Dual Pressure Sensor Aortic-Valve Catheter

Abstract

Disclosed is a system and method for in-situ and instantaneous measurement of a pressure gradient by means of real-time localized pressure measurement with two or more pressure sensors, operating under particular application with respect to blood pressure gradient across the aortic valve, or other heart valves, and associated regurgitation of blood flow due to leakage resulting from insufficient valve closure. The pressure gradient across a diseased valve can provide an indication for the clinical indication for therapeutic intervention, as well as performing quality control following prosthetic valve placement. The body can have a construction including at least one opening in communication with the fluid bed of the circulation of blood, connected by means of a fluid canal passing the length of the catheter in contact with the proximal exterior space for introduction of a guidewire, diagnostic fluid or other therapeutic or diagnostic catheter devices. The system includes a multi-sensor catheter, with sensors arranged along the length of the distal segment of the catheter body, spaced apart to provide simultaneous pressure measurement on either side of the respective valves of the heart, in addition to one or more lumina in the core of the catheter that will provide the means for introduction of diagnostic fluids which flow out through a multitude of holes in the body of the distal segment of the catheter body. Each respective pressure recording can be monitored synchronized with physiological effects, specifically cardiac contraction and electrocardiogram (ECG) events in high temporal resolution.

Claims

1. A blood pressure monitoring system comprising: a catheter body; and a construction having both distal and proximal pressure sensors that are spaced apart, and are placed on the exterior surface of the catheter body, wherein the pressure sensors comprise connections that are configured such that in use the sensors can be connected to both electronic sensor drivers, decoding and identification and signal processing devices, respectively individual or combined power sources connected to both said device drivers and said decoding and identification and signal processing devices, said electronic sensor drivers also connected to said identification and signal processing devices.

2. The system of claim 1, wherein the sensors are capable of operating under a data acquisition rate that is significantly higher than the highest frequency information imbedded in the physiological processes that are being monitored, and wherein said data acquisition processes is provided with adjustment means that are configured to be adjusted in operational frequency to suit the desired application and support energy consumption economy.

3. The system of claim 1, wherein the pressure sensor units having the pressure sensing area facing radially outward such that the pressure detection surface area is in use in direct contact with the local bloodstream in the cardiovascular circulatory system, including arterial lumina as well as ventricular and atrial chambers, such that the respective pressure sensors can measure the pressure in-situ on the first side of a lesion: stenosis, respectively orifice, and on the second side of the lesion.

4. The system of claim 1, wherein the pressure sensor units comprise one or more collectors configured for collecting pressure values based on a variety of technical mechanisms, including but not limited to: optical spectroscopic, respectively fiber-optic technology (e.g. laser-based fiber-Bragg grating); piezo-electric mechanism; capacitive sensing mechanism; cantilever mechanical technology; electromagnetic technology; resistive strain technology; thermal mechanism; ionization mechanism; acoustic, radio-frequency, respectively resonant or MEMS technology; or ISFET transistor junction electronic technology, hybrid sensor, and any combinations thereof.

5. The system of claim 1, wherein the electronic values of the data acquisition can be routed to a multitude of signal processing and derived diagnostic value display systems by means of signal pre-processing in the routing mechanisms incorporated in the electronic plug and signal conditioning unit attached to the sensors on the proximal end of the sensing device (i.e. the catheter).

6. The system of claim 1, wherein the catheter comprises a single lumen, or multiple lumina that are individually or combined encapsulated by a braided jacket material.

7. The system of claim 1, wherein the catheter body is resilient to the high pressure fluid injection originating from the proximal side, the system comprising side-holes in the body of the distal segment of the catheter and respectively distal tip orifice enabling outflow.

8. The system of claim 1, wherein a distal side of the catheter having the shape of a pig-tail or J-shape (angiographic) catheter, having the shape of a left-, or respectively, right-Amplatz configuration, or Judkins coronary catheter, or other shaped tip configuration that is preferably curved, placed on the first side of the lesion.

9. The system of claim 1, applying to a left-heart approach.

10. The system of claim 1, wherein the distal shape has mechanical attributes that anchor the distal segment of the catheter on the first side of the lesion.

11. The system of claim 1, wherein the distal side of the catheter having the straight shape placed on the first side of the lesion, with a balloon at the distal tip, anchoring the catheter, resembling a Swan-Ganz catheter configuration.

12. The system of claim 1, applying to the right-heart approach.

13. The system of claim 1, further comprising a bend configuration of the distal portion of the catheter for positioning the distal segment of the catheter on the first side of the lesion.

14. The system of claim 1, wherein the pressure gradient between the first and second part of the catheter across the lesion is measured.

15. The system of claim 1, wherein the frequency content of the pressure signal resulting from a heart beat is acquired and routed to the monitoring system connected to the proximal end of the catheter.

16. The system of claim 1, wherein the spectral pressure wave is used to derive geometric information about the shape and surface contour of the enclosure on the first and respectively the second side of the lesion, and allows this information to contribute to the geometric analysis of the lesion between the first and second side.

17. The system of claim 1, wherein the first segment of the catheter is curved or straight, a bend second, connecting with the second segment of the catheter which is straight.

18. The system of claim 1, further comprising a first section having a plurality of holes over a length between 1.5 to 2.5 cm in either a spiral configuration at incremental angular rotation of the single hole, respectively any combination of multiple holes in one circumferential placement; or an alternating configuration of two opposing holes at a fixed angle; for instance: +10, and next 10 degrees; respectively +20, followed by 20 degrees, and so on, or any other angular back-forth switching configuration.

19. The system of claim 18, further comprising a second section having a plurality of holes over a length between 3.5 to 4.5 cm in either a spiral configuration at incremental angular rotation of the single hole, respectively any combination of multiple holes in one circumferential placement; or an alternating configuration of two opposing holes at a fixed angle; for instance +10, and next 10 degrees; respectively +20, followed by 20 degrees, and so on, or any other angular back-forth switching configuration, wherein in use this plurality of holes is located in the second side of the lesion.

20. The system of claim 1, wherein the pressure sensor units will be unaffected by the conditions resulting from urging diagnostic fluid through the single lumen, respectively any of the multiple lumen of the catheter up to 1200 PSI (approx. equivalence: 10345 kPa) pressure applied on the proximal entry of the catheter, resulting in an outflow from the distal side of the catheter.

21. A method for measuring the in-situ blood-pressure difference between the left ventricular pouch and the volume in the aortic arch, comprising the step of providing and positioning a blood pressure monitoring system according to claim 1.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Exemplary embodiments of a lifting system and/or the method according to the present invention are described here below on the basis of a non-limitative exemplary embodiment therefor shown in the accompanying drawings, wherein:

[0028] FIG. 1 shows an embodiment of a catheter according to the invention;

[0029] FIG. 2 shows a distal tip of the pig-tail configuration of the distal end of the catheter of FIG. 1;

[0030] FIGS. 3A-D show alternative tips in accordance with alternative embodiments of the invention including Judkins right (FIG. 3A), Judkins left (FIG. 3B), Amplatz left (FIG. 3C), Hockey stick (FIG. 3D);

[0031] FIG. 4 shows al alternative embodiment of the invention with flush side-holes;

[0032] FIG. 5 shows a detail of the catheter of FIG. 1;

[0033] FIG. 6 shows a pigtail pressure curve over the aortic valve with the catheter of FIG. 1 when measuring the pressure in two locations simultaneously, the left ventricle (bottom curve) and the aorta (top curve);

[0034] FIG. 7 shows the field for application of the catheter of FIGS. 1-5 with ruptured and unruptured Chordae Tendineae strands in relation to aortic regurgitation; and

[0035] FIGS. 8A-B show a healthy aortic valve (FIG. 8A) and an aortic valve with unhealthy stenosis (FIG. 8B).

DETAILED DESCRIPTION

[0036] The following description is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses. While the disclosure is described as having exemplary attributes and applications, the present disclosure can be further modified. This application is therefore intended to cover any variations, uses, or adaptations of the disclosure using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice of those skilled in the art to which this disclosure pertains and which fall within the limits of the appended claims. Accordingly, the following description of certain embodiments and examples should be considered merely exemplary and not in any way limiting.

[0037] Catheter 2 (FIG. 1) comprises two (2) pressure sensors 4, 6. One sensor 4 at distal segment 8 of pigtail (sensor 1), one sensor 6 recessed on the main shaft 10 (sensor 2). A distal pressure chip 12 of sensor 4 is mounted on the exterior of the catheter shaft, facing outward. In use, the distal pressure sensor 4 measures the in-situ pressure under direct fluid contact with the lumen/reservoir. During clinical practice the distal pressure sensor 4 is generally placed inside the left ventricle. The second pressure sensor 6 is also placed on the exterior 10 of the shaft of catheter 2, proximal from first sensor 4. The second sensor 6 will be placed in the aorta on the outflow side of the aortic valve transition, originating in the left ventricle. The location for in-situ pressure measurement with respect to the second, proximal, pressure sensor 6 can, more specifically, be the aortic arch. The proximal pressure sensor 6 is facing outward, in direct fluid contact with the fluid-flow of the aorta. Flush side holes 14 are provided as can be seen in FIGS. 2 and 4.

[0038] In the illustrated embodiment catheter 2 shows wire 16, shrinking tube 18, basecoat 20, braid 22 and topcoat 24. Body 10 comprises angle .

[0039] Catheter 2 in the illustrated embodiment comprises at least two sensors 4, 6, whereof: [0040] a. Outside pressure sensor (sensor 1) 4 is used to measure in-situ ventricular pressure through direct fluid contact. [0041] b. Outside pressure sensor (sensor 2) 6 is used to measure in-situ aortic pressure through direct fluid contact.

[0042] Lumina may be connected to the backside of the sensors, the side that is not exposed to the fluid in which the pressure is recorded. These lumina can act as a pressure vents, allowing for stabilization and real-time calibration of the pressure recordings. In this measurement configuration both pressure sensor chips act as differential pressure sensors and are therefore not sensitive to atmospheric changes or, in reference to other measurement designs (such as a hemodynamic system, operating by means of a fluid column, transferring the pressure over a distance to an external pressure sensor. The invention is as such not sensitive to the height of fluid columns in the patient's body, or respectively with respect to the connections on the proximal end of catheter 2 to pressure transducers as used in a conventional hemodynamic configuration, nor will the invention produce pressure values that are influenced by pressure build up internal to the measurement configuration, such as may result from temperature changes.

[0043] In the illustrated embodiment both pressure recordings are acquired simultaneously and synchronized in time, as well as synchronized with biological events, specifically cardiac contraction, next to potentially electrocardiogram (ECG) information obtained from electrodes, either placed on the surface of the skin of the patient undergoing diagnostic procedures or mounted on the catheter for in-situ depolarization recordings. Furthermore, pressure signal may additionally be synchronized with ElectroCardioGram (ECG) for determination of flow velocity based on wave-dispersion calculations with respect to the cardiac output fluid-dynamics. For the flow velocity determination, the acquisition of a high frequency-content pressure wave for each heart-beat is performed. For these purposes catheter 2 is capable of being functionally coupled to analysis system 102.

[0044] Referring to FIG. 1, an invention is presented that describes a system, means and methods for the minimally invasive detection of the pressure gradient across the aortic valve, and hence provide the ability to quantify the pathological condition with respect to the aortic valve. Recognized clinical parameters used for diagnostic analysis of the pathological condition of a patient's heart valve can be measured on a beat-by-beat basis, resolving the diastolic and systolic phases of the heart-beat, subsequently clinical prognoses parameters can be calculated such as the Regurgitation Index, Cardiac Output and Flow-Velocity, using documented analytical mathematical procedures. Referring to FIG. 1, an invention is presented that describes a system, means and methods for minimally invasive detection of the pressure gradient across a prosthetic valve, following either surgical intervention or transcatheter valve replacement, measuring the transient pressure behaviour in-situ in the first location and simultaneously and synchronized with this first recording measuring the transient pressure behaviour in the second location, as a function of time with respect to the cardiac motion.

[0045] In the current clinical procedures, the fluid pressure in different locations in the circulatory system of a patient as a function of time is most often determined by means of a fluid column connecting the orifice in the distal segment of a catheter body to a pressure sensor located in a detection system mounted on a pole standing beside the patient. In this situation the track of the fluid line leading to the sensor unit located on the exterior of the patient body has the potential of influencing the pressure magnitude due to movement of the fluid line, or the geometry of the path of the fluid-line, next to the respective height of attachment to the pressure sensor in relation to the anatomical position of the orifice used to acquire the localized pressure in the bloodstream. The fluid column has the potential for inertial dampening due to flow friction and the energy requirements to initiate the increase and decrease of flow velocity of a fluid column.

[0046] Next, some embodiments according to the invention will be briefly described. It will be understood that these embodiments are examples and other embodiments according to the invention can also be envisaged.

[0047] In Embodiment 1, the medical device having a construction of a minimum of two pressure sensor units, wherein the respective distal and proximal pressure sensors are spaced apart, placed on the exterior surface of a catheter body. The spacing is optimally configured to allow the measurement of a pressure gradient between the two pressure points that has minimal impact resulting from boundary flow conditions resulting from the geometry of the cardia and vascular system.

[0048] In Embodiment 2, the medical device comprises a minimum of one axial lumen running the length of the catheter.

[0049] In Embodiment 3, the device of Embodiment 1 is optionally configured to provide an outflow track on the distal end of the catheter body through a single lumen, or through a multitude of lumina.

[0050] In Embodiment 4, the device of Embodiment 1, 2 and 3 is optionally configured in a preform shape, resembling a Amplatz, PigTail, J-shape, Hockeystick, or shape combinations with respective straight segments in preferred locations.

[0051] In Embodiment 5, the device of Embodiment 1-4, respectively, has one or more radiopaque markers identifying the respective locations of the distal tip of the catheter as well as the individual locations of the various pressure sensors.

[0052] In Embodiment 6, the device of Embodiment 1-4, respectively, has a braided or reinforced catheter wall that supports the infusion of various liquids through one of the lumina of the catheter from the external proximal end, out of the distal tip. One of the fluids that can be injected can be a diagnostic fluid that provides an enhancement of visual contrast between the biological media in the volume of interest in the patient under radiographic examination. This injection may be achieved under elevated pressure, up to 1200 PSI, provided by specialized external injection equipment.

[0053] In Embodiment 7, the device of Embodiment 1-6 uses a bifurcation in the proximal configuration in order to separate the flush lumen from the venting lumen of the pressure sensors, next to feeding through of the electrical connections for the respective pressure sensor units.

[0054] Next, a more detailed description will be presented of Embodiment 1. It will be understood that this detailed description is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses and/or may apply in similar manner to one or more of the other embodiments.

[0055] In Embodiment 1, the pressure detection units can operate under a multitude of sensing mechanism of action, wherein one option includes the uses of a piezo-resistive or MEMS detector either as a single unit operating in a Full-Bridge Wheatstone configuration, or respectively when a half-bridge or quarter bridge sensing design is used, compensated in a location more proximal from the sensor, acting to complete the full-bridge electronic configuration to providing built-in error detection and respective corrections to the acquired data stream with respect to, for instance, temperature effects; as well as measurement of temperature itself.

[0056] In Embodiment 1, the pressure detection units providing the means for corrections for changing boundary conditions to other pressure sensors on same catheter based on information from Full-Bridge Sentron pressure sensor [0057] In Embodiment 1, the pressure detection units can provide corrections for boundary conditions to other pressure sensors on other catheters placed in the same patient based on information from Full-Bridge Sentron pressure sensor; including a second transducer on other catheter placed in another vessel to measure regurgitation; yielding full identification of all vascular flow influences on clinical pathology.

[0058] In Embodiment 1, the pressure detection units supporting high data transfer rate, respectively: speed of data exchange, supporting frequency resolved data analysis well beyond (at least two orders of magnitude greater) the physiological changes with respect to time. The high frequency content of the acquired pressure signal evolution over time provides the means to calculate a rudimentary impression of the average flow rate in the circulatory system at the location between the sensors being addressed for pressure recordings, without the direct requirement of electronically coupling with the ECG data-stream.

[0059] In Embodiment 1, the pressure detection units operating under Low Power consumption requirements, since only one sensor is selected at a time. This can provide specific advantages when operating with the assistance portable data recorders which may be battery powered, and hence have operational time constraints.

[0060] The present invention is by no means limited to the above described preferred embodiments. The rights sought are defined by the following claims within the scope of which many modifications can be envisaged. For example, the present invention can be applied to alternative catheters 2 that is illustrated in FIG. 1.