess valve function. For example, before the balloon is inflated, readings are collected from the pressure sensors (distal and proximal sensors) to assess valve function before treatment.
- the assessment of the pressure differences is equivalent to or like a fractional flow reserve (FFR).
- FFR fractional flow reserve
- iFR PHILIPS® Instant Wave-free Ratio
- FFR and iFR can be obtained during routine coronary angiography by using a pressure wire to calculate the ratio between coronary pressure distal to stenosis and the aortic pressure proximal. When resistance is constant, this ratio represents the potential decrease in coronary flow distal to the coronary stenosis. Change in pressure equals the change in flow multiplied by the constant resistance.
- the FFR is equal to the difference in the Distal Coronary Pressure (Pd) to Proximal Coronary Pressure (Pa) (during maximal hyperemia).
- the iFR is equal to the difference in the Distal Coronary Pressure (Pd) to Proximal Coronary Pressure (Pa) (during the wave-free period).
- the laser catheter can apply shock waves to the calcified leaflets of a valve situs that can expand and soften the leaflets or can break the calcium deposits, to loosen and/or remove calcium deposits that can stiffen the properties of the valve leaflets preventing the normal functioning of the valve.
- the valvuloplasty balloon 5 is a balloon that is sized and shaped to fit within a concave portion of a valve cusp when inflated with the contrast agent within the balloon.
- the imaging catheter is removed and the laser (treatment) catheter is inserted.
- the laser fiber catheter is implemented to create laser-induced pressure waves (LIPW) or shock waves.
- the fluid in the balloon will include a certain amount of contrast agent to absorb the laser light and to create the LIPWs (i.e., the pressure or shock waves).
- LIPW laser-induced pressure waves
- shock waves i.e., the pressure or shock waves.
- U.S. Patent No. 10,201,387B2 filed on December 30 th , 2015, entitled, “Laser-induced fluid-filled balloon catheter” assigned to
- SPECTRANETICS® CORPORATION Subsidiary of PHILIPS® Holding USA
- Kenneth Grace, Thomas Triffo, and James Cezo describes devices and processes using laser-induced pressure waves to disrupt vascular blockages, and is incorporated by reference.
- the laser catheter is configured to commence at a location of the distal end of the valvuloplasty balloon 5 and is pulled back while activated to create the LIPW (shock wave) across the length of the valve.
- the LIPW has been shown to significantly break up calcium, which is beneficial in valvuloplasty to create more compliant leaflets, and in turn a more functioning valve.
- the laser catheter is removed and the imaging catheter can be reinserted to re-image the valve leaflets, and thus confirm the effectiveness of treatment. Following deflation of the balloon, readings can then be collected from the pressure sensors to quantify valve functionality.
- the laser catheter can also have a focusing tip on the end of the catheter to focus the LIPW into a specific direction, therefore creating targeted therapy that can be guided by the imaging catheter.
- the laser fiber tip can be modified to increase LIPW energy density.
- the laser catheter can be deflectable within a balloon catheter to target the LIPW towards specific treatment areas.
- the control system will connect to the balloon catheter for the acquisition of the pressure data and control of balloon inflation. This system can be integrated into the fluoroscopy suite to provide relevant data on the main fluoroscopy screen.
- the catheter balloon device for treating a calcified heart valve may be made up of multiple valvuloplasty balloons (e.g., two, three valvuloplasty balloons, etc. as desired) that are each sized and shaped to fit within a concave portion of a valve cusp when inflated with a liquid and a shock wave is applied in each one of the multiple balloons.
- Each balloon can also be configured in a manner for independent or separate inflation and each shock wave applied separately and/or independently controllable.
- the shock wave can be applied from three balloons and three shock wave laser catheter sources may be used for treating a tricuspid valve, such as the pulmonary valve and the aortic valve.
- the shock wave laser catheters can be configured with one or two balloons that may be used for treating unicuspid, bicuspid, and/or tricuspid valves.
- FIG. 2 depicts a snapshot image of a simulated calcification post LIPW treatment from OCT imaging balloon of the image-guided valvuloplasty catheter system to treat stenotic valves in accordance with one or more exemplary embodiments.
- the imaging catheter will visualize the degraded valve through the balloon catheter and balloon itself.
- an imaging solution used can help to distinguish calcium from soft tissue.
- the imaging catheter implemented in the balloon catheter device is an Optical coherence tomography (OCT) catheter, Intravascular ultrasound (IVIJS) catheter, white-light spectroscopy, Raman spectroscopy, or fluorescence/lifetime spectroscopy.
- OCT Optical coherence tomography
- IVIJS Intravascular ultrasound
- white-light spectroscopy i.e., Raman spectroscopy
- Raman spectroscopy i.e., Raman spectroscopy
- fluorescence/lifetime spectroscopy Optical coherence tomography
- the imaging actions before treatment will provide the user (i.e., medical provider, physician, etc..) a direct view of the location and severity of calcified areas on the valve, which can assist to guide targeted therapy directed to the calcified regions.
- the imaging actions post-treatment of the valve will provide the user (i.e., medical provider, physician, etc..) with the ability to see the effect of therapy and confirm successful therapy.
- FIGS. 3A, 3B, and 3C depict exemplary valvuloplasty balloons for use in an exemplary balloon catheter device incorporating a valvuloplasty balloon and pressure sensors of the image-guided valvuloplasty catheter system to treat stenotic valves in accordance with one or more exemplary embodiments.
- a valvuloplasty balloon 300 is depicted with imaging that includes a multi -lumen extrusion (inflation, wire, accessory lumens) with rigid spine connection with the balloon to allow 240 e degrees visual field.
- imaging includes a multi -lumen extrusion (inflation, wire, accessory lumens) with rigid spine connection with the balloon to allow 240 e degrees visual field.
- a valvuloplasty balloon 310 is configured without imaging with a concentric catheter design, pressure sensor wires in extrusion, fibers eccentric bundling after tip, cut a channel in an outer catheter to translate laser sheath with the valvuloplasty balloon.
- the valvuloplasty balloon 320 is configured with imaging and a perfusion balloon design includes a multi-lumen extrusion (inflation, wire, accessory lumens) with half cute lumen to give 180 ® degrees visual field but the balloon has a single pleat fused to catheter along the length to allow perfusion.
- FIG. 4 depicts an exemplary diagram of the exemplary balloon catheter device places at a situs across the valve wherein the exemplary balloon catheter device incorporates a valvuloplasty balloon and pressure sensors of the image-guided valvuloplasty catheter system to treat stenotic valves in accordance with one or more exemplary embodiments.
- a heart 400 with a valve 410 and a balloon catheter 100 device positioned across the valve 410. Also shown are the distal sensor 20, proximal sensor 40, internal sensor 10, inflation lumen 25, and valvuloplasty balloon 5.
- FIG. 5 is an exemplary flowchart of the endoscopic procedure for operating the exemplary balloon catheter device incorporating a valvuloplasty balloon and pressure sensors of the image-guided valvuloplasty catheter system to treat stenotic valves in accordance with one or more exemplary embodiments.
- the flow chart in FIG. 5 of the present disclosure includes a method for treating a subject with a valvuloplasty procedure using embodiments of the balloon catheter device described herein.
- the method in FIG. 5 includes inserting at step 510, a valvuloplasty balloon catheter device into a subject via a femoral, carotid, or apical access guided to the valve in question over a guidewire that has been previously placed to locate a situs of calcification of the valve leaflet in a ventricle.
- pressure measurements are taken to assess valve function.
- readings are collected from pressure sensors located at the distal and proximal ends of the balloon catheter to assess the valve functionality using a process similar to fractional flow reserve or other assessments available.
- the balloon is inflated with contrast-infused saline to press against the valvular wall where the contrast agent (i.e., the saline fluid in this case) is included to improve the visibility of the balloon under fluoroscopy and to assist in the treatment phase of the procedure.
- the pressure within the balloon and the time-response are measured by the sensors, and the reading a collected by a monitoring device in communication (i.e., connected to the sensors) to determine compliance of the valve leaflets.
- an imaging catheter is inserted through the accessory lumen of the balloon catheter to image the valve.
- the imaging catheter will visualize the degraded valve through the balloon catheter and balloon itself. Since the valves are likely significantly calcified, the application of the imaging solution aids in distinguishing calcium from soft tissue at the procedure situs.
- a variety of types of imaging catheter can be used, that include an OCT catheter, IVUS catheter, etc... The imaging that is done prior to the treatment will enable the user to independently by visual inspection assess the severity of the calcification in a region about the valve, and this can also guide the eventual treatment targeted at the situs of the valve.
- the imaging catheter is removed, and a treatment or laser catheter is inserted into the accessory catheter lumen.
- the laser catheter is used to create laser-induced pressure waves (LIPWs) or sonic waves.
- LIPWs laser-induced pressure waves
- the contrast agent and/or fluid contained in the balloon will absorb the laser light and also create pressure waves.
- the laser catheter is removed from the accessory catheter lumen, and the imaging catheter is inserted to conduct the post-treatment imaging.
- a post-treatment imaging at the target region is conducted to independently assess the results by visual inspection of the treatment.
- the readings then can be collected from the pressure sensors to quantify valve functionality.
- the laser catheter can have a focusing tip to target the LIPW to a specific location, the tip can also be modified to increase the energy of the LIPW.
- the laser catheter can be deflectable within the balloon to target the LPIW.
- the balloon catheter can also be large enough to accommodate multiple lumens, catheters where each is inserted simultaneously to guide treatment confirmation steps and to reinsert imaging and other accessory catheters.
- the control system can be connected to the balloon catheter device for the acquisition of the pressure data and control of the balloon inflation.
- the system can be integrated into the fluoroscopy suite to display relevant data on a fluoroscopy display device.
Abstract
Systems, Apparatuses, and Methods of operating a balloon valvuloplasty system for performing a balloon valvuloplasty procedure. The system includes a balloon catheter configured with a balloon and an inflation lumen wherein the inflation lumen is configured to both inflate the balloon and to receive an accessory catheter lumen for enabling imaging through the balloon catheter of a valve to perform a valvuloplasty procedure, and a set of pressure sensors including a first pressure sensor coupled to a proximate end of the balloon catheter, and a second pressure sensor coupled to a distal end of the balloon catheter to monitor pressure differences across the valve to assess the functionality of the valve while during the valvuloplasty procedure.
Description
SYSTEMS, APPARATUSES, AND METHODS FOR IMAGE-GUIDED VALVULOPLASTY CATHETER PROCEDURES TO TREAT STENOTIC VALVES, INCORPORATING VALVULOPLASTY BALLOON AND PRESSURE SENSORS
TECHNICAL FIELD
[0001] Embodiments of the subject matter described herein relate generally to medical devices, and more particularly, embodiments of the subject matter relate to systems, apparatuses, and methods to treat stenoses in the vascular system by balloon valvuloplasty via placing a balloon catheter across the stenosed valve, to expand the opening of the valve leaflets by laser-induced pressure waves, and to monitor pressures by a set of sensors to quantify the valve functionality.
BACKGROUND
[0002] The openings to heart valves can become narrowed due to anatomical abnormalities or degenerative diseases, a situation called stenosis. The narrow openings to the heart valves limit the amount of blood flow through the heart, which can cause either decreased circulatory volumes or increased back pressure to the heart. Both of these conditions can lead to patient morbidity and can eventually result in heart failure. The use of balloon valvuloplasty is a treatment procedure to prevent heart failure and to improve quality of life because of decreased blood circulations by combating the effects caused by the narrow or narrowing of heart openings. The balloon valvuloplasty is performed by a medical provider placing a transvenous balloon catheter across the stenosed valve, then expanding the balloon of the transvenous balloon catheter to increase the opening of the valve leaflets. The balloon catheter is guided only by fluoroscopy. The stenosed valve condition may be diagnosed using either echocardiogram (ultrasound of the heart) or x-ray with contrast. Both diagnostic methods have drawbacks as the mechanism causing the stenosis of the heart valve may not be clearly shown. Also, while valvuloplasty is deemed a beneficial procedure to alleviating symptoms experienced by the valve stenosis, it does not treat or address directly the underlying causes of the valve stenosis.
[0003] It is desirable to implement systems, apparatuses, and methods for the valvuloplasty procedure with a balloon catheter configured with a balloon and an inflation lumen, the inflation lumen is configured to both inflate the balloon and to receive an accessory catheter lumen which can be implemented to insert an imaging catheter to image through the balloon catheter and to view a valve situs. Also, it is desirable for the balloon catheter to be configured with a set of pressure sensors to monitor pressure differences across the valve to assess the functionality of the valve during and after the valvuloplasty procedure and to provide metrics for confirming treatment results.
[0004] The above information disclosed in this Background section is only for enhancement of the understanding of the background of the present disclosure and therefore it may contain information that does not form the prior art that is already known in this country to a person of ordinary skill in the art.
SUMMARY
[0005] Disclosed herein are systems and apparatuses of balloon valvuloplasty via placing a balloon catheter across the stenosed valve, to expand the opening of the valve leaflets by laser-induced pressure waves, and to monitor pressures by a set of sensors to quantify the valve functionality.
[0006] In accordance with an aspect of the present invention, a valvuloplasty system is provided. The system includes a balloon catheter configured with a balloon and an inflation lumen wherein the inflation lumen is configured to both inflate the balloon and to receive an accessory catheter lumen for enabling imaging through the balloon catheter of a valve to perform a valvuloplasty procedure, and a set of pressure sensors including a first pressure sensor coupled to a proximate end of the balloon catheter, and a second pressure sensor coupled to a distal end of the balloon catheter to monitor pressure differences across the valve to assess the functionality of the valve while during the valvuloplasty procedure.
[0007] In at least one exemplary embodiment, the valvuloplasty system includes a third pressure sensor configured within the balloon of the catheter balloon to provide measurements to monitor the pressure of the balloon during the valvuloplasty procedure.
[0008] In at least one exemplary embodiment, the valvuloplasty system includes a laser catheter that is inserted through the accessory catheter lumen and positioned at a location within the balloon of the balloon catheter to treat tissue about a situs of the valve.
[0009] In at least one exemplary embodiment, the valvuloplasty system includes a control device to monitor the pressure measured by at least one pressure sensor of the first, second, and third pressure sensors.
[0010] In at least one exemplary embodiment, the valvuloplasty system includes an inflation mechanism coupled to the balloon catheter to inflate the balloon and to introduce a contrast agent into the balloon to provide visibility of an outline of the balloon under fluoroscopy.
[0011] In at least one exemplary embodiment, the valvuloplasty system includes the laser catheter that is at least a deflectable type of laser.
[0012] In at least one exemplary embodiment, the valvuloplasty system includes the balloon of a material that is transparent to infrared light and sufficiently rigid to enable treatment of calcific valve leaflets at the valve situs.
[0013] In at least one exemplary embodiment, the valvuloplasty system includes prior to inflation of the balloon, the control system is configured to collect the set of measurements sensed by at least one pressure value to assess the functionality of a valve before commencing treatment of the tissue about the situs of the valve; wherein the balloon is inflated with contrast-infused saline to compress the valve leaflets against an anatomical vascular wall; wherein the contrast agent is infused into the balloon to enable viewing under fluoroscopy and to assist in the treatment to the tissue at the situs of the valve; wherein the pressure within the balloon is measured with time-response to determine amounts of valvular insufficiency; and wherein after the balloon is expanded within the valve, an imaging catheter is inserted through the accessory lumen of the balloon catheter to image the valve.
[0014] In at least one exemplary embodiment, the valvuloplasty system includes in response to completion of an imaging action and removal of the imaging catheter in the valvuloplasty procedure, the laser catheter is inserted into the accessory lumen and positioned in a manner to direct multiple laser-induced pressure waves (LIPWs) at the situs to treat the calcified leaflets.
[0015] In at least one exemplary embodiment, the valvuloplasty system includes wherein fluid in the balloon filled with the contrast agent enables absorption of laser light and for the LIPWs by the laser catheter to apply pressure at the situs to expand the calcified leaflets.
[0016] In at least one exemplary embodiment, the valvuloplasty system includes in response to the completion of a treatment action including the multiple LIPWs by the laser catheter, the laser catheter is removed, and the imaging catheter is reinserted to re-image the valve leaflets to view the situs of the treatment action; and in response to a deflation action of the balloon, the control device is configured to collect the measurements from the set of pressure sensors to quantify functionality of the valve.
[0017] In another exemplary embodiment, a valvuloplasty apparatus is provided. The valvuloplasty apparatus includes a balloon catheter configured with a balloon and an inflation lumen wherein the inflation lumen is configured to both inflate the balloon and to receive an accessory catheter lumen for enabling imaging through the balloon catheter of a valve to perform a valvuloplasty procedure; and a set of pressure sensors including a proximal sensor coupled to a proximate end of the balloon catheter, a distal sensor coupled to a distal end of the balloon catheter to monitor pressure differences across the valve to assess the functionality of the valve while during the valvuloplasty procedure; an internal sensor configured within the balloon of the
catheter balloon to provide measurements to monitor the pressure of the balloon during the valvuloplasty procedure.
[0018] In at least one exemplary embodiment, the apparatus includes a laser catheter inserted through the accessory catheter lumen and positioned at a location within the balloon of the balloon catheter to treat tissue about a situs of the valve.
[0019] In at least one exemplary embodiment, the apparatus includes a control device coupled to the balloon catheter to monitor the pressure measured by at least one pressure sensor of the set of pressure sensors.
[0020] In at least one exemplary embodiment, the apparatus includes an inflation mechanism coupled to the balloon catheter to inflate the balloon and to introduce a contrast agent into the balloon to provide visibility of an outline of the balloon under fluoroscopy.
[0021] In at least one exemplary embodiment, the apparatus includes the laser catheter that is at least a deflectable configured laser; and the balloon that is a material that is transparent to infrared light and sufficiently rigid to enable treatment of calcific valve leaflets at a valve situs.
[0022] In yet another exemplary embodiment, a valvuloplasty system that includes a balloon catheter configured with an accessory catheter lumen for insertion of a laser catheter and coupled to a control device that monitors pressure measurements sensed by a set of multiple pressure sensors configured with the balloon catheter during a valvuloplasty procedure is provided. The valvuloplasty system includes the balloon catheter configured with at least one balloon and at least one an inflation lumen wherein the inflation lumen is configured to both inflate the at least one balloon and to receive the accessory catheter lumen for enabling imaging through the balloon catheter of a valve to perform the valvuloplasty procedure; and the set of multiple pressure sensors includes a proximal sensor coupled to a proximate end of the balloon catheter, a distal sensor coupled to a distal end of the balloon catheter to monitor pressure differences across the valve to assess the functionality of the valve while during the valvuloplasty procedure, and an internal sensor configured within the at least one balloon of the catheter balloon to provide the measurements to monitor the pressure of the at least one balloon during the valvuloplasty procedure.
[0023] In at least one exemplary embodiment, the valvuloplasty system includes an inflation mechanism coupled to the balloon catheter to inflate at least one balloon and to introduce a contrast agent into at least one balloon to provide visibility of an outline of at least one balloon under fluoroscopy.
[0024] In at least one exemplary embodiment, the valvuloplasty system includes the laser catheter that is at least a deflectable type of laser; and at least one balloon that is a material that is transparent to infrared light and sufficiently rigid to enable treatment of calcific valve leaflets at a valve situs.
[0025] In at least one exemplary embodiment, the valvuloplasty system includes in response to completion of an imaging action and removal of an imaging catheter in the valvuloplasty procedure, the laser catheter is inserted into the accessory lumen and positioned in a manner to direct multiple laser-induced pressure waves (LIPWs) at the situs to treat calcified leaflets; and wherein prior to inflation of the balloon, the control system is configured to collect the set of measurements sensed by multiple pressure values to assess functionality of a valve before commencing treatment of the tissue about the situs of the valve; wherein the balloon is inflated with contrast-infused saline to compress the valve leaflets against an anatomical vascular wall; wherein the contrast agent is infused into the balloon to enable viewing under fluoroscopy and to assist in the treatment to the tissue at the situs of the valve; wherein the pressure within the at least one balloon is measured with time- response to determine amounts of valvular insufficiency; and wherein after the at least one balloon is expanded within the valve, the imaging catheter is inserted through the accessory lumen of the balloon catheter to image the valve.
[0026] The above-mentioned and other features and advantages of this invention, and the manner of attaining them, will become more apparent and the invention will be better understood by reference to the following description of embodiments of the invention taken in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0027] A more complete understanding of the subject matter may be derived by referring to the detailed description and claims when considered in conjunction with the following figures, wherein like reference numbers refer to similar elements throughout the figures, which may be illustrated for simplicity and clarity and are not necessarily drawn to scale.
[0028] FIG. 1 depicts an exemplary balloon catheter device incorporating a valvuloplasty balloon and pressure sensors of the image-guided valvuloplasty catheter system to treat stenotic valves in accordance with one or more exemplary embodiments;
[0029] FIG. 2 depicts a snapshot image of a simulated calcification post FIPW treatment from OCT imaging balloon of the image-guided valvuloplasty catheter system to treat stenotic valves in accordance with one or more exemplary embodiments;
[0030] FIGS. 3A, 3B, and 3C depict exemplary valvuloplasty balloons for use in an exemplary balloon catheter device incorporating a valvuloplasty balloon and pressure sensors of the image-guided valvuloplasty catheter system to treat stenotic valves in accordance with one or more exemplary embodiments;
[0031] FIG. 4 depicts an exemplary diagram of the exemplary balloon catheter device placed at a situs across the valve wherein the exemplary balloon catheter device incorporates a valvuloplasty balloon and pressure sensors of the image-guided valvuloplasty catheter system to treat stenotic valves in accordance with one or more exemplary embodiments; and
[0032] FIG. 5 is an exemplary flowchart of the endoscopic procedure for operating the exemplary balloon catheter device incorporating a valvuloplasty balloon and pressure sensors of the image-guided valvuloplasty catheter system to treat stenotic valves in accordance with one or more exemplary embodiments.
[0033] The exemplifications set out herein illustrate preferred embodiments of the invention, and such exemplifications are not to be construed as limiting the scope of the invention in any manner.
DETAILED DESCRIPTION
[0034] Embodiments of the present disclosure are described herein. It is to be understood, however, that the disclosed embodiments are merely examples and other embodiments can take various and alternative forms. The figures are not necessarily to scale; some features could be exaggerated or minimized to show details of particular components. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting but are merely representative. The various features illustrated and described with reference to any one of the figures can be combined with features illustrated in one or more other figures to produce embodiments that are not explicitly illustrated or described. The combinations of features illustrated provide representative embodiments for typical applications. Various combinations and modifications of the features consistent with the teachings of this disclosure, however, could be desired for particular applications or implementations.
[0035] While the subject matter described herein can be implemented in the form of medical devices, such as valvuloplasty balloons inserted into the subject via femoral, carotid, or apical access, guided to the valve in question over a guidewire placed previously. For the sake of brevity, conventional techniques related to balloon valvuloplasty system operation, and other functional aspects of the systems (and the individual operating components of the systems) may not be described in detail here.
[0036] Balloon valvuloplasty or balloon valvuloplasty is a procedure to repair a heart valve that has a narrowed opening. In a narrowed heart valve, the valve flaps (leaflets) may become thick or stiff and fuse
together (stenosis). This reduces blood flow through the valve. The valvuloplasty treatment may improve blood flow through the heart valve and improve the subject's symptoms.
[0037] Balloon valvuloplasty is an endoscopic treatment that relies on a catheter (thin, flexible tube) inserted into a vein or artery in your groin to repair your heart valve. A balloon is guided with the catheter to the heart and expanded in the narrowed valve to split the leaflets apart. The balloon valvuloplasty is used to treat mitral valve stenosis in the case when the valvuloplasty has been deemed a treatment of choice for patients with rheumatic mitral valve stenosis whose anatomy is suitable for the procedure. It is used to treat pulmonary stenosis which is often a congenital disease and pulmonary stenosis can be treated in childhood. It is used to treat aortic stenosis where the cardiologists use balloon valvuloplasty as a palliative treatment to improve aortic stenosis-related symptoms in patients who are not candidates for aortic valve surgery and transcatheter aortic valve replacement (TAVR).
[0038] The use of balloon aortic valvuloplasty (BAV) has also in the past been deemed a potential alternative treatment for selected patients with severe calcified aortic stenosis. With the emergence of transcatheter aortic valve replacement (TAVR), there is more discussion of the use of BAV as a diagnostic tool in patients with another potential source of symptoms (severe lung disease), or as a bridge to valve replacement in subjects with acute decompensated aortic stenosis.
[0039] The present disclosure describes various exemplary embodiments that provide systems and processes for improving difficulties experienced in characterizing the amount and location of calcification on aortic valves by clearer imaging of valve situses, and calcification to treat the calcification, and providing metrics to monitor for confirming the appropriate treatment for the calcification.
[0040] The present disclosure describes systems, apparatuses and methods of a balloon catheter device that can include elements as follows: a balloon catheter equipped with pressure sensors, a guidewire lumen, and inflation lumen large enough to insert accessory catheters, or a separate accessory catheter lumen, an imaging catheter that can pass through the catheter lumen to image through balloon catheter, a laser catheter to treat surrounding tissue through balloon catheter, 4) laser source to connect to laser catheter, an inflation mechanism to inflate the balloon and introduce contrast into the balloon, and a control system to monitor inflation pressures and analyze pressure sensors on the balloon.
[0041] The present disclosure describes systems, apparatuses, and methods that start with a valvuloplasty balloon inserted into the subject via femoral, carotid, or apical access, guided to the valve in question over a guidewire placed previously. The balloon material is transparent to infrared light and stiff enough to expand calcific valve leaflets. The catheter material within the balloon is transparent to light. The balloon catheter has
two pressure sensors, one distal and one proximal to the balloon, to measure pressure differences across the valve. The pressure measurements are used to assess valve functions. Before the balloon inflation, readings are collected from the pressure sensors to assess valve functions before treatment. As an example, this assessment equates to a Fractional Flow Reserve (FFR), or the PHILIPS® Instant Wave-free Ratio Philips (iFR) assessment. The balloon is then inflated with contrast-infused saline to press the valve leaflets against the valvular apparatus wall. Contrast is included to see the balloon under fluoroscopy and to assist in the treatment phase of this system. The pressure within the balloon and time-response can be measured to know the compliance of the valve leaflets. After the balloon is expanded within the valve, an imaging catheter is inserted through the accessory lumen of the balloon catheter to image the valve.
[0042] FIG. 1 depicts an exemplary balloon catheter device 100 incorporating a valvuloplasty balloon 5 and pressure sensors of the image-guided valvuloplasty catheter system to treat stenotic valves in accordance with one or more exemplary embodiments.
[0043] In FIG. 1, the exemplary balloon catheter device 100 includes a valvuloplasty balloon 5, an internal sensor 10, a distal sensor 20, an accessory catheter lumen 15 for imaging or treatment, and a laser catheter 30. In an exemplary embodiment, the accessory catheter lumen 15 can be configured with an imaging catheter. In another exemplary embodiment, the accessory catheter lumen 15 can also be configured with a laser catheter for treatment. The deflectable laser can be implemented as a type of laser catheter.
[0044] In an exemplary embodiment, the balloon catheter 100 device is equipped with the multiple pressure sensors of the distal sensor 20, the proximal sensor 40, and the internal sensor 10. The balloon catheter 100 device is configured with guidewire lumen 35, and inflation lumen 25 that is large enough to allow a user to insert a series of accessory catheters or a separate accessory catheter lumen. For example, an imaging catheter can be inserted or pass through the catheter lumens such as the inflation lumen 25 (i.e., an input port for the balloon catheter 100) or the accessory catheter lumen 15. The imaging catheter once passed through an image through the balloon catheter lumen or at an output port of the accessory catheter lumen 15 which can position at the situs for the valvuloplasty procedure. The laser catheter can also be inserted once the imaging catheter is removed from a catheter lumen to treat the surrounding tissue through the balloon catheter (inflation lumen 25). A laser source 45 can connect to the laser catheter inserted into the balloon catheter 100 or accessory catheter lumen. Similarly, an inflation mechanism 50 is connected to the balloon catheter 100 to inflate the valvuloplasty balloon 5 and introduce the contrast agent to the valvuloplasty balloon 5. Finally, a monitor system 55 may be connected to the balloon catheter 100
[0045] The monitor system 55 can monitor the pressures sensed by the balloon catheter with two pressure sensors, the distal sensor 20 and the proximal sensor 40 to measure the pressure differences across the valve.
The pressure measurements which are monitored in the procedure can be used to assess valve function. For example, before the balloon is inflated, readings are collected from the pressure sensors (distal and proximal sensors) to assess valve function before treatment.
[0046] In an exemplary embodiment, the assessment of the pressure differences is equivalent to or like a fractional flow reserve (FFR). For example, the PHILIPS® Instant Wave-free Ratio (iFR) is a hyperemia-free physiologic index for measuring pressure in diagnostic and interventional procedures. FFR and iFR can be obtained during routine coronary angiography by using a pressure wire to calculate the ratio between coronary pressure distal to stenosis and the aortic pressure proximal. When resistance is constant, this ratio represents the potential decrease in coronary flow distal to the coronary stenosis. Change in pressure equals the change in flow multiplied by the constant resistance. The FFR is equal to the difference in the Distal Coronary Pressure (Pd) to Proximal Coronary Pressure (Pa) (during maximal hyperemia). The iFR is equal to the difference in the Distal Coronary Pressure (Pd) to Proximal Coronary Pressure (Pa) (during the wave-free period).
[0047] In an exemplary embodiment, the laser catheter can apply shock waves to the calcified leaflets of a valve situs that can expand and soften the leaflets or can break the calcium deposits, to loosen and/or remove calcium deposits that can stiffen the properties of the valve leaflets preventing the normal functioning of the valve. The valvuloplasty balloon 5 is a balloon that is sized and shaped to fit within a concave portion of a valve cusp when inflated with the contrast agent within the balloon.
[0048] After initial imaging, the imaging catheter is removed and the laser (treatment) catheter is inserted. The laser fiber catheter is implemented to create laser-induced pressure waves (LIPW) or shock waves. The fluid in the balloon will include a certain amount of contrast agent to absorb the laser light and to create the LIPWs (i.e., the pressure or shock waves). In an exemplary embodiment, U.S. Patent No. 10,201,387B2, filed on December 30th, 2015, entitled, “Laser-induced fluid-filled balloon catheter” assigned to
SPECTRANETICS® CORPORATION (Subsidiary of PHILIPS® Holding USA) with inventors Kenneth Grace, Thomas Triffo, and James Cezo, describes devices and processes using laser-induced pressure waves to disrupt vascular blockages, and is incorporated by reference.
[0049] In an exemplary embodiment, the laser catheter is configured to commence at a location of the distal end of the valvuloplasty balloon 5 and is pulled back while activated to create the LIPW (shock wave) across the length of the valve. The LIPW has been shown to significantly break up calcium, which is beneficial in valvuloplasty to create more compliant leaflets, and in turn a more functioning valve.
[0050] After completion of the LIPW treatment, the laser catheter is removed and the imaging catheter can be reinserted to re-image the valve leaflets, and thus confirm the effectiveness of treatment. Following deflation of the balloon, readings can then be collected from the pressure sensors to quantify valve functionality.
[0051] In another exemplary embodiment, the laser catheter can also have a focusing tip on the end of the catheter to focus the LIPW into a specific direction, therefore creating targeted therapy that can be guided by the imaging catheter.
[0052] In an exemplary embodiment, the laser fiber tip can be modified to increase LIPW energy density. In another exemplary embodiment, the laser catheter can be deflectable within a balloon catheter to target the LIPW towards specific treatment areas.
[0053] In another exemplary embodiment, if the balloon catheter is large enough, and with additional lumens, multiple catheters can be inserted at the same time to guide-treat-confirm with removing or reinserting accessory catheters. In another exemplary embodiment, the control system will connect to the balloon catheter for the acquisition of the pressure data and control of balloon inflation. This system can be integrated into the fluoroscopy suite to provide relevant data on the main fluoroscopy screen.
[0054] In another exemplary embodiment, the catheter balloon device for treating a calcified heart valve may be made up of multiple valvuloplasty balloons (e.g., two, three valvuloplasty balloons, etc. as desired) that are each sized and shaped to fit within a concave portion of a valve cusp when inflated with a liquid and a shock wave is applied in each one of the multiple balloons. Each balloon can also be configured in a manner for independent or separate inflation and each shock wave applied separately and/or independently controllable.
[0055] In another exemplary embodiment, the shock wave can be applied from three balloons and three shock wave laser catheter sources may be used for treating a tricuspid valve, such as the pulmonary valve and the aortic valve. The shock wave laser catheters can be configured with one or two balloons that may be used for treating unicuspid, bicuspid, and/or tricuspid valves.
[0056] FIG. 2 depicts a snapshot image of a simulated calcification post LIPW treatment from OCT imaging balloon of the image-guided valvuloplasty catheter system to treat stenotic valves in accordance with one or more exemplary embodiments. As shown in FIG 2, the imaging catheter will visualize the degraded valve through the balloon catheter and balloon itself. When the valves are significantly calcified, an imaging solution used can help to distinguish calcium from soft tissue.
[0057] In an exemplary embodiment, the imaging catheter implemented in the balloon catheter device is an Optical coherence tomography (OCT) catheter, Intravascular ultrasound (IVIJS) catheter, white-light
spectroscopy, Raman spectroscopy, or fluorescence/lifetime spectroscopy. The imaging actions before treatment will provide the user (i.e., medical provider, physician, etc..) a direct view of the location and severity of calcified areas on the valve, which can assist to guide targeted therapy directed to the calcified regions. The imaging actions post-treatment of the valve will provide the user (i.e., medical provider, physician, etc..) with the ability to see the effect of therapy and confirm successful therapy. In FIG 2., the snapshot is an image 200 of a simulated calcified vessel collected with an OCT catheter inside of a balloon.
[0058] FIGS. 3A, 3B, and 3C depict exemplary valvuloplasty balloons for use in an exemplary balloon catheter device incorporating a valvuloplasty balloon and pressure sensors of the image-guided valvuloplasty catheter system to treat stenotic valves in accordance with one or more exemplary embodiments. In FIG. 3 A, a valvuloplasty balloon 300 is depicted with imaging that includes a multi -lumen extrusion (inflation, wire, accessory lumens) with rigid spine connection with the balloon to allow 240e degrees visual field. In FIG. 3B, a valvuloplasty balloon 310 is configured without imaging with a concentric catheter design, pressure sensor wires in extrusion, fibers eccentric bundling after tip, cut a channel in an outer catheter to translate laser sheath with the valvuloplasty balloon. In FIG. 3C the valvuloplasty balloon 320 is configured with imaging and a perfusion balloon design includes a multi-lumen extrusion (inflation, wire, accessory lumens) with half cute lumen to give 180® degrees visual field but the balloon has a single pleat fused to catheter along the length to allow perfusion.
[0059] FIG. 4 depicts an exemplary diagram of the exemplary balloon catheter device places at a situs across the valve wherein the exemplary balloon catheter device incorporates a valvuloplasty balloon and pressure sensors of the image-guided valvuloplasty catheter system to treat stenotic valves in accordance with one or more exemplary embodiments. In FIG. 4, there is depicted a heart 400 with a valve 410 and a balloon catheter 100 device positioned across the valve 410. Also shown are the distal sensor 20, proximal sensor 40, internal sensor 10, inflation lumen 25, and valvuloplasty balloon 5.
[0060] FIG. 5 is an exemplary flowchart of the endoscopic procedure for operating the exemplary balloon catheter device incorporating a valvuloplasty balloon and pressure sensors of the image-guided valvuloplasty catheter system to treat stenotic valves in accordance with one or more exemplary embodiments.
[0061] The flow chart in FIG. 5 of the present disclosure includes a method for treating a subject with a valvuloplasty procedure using embodiments of the balloon catheter device described herein. The method in FIG. 5 includes inserting at step 510, a valvuloplasty balloon catheter device into a subject via a femoral, carotid, or apical access guided to the valve in question over a guidewire that has been previously placed to locate a situs of calcification of the valve leaflet in a ventricle. At step 520, once the balloon catheter device has been placed across the valve, pressure measurements are taken to assess valve function. At step 520, prior
to or before the balloon being inflated, readings are collected from pressure sensors located at the distal and proximal ends of the balloon catheter to assess the valve functionality using a process similar to fractional flow reserve or other assessments available. At step 530, the balloon is inflated with contrast-infused saline to press against the valvular wall where the contrast agent (i.e., the saline fluid in this case) is included to improve the visibility of the balloon under fluoroscopy and to assist in the treatment phase of the procedure. At step 540, the pressure within the balloon and the time-response are measured by the sensors, and the reading a collected by a monitoring device in communication (i.e., connected to the sensors) to determine compliance of the valve leaflets. At step 550, after the balloon is expanded within the valve, an imaging catheter is inserted through the accessory lumen of the balloon catheter to image the valve. The imaging catheter will visualize the degraded valve through the balloon catheter and balloon itself. Since the valves are likely significantly calcified, the application of the imaging solution aids in distinguishing calcium from soft tissue at the procedure situs. A variety of types of imaging catheter can be used, that include an OCT catheter, IVUS catheter, etc... The imaging that is done prior to the treatment will enable the user to independently by visual inspection assess the severity of the calcification in a region about the valve, and this can also guide the eventual treatment targeted at the situs of the valve. At step 560, after imaging, the imaging catheter is removed, and a treatment or laser catheter is inserted into the accessory catheter lumen. The laser catheter is used to create laser-induced pressure waves (LIPWs) or sonic waves. The contrast agent and/or fluid contained in the balloon will absorb the laser light and also create pressure waves. At step 570, after the LIPW treatment, the laser catheter is removed from the accessory catheter lumen, and the imaging catheter is inserted to conduct the post-treatment imaging. At step 580, after the treatment, a post-treatment imaging at the target region is conducted to independently assess the results by visual inspection of the treatment. At step 590, following deflation of the balloon, the readings then can be collected from the pressure sensors to quantify valve functionality. In an alternate embodiment, the laser catheter can have a focusing tip to target the LIPW to a specific location, the tip can also be modified to increase the energy of the LIPW. Also, the laser catheter can be deflectable within the balloon to target the LPIW. The balloon catheter can also be large enough to accommodate multiple lumens, catheters where each is inserted simultaneously to guide treatment confirmation steps and to reinsert imaging and other accessory catheters. Finally, the control system can be connected to the balloon catheter device for the acquisition of the pressure data and control of the balloon inflation. The system can be integrated into the fluoroscopy suite to display relevant data on a fluoroscopy display device.
[0062] For the sake of brevity, conventional techniques related to laser atherectomy, and other functional aspects of the subject matter may not be described in detail herein. Also, certain terminology may be used herein for reference only, and thus is not intended to be limiting. For example, terms such as “first,” “second,” and other such numerical terms referring to structures do not imply a sequence or order unless indicated by the
context. The foregoing description may also refer to elements or nodes or features being “connected” or “coupled” together. As used herein, unless expressly stated otherwise, “coupled” means that one element/node/feature is directly or indirectly joined to (or directly or indirectly communicates with) another element/node/feature, and not necessarily mechanically.
[0063] While at least one exemplary embodiment has been presented in the foregoing detailed description, it should be appreciated that a vast number of variations exist. It should also be appreciated that the exemplary embodiment or embodiments described herein are not intended to limit the scope, applicability, or configuration of the claimed subject matter in any way. For example, the subject matter described herein is not limited to the infusion devices and related systems described herein. Moreover, the foregoing detailed description will provide those skilled in the art with a convenient road map for implementing the described embodiment or embodiments. It should be understood that various changes can be made in the function and arrangement of elements without departing from the scope defined by the claims, which includes known equivalents and foreseeable equivalents at the time of filing this patent application. Accordingly, details of the exemplary embodiments or other limitations described above should not be read into the claims absent a clear intention to the contrary.
Claims
1. A valvuloplasty system, comprising: a balloon catheter configured with a balloon and an inflation lumen wherein the inflation lumen is configured to both inflate the balloon and to receive an accessory catheter lumen for enabling imaging through the balloon catheter of a valve to perform a valvuloplasty procedure; and a set of pressure sensors comprising a first pressure sensor coupled to a proximate end of the balloon catheter, and a second pressure sensor coupled to a distal end of the balloon catheter to monitor pressure differences across the valve to assess functionality of the valve while during the valvuloplasty procedure.
2. The valvuloplasty system of claim 1, further comprising: a third pressure sensor configured within the balloon of the catheter balloon to provide measurements to monitor the pressure of the balloon during the valvuloplasty procedure.
3. The valvuloplasty system of claim 2, further comprising: a laser catheter that is inserted through the accessory catheter lumen and positioned at a location within the balloon of the balloon catheter to treat tissue about a situs of the valve.
4. The valvuloplasty system of claim 3, further comprising: a control device to monitor the pressure measured by at least one pressure sensor of the first, second, and third pressure sensors.
5. The valvuloplasty system of claim 4, further comprising: an inflation mechanism coupled to the balloon catheter to inflate the balloon and to introduce a contrast agent into the balloon to provide visibility of an outline of the balloon under fluoroscopy.
6. The valvuloplasty system of claim 5, wherein the laser catheter comprises at least a deflectable type of laser.
7. The valvuloplasty system of claim 6, wherein the balloon comprises a material that is transparent to infrared light and sufficiently rigid to enable treatment of calcific valve leaflets at the valve situs.
8. The valvuloplasty system of claim 7, further comprising:
wherein prior to inflation of the balloon, the control system is configured to collect the set of measurements sensed by at least one pressure value to assess functionality of a valve before commencing treatment of the tissue about the situs of the valve; wherein the balloon is inflated with contrast-infused saline to compress the valve leaflets against an anatomical vascular wall; wherein the contrast agent is infused into the balloon to enable viewing under fluoroscopy and to assist in the treatment to the tissue at the situs of the valve; wherein the pressure within the balloon is measured with time-response to determine amounts of valvular insufficiency; and wherein after the balloon is expanded within the valve, an imaging catheter is inserted through the accessory lumen of the balloon catheter to image the valve.
9. The valvuloplasty system of claim 8, further comprising: in response to completing of an imaging action and removal of the imaging catheter in the valvuloplasty procedure, the laser catheter is inserted into the accessory lumen and positioned in a manner to direct multiple laser-induced pressure waves (LIPWs) at the situs to treat the calcified leaflets.
10. The valvuloplasty system of claim 9, further comprising: wherein fluid in the balloon filled with the contrast agent enables absorption of laser light and for the LIPWs by the laser catheter to apply pressure at the situs to expand the calcified leaflets.
11. The valvuloplasty system of claim 10, further comprising: in response to the completion of a treatment action comprising the multiple LIPWs by the laser catheter, the laser catheter is removed, and the imaging catheter is reinserted to re-image the valve leaflets to view the situs of the treatment action; and in response to a deflation action of the balloon, the control device is configured to collect the measurements from the set of pressure sensors to quantify functionality of the valve.
12. A valvuloplasty apparatus comprising: a balloon catheter configured with a balloon and an inflation lumen wherein the inflation lumen is configured to both inflate the balloon and to receive an accessory catheter lumen for enabling imaging through the balloon catheter of a valve to perform a valvuloplasty procedure; and a set of pressure sensors comprising a proximal sensor coupled to a proximate end of the balloon catheter, a distal sensor coupled to a distal end of the balloon catheter to monitor pressure differences across the valve to assess functionality of the valve while during the valvuloplasty procedure; an internal sensor
configured within the balloon of the catheter balloon to provide measurements to monitor the pressure of the balloon during the valvuloplasty procedure.
13. The apparatus of claim 12, further comprising: a laser catheter inserted through the accessory catheter lumen and positioned at a location within the balloon of the balloon catheter to treat tissue about a situs of the valve.
14. The apparatus of claim 13, further comprising: a control device coupled to the balloon catheter to monitor the pressure measured by at least one pressure sensor of the set of pressure sensors.
15. The apparatus of claim 14, further comprising: an inflation mechanism coupled to the balloon catheter to inflate the balloon and to introduce a contrast agent into the balloon to provide visibility of an outline of the balloon under fluoroscopy.
16. The apparatus of claim 15, further comprising: wherein the laser catheter comprises at least a deflectable configured laser; and wherein the balloon comprises a material that is transparent to infrared light and sufficiently rigid to enable treatment of calcific valve leaflets at a valve situs.
17. A valvuloplasty system comprising a balloon catheter configured with an accessory catheter lumen for insertion of a laser catheter and coupled to a control device that monitors pressure measurements sensed by a set of multiple pressure sensors configured with the balloon catheter during a valvuloplasty procedure, the valvuloplasty system comprising: the balloon catheter configured with at least one balloon and at least one an inflation lumen wherein the inflation lumen is configured to both inflate the at least one balloon and to receive the accessory catheter lumen for enabling imaging through the balloon catheter of a valve to perform the valvuloplasty procedure; and the set of multiple pressure sensors comprises a proximal sensor coupled to a proximate end of the balloon catheter, a distal sensor coupled to a distal end of the balloon catheter to monitor pressure differences across the valve to assess functionality of the valve while during the valvuloplasty procedure, and an internal sensor configured within the at least one balloon of the catheter balloon to provide the measurements to monitor the pressure of the at least one balloon during the valvuloplasty procedure.
18. The valvuloplasty system of claim 17, further comprising: an inflation mechanism coupled to the balloon catheter to inflate the at least one balloon and to introduce a contrast agent into the at least one balloon to provide visibility of an outline of the at least one balloon under fluoroscopy.
19. The valvuloplasty system of claim 18, further comprising: wherein the laser catheter comprises at least a deflectable type of laser; and wherein the at least one balloon comprises a material that is transparent to infrared light and sufficiently rigid to enable treatment of calcific valve leaflets at a valve situs.
20. The valvuloplasty system claim 19, further comprising: in response to completion of an imaging action and removal of an imaging catheter in the valvuloplasty procedure, the laser catheter is inserted into the accessory lumen and positioned in a manner to direct multiple laser-induced pressure waves (LIPWs) at the situs to treat calcified leaflets; and wherein prior to inflation of the balloon, the control system is configured to collect the set of measurements sensed by multiple pressure values to assess functionality of a valve before commencing treatment of the tissue about the situs of the valve; wherein the balloon is inflated with contrast-infused saline to compress the valve leaflets against an anatomical vascular wall; wherein the contrast agent is infused into the balloon to enable viewing under fluoroscopy and to assist in the treatment to the tissue at the situs of the valve; wherein the pressure within the at least one balloon is measured with time-response to determine amounts of valvular insufficiency; and wherein after the at least one balloon is expanded within the valve, the imaging catheter is inserted through the accessory lumen of the balloon catheter to image the valve.
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| Application Number | Priority Date | Filing Date | Title |
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| US202163217643P | 2021-07-01 | 2021-07-01 | |
| US63/217,643 | 2021-07-01 |
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| WO2023275122A1 true WO2023275122A1 (en) | 2023-01-05 |
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| PCT/EP2022/067848 WO2023275122A1 (en) | 2021-07-01 | 2022-06-29 | Systems, apparatuses, and methods for image-guided valvuloplasty catheter procedures to treat stenotic valves, incorporating valvuloplasty balloon and pressure sensors |
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Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4800876A (en) * | 1981-12-11 | 1989-01-31 | Fox Kenneth R | Method of and apparatus for laser treatment of body lumens |
| US20050090846A1 (en) * | 2003-07-18 | 2005-04-28 | Wesley Pedersen | Valvuloplasty devices and methods |
| US20090054803A1 (en) * | 2005-02-02 | 2009-02-26 | Vahid Saadat | Electrophysiology mapping and visualization system |
| US20100217119A1 (en) * | 2006-05-24 | 2010-08-26 | Forster David C | Assessment Of Aortic Heart Valve To Facilitate Repair Or Replacement |
| US20130226163A1 (en) * | 2012-02-24 | 2013-08-29 | Isolase, Ltd. | Ablation Techniques for the Treatment of Atrial Fibrillation |
| US20140046353A1 (en) * | 2012-08-08 | 2014-02-13 | Shockwave Medical, Inc. | Shockwave valvuloplasty with multiple balloons |
| US20140194704A1 (en) * | 2012-12-21 | 2014-07-10 | Volcano Corporation | Intraluminal imaging system |
| US10201387B2 (en) | 2013-03-13 | 2019-02-12 | The Spectranetics Corporation | Laser-induced fluid filled balloon catheter |
-
2022
- 2022-06-29 WO PCT/EP2022/067848 patent/WO2023275122A1/en unknown
Patent Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4800876A (en) * | 1981-12-11 | 1989-01-31 | Fox Kenneth R | Method of and apparatus for laser treatment of body lumens |
| US4800876B1 (en) * | 1981-12-11 | 1991-07-09 | R Fox Kenneth | |
| US20050090846A1 (en) * | 2003-07-18 | 2005-04-28 | Wesley Pedersen | Valvuloplasty devices and methods |
| US20090054803A1 (en) * | 2005-02-02 | 2009-02-26 | Vahid Saadat | Electrophysiology mapping and visualization system |
| US20100217119A1 (en) * | 2006-05-24 | 2010-08-26 | Forster David C | Assessment Of Aortic Heart Valve To Facilitate Repair Or Replacement |
| US20130226163A1 (en) * | 2012-02-24 | 2013-08-29 | Isolase, Ltd. | Ablation Techniques for the Treatment of Atrial Fibrillation |
| US20140046353A1 (en) * | 2012-08-08 | 2014-02-13 | Shockwave Medical, Inc. | Shockwave valvuloplasty with multiple balloons |
| US20140194704A1 (en) * | 2012-12-21 | 2014-07-10 | Volcano Corporation | Intraluminal imaging system |
| US10201387B2 (en) | 2013-03-13 | 2019-02-12 | The Spectranetics Corporation | Laser-induced fluid filled balloon catheter |
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