Catheter insertion method and instrument

Abstract

The invention relates to a catheter insertion method and apparatus. Catheter insertion methods and instruments allow for sensing pressure inside the heart and removing air from the catheter. A delivery system may use the same assembly for delivering a valve repair or replacement device to measure pressure in the atrium or other heart chamber. The pressure sensor may be included in one of the conduits of the delivery system, or the pressure may be measured through the same port used to irrigate the conduit. The delivery system may be inserted into an atrium of a heart to deliver a valve repair or replacement device to a native valve, such as a mitral valve, a tricuspid valve, an aortic valve, or a pulmonary valve.

Description

[0001] This application is a divisional application. The application date of the original application is November 25, 2019, the application number is 201980088727.0, and the name of the invention is “Catheter Insertion Method and Device”, which is incorporated herein by reference in its entirety.

[0002] Related Applications

[0003] This application claims the benefit of U.S. Provisional Patent Application Serial No. 62 / 772,735, filed on November 29, 2018, entitled “Method for Measuring Atrial Pressures Intraoperatively Without Requiring A Separate Catheter,” which is incorporated herein by reference in its entirety for all purposes. Technical Field

[0004] The present application relates to catheterization methods and devices. Background Art

[0005] Natural heart valves (i.e., aortic valve, pulmonary valve, tricuspid valve, and mitral valve) play a key role in ensuring that adequate blood supply flows forward through the cardiovascular system. These heart valves may be damaged due to congenital malformations, inflammatory processes, infectious conditions, diseases, etc., and thus reduce their effectiveness. Such damage to the valves can lead to severe cardiovascular damage (cardiovascular compromise) or death. The damaged valve can be surgically repaired or replaced during open heart surgery. However, open heart surgery is highly invasive and complications may occur. Transvascular techniques can be used to introduce and implant prosthetic devices in a less invasive manner than open heart surgery. As an example, a transvascular technique that can be used to access the natural mitral valve and aortic valve is the transseptal technique. The transseptal technique includes advancing a catheter into the right atrium (e.g., inserting a catheter into the right femoral vein, inserting it upward into the inferior vena cava and inserting it into the right atrium). The septum is then punctured and the catheter is passed into the left atrium. A similar transvascular technique can be used to implant a prosthetic device within the tricuspid valve, which begins similarly to the transseptal technique but stops without puncturing the septum, and instead diverts the delivery catheter toward the tricuspid valve in the right atrium. Being able to make pressure measurements from one or more surrounding chambers of the heart can provide information indicating whether the implant is effective.

[0006] A healthy heart is generally in the shape of a cone that tapers to a lower apex. The heart is a four-chambered heart that includes a left atrium, a right atrium, a left ventricle, and a right ventricle. The left and right sides of the heart are separated by a wall commonly referred to as the septum. The natural mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has an anatomical structure that is very different from other natural heart valves. The mitral valve includes a valve ring portion (which is an annular portion of natural valve tissue surrounding the mitral valve orifice) and a pair of cusps or leaflets that extend downward from the valve ring into the left ventricle. The mitral valve ring can form a "D" shape, an ellipse, or other non-circular cross-sectional shape with a major axis and a minor axis. The anterior leaflet can be larger than the posterior leaflet, forming a roughly "C" shaped boundary between the adjacent sides of the leaflet when they are closed together.

[0007] When functioning correctly, the anterior and posterior leaflets together act as a one-way valve to allow blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle expand (also known as "ventricular diastole" or "diastole"), the oxygenated blood collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract (also known as "ventricular systole" or "systole"), the increased blood pressure in the left ventricle pushes the two sides of the two leaflets together, thereby closing the single mitral valve so that blood cannot flow back into the left atrium, but is instead discharged from the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding back through the mitral annulus toward the left atrium, multiple fibrous cords called chordae tendineae tether the leaflets to the papillary muscles in the left ventricle.

[0008] Valve regurgitation involves the valve incorrectly allowing some blood to flow through the valve in the wrong direction. For example, mitral regurgitation occurs when the native mitral valve fails to close properly and blood flows from the left ventricle into the left atrium during the systolic phase of the heart's contraction. Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation may have many different causes, such as leaflet prolapse, dysfunctional papillary muscles, stretching of the mitral annulus caused by dilation of the left ventricle, more than one of these, etc. Mitral regurgitation at the central portion of the leaflet may be referred to as central jet mitral regurgitation, while mitral regurgitation closer to one of the commissures of the leaflets (i.e., where the leaflets meet) may be referred to as eccentric jet mitral regurgitation. Central jet regurgitation occurs when the edges of the leaflets do not meet in the middle and therefore the valve does not close, and there is regurgitation. During a procedure to address a valve problem, monitoring the pressure in one or more chambers may provide helpful information. Summary of the invention

[0009] This summary of the invention is intended to provide some examples and is not intended to limit the scope of the invention in any way. For example, the claims do not require any features included in the examples of this summary of the invention unless the claims clearly list the feature. Moreover, the features, components, steps, concepts, etc. described in the examples in this summary of the invention and elsewhere in this disclosure can be combined in various ways. Various features and steps described elsewhere in this disclosure may be included in the examples summarized here.

[0010] Catheterization methods and apparatus are described herein. Some methods and apparatus relate to catheter flushing and couplers for catheter flushing. Some methods and apparatus relate to cardiac chamber pressure measurement and catheter assemblies for cardiac chamber pressure measurement. The therapeutic methods steps shown and / or discussed herein can be performed in living animals or on simulations (e.g., cadavers, cadaver hearts, simulators (e.g., having simulated body parts, hearts, tissues, etc.), etc.

[0011] In one example embodiment, the conduit coupler, flushing section, or flushing port comprises a housing, a cap, and one or more seals. The housing has a conduit connection cavity, a plurality of passages, and an outer peripheral passage. A plurality of passages each connect the conduit connection cavity to the outer peripheral passage. The cap is rotatably coupled to the housing. The cap has an outlet port that is in fluid communication with the outer peripheral passage. One or more seals provide a seal between the housing and the cap that guides fluid flow from the outer peripheral passage to the outlet port. The cap is rotatable to position the outlet port to be vertically oriented without rotating the housing.

[0012] In one example embodiment, a method of flushing a catheter coupler includes rotating a cap while maintaining a fixed position of a housing. The cap rotates an outlet port to a top dead center position. A vacuum is applied to the outlet port to flush the catheter coupler.

[0013] In an example embodiment, the delivery system includes a first conduit coupler, a second conduit coupler, a first conduit connected to the first conduit coupler, and a second conduit connected to the second conduit coupler. Each of the first and second conduit couplers has a housing, a cap, and one or more seals. In some embodiments, the housing has a conduit connection cavity, a plurality of passages, and an outer peripheral channel. A plurality of passages connect the conduit connection cavity to the outer peripheral channel. The cap is rotatably coupled to the housing. The cap has an outlet port that is fluidly connected to the outer peripheral passage. One or more seals provide a seal between the housing and the cap, and the seal guides the fluid flow from the outer peripheral passage to the outlet port. Each cap is rotatable, so as to position the outlet port in a vertical orientation without rotating the housing or the conduit connected. The second conduit extends through the first conduit coupler and the first conduit.

[0014] In one example embodiment, a method for measuring fluid pressure includes inserting a first conduit through a second conduit, wherein a radially inwardly extending protrusion on an inner surface of the second conduit maintains a flow space between the first conduit and the second conduit, and measuring the pressure of the fluid in the flow space.

[0015] In one example embodiment, the catheter coupler, flushing section, or flushing port includes a catheter connection cavity, an outer peripheral passage, a plurality of connection passages, and an outlet port. Each connection passage connects the catheter connection cavity to the outer peripheral passage. The outlet port is in fluid communication with the outer peripheral passage. The outer peripheral passage and the plurality of connection passages are sized so that when: 1) the outlet port is not oriented in a vertically upward direction (e.g., downward direction, etc.); 2) the upper connection passage in the connection passage contains air; and 3) the lower connection passage in the connection passage contains liquid, air is drawn out from the outlet port.

[0016] In an example embodiment, the delivery system includes a first conduit coupler, a second conduit coupler, a first conduit connected to the first conduit coupler, and a second conduit connected to the second conduit coupler. Each conduit coupler includes a conduit connection cavity, an outer peripheral passage, a plurality of connection passages, and an outlet port. Each connection passage of the coupler connects the conduit connection cavity to the outer peripheral passage. The outlet ports are each in fluid communication with the corresponding outer peripheral passage of the coupler. The outer peripheral passage and the plurality of connection passages of each coupler are sized so that when: 1) the outlet port is not oriented in a vertically upward direction (e.g., downward direction, etc.); 2) the upper connection passage in the connection passage contains air; and 3) when the lower connection passage in the connection passage contains liquid, air is extracted from the outlet port. The second conduit extends through the first conduit coupler and the first conduit.

[0017] In one example embodiment, a method for measuring pressure in a cardiac chamber includes inserting a valve implant or a repair device delivery system into the left atrium. The valve implant or the repair device delivery system includes a catheter, a pusher element, and a pressure sensor. The first catheter has a delivery cavity. The pusher element is positioned in the delivery cavity of the first catheter. The valve implant or the repair device is detachably connected to the pusher element. The pressure sensor cavity is in at least one of the catheter and the pusher element. The pressure sensor and the fluid are arranged in the pressure sensor cavity. The open distal end of the pressure sensor cavity is exposed to the left atrium. The first blood pressure measurement is performed in the left atrium with the pressure sensor at a specified time during the cardiac cycle. The method can be performed on a living animal or on a simulator (such as a corpse, a corpse heart, a simulator (e.g., with a simulated body part, heart, tissue, etc.), etc.

[0018] In one example embodiment, a device for measuring pressure in a heart chamber using a valve implant or repair device delivery system includes a catheter, a pusher element, a pressure sensor cavity, and a pressure sensor. The catheter has a delivery cavity. The pusher element is positioned in the delivery cavity of a first catheter. The valve implant or repair device is removably connected to the pusher element. The pressure sensor cavity is in at least one of the first catheter and the pusher element. The pressure sensor and fluid are arranged in the pressure sensor cavity. The pressure sensor cavity includes an open distal end.

[0019] Other examples from the rest of the disclosure may also be used, and features from any described example may be incorporated into the above examples mutatis mutandis. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] In order to further illustrate various aspects of the embodiments of the present disclosure, certain embodiments will be described in more detail by reference to various aspects of the accompanying drawings. It should be appreciated that these drawings depict only typical embodiments of the present disclosure and should not be considered to limit the scope of the present disclosure. In addition, while the drawings may be drawn to scale for some embodiments, it is not necessary to draw the drawings to scale for all embodiments. The embodiments of the present disclosure and other features and advantages will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which:

[0021] Figure 1 illustrates a cross-sectional view of a human heart in diastole;

[0022] Figure 2 illustrates a cross-sectional view of a human heart in systole;

[0023] Figure 3 illustrates a cross-sectional view of a human heart in diastole showing chordae tendineae attaching leaflets of the mitral and tricuspid valves to the ventricular wall;

[0024] Figure 4 A healthy mitral valve with closed leaflets as viewed from the atrial side of the mitral valve is illustrated;

[0025] Figure 5 A dysfunctional mitral valve with visible gaps between the leaflets as viewed from the atrial side of the mitral valve is illustrated;

[0026] Figure 6 A mitral valve with a wide gap between the posterior and anterior leaflets is illustrated;

[0027] Figure 7 An illustration of the tricuspid valve as viewed from the atrial side of the tricuspid valve is shown;

[0028] Figure 8– 14 illustrates example embodiments of implantable prosthetic devices at various stages of deployment;

[0029] Fig.15 –20 Examples of valves delivered and implanted in native valves Figure 8 –14 instances of implantable prosthetic devices;

[0030] Fig.21A A schematic diagram illustrating an example embodiment of a catheter configured with a pressure sensor for delivering an implant into a heart;

[0031] Fig.21B A schematic diagram illustrating an example embodiment of a catheter configured with a pressure sensor for delivering an implant into a heart;

[0032] Fig. 21C A schematic diagram illustrating an example embodiment of a catheter configured with a pressure sensor for delivering an implant into a heart;

[0033] Fig.21D A schematic diagram illustrating an example embodiment of a catheter configured with a pressure sensor for delivering an implant into a heart;

[0034] Fig.22A illustrates a cross-sectional view of a human heart in diastole with a delivery device for a replacement valve or valve repair device, wherein a pressure sensor is positioned within the left atrium;

[0035] Fig. 22B illustrates a cross-sectional view of a human heart in systole with a delivery device for a replacement valve or valve repair device, wherein a pressure sensor is positioned within the left atrium;

[0036] Fig.23A illustrates a schematic cross-sectional view of an example delivery system configured to include a pressure sensor in accordance with an example embodiment;

[0037] Fig. 23B 1 and ... Fig.23A Schematic cross section of a delivery system;

[0038] Fig.23C 1 and ... Fig.23A Schematic cross section of a delivery system;

[0039] Fig.23D An example of a device taken along line AA and having a fluid filled lumen for measuring pressure according to an example embodiment is shown. Fig.23A Schematic cross section of a delivery system;

[0040] Fig.24A illustrates a schematic cross-sectional view of an example delivery system configured to include a pressure sensor in accordance with an example embodiment;

[0041] Fig. 24B 1 and 2. An example of a cross-sectional view of a pressure sensor taken along line BB and having a pressure sensor according to an example embodiment is shown. Fig.24A Schematic cross section of a delivery system;

[0042] Fig.24C 1 and 2. An example of a cross-sectional view of a pressure sensor taken along line BB and having a pressure sensor according to an example embodiment is shown. Fig.24A Schematic cross section of a delivery system;

[0043] Fig.25A illustrates a schematic end view of an example delivery system configured to include a pressure sensor in accordance with an example implementation;

[0044] Fig.25B 1 and 1. An example of a cross-sectional view of a pressure sensor taken along line CC and having a pressure sensor according to an example embodiment. Fig.25A Schematic cross section of a delivery system;

[0045] Fig.25C 1 and 1. An example of a cross-sectional view of a pressure sensor taken along line CC and having a pressure sensor according to an example embodiment. Fig.25A Schematic cross section of a delivery system;

[0046] Fig.26A illustrates a schematic cross-sectional view of an example delivery system configured to include a pressure sensor in accordance with an example embodiment;

[0047] Fig.26B 1 and 2. An example of a cross-sectional view of a pressure sensor taken along line DD and having a pressure sensor according to an example embodiment is shown. Fig.26A Schematic cross section of a delivery system;

[0048] Fig.26C 1 and 2. An example of a cross-sectional view of a pressure sensor taken along line DD and having a pressure sensor according to an example embodiment is shown. Fig.26A Schematic cross section of a delivery system;

[0049] Fig. 27 is a perspective view of an example embodiment of a catheter coupler;

[0050] Fig.28 yes Fig. 27 An exploded view of various components of a conduit coupling;

[0051] Fig.29 yes Fig. 27 A perspective view of a catheter connector housing of a catheter connector;

[0052] Fig.30 yes Fig. 27 A side view of a conduit connector;

[0053] Fig.31A -C is along the lines of Fig.30 Cross-sectional views of the catheter coupling rotated to various positions taken along the plane indicated by the centerline 31-31;

[0054] Fig.32 It is along Fig.31C a cross-sectional view taken along a plane indicated by centerline 32 - 32 ;

[0055] Fig.33 Example of a device coupled to a catheter and a pressure sensor Fig.32 A cross-sectional view of a conduit coupling shown in ;

[0056] Fig.34 illustrates a partial cross-sectional view of a catheter coupler attached to a guide sheath of a system for implanting an implantable prosthetic device;

[0057] Fig.35 illustrates a cross-sectional view of an example catheter coupler attached to an introducer sheath and a steerable catheter of an implantable prosthetic device;

[0058] Fig.36 is a schematic cross-sectional view of an example catheter of a delivery system for an implantable prosthetic device;

[0059] Fig.37 illustrates a cross-sectional view of an example embodiment of a conduit coupler;

[0060] Fig.38 It is along Fig.37 a cross-sectional view taken along the plane indicated by centerline 38-38; and

[0061] Fig.39A -D example Fig.38 Operation of the conduit coupler. DETAILED DESCRIPTION

[0062] The following description refers to the accompanying drawings, which illustrate specific embodiments of the present disclosure. Other embodiments having different structures and operations do not depart from the scope of the present disclosure.

[0063] Describe the delivery system, apparatus, device and method for measuring atrial pressure during transcatheter valve repair and / or replacement procedures. The delivery system uses the same components as for delivering valve repair and / or replacement devices to measure pressure in the atrium (or other heart chambers). The delivery device and method can use a pressure sensor in a catheter and / or pusher rod or a tube system and / or a pressure sensor delivered by a catheter and / or pusher rod or a tube system, and the catheter and / or pusher rod or a tube system are used to perform heart valve therapy. The method includes inserting the delivery system into the atrium of the heart, delivering the valve repair and / or replacement device to a natural valve (such as a mitral valve, a tricuspid valve, aortic valve, or a pulmonary valve) with the delivery system, and measuring pressure with a pressure sensor through an opening in one of the catheters and / or pushers of the delivery system. In example embodiments, the delivery system and method eliminate the need for a separate catheter to be introduced into the heart. For example, during ventricular contraction, the lower atrial pressure in the left atrium at the position of the delivery device indicates less regurgitation through the mitral valve. This lower pressure can be indicative of an effectively delivered mitral valve repair device (eg, a leaflet repair or modification device, an annulus modification device, or a chordae modification or replacement device) or replacement mitral valve implant.

[0064] The disclosed delivery systems and methods do not require re-catheterization or other access to the left atrium to measure pressure. The disclosed delivery systems and methods also reduce reliance on echo and other imaging to determine whether valve therapy is effective.

[0065] It should be noted that various embodiments of methods for measuring atrial pressure in a heart during systole and / or diastole, before, during, and / or after performing valve repair therapy are disclosed herein, and any combination of these options may be performed unless specifically excluded. In other words, the individual components of the disclosed devices and methods may be combined unless mutually exclusive or otherwise physically impossible. Further, these methods may be performed on a living animal or on a simulator (e.g., a cadaver, a cadaver heart, a simulator (e.g., having a simulated body part, heart, tissue, etc.), etc.

[0066] The example embodiments disclosed herein rely on the presence of space and / or structure within the catheter and / or pusher rod or tube for delivering valve repair or replacement devices to more reliably measure atrial pressure, including mitral and tricuspid valves, during and / or after a procedure for heart valve repair or replacement. In some example embodiments, a delivery device for replacing an aortic valve may include the disclosed pressure measurement features. The valve repair therapy may be a replacement valve implant or a valve repair device. Atrial pressure may be in the right atrium or the left atrium. In some example embodiments, when the delivery device is positioned in the ventricle, the delivery device may be configured to measure the pressure in the ventricle. The space may be within a catheter sheath, a steering catheter, a device delivery catheter, and / or a pusher rod or tube. The space within the catheter and / or pusher rod or tube may be within the main cavity of the catheter or pusher or may be within the wall of the catheter or pusher. The cavity may be reinforced with a pressure sensor catheter. The pressure sensor catheter may be a reinforced sheath with its own cavity. The pressure may be measured with a pressure sensor. The pressure sensor can be an electric pressure sensor in a fluid-filled lumen or in communication with the lumen fluid. The fluid can be saline or another biocompatible fluid. In an example embodiment, the pressure sensor is placed in an optionally reinforced lumen, or a port for entering the body is provided for an existing catheter without having to intubate the heart. The integration of the pressure sensor reduces the movement and / or vibration of the pressure sensor to provide a more accurate pressure measurement. This more accurate measurement provides valuable data for the operator to determine the efficacy of the implanted device. By providing a cavity for an existing pressure sensor in the body of a delivery catheter (e.g., a steerable catheter), due to the flow of blood and the beating of the heart, the noise or vibration sensed by the pressure sensor in the heart chamber is reduced, and a better indication of the efficacy of the therapy can be obtained.

[0067] In an example embodiment, the cavity for the pressure sensor may have an outlet opening at the tip of the outer catheter, where the implant catheter leaves. In another example embodiment, the cavity for the pressure sensor may leave at the tip of the steering catheter. In an example embodiment, when the catheter is in the heart and positioned toward the valve, the cavity may leave in the flexible section where the catheter is positioned in the atrium. The steerable catheter can be used for any example embodiment described herein. Other existing catheters may also be used. The pressure sensor may be connected to the monitoring system through a flushing port on the handle or an independent port on the handle designed for introducing a pressure sensor and / or directly attaching a pressure sensor. During use, the pressure sensor may be optionally positioned outside the delivery device so that the pressure sensor extends distally therefrom. In an example embodiment, the pressure sensor may be positioned so that a portion of the pressure sensor extends distally from the opening. In an example embodiment, the pressure sensor may be positioned in the cavity of the delivery device.

[0068] The pressure monitoring device may be selected to accommodate normal positioning of the catheter, which typically includes, but is not limited to, deflection, advancement, retraction, and / or rotation of the catheter.

[0069] As described herein, when one or more components are described as being connected, linked, adhered, coupled, attached, or otherwise interconnected, such interconnection may be direct between the components or may be indirect, such as through the use of one or more intermediate components. As also described herein, references to "member," "component," or "portion" should not be limited to a single structural member, component, or element, but may include an assembly of components, members, or elements. As also described herein, the terms "substantially" and "approximately" are defined as at least close to (and including) a given value or state (preferably within 10%, more preferably within 1%, and most preferably within 0.1%).

[0070] Figure 1 and 2 are cross-sectional views of a human heart H in diastole and systole, respectively. The right ventricle RV and the left ventricle LV are separated from the right atrium RA and the left atrium LA by the tricuspid valve TV and the mitral valve MV (i.e., the atrioventricular valves), respectively. In addition, the aortic valve AV separates the left ventricle LV from the ascending aorta AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has a flexible leaflet (e.g., Figure 4 and 5 ), the leaflets come together or "abut" in the flowstream to form a single, fluid-blocking surface. The methods, systems, devices, apparatus, etc. herein are primarily described with respect to the mitral valve MV. Therefore, the left atrium LA and left ventricle LV anatomical structures will be explained in more detail. It should be understood that the devices described herein can also be used to repair other natural valves, for example, the devices can be used to repair the tricuspid valve TV, the aortic valve AV, and the pulmonary valve PV. Therefore, the pressure in the right atrium RA and / or the right ventricle RV can be measured in the same or similar manner as the left atrium LA and / or the left ventricle LV.

[0071] The left atrium LA receives oxygenated blood from the lungs. Figure 1 As shown in FIG, blood previously collected in the left atrium LA (during systole) passes through the mitral valve MV and into the left ventricle LV by the dilation of the left ventricle LV. Figure 2As shown in , the left ventricle LV contracts to force blood into the body through the aortic valve AV and the ascending aorta AA. During contraction, the leaflets of the mitral valve MV close to prevent blood from flowing back from the left ventricle LV and into the left atrium LA, and collect blood from the pulmonary veins PV in the left atrium. In one example embodiment, the device described in the present application is used to repair the function of a defective mitral valve MV. In other words, the device is configured to help close the leaflets of the mitral valve to prevent blood from flowing back from the left ventricle LV and into the left atrium LA.

[0072] Reference now Figure 1 –6, the mitral valve MV includes two leaflets, an anterior leaflet 20 and a posterior leaflet 22. The mitral valve MV also includes a valve annulus 24, which is a fibrous tissue ring of variable density surrounding the leaflets 20, 22. Figure 3 , the mitral valve MV is anchored to the wall of the left ventricle LV by chordae tendineae 10. The chordae tendineae 10 are cord-like tendons that connect papillary muscles 12 (i.e., muscles located at the base of the chordae tendineae and within the wall of the left ventricle) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles 12 serve to limit the movement of the mitral valve MV and prevent the mitral valve from reverting. The mitral valve MV opens and closes in response to pressure changes in the left atrium LA and the left ventricle LV. The papillary muscles do not open or close the mitral valve MV. Rather, the papillary muscles brace the mitral valve MV against the high pressure required to circulate blood throughout the body. The papillary muscles and chordae tendineae are together referred to as the subvalvular apparatus, whose function is to keep the mitral valve MV from prolapsing into the left atrium LA when the mitral valve is closed.

[0073] Various disease processes can impair the proper function of one or more native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow's disease, fibroelastic tissue deficiency), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis). In addition, damage to the left ventricle LV or right ventricle RV from a previous heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other heart disease (e.g., cardiomyopathy) can distort the geometry of the native valve, which can lead to poor function of the native valve. However, the vast majority of patients who undergo valve surgery (such as surgery on the mitral valve MV) suffer from degenerative diseases that cause dysfunction in the leaflets (e.g., leaflets 20, 22) of the native valve (e.g., mitral valve MV), which leads to prolapse and regurgitation.

[0074] In general, native valves can malfunction in two different ways: (1) valvular stenosis; and (2) valvular regurgitation. Valvular stenosis occurs when the native valve does not open fully, thereby causing obstruction of blood flow. Typically, valvular stenosis is caused by the accumulation of calcified material on the leaflets of the valve, which thickens the leaflets and impairs the ability of the valve to open fully to allow forward blood flow.

[0075] The second type of valve dysfunction, valvular regurgitation, occurs when the leaflets of the valve do not completely close, allowing blood to leak back into the previous chamber (for example, allowing blood to leak from the left ventricle to the left atrium). The three main mechanisms by which regurgitation or dysfunction of a native valve occurs include Carpenter's Type I, Type II, and Type III dysfunction. Carpenter's Type I dysfunction involves dilation of the annulus, causing the normally functioning leaflets to separate from each other and fail to form a tight seal (i.e., the leaflets do not appose properly). Type I mechanism dysfunction includes perforation of the leaflets, such as occurs in endocarditis. Carpenter's Type II dysfunction involves prolapse of one or more leaflets of the native valve above the plane of apposition. Carpenter's Type III dysfunction involves restriction of the movement of one or more leaflets of the native valve, causing the leaflets to be abnormally constrained below the plane of the annulus. Leaflet restriction can be caused by rheumatic disease (Ma) or ventricular dilatation (IIIb).

[0076] refer to Figure 4 , when the healthy mitral valve MV is in the closed position, the anterior leaflet 20 and the posterior leaflet 22 coapt, which prevents blood from leaking from the left ventricle LV into the left atrium LA. Figure 5 , regurgitation occurs when the anterior leaflet 20 and / or the posterior leaflet 22 of the mitral valve MV are displaced into the left atrium LA during systole. This failure to coapt results in a gap 26 between the anterior leaflet 20 and the posterior leaflet 22, which allows blood to flow from the left ventricle LV back into the left atrium LA during systole. As explained above, there are several different ways in which leaflets (e.g., leaflets 20, 22 of the mitral valve MV) may malfunction, which may result in regurgitation.

[0077] refer to Figure 6 In some cases, the patient's mitral valve MV may have a wide gap 26 between the anterior leaflet 20 and the posterior leaflet 22 when the mitral valve is in a closed position (i.e., during systole). For example, the width W of the gap 26 may be between about 2.5 mm and about 17.5 mm, such as between about 5 mm and about 15 mm, such as between about 7.5 mm and about 12.5 mm, such as about 10 mm. In some cases, the width W of the gap 26 may be greater than 15 mm. In any of the above cases, it is desirable that the valve repair device be able to engage the anterior leaflet 20 and the posterior leaflet 22 to close the gap 26 and prevent blood from flowing back through the mitral valve MV.

[0078] When mitral regurgitation occurs, blood passes from the left ventricle into the left atrium during systole. In a healthy heart, blood should only pass from the pulmonary veins into the left atrium, not from the left ventricle. The left atrial pressure then increases to the pressure it should be. For example, normal left atrial pressure may range from about 5 to about 15 mmHg. But when mitral regurgitation occurs, the left atrial pressure may increase to a higher pressure, for example, 25 mmHg. With mitral regurgitation, the left atrial pressure generally increases throughout the cardiac cycle and may be most noticeable at the end of systole.

[0079] Although stenosis or regurgitation can affect any valve, stenosis is found to overwhelmingly affect the aortic valve AV or the pulmonary valve PV, while regurgitation is found to overwhelmingly affect the mitral valve MV or the tricuspid valve TV. Both valvular stenosis and valvular regurgitation increase the workload of the heart H and can lead to various serious conditions if not treated; such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. Because the left side of the heart (i.e., the left atrium LA, the left ventricle LV, the mitral valve MV, and the aortic valve AV) is primarily responsible for circulating blood throughout the body, dysfunction of the mitral valve MV or the aortic valve AV is particularly problematic and often life-threatening. Therefore, due to the substantially greater pressure on the left side of the heart, malfunction of the mitral valve MV or the aortic valve AV is more problematic.

[0080] Dysfunctional native heart valves can be repaired or replaced. Repair typically involves preservation and correction of the patient's native valve. Replacement typically involves replacing the patient's native valve with a biological or mechanical substitute. Typically, the aortic valve AV and the pulmonary valve PV are more susceptible to stenosis. Because the damage sustained by the stenosis of the leaflets is irreversible, the most conventional treatment for a stenotic aortic valve or a stenotic pulmonary valve is to remove and replace the valve with a surgically implanted heart valve, or to replace the valve with a transcatheter heart valve.

[0081] Reference now Figure 8 –14, a schematic example of an implantable prosthetic device 100 is shown in various stages of deployment. The prosthetic device 100 and related systems, methods, etc. are described in more detail in International Application Nos. PCT / US2018 / 028189 and PCT / US2019 / 055320, the disclosures of which are incorporated herein by reference in their entirety. The device 100 may include any other features for the implantable prosthetic device disclosed in the present application, and the device 100 may be positioned to engage valve tissue (e.g., leaflets 20, 22) as a component of any suitable valve repair system (e.g., any valve repair system disclosed in the present application).

[0082] The device 100 is deployed and may include a coaption portion or coaption portion 140 and an anchoring portion 106. The device 100 may be deployed from a delivery sheath and / or may be deployed by a pusher tube or rod 81. The coaption portion 140 of the device 100 includes a coaption element 110, which is suitable for implantation between the leaflets of a native valve (e.g., a native mitral valve, a native tricuspid valve, etc.) and is slidably attached to an actuation member or actuation element 112 (e.g., a wire, shaft, rod, wire, suture, tether, etc.). The anchoring portion 106 may be actuated between open and closed states and may take a variety of forms, such as, for example, a paddle, a gripping element, etc. Actuation of the actuation element 112 opens and closes the anchoring portion 106 of the device 100 to grip the native valve leaflets during implantation. The actuation element 112 may take a variety of different forms. For example, the actuation element may be threaded such that rotation of the actuation element moves the anchor portion 106 relative to the mating portion 140. Alternatively, the actuation element may be non-threaded such that pushing or pulling the actuation element 112 moves the anchor portion 106 relative to the mating portion 140.

[0083] The anchoring portion 106 of the device 100 includes an outer paddle 120 and an inner paddle 122 connected between the cap 114 and the apposition element 110 by portions 124, 126, 128. Portions 124, 126, 128 can be jointed and / or flexible to move between all positions described below. The interconnection of the outer paddle 120, the inner paddle 122, the apposition element 110, and the cap 114 by portions 124, 126, and 128 can constrain the device to the positions and movements exemplified herein.

[0084] An actuation member or actuation element 112 extends through the delivery sheath and / or pusher tube / rod and the apposition element 110 to a cap 114 at the distal connection of the anchoring portion 106. Extending and retracting the actuation element 112 increases and decreases the spacing between the apposition element 110 and the cap 114, respectively. A collar 115 removably attaches the apposition element 110 to the pusher tube or rod 81, such that the actuation element 112 slides through the collar 115 and the apposition element 110 during actuation to open and close the paddles 120, 122 of the anchoring portion 106. After the device 100 is connected to the valve tissue, if the device 100 needs to be removed from the valve tissue, a retrieval device can be used to connect to the collar 115 so that the actuation wire can extend through the collar 115 and the apposition element 110 to engage the anchoring portion 106, thereby opening the paddles 120, 122 and removing the device 100 from the valve tissue. An example of a retrieval device that may be used is shown in PCT Application No. PCT / US2019 / 062391, filed on November 20, 2019, which is incorporated herein by reference in its entirety.

[0085] Reference now Figure 8 , the device 100 is shown in an elongated or fully open state for deployment from a delivery sheath. The device 100 is loaded into the delivery sheath in a fully open position because the fully open position takes up the least space and allows the smallest catheter to be used (or the largest implantable device 100 for a given catheter size). In the elongated state, the cap 114 is spaced apart from the apposition element 110 so that the paddles 120, 122 of the anchoring portion 106 are fully extended. In some embodiments, the angle formed between the outer paddle 120 and the interior of the inner paddle 122 is approximately 180 degrees. The barbed fastener 130 remains in a closed state during deployment through the delivery sheath 83 so that the barbs 136 ( Fig. 9 and 11 ) will not capture or damage the sheath or tissue in the patient's heart.

[0086] Reference now Fig. 9 , the device 100 is shown in an elongated detangling condition, similar to Figure 8 , but wherein the barbed fastener 130 is in a fully open position, such that there is about 140 degrees to about 200 degrees, such as about 170 degrees to about 190 degrees, or about 180 degrees between the fixed and movable portions of the barbed fastener 130. It has been found that the fully open paddles 120, 122 and fastener 130 improve the ease of detanglement from the patient's anatomy during implantation of the device 100.

[0087] Reference now Fig.10, the device 100 is shown in a shortened or fully closed state. The compressed size of the device 100 in the shortened state allows for easier manipulation and placement within the heart. To move the device 100 from the elongated state to the shortened state, the actuating member or actuating element 112 is retracted to pull the cap 114 toward the apposition element 110. The joint or flexible connection 126 between the outer paddle 120 and the inner paddle 122 is constrained in motion so that the compressive force acting on the outer paddle 120 from the cap 114 retracted toward the apposition element 110 causes the paddles 120, 122 or clamping elements to move radially outward. During movement from the open to the closed position, the outer paddle 120 maintains an acute angle with the actuating element 112. The outer paddle 120 may optionally be biased toward the closed position. During the same movement, the inner paddles 122 move through a considerable angle because they are oriented away from the engaging element 110 in the open state and crimped along the sides of the engaging element 110 in the closed state. In some embodiments, the inner paddles 122 are thinner and / or narrower than the outer paddles 120, and the joints or flexible portions 126, 128 connected to the inner paddles 122 can be thinner and / or more flexible. For example, this increased flexibility can allow more movement than the joints or flexible portions 124 connecting the outer paddle 124 to the cap 114. In some embodiments, the outer paddle 120 is narrower than the inner paddle 122. The joints or flexible portions 126, 128 connected to the inner paddle 122 can be more flexible, for example, to allow more movement than the joints or flexible portions 124 connecting the outer paddle 124 to the cap 114. In some embodiments, the inner paddle 122 can have the same width or approximately the same width as the outer paddle.

[0088] Reference now Fig.11 –13, the device 100 is shown in a partially open, ready-to-clip state. To transition from the fully closed to the partially open state, the actuation member or actuation element 112 (e.g., an actuation wire, an actuation shaft, etc.) is extended to push the cap 114 away from the apposition element 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the anchoring portion 106 to partially deploy. The actuation wire 116 is also retracted to open the fastener 130 so that the leaflet can be clamped. Fig.11 In the illustrated example, the pair of inner paddles 122 and outer paddles 120 are moved in unison rather than independently by a single actuating element 112. Furthermore, the position of the fastener 130 depends on the position of the paddles 122, 120. For example, referring to Fig.10, closing paddles 122, 120 also closes the fastener. In some embodiments, paddles 120, 122 may be independently controllable. For example, device 100 may have two actuating elements and two independent caps, such that one independent wire and cap is used to control one paddle, and another independent wire and cap is used to control the other paddle.

[0089] Reference now Fig.12 , one of the actuation wires 116 is extended to allow one of the fasteners 130 to close. Referring now to Fig.13 , the other actuation wire 116 extends to allow the other fastener 130 to close. One or both of the actuation wires 116 can be repeatedly actuated to repeatedly open and close the fastener 130 with the barbs.

[0090] Reference now Fig.14 , the device 100 is shown in a fully closed and deployed state. The pusher tube or rod 81 and the actuating element 112 are retracted and the paddles 120, 122 and the fastener 130 are maintained in the fully closed position. Once deployed, the device 100 can be maintained in the fully closed position with a mechanical latch, or can be biased to maintain closure using a spring material (such as steel, other metals, plastics, composite materials, etc.) or a shape memory alloy (such as Nitinol). For example, the coupling or flexible portion 124, 126, 128, 138 and / or the inner and outer paddles 122 and / or additional biasing components can be formed of a metal (such as steel or a shape memory alloy such as Nitinol) produced from wire, sheet, tubing, or laser sintered powder, and biased to keep the outer paddle 120 closed around the apposition element 110 and the barbed fastener 130 compressed around the native leaflet. Similarly, the fixed and movable arms 132, 134 of the barbed fastener 130 are biased to compress the leaflets. In some embodiments, the joint portions 124, 126, 128, 138 and / or the inner and outer paddles 122 and / or additional biasing components can be formed of any other suitable resilient material (e.g., metal or polymer material) to maintain the device in a closed state after implantation.

[0091] Reference now Fig.15 –20, Figure 8 -14 is shown delivered and implanted within the native mitral valve MV of the heart H. Referring now to Fig.15 , the outer catheter or sheath 83 is inserted through the septum into the left atrium LA, and the device 100 is deployed from the outer catheter in a fully open state. The actuator element 112 is then retracted to move the device 100 into Fig.16 The fully closed state is shown in Fig.17As shown in , the device 100 is moved into position within the mitral valve MV into the ventricle LV and partially opened so that the leaflets 20, 22 are clamped. The steerable catheter 82 extends out past the distal end of the outer catheter 83, and the pusher tube or rod 81 extends out past the distal end of the steerable catheter. Now referring to Fig.18 , the actuation wire 116 extends to close one of the fasteners 130 , capturing the leaflet 20 . Fig.19 The other actuation wire 116 is shown then extending to close the other fasteners 130, capturing the remaining leaflets 22. Finally, as can be seen in FIG. Fig. 20 As shown in , the pusher tube or rod 81 and actuation element 112 and actuation wire 116 are then retracted and the device 100 is fully closed and deployed in the native mitral valve MV.

[0092] Reference now Figures 21A-21D , illustrates schematic diagrams of various example embodiments of a delivery system 80 for delivering an implant into the heart. Both the steerable catheter 82 and the outer catheter 83 have a central lumen that can be considered a delivery lumen. Referring now to Fig.21A , illustrates a schematic diagram of an example embodiment of a delivery system 80 for delivering an implant to the heart. The example embodiment is configured to have a pressure sensor in one of the catheters or pushers of the delivery device. The delivery system 80 may include an implant delivery pusher tube or rod 81, a steerable catheter 82, and an outer catheter or sleeve 83. The steerable catheter 82 may extend from the distal end 87 of the outer catheter, and the pusher tube or rod may extend outward from the distal end 85 of the steerable catheter. In an example embodiment, a valve implant, a valve repair device, or other therapy is pushed out of the end 85 of the steerable catheter 82 by the distal end 86 of the pusher tube or rod 81. In another example embodiment, the valve repair device or other therapy is initially positioned distally from the end 85 of the steerable catheter on the inner side of the outer catheter 83 (i.e., not the inner side of the steerable catheter). This allows the device to have a larger size because it does not need to be assembled on the inner side of the steerable catheter 82. The pressure sensor P may be arranged in a cavity within the wall of any one of the steerable catheter 82, the outer sleeve or catheter 83, the pusher tube or rod 81, and the actuator rod 112, or in a separate catheter arranged in the space between two of the steerable catheter 82, the outer sleeve or catheter 83, the pusher tube or rod 81, and the actuator rod 112.

[0093] exist Fig.21A In an example embodiment, the pressure sensor lumen 88 may run along the length of the steerable catheter 82. The pressure sensor lumen 88 may be formed in the steerable catheter or may be a lumen of a separate catheter disposed within the steerable catheter. Fig.21AIn the embodiment illustrated in FIG. 1 , the open distal end 89 of the lumen 88 can be along the length of the steerable catheter (i.e., not at the end 85 of the steerable catheter). A pressure sensor P can be at port 89 to directly measure blood pressure. Reference character P' represents another example embodiment in which the pressure sensor P' is upstream of port 89 so that blood pressure in the heart is indirectly measured via fluid in the pressure sensor lumen 88. The pressure sensor port 89 can be located anywhere along the catheter, and is typically located in the atrium of the heart during a valve therapy procedure.

[0094] Reference now Fig.21B , depicts another example embodiment of a delivery system 80 for measuring intra-atrial pressure during delivery of a heart valve implant or repair without the need for a separate introduction catheter. Fig.21B An example implementation of Fig.21A , except that the open distal end or pressure port 89 for the pressure monitoring lumen 88 is at the distal end 85 of the steerable catheter 82. Fig.21B In the illustrated embodiment, a pressure sensor P is positioned at port 89 to directly measure blood pressure.

[0095] Reference now Fig. 21C , depicts another example embodiment of a delivery system 80 for measuring intra-atrial pressure during delivery of a heart valve implant or repair without the need for a separate introduction catheter. In this example embodiment, a pressure sensor cavity 88 is optionally embedded in the wall of a steerable catheter 82. In the illustrated embodiment, the pressure sensor P is located proximal to a port 89 of the pressure sensor cavity. However, the pressure sensor may be at the port 89 of the steerable catheter as mentioned above.

[0096] Reference now Fig.21D , the pressure sensor cavity 88 may be embedded in the wall of the pusher rod or tube 81 or arranged on the inner side of the pusher rod or tube 81, and may have an open distal end or port 89 at the distal end of the pusher tube or rod. In some embodiments, the opening or port 89 may be at any position along the pusher tube or rod 81 extending from the steerable catheter 82. In an example embodiment, the pressure sensor cavity may be completely embedded in the wall of the steerable catheter or pusher tube or rod, or it may be partially embedded in the wall and protrude toward the center of the cavity of the catheter. In some embodiments, the cavity described herein may be defined by another catheter extending inside the cavity in the pusher 81, and the other catheter may be a pressure monitoring catheter. In some embodiments, a pressure measuring catheter having a cavity is in the space between the steerable catheter and the pusher tube 81. In this embodiment, the pressure measuring catheter may be optionally fixed to the inner wall of the steerable catheter. In the embodiment composed of Fig.21D In the illustrated example, the pressure sensor P is positioned at port 89. However, in some example embodiments, the pressure sensor P is positioned upstream of the port.

[0097] Reference now Fig.22A and 22B , illustrate cross-sectional views of a human heart H in diastole and systole, respectively. In the left atrium LA is a delivery system 80 having a pressure sensor P therein. The pressure sensor may record a pressure in the left atrium during diastole and another pressure in the left atrium during systole. The pressure sensor is not limited to measuring pressure in the left atrium and may also be used in the right atrium or in one of the ventricles. Figure 8-20 An example of one of many different types of valve therapies that may be delivered by delivery system 80 is illustrated. Fig.22A and 22B Typical valve therapy involves positioning and / or deploying a valve implant or valve repair device in the heart's native valve (see Figure 8-20 ), the native valve can be a mitral valve or a tricuspid valve. However, valve therapy is not limited to replacement valves or valve repair devices; it can also be a docking coil with a valve implant, a suture or cable replacement device, annuloplasty device, and / or other implant for correcting the function of the heart's native valve. The delivery system can use transvascular technology, such as transseptal technology, but is not limited to this; the delivery system can be delivered to the atrium of the heart by any currently known and future developed technology. When the valve implant or repair is in place, the pressure can be measured again to determine whether the therapeutic effect has occurred, that is, whether regurgitation or other heart valve defects have been repaired and / or improved.

[0098] Reference now Figures 23A-23C , illustrating a schematic diagram of an example embodiment of a delivery system for delivering a valve implant or repair. Fig.23A An end view is illustrated, with an implant pusher or catheter 81, a steerable catheter 82, and an outer sheath 83. The steerable catheter can have an integrated lumen, typically for a steering cable (not shown) extending along at least a length of the steerable catheter. In some embodiments, an additional pressure sensor catheter 102 is positioned in a lumen 104 of the steerable catheter, adjacent to the interior surface of the steerable catheter wall. The pressure sensor catheter can have a lumen 105. The pressure sensor catheter 105 can have a pressure sensor ( Fig. 23B -C) or can be filled with a biocompatible fluid to measure pressure ( Fig.23D ). The pressure sensor catheter shown here is not limited to this location, but can be positioned anywhere in the space between the pusher tube and the steerable catheter, so that the steerable catheter 82 and delivery system 80 as a whole can still achieve sufficient flexibility so that the valve implant or repair device can be implanted in the desired location.

[0099] Fig. 23BA cross section of the delivery system 80 taken along line AA is illustrated. Fig. 23B In the embodiment, the opening at the end 86 of the pusher tube 81 for the actuating rod 112 is not shown (see Fig.10 ), because the opening is offset from the cross-sectional plane AA. Fig. 23B In the embodiment, pressure sensor P is positioned inside the distal end of pressure sensor catheter lumen 105 and connected to a communication link 103, such as a wire or wire pair. Communication link 103 can extend out of the proximal end (not shown, outside the patient) to allow the pressure sensed at pressure sensor P to be monitored outside the patient by a monitoring device.

[0100] The pressure sensor P can be any of a variety of pressure sensors. For example, the pressure sensor can be a piezoelectric sensor, a pressure-sensitive detector, or a barometric pressure sensor. In the example embodiments described herein, the pressure sensor can be an electric pressure sensor that measures the pressure of a fluid (which can be blood in the left atrium of the heart) or can be the pressure of a fluid in a pressure sensor cavity (which can be a saline solution). The pressure sensor can be positioned to extend distally from the end of the pressure sensor cavity 105, or the pressure sensor can be completely within the pressure cavity. The pressure sensor P can be positioned anywhere along the length of the pressure sensor cavity 105. For example, the pressure sensor P can be flush or approximately flush with the port 89, or the pressure sensor P can be spaced proximally from the port on the inside of the pressure sensor cavity. Fig. 23B In the exemplary embodiment of the present invention, the distal end of the pressure sensor cavity or port 89 is flush with the distal end of the steerable catheter. In some embodiments, the port 89 is spaced apart from the end of the steerable catheter. In some embodiments, the pressure sensor can be embedded in the wall of the catheter having a pressure sensor cavity or pressure sensor catheter cavity.

[0101] The pressure sensor catheter 102 may be fixedly connected to the inner wall of the steerable catheter by any means of securing the catheter tubing together. The steerable catheter extends distally beyond the outer catheter 83. The pusher tube or rod extends even further distally from the distal end of the steerable catheter. Since the pusher tube or rod delivers the valve implant or repair device to the valve, it may be extendable from the end of the steerable catheter. The pusher tube or rod may extend past the distal end of the steerable catheter so that it may reach through the mitral valve (or tricuspid valve) toward the left ventricle to allow the operator to properly position the valve implant or repair device during its deployment. The pressure sensor may provide an accurate measurement of the pressure in the atrium when the delivery system is inserted so that the steerable catheter is still in the atrium, but not at or below the annulus, nor in the ventricle. In Fig. 23BIn the example embodiment illustrated in , the pressure sensor P is located at the distal end of the cavity and can detect the pressure of the cavity fluid at the distal end of the cavity. Because the distal end of the cavity can be open, the pressure applied to the sensor by the fluid in the cavity will be the same as the blood pressure in the left atrium, because the blood pressure in the left atrium pushes the fluid in the cavity.

[0102] By placing the pressure sensor in a pressure sensor cavity that fits within the existing space in the main lumen of the steerable catheter, the number of catheterizations of the heart required to implant a valve device and record pressures to measure its efficacy is reduced, thereby reducing noise that may affect pressure measurements.

[0103] refer to Fig.23C , illustrating an example embodiment of a delivery system 80 having a pressure sensor along Fig.23A Schematic diagram of a cross section taken along line AA. Fig.23C In the embodiment, the actuator rod 112 (see Fig.10 ) of the pusher tube 81 because the opening is offset from the cross-sectional plane AA. Fig.23C In the embodiment, the pressure sensor is according to an example embodiment. In this embodiment, the pressure sensor is located at Fig.23A The more proximal fluid fills the pressure sensor P. Fig.23C In the embodiment of the present invention, a pressure sensor catheter within the lumen of the steerable catheter is filled with a fluid. The fluid can be saline or other biocompatible fluid. Because the pressure sensor catheter is within a delivery system already inserted in the heart, pressure measurements can be made without inserting an additional catheter. Noise in the atrium is reduced by the separate chamber 102, and the pressure measurement can provide the operator with better feedback on the efficacy of the valve implant or repair being performed. The reduced noise is noise that might otherwise be caused by movement, increased pressure, and additional disturbances to blood flow in the left atrium, which might be caused by, for example, another catheter in the left atrium.

[0104] Reference now Fig.23D , illustrating another example embodiment of a delivery system 80 for measuring pressure in a heart chamber along Fig.23A Schematic diagram of a cross section taken along line AA. Fig.23D In the embodiment, the actuator rod 112 (see Fig.10 ) of the pusher tube 81 because the opening is offset from the cross-sectional plane AA. Fig.23DIn the embodiment, the pressure sensor catheter cavity 105 is filled with a fluid, which can be saline, and the pressure of the fluid is measured by a monitoring system. The monitoring system can be connected to the cavity 105 and / or the fluid therein through a flushing port on the handle or a separate port on the handle designed for introducing a pressure sensor, as in other example embodiments described herein. In this embodiment, no pressure sensor P is positioned in the cavity 105 to measure the pressure electronically or otherwise. Instead, the pressure of the fluid in the cavity 105 is measured with a monitoring system. The pressure of the fluid in the cavity is consistent with the entire cavity, and because the distal end of the cavity is open to the left atrium, the pressure applied by the fluid in the cavity will be the same as the blood pressure in the left atrium.

[0105] In any of the example embodiments described herein, pressure may be measured using a fluid instead of a pressure sensor P. This includes embodiments having a pressure sensor cavity 88 embedded within the wall of the catheter, and also includes some embodiments having a pressure sensor catheter cavity 105. Fig.23D The embodiment measures pressure in the same manner as measuring pressure.

[0106] An example embodiment may be to embed the pressure sensor P in the wall of any conduit surrounding a fluid filled cavity. The conduit wall may be the pusher tube or rod 81, the steerable conduit 82, the pressure sensor conduit 102, and / or the actuation rod 112 (see Fig.10 ) wall. The fluid-filled cavity can be the pressure catheter cavity 105 or the pressure sensor cavity 88.

[0107] Reference now Figures 24A-24C , illustrating a schematic diagram of an example embodiment of a delivery system for delivering a valve device. Fig.24A An end view is illustrated, with a pusher tube or rod 81, a steerable catheter 82, and an outer sheath 83. In this embodiment, an additional pressure sensor cavity 88 is integrated into the wall of the steerable catheter. Fig.24A As shown in , the pressure sensor cavity can be bumped out into the central lumen 104 of the steerable catheter, or it can be flush within the wall of the steerable catheter. Fig.24A As shown in the example in FIG. , the integrated pressure sensor lumen may be adjacent to the integrated steerable catheter lumen, or it may be spaced apart therefrom.

[0108] Fig. 24B A cross section of the delivery system 80 taken along line BB is illustrated. Fig. 24B In the embodiment, the actuator rod 112 (see Fig.10 ) of the pusher tube 81 because the opening is offset from the cross-sectional plane BB. Fig. 24BIn the embodiment of the present invention, the pressure sensor P is positioned inside the distal end of the pressure sensor cavity 88 of the steerable catheter 82 and is held in place at least by a connecting link 103. Figures 23A-23B In the example embodiment described, the pressure sensor can be an electric pressure sensor (or other type of pressure sensor). The pressure sensor can be positioned to extend distally from the end of the pressure sensor cavity 88, or it can be completely in the pressure cavity. In this example embodiment, the distal end 89 of the pressure sensor cavity can be flush with the distal end of the steerable catheter, but is not limited to such a length. The steerable catheter extends distally beyond the outer catheter 83. The pusher tube or rod extends even further distally from the distal end of the steerable catheter. Since the pusher tube or rod delivers the valve implant or repair device to the valve, it can be extendable from the end of the steerable catheter. The pusher tube or rod can extend through the distal end of the steerable catheter so that it can pass through the mitral valve (or tricuspid valve) toward the left ventricle to allow the operator to correctly position the valve implant or valve repair device during its deployment. When the delivery system is inserted so that the steerable catheter is still in the atrium, but not at the annulus or in the ventricle, the pressure sensor can provide accurate measurements in the atrium.

[0109] refer to Fig.24C , illustrating another example embodiment of a delivery system 80 having a pressure sensor along Fig.24A Schematic diagram of a cross section taken along line BB. Fig.24C In the embodiment, the actuator rod 112 (see Fig.10 ) of the pusher tube 81 because the opening is offset from the cross-sectional plane BB. Fig.24C In the embodiment, the pressure sensor is according to another example embodiment. In this embodiment, the pressure sensor is a fluid-filled pressure sensor cavity with a pressure sensor P at a more proximal position within the pressure sensor cavity, which is described in more detail above. Fig.24C In the embodiment of the present invention, the lumen 104 of the steerable catheter is filled with a fluid, as described above. Because this example embodiment of the pressure sensor catheter is within a delivery system that is already implanted in the heart, no additional catheter needs to be inserted to make pressure measurements. Therefore, noise in the atrium is reduced, and the pressure measurement can provide the operator with better feedback on the efficacy of the valve implant or repair device being performed.

[0110] Reference now Figures 25A-25C , illustrating a schematic diagram of an example embodiment of a delivery system for delivering a valve implant or repair device. Fig.25AAn end view is illustrated, with a pusher tube or rod 81, a steerable catheter 82, and an outer sheath 83. The steerable catheter may have an integrated lumen as described above. The steerable catheter may have another integrated lumen 88. In this embodiment, an additional pressure sensor catheter 102 is positioned in the additional lumen 88 of the steerable catheter, adjacent to the interior surface of the steerable catheter wall. The pressure sensor catheter may have its own lumen 105. Fig.25A As shown in , the pressure sensor cavity can be punched out into the central lumen 104 of the steerable catheter, or it can be flush within the wall of the steerable catheter. Fig.25A In the example of FIG. 1 , the integrated pressure sensor lumen may be adjacent to the integrated steerable catheter lumen, or the integrated pressure sensor lumen may be spaced apart from the integrated steerable catheter lumen. Fig.25A The additional lumen within the steerable catheter shown in is not limited to the location described herein, but can be positioned anywhere that is at least partially embedded in the wall of the steerable catheter so that sufficient flexibility of the steerable catheter and delivery system as a whole is still achieved so that the valve therapy can be implanted in the desired location.

[0111] Fig.25B A cross section of the delivery system 80 taken along line CC is illustrated. Fig.25B In the embodiment, the actuator rod 112 (see Fig.10 ) of the pusher tube 81 because the opening is offset from the cross-sectional plane CC. Fig.25B In the embodiment, the pressure sensor P is positioned inside the distal end of the pressure sensor cavity 105 and can be held in place by an optional connecting link 103. The pressure sensor can be an electric pressure sensor or other sensor. The pressure sensor can be positioned to extend distally from the end of the pressure sensor catheter cavity 105, or it can be completely in the pressure cavity. In this example embodiment, the distal end 89 of the pressure sensor catheter cavity is flush with the distal end of the steerable catheter, but is not limited to such a length. The pressure sensor catheter 102 can be fixedly connected to the inner wall of the steerable catheter cavity 104 by any means of fixing the catheter tubing together. In another embodiment, the pressure sensor catheter can be slidably positioned in the steerable catheter cavity 104. The steerable catheter extends distally beyond the outer catheter 83. The pusher tube or rod 86 extends even further distally from the distal end of the steerable catheter. Since the pusher tube or rod delivers the valve implant or repair to the valve, it can be extendable from the end of the steerable catheter. The pusher tube or rod may extend through the distal end of the steerable catheter so that it can penetrate the mitral valve (toward the left ventricle) to allow the operator to properly position the valve implant or repair during its deployment. When the delivery system is inserted so that the steerable catheter is still in the atrium but not at the annulus or in the ventricle, the pressure sensor can provide accurate measurements in the atrium.

[0112] refer to Fig.25C, illustrating another example embodiment of a delivery system 80 having a pressure sensor along Fig.25A Schematic diagram of a cross section taken along line CC. Fig.25C In the embodiment, the actuator rod 112 (see Fig.10 ) at the end 86 of the pusher tube 81 because the opening is offset from the cross-sectional plane CC. In this example embodiment, the pressure sensor is a fluid-filled pressure sensor cavity with a pressure sensor P at a more proximal position within the pressure sensor cavity, which is described in more detail above. Because this example embodiment of the pressure sensor catheter is within a delivery system that is already implanted in the heart, there is no need to insert an additional catheter to take pressure measurements. Therefore, noise in the atrium is reduced, and the pressure measurement can provide the operator with more reliable feedback on the efficacy of the valve implant or repair being performed.

[0113] Reference now Figures 26A-26C , illustrating a schematic diagram of an example embodiment of a delivery system for delivering a valve implant or repair device. Fig.26A An end view is illustrated, with a pusher rod or tube 81, a steerable catheter 82, and an outer sheath 83. Fig.26B In the embodiment, the actuator rod 112 (see Fig.10 ) at the end 86 of the pusher tube 81 because the opening is offset from the cross-sectional plane CC. In this embodiment, the additional pressure sensor cavity 88 is integrated in the wall of the pusher rod or tube 81. Fig.26A As shown in , the pressure sensor cavity can be flush within the wall of the pusher rod or tube 81, or it can be punched out into the central cavity of the pusher tube or rod 81.

[0114] Fig.26B A cross section of the delivery system 80 taken along line DD is illustrated. Fig. 24B In the embodiment, the pressure sensor P is positioned inside the distal end of the pressure sensor cavity 88 of the pusher rod or tube 81 and can be held in place at least by the connecting link 103. Figures 23A-23BIn the example embodiment described, the pressure sensor may be positioned to extend distally from the end of the pressure sensor cavity 88, or it may be completely within the pressure sensor cavity. The pressure sensor cavity may be filled with a biocompatible fluid, such as saline. In this example embodiment, the distal end 89 of the pressure sensor cavity is flush with the distal end of the pusher rod or tube 81, but is not limited to such a length. The steerable catheter extends distally beyond the outer catheter 83. The pusher tube or rod extends even further distally from the distal end of the steerable catheter. Since the pusher tube or rod delivers the valve implant or repair device to the valve, it may be extendable from the end of the steerable catheter. The pusher tube or rod may extend through the distal end of the steerable catheter so that it can pass through the mitral valve (or tricuspid valve) toward the left ventricle to allow the operator to correctly position the valve implant or repair during its deployment. As in other example embodiments described herein, when its opening to the outside of the delivery system is located in the atrium, the pressure sensor can measure accurate atrial pressure. When the delivery system is inserted so that the pusher tube or rod remains in the atrium, but not at the annulus or in the ventricle, the pressure sensor can provide accurate measurements in the atrium.

[0115] As with other integrated cavity embodiments, placing the pressure sensor cavity in a pressure sensor integrated within the pusher stem or tube 81 reduces the number of catheterizations of the heart required to implant a valve implant or repair and record pressures to measure its efficacy, thereby reducing noise that may affect pressure measurements.

[0116] refer to Fig.26C , illustrating another example embodiment of a delivery system 80 having a pressure sensor along Fig.26A Schematic diagram of a cross section taken along line DD. Fig.26C In the embodiment, the actuator rod 112 (see Fig.10 ) of the pusher tube 81 because the opening is offset from the cross-sectional plane CC. Fig.26C In the embodiment, the pressure sensor is according to another example embodiment. Fig.26C In the embodiment of the present invention, the pressure sensor is a fluid-filled pressure sensor cavity with a pressure sensor P at a more proximal position within the pressure sensor cavity, which is described in more detail above. Because the pressure sensor catheter is within the delivery system already implanted in the heart, no additional catheter needs to be inserted to make pressure measurements. Therefore, the noise in the atrium is reduced, and the pressure measurement can provide the operator with better feedback on the efficacy of the valve implant or repair device.

[0117] In such as Figures 23A-23C In the example embodiment of the catheter having a pressure sensor within the lumen of the steerable catheter illustrated in FIG, pressure may be measured according to the following method. Fig. 23B In the embodiment, the pressure sensor may be an electric pressure sensor. Fig. 23BThe pressure sensor in the delivery system is accessible to the left atrium because it is positioned at the distal end of the pressure sensor catheter, which is flush with the distal end of the steerable catheter, and at least the distal end of the pressure sensor catheter is open to the atrium. In one embodiment, the pressure sensor can be connected to a monitoring system (not shown) via a flushing port on the handle of the delivery system. In another embodiment, the pressure sensor can be connected to the monitoring system via a separate port on the handle, wherein the separate port is used to introduce the pressure sensor catheter or directly attach a pressure monitor. As explained above, Fig. 23B The pressure sensor in may also be positioned in other locations.

[0118] exist Fig. 23B In an example embodiment, a baseline pressure measurement may be performed when the distal end 86 of the steerable catheter is in the left atrium before delivering the valve implant or repair device. The pressure of the fluid in the pressure sensor cavity may be electronically taken and may be recorded and / or displayed in a monitoring system. As explained above, the pressure is about the same as or the same as the pressure in the left atrium of the heart. The baseline pressure measurement may be recorded during contraction and / or diastole, and measurements during contraction and / or at the end of contraction may determine whether regurgitation occurs. The valve implant or repair device may then be delivered, but before withdrawing the delivery system, the distal end of the steerable catheter may be positioned in the left atrium again and another pressure measurement may be performed. Now that the valve implant or repair device is positioned in the native valve, the pressure measurement may determine whether the pressure has changed. The pressure measurement should be performed at the same point (one or more) in the cardiac cycle (during contraction and / or at the end of contraction) as the baseline measurement. Due to correction for blood regurgitation back into the atrium, the pressure measurement (one or more) performed by the pressure sensor at this time should be lower than the baseline pressure measurement. The pressure can be measured before the valve implant or repair device is separated from the delivery catheter so that it can be repositioned if the operator needs to for effective placement. If the valve implant or repair is effectively implanted, blood will flow from the left ventricle to the aorta instead of back through the mitral valve. The pressure can be measured as many times as needed. The pressure can also be measured continuously.

[0119] In use Fig.23CIn some example embodiments of the method of measuring atrial pressure with a fluid-filled pressure sensor, the pressure sensor cavity can be filled with a fluid (such as saline or other biocompatible fluids known to those of ordinary skill in the art for use in fluid-filled atrial pressure monitors). The pressure sensor P can be at a more proximal position along the length of the catheter delivery system. Before delivering the valve implant or repair device, a baseline pressure measurement can be made when the distal end 86 of the steerable catheter is in the left atrium. This baseline pressure measurement can be recorded at any time (such as during contraction or at the end of contraction), as explained above. The valve implant or repair device can then be delivered, but before withdrawing the delivery system, the distal end of the steerable catheter can be positioned in the left atrium and another pressure measurement can be made. Now that the valve implant or repair device has been positioned in the native valve, the pressure can be measured again to determine whether it has changed. The pressure measurement can be made at the same point in the cardiac cycle as the baseline measurement. Due to the correction of blood reflux back into the atrium (which can result in a pressure higher than the normal pressure in the left atrium), the pressure measurement made by the pressure sensor at this time should be lower than the baseline pressure measurement. Conversely, a higher pressure in the left atrium will result in a higher pressure in the fluid in the pressure sensor chamber. The pressure can be measured before the valve implant or repair device is separated from the pusher tube or rod so that it can be repositioned for effective placement. If the valve implant or repair device is effectively positioned, blood will flow from the left ventricle to the aorta instead of flowing back through the mitral valve. The pressure can be measured multiple times as needed. The method can be performed in a living animal or on a simulator (such as a corpse, a cadaver heart, a simulator (e.g., having a simulated body part, heart, tissue, etc.), etc.).

[0120] With respect to embodiments having a pressure sensor P embedded in the wall, left atrial pressure may be measured in the same manner as pressure is measured for embodiments having a pressure sensor P positioned within a fluid-filled cavity as described herein, e.g. Fig.23C Example implementations of .

[0121] In use Fig.23DIn some example embodiments of a method of measuring atrial pressure by a fluid-filled pressure sensor cavity 105, the pressure sensor cavity can be filled with a fluid (such as saline or other biocompatible fluid known to those of ordinary skill in the art for use in fluid-filled atrial pressure monitors). Prior to delivering a valve implant or repair device, a baseline pressure measurement can be taken when the distal end 86 of the steerable catheter is in the left atrium. This baseline pressure measurement can be recorded by the monitoring system at any time, such as during contraction or at the end of contraction, as explained above. The valve implant or repair device can then be delivered, but before the delivery system is withdrawn, the distal end of the steerable catheter can be positioned in the left atrium and another pressure measurement can be taken. Now that the valve implant or repair device has been positioned in the native valve, the pressure can be measured again to determine whether it has changed. The pressure measurement can be taken at the same point in the cardiac cycle as the baseline measurement. The pressure measurement taken at this time should be lower than the baseline pressure measurement due to correction for blood reflux back into the atrium (which can result in a higher pressure than the normal pressure in the left atrium). Conversely, a higher pressure in the left atrium will result in a higher pressure in the fluid in the pressure sensor cavity. The pressure can be measured before the valve implant or repair device is separated from the pusher tube or rod so that it can be repositioned for effective placement. If the valve implant or repair device is effectively positioned, blood will flow from the left ventricle to the aorta rather than back through the mitral valve. The pressure can be measured multiple times as needed. For any fluid-filled chamber embodiment without the pressure sensor P described herein, the left atrial pressure can be measured in the same manner. The method can be performed in a living animal or on a simulator (such as a cadaver, a cadaver heart, a simulator (e.g., having a simulated body part, heart, tissue, etc.), etc.)

[0122] In such Figures 24A-24C In the example embodiment of the embodiment with a pressure sensor cavity integrated into the wall of the steerable catheter as exemplified in Figures 25A-25C In an example embodiment of the integrated intraluminal pressure sensor catheter exemplified in FIG. 1 , a method of measuring pressure in the left atrium may have the same characteristics as described above with respect to Figures 23A-23C The same steps as described above were applied using Fig. 24B and 25B Embodiments of the present invention provide a method for measuring pressure (wherein the pressure sensor is an electric pressure sensor), using Fig. 23B The only difference is that in Fig. 24B In an embodiment of the present invention, rather than having a separate pressure sensor catheter lumen 102 , there is an integrated pressure sensor lumen 88 in the wall of the steerable catheter 82 . Fig.25B Similar to Fig. 24B , but with a pressure sensor catheter 102 with its own lumen 105 extending along the lumen 88 of the steerable catheter.

[0123] In such Figures 26A-26C In the example embodiment illustrated in with a pressure sensor cavity integrated into the wall of a valve implant or repair delivery catheter, the method is similar to the example embodiment of the method described above. Figures 26A-26C In the embodiment of the present invention, the open distal end 89 of the pressure sensor chamber of the valve delivery catheter should be positioned in the left atrium to obtain the left atrial pressure. The following steps may be used to measure pressure using the electric pressure sensor P. The delivery system 80 is inserted through a transseptal procedure so that the delivery system 80 enters the left atrium. The method may include taking a baseline pressure measurement in any manner described herein. The valve implant or repair device may then be positioned and another pressure measurement may then be taken. In any of the example embodiments described herein, the pressure may be measured continuously, or it may be measured at discrete time points. The valve implant or repair device may be repositioned and the pressure in the left atrium may be measured as described above with respect to Fig. 23B The measurement described in the embodiment of the invention. Fig.26C In the example embodiment of Fig.23C The measurements described in the example embodiments of the present invention.

[0124] The same method can be used in example embodiments for measuring right atrial pressure without the step of puncturing the septum. The measurement is performed when the distal end of the delivery system is positioned on the right side of the heart. These various methods can be performed in a living animal or on a simulated object such as a cadaver, a cadaver heart, a simulator (e.g., having a simulated body part, heart, tissue, etc.), etc.

[0125] As described above, a delivery system for delivering a valve device may include at least one of an outer sheath 83, a steerable catheter 82, or an implant pusher or rod 81. The central lumen 104 ( Fig.24A ) and the lumen 90 of the outer sheath 83 ( Fig.36 ) can be filled with a biocompatible fluid, such as saline. At various stages before, during, and after delivery of the valve device, the fluid or air present in the delivery system can be detected, flushed, and / or removed according to various embodiments described herein.

[0126] Reference now Fig. 27 , illustrates a schematic diagram of an example embodiment of a rotatable flush port or catheter coupler 150. In various embodiments, the catheter coupler 150 can be coupled to at least one of the implant pusher or implant catheter 81, the steerable catheter 82, or the outer sheath 83. Each catheter coupler can be connected to a control handle (not shown) that controls the operation / positioning of the attached implant catheter 81, the steerable catheter 82, and the outer sheath 83. The catheter coupler 150 can be used to sense or monitor the fluid pressure in the catheter and / or can be used to flush the catheter so that there is no air in the catheter.

[0127] The catheter coupler 150 coupler can take many forms. Moreover, although the term catheter coupler is generally used herein, this can also be referred to as a flush port and can be positioned at various locations along the catheter and / or catheter handle. In the embodiments disclosed below, the catheter coupler is configured to allow flushing of the catheter in the case of rotating the catheter. This can be done in a variety of different ways. The embodiments described below are two ways in which the catheter coupler can be configured to allow flushing of the catheter without rotating the catheter.

[0128] refer to Figure 27-28 , an example embodiment of a catheter coupler 150. The example coupler includes a cap 152 rotatably mounted to a housing 154. The cap 152 is coupled to a tube 156. The tube 156 can be used for a variety of different purposes. For example, the tube 156 can be used to flush the catheter, measure the pressure in the catheter, sample the fluid from the catheter, deliver the fluid through the catheter, etc.

[0129] refer to Figure 28-29 , the housing 154 may include a fluid passage 158 arranged circumferentially around the housing 154. The passage 158 is illustrated in the housing, but may be defined or partially defined in the cap 152. The passage 158 is connected to at least one port 160. The port 160 connects the passage 158 to a cavity or central passage 162 of the housing 154. The cavity or central passage 162 extends between a first end 164 and a second end 174 of the housing of the housing 154.

[0130] Cap 152 is rotatably attached to housing 154 at first end 164 of housing 154. Cap 152 is a ring formed with a central opening 176. A cavity or passage 177 extends from central opening 176 of cap 152 to tube 156. As a result, fluid inside central opening 176 flows through the cap to tube 156.

[0131] The cap 152 may be assembled on top of the first end 164 of the housing 154 so that a seal is formed between the cap 152 and the housing 154 on both sides of the passage 158. The seal between the cap 152 and the housing 154 may be formed in a variety of ways. For example, referring to Fig.28, the conduit coupler 150 may include one or more sealing members. For example, the conduit coupler 150 may include a first sealing member 165 and a second sealing member 166. The sealing member may be annular and assembled between the housing 154 and the cap 152. The first sealing member 165 and the second sealing member 166 are assembled in a groove 168, which is disposed in the housing 154. The seals 165, 166 prevent any fluid in the passage 158 from escaping through the rotatable connection between the cap 152 and the housing 154. As a result, the fluid in the passage 162 can flow through the port 160, into the passage 158, through the passage 177, and through the tube 156 (or vice versa) without leaking between the cap 152 and the housing 154.

[0132] The cap 152 is rotatable relative to the housing 154. For example, in various embodiments, the cap 152 is rotatable 160 degrees about the housing 154, and is rotatable clockwise and / or counterclockwise relative to the housing 154. The sealing members 165, 166 are configured to maintain a seal between the housing 154 and the cap 152 when the cap is rotated relative to the housing.

[0133] Fig.31A -C example follows Fig.30 31-31 plane indicated by the center line 31-31. In the illustrated example, the housing 154 includes four passages 160 connecting the cavity or passage 162 to the circumferential channel 158. The housing 154 can have any number of passages 160 connecting the cavity or passage 162 to the channel or groove 158. For example, the housing 154 can have any number of passages between three and twenty. The tube 156 is in fluid communication with the channel 158, the passage 160, and the cavity or passage 162.

[0134] refer to Fig.31B -C, where the cap 152 can be rotated circumferentially about the housing 154 in the A' direction. This allows the tube 156 to rotate to a "top dead center" or Fig. 31C 156, and the attached catheter. In this position, applying a vacuum to the tube 156 can remove all air from the tube 156, the coupler 150, and the attached catheter, leaving only fluid, such as saline solution and blood. The process of filling the open space in the lumen of the catheter with liquid and removing the air is called flushing. Injecting a liquid (e.g., saline solution, etc.) through the port should fill the lumen with the liquid. If any air remains, when the tube 156 is in the upright position, the air can be removed before the liquid because the air is lighter than the liquid and moves in an upward direction.

[0135] refer to Figure 32-33, illustrates a cross section of a conduit coupler 150 and a cross section of the coupler 150 with a conduit 172. As described above, the first sealing member 165 and the second sealing member 166 are positioned circumferentially around the housing 154 between the housing 154 and the cap 152. The first sealing member 165 and the second sealing member 166 may be at least partially disposed within the groove 168 of the housing 154. Fluid may flow from the cavity or passage 162, through the passage 160, into the channel 158, through the passage 177, and through the tube 156.

[0136] refer to Fig.33 , the catheter coupler 150 can be connected to the pressure sensor 170 via the tube 156. The housing 154 can be coupled to the catheter 172 at the second end 174 of the housing 154. The catheter 172 can include a pusher tube or rod 81, a steerable catheter 82, or an outer catheter or cannula 83. Different catheter couplers 150 can have different sized lumens or passages 162 to cooperate with different sized pusher tubes or rods 81, steerable catheters 82, and / or outer catheters or cannula 83. As described above, the pressure sensor 170 can be used to measure pressure in the heart, except that the pressure is monitored through the primary lumen of the pusher tube or rod 81, the steerable catheter 82, and / or the outer catheter or cannula 83.

[0137] refer to Fig.34 , the catheter coupler 150 is illustrated on the proximal end of the steerable catheter 82. Fluid, which may be blood in the left atrium of the heart, may travel through the central lumen 104 of the steerable catheter 82, through flow path B, and into the cavity 162 of the catheter coupler 150. The flow path B is the volume between the pusher or implant catheter 81 and the steerable catheter 82. In this example, the fluid traveling into the central lumen 104 of the steerable catheter 82 is in fluid communication with the cavity 162, the port 160, the channel 158, the tube 156, and the pressure sensor 170.

[0138] Pressure sensor 170 can be a fluid-filled pressure sensor, and the pressure sensor cavity can be filled with fluid (such as saline or other known biocompatible fluids used by ordinary technicians in fluid-filled atrial pressure monitors). Pressure sensor P can be at a more proximal position along the length of the catheter delivery system. Before delivering the valve implant or repair device, when the steerable catheter 82 is in the left atrium, a baseline pressure measurement can be performed. This baseline pressure measurement can be recorded at any time, such as during contraction or at the end of contraction, as explained above. The valve implant or repair device can then be delivered, but before withdrawing the delivery system, the distal end of the steerable catheter 82 can be positioned in the left atrium, and another pressure measurement can be performed. Now that the valve implant or repair device has been positioned in the native valve, the pressure can be measured again to determine whether it has changed. The pressure measurement can be performed at the same point in the cardiac cycle as the baseline measurement. Due to the correction of blood reflux back into the atrium (which can result in a pressure higher than the normal pressure in the left atrium), the pressure measurement performed by the pressure sensor at this time should be lower than the baseline pressure measurement. Conversely, a higher pressure in the left atrium will result in a higher pressure in the fluid in the pressure sensor chamber. The pressure can be measured before the valve implant or repair device is separated from the pusher tube or rod so that it can be repositioned for effective placement. If the valve implant or repair device is effectively positioned, blood will flow from the left ventricle to the aorta instead of back through the mitral valve. The pressure can be measured as many times as needed.

[0139] refer to Fig.34 , the catheter coupler 150 can be used to flush the fluid through at least one of the implant pusher or rod 81, the steerable catheter 82, or the outer sheath 83 to ensure that there is no air in the delivery system. As described above, when the catheter coupler 150 is placed in the heart, the catheter coupler 150 can be filled with saline or other biocompatible fluids. The user can "pull back" the fluid to the proximal side through the coupler catheter 150 to ensure that the system is in the correct working state and there are no pockets of air or other fluids in the system. Pulling back the fluid can pull blood through the flow path B and toward the proximal end of the catheter coupler 150. When a vacuum is applied to the tube, blood and / or flushing fluid (such as saline) can fill the cavity 162, the port 160, the channel 158, the tube 156. Fluid and / or blood can be collected by the tube 156, or fluid or medicine can be introduced by the tube. The flushing of the catheter 82 can be carried out by the tube 156 to remove any air in the catheter 82, the coupler 150, and / or the tube 156. One or more air pockets may exist in cavity 162, port 160, passage 158, and / or tube 156. When the vacuum is used to "pull back" or withdraw the fluid, air may travel through flow path B and toward the proximal end of catheter coupler 150. The air may travel into port 160 and into passage 158. Fig.34 and 31A-C, the cap 152 of the conduit coupler 150 may be, for example, in the A' direction (ie, Fig.31B The housing 154 is rotated (vertically) relative to the housing 154 to facilitate air pockets to travel through the port 160 through the passage 158 and into the tube 156. Air pockets or fluid can travel through the tube 156 and be evacuated from the system.

[0140] refer to Fig.34 , the implant pusher or catheter 81 of the delivery system and the valve repair device can extend through the cavity or passage 162 of the housing 152. Although not shown, the implant pusher or catheter 81 can be connected to the catheter coupler 150 at the proximal end of the implant pusher or catheter 81.

[0141] In various embodiments, multiple catheter couplers or rotatable fluid ports can be simultaneously coupled to various components of a delivery system for delivering a valve device. The catheter coupler can flush various components of a delivery system for delivering a valve repair device or a valve replacement device. As described above, the distal ends of the steerable catheter, outer catheter, and pusher tube or rod can terminate at different corresponding areas of the heart.

[0142] refer to Fig.35 , for example, the proximal end of the steerable catheter 82 and the proximal end of the outer catheter or guide sheath 83 are both attached to the catheter coupler 150. The steerable catheter 82 is at least partially disposed within the passageway 162 of the housing 152. The implant pusher or catheter 81 is at least partially disposed within the lumen or passageway 162 of the housing 152. The implant pusher or catheter 81 extends through the outer catheter or guide sheath 83, and the coupler connected to the outer lumen or guide sheath.

[0143] Liquid, which may be blood and / or flushing fluid, may travel through the main or central lumen 104 of the steerable catheter 82, through flow path B, and into the catheter coupler 150. The flow path B is the volume between the pusher or implant catheter 81 and the steerable catheter 82. In this example, the liquid that travels into the central lumen 104 of the steerable catheter 82 is in fluid communication with the lumen 162, the port 160, the channel 158, the tube 156, and the pressure sensor 170.

[0144] Liquid (which may be blood and / or irrigation fluid in the left atrium of the heart) may travel through the lumen 90 of the outer catheter 83, through the flow path C, and into the lumen or passage 162 of the catheter coupler 150. The flow path C is the volume between the steerable catheter 82 and the guide sheath 83. In this example, the liquid that travels into the lumen 90 of the outer catheter 83 is in fluid communication with the lumen or passage 162, the port 160, the channel 158, and the pressure sensor 170. The catheter coupler 150 may also be provided on the proximal end of the pusher tube 81. Thus, the coupler may be provided on any one or more of the pusher tube 81, the steerable catheter 82, and the guide sheath 83.

[0145] The catheter coupler 150 connected to the outer introducer sheath 83 can be used to flush liquid through the outer introducer sheath 83 to ensure that there is no air in the introducer sheath portion of the delivery system. When the vacuum is used to "pull back" or withdraw the liquid, air can travel through the flow path C and toward the proximal end of the catheter coupler 150. The air can travel into the port 160 and enter the channel 158. Fig.35 and 31A -C, the cap 152 of the conduit coupler 150 may be, for example, in the A' direction (ie, Fig.31B The housing 154 is rotated (vertically) relative to the housing 154 to facilitate the passage of cavitation through the port 160, through the passage 158 and into the tube 156. The cavitation can pass through the tube 156 and be evacuated from the system. When the user draws, blood can fill the cavity or passage 162, the port 160, the passage 158, and / or the tube 156. Flushing fluid and blood can pass through the tube 156 to a collection tube, medications can be introduced through the tube, and / or pressure inside the heart can be measured through the tube.

[0146] In various embodiments, air present in the outer sheath 83 can be detected and / or removed by the catheter coupler 150. The air can travel through the flow path C and toward the proximal end of the attached catheter coupler 150. The air can travel into the port 160 and toward the channel 158. Fig.35 and 31A -C, the cap 152 of the catheter coupling 150 connected to the outer sheath 83 may be, for example, in the A' direction ( Fig.31B ) rotates relative to housing 154 to facilitate air pockets to travel through port 160, through passage 158 and tube 156. Air pockets may be evacuated through tube 156.

[0147] Fig.36 It is along the Fig.35 36-36 in FIG. 36A and 36B , a cross-sectional view of the pusher rod or tube 81, the steerable catheter 82, and the outer sheath 83 taken along the plane indicated by line 36-36 in FIG. Prior to being introduced into the patient's vasculature, the space 3600 between the actuation rod 112 and the pusher tube 81, the space or flow path B between the pusher tube 81 and the steerable catheter 82, and / or the space or flow path C between the steerable catheter 82 and the outer sheath 83 may be filled with a flushing fluid. These spaces may be flushed as described herein to remove any air from these spaces.

[0148] exist Fig.36In the illustrated example, the steerable catheter 82 includes a radially inwardly extending protrusion 3602 for a pull wire that is used to steer the steerable catheter 82. The radially inwardly extending protrusion 3602 maintains a space or path B between the outer side surface 3604 of the pusher catheter 81 and the inner side surface 3605 of the steerable catheter 82. This space or path B is maintained as the catheter is flexed and steered through the patient's vasculature to the implantation site (such as the mitral valve). As a result of the unobstructed path B, the pressure in the heart can be accurately measured at the connector 150 connected to the steerable catheter 82.

[0149] Still refer to Fig.36 , the guide sheath or outer sheath 83 includes a radially inwardly extending protrusion 3612 for a pull wire that is used to steer the guide sheath or outer sheath 83. The radially inwardly extending protrusion 3612 maintains a space or path C between the outer side surface 3614 of the steerable catheter 82 and the inner side surface 3615 of the guide sheath 83. This space or path C is maintained as the catheter is flexed and steered through the patient's vasculature to the implantation site (such as the mitral valve). As a result of the clear path C, the pressure in the heart can be accurately measured at the connector 150 connected to the guide sheath 83.

[0150] refer to Figure 37-39D , an example embodiment of a flush port or catheter coupler 450 includes a housing 454 and an outlet extension 452 fixed relative to the housing. The housing 454 and the outlet extension 452 can be fixed relative to each other in a variety of different ways. For example, the flush port or coupler can be integrally formed (such as by casting, molding, 3-D printing, etc.) as illustrated, or formed from multiple parts fixed together. Figure 37-39D In the illustrated example embodiment, the tube 156 is not rotatable relative to the housing 454, unlike the embodiments illustrated by 27-35.

[0151] refer to Fig.37 and 38 , the catheter coupler 450 couples the catheter 172 (such as the guide sheath 83, the steerable catheter 82, or the pusher tube 81) to the port tube 156. The coupler includes a cavity or passage 462 configured to connect to the catheter 172. The cavity or passage 462 is configured to connect to the guide sheath 83, the steerable catheter 82, or the pusher catheter 81 in the same manner as the cavity or passage 162. The channels 458 are circumferentially arranged within the catheter coupler 450. The channels 458 are connected to the cavities or passages 462 via a plurality of ports 460. The channels 458 are connected to the tube 156 via an outlet port 477.

[0152] refer to Fig.39A-C, the catheter coupler or flush port 450 can be used to flush air out of a connected catheter, such as an implant pusher or catheter 81, a steerable catheter 82, or an outer sheath 83, without rotating the tube 156 to an upright or vertical position (see Fig. 31C ). When catheter coupler 450 is to be used, catheter coupler 450 and the attached catheter may be filled with saline or other biocompatible liquid.

[0153] The viscosity of air is less than the viscosity of liquids, such as water (i.e., saline) and / or blood. Therefore, air presents a lower resistance to fluid flow. When a vacuum is applied to tube 156, the passages with the lowest resistance to fluid flow (i.e., the upper passages of passage 460 and the upper portion of circumferential passage 458 containing air) will observe the greatest total volume (air + liquid) flow through them. If the potential created by the vacuum applied to tube 156 ("NPSH Available" or "NPSHA") is greater than the height potential between the top and bottom ports 460 ("NPSH Required" or "NPSHR"), fluid may flow first and most rapidly through the air exposure ports, resulting in air being evacuated from the sealed housing, regardless of the orientation of the flush tube, such as Figures 39A-39C The example given.

[0154] refer to Fig.39A , the user can draw a vacuum through tube 156, which pulls fluid 3900 in conduit 172 into passageway 462. Liquid 3900 (e.g., flushing fluid and / or blood) in passageway 462 displaces air in passageway 462 through upper port or passageway 460, as illustrated by arrow 3902. The circumferential passageway 458 and / or ports or passageways 460 can be sized such that air or a mixture of air and liquid 3900 in the upper passageway and circumferential passageway 458 in passageway 460 flows to outlet port 477 before or faster than liquid in the lower port flows to outlet port 477. This preferential flow is independent of the orientation / direction of the coupler 450 and the fixed outlet port. That is, the circumferential passage 458 and / or the port or passage 460 are small enough or constricted enough to allow the air or mixture of air and liquid 3900 in the upper passage and circumferential passage 458 to flow to the outlet port 477 before or faster than the liquid in the lower port flows to the outlet port 477, regardless of the orientation of the coupler 450 and the fixed outlet port. The circumferential passage 458 and / or the port or passage 460 can be sized for this advantageous flow of air or air mixed with liquid over liquid alone because air or air mixed with liquid has a lower viscosity than liquid alone. In an example embodiment, the cross-section of the circumferential passage 458 is generally rectangular, wherein the cross-sectional width (i.e., Fig.38inch, such as between 0.015 and 0.125 inches, such as between 0.030 and 0.110 inches, such as between 0.050 and 0.100 inches, such as between 0.060 and 0.080 inches, such as about 0.070 inches, such as 0.070 inches, and the height (i.e., Fig.38 0.010 and 0.100 inches, such as between 0.020 and 0.80 inches, such as between 0.025 and 0.050 inches, such as between 0.030 and 0.040 inches, such as about 0.035 inches, such as 0.035 inches, and the port or passage is generally circular with a cross-sectional diameter of between 0.015 and 0.125 inches, such as between 0.030 and 0.110 inches, such as between 0.050 and 0.100 inches, such as between 0.060 and 0.080 inches, such as about 0.070 inches, such as 0.070 inches to promote the dominant flow of air and air mixed with liquid relative to liquid alone.

[0155] refer to Fig.39A and 39B , when the circumferential passage 458 and / or the port or passage 460 are appropriately sized, air can more easily travel from the cavity or passage 462, out of the upper passage as indicated by arrow 3902, along the circumferential passage 458 as indicated by arrow 3904, and out through the outlet 452 and the tube 156. Fig.39B , liquid 3900 begins to fill the upper cavity or passage 460, forcing air into circumferential passage 458. The air and air mixed with liquid continue to move along circumferential passage 458 as indicated by arrow 3904 and out through outlet 452 and tube 156. Fig.39C , all passages of the coupling have been filled with liquid and all air has been forced out of tube 156.

[0156] If the circumferential passage 458 and / or the ports or passages 460 are too large, there will be less restriction on the flow of liquid through the lower portion of the circumferential passage 458 and / or the lower ports or passages in the ports or passages 460. As a result, the dominant flow of air or air and liquid mixtures over the liquid alone will not occur. In some example embodiments, if the vacuum applied for a given size of the circumferential passage 458 and ports or passages 460 does not result in a dominant flow of air out of the conduit, a larger vacuum may be applied to the tube. However, the large size of the circumferential passage 458 and / or ports or passages may prevent any reasonable vacuum force from advantageously drawing air out of the conduit.

[0157] Still refer to Figures 39A-39DThe tube 156 can be used for a variety of different purposes. For example, the tube can be used to flush the catheter, measure the pressure in the catheter, sample fluid from the catheter, deliver fluid through the catheter, etc.

[0158] refer to Fig.39D , the example coupler 450 can be used to measure pressure in a connected catheter (such as the introducer sheath 83, the steerable catheter 82, or the implant catheter) without rotating the tube 156. Any combination of the above example embodiments can be used in a method for measuring pressure in the heart (such as atrial pressure) without having to enter a new catheter for the purpose of measuring atrial pressure. Figure 37-39D The exemplary coupler 450 may be used to connect to Figure 27-36 The pressure is measured in the same manner as described for the coupling 150 shown in FIG.

[0159] The method of measuring pressure can begin with the entry of a delivery system that delivers a valve implant or prosthetic device. In order to obtain left atrial pressure when using the trans-septal technique, an outer catheter with an inner catheter as described above can be inserted into the right femoral vein. From there, the catheter is advanced upward into the inferior vena cava and into the right atrium. Once the distal end of the delivery system is in the right atrium, the septum is punctured and the catheter is then passed into the left atrium. Once in the left atrium, any pressure sensing arrangement disclosed herein can be used to monitor atrial pressure. The method can be performed in a living animal or on a simulator, such as a cadaver, a cadaver heart, a simulator (e.g., having a simulated body part, heart, tissue, etc.), etc.

[0160] Although various inventive aspects, concepts and features of the present disclosure may be described and illustrated herein as being embodied in combination in example embodiments, these various aspects, concepts, and features may be used in many alternative embodiments individually or in various combinations and sub-combinations thereof. Unless expressly excluded herein, all such combinations and sub-combinations are intended to be within the scope of the present application. Further, although various alternative embodiments of various aspects, concepts, and features of the present disclosure may be described herein, such as alternative materials, structures, configurations, methods, devices, and components, alternatives to form, coordination, and function, etc., such descriptions are not intended to be complete or exhaustive lists of available alternative embodiments, whether currently known or developed later. Those skilled in the art may easily incorporate one or more inventive aspects, concepts, or features into additional embodiments and applications within the scope of the present application, even if these embodiments are not expressly disclosed herein.

[0161] In addition, even if some features, concepts, or aspects of the present disclosure may be described herein as being a preferred arrangement or method, unless expressly so specified, such description is not intended to suggest that such features are required or essential. Further, examples or representative values ​​and ranges may be included to aid in understanding the present application, however, such values ​​and ranges should not be interpreted in a limiting sense, and are intended to be critical values ​​or ranges only when so expressly specified.

[0162] In addition, while various aspects, features, and concepts may be expressly identified herein as being inventive or forming part of the present disclosure, such identification is not intended to be exclusive, and inventive aspects, concepts, and features fully described herein may exist without being expressly identified as part of such or specific disclosure, instead the present disclosure is set forth in the appended claims. The description of an example method or process is not limited to including all steps required in all cases, and the order in which the steps are presented is not to be construed as required or necessary unless expressly so provided. In addition, the therapeutic techniques, methods, operations, steps, etc. described or suggested herein may be performed in living animals or on non-living simulators such as cadavers, cadaver hearts, simulators (e.g., having simulated body parts, tissues, etc.), etc. The words used in the claims have their full different meanings and are not limited in any way by the description of the embodiments in the specification.

Claims

1. A catheter connector, comprising: a housing having a conduit connection cavity, a plurality of passages, and an outer circumferential channel, wherein the plurality of passages each connect the conduit connection cavity to the outer circumferential channel; a cap rotatably coupled to the housing, wherein the cap has an outlet port in fluid communication with the outer circumferential passageway; as well as one or more seals providing a seal between the housing and the cap, the seal directing fluid flow from the outer peripheral passageway to the outlet port; Wherein the cap is rotatable to position the outlet port in a vertical orientation without rotating the housing.

2. The catheter coupler of claim 1, wherein the outlet port is coupled to a pressure sensor.

3. The conduit coupling of any one of claims 1 and 2, wherein the one or more sealing members include a first sealing member and a second sealing member at least partially positioned within a groove on the housing.

4. The conduit coupling of claim 3, wherein the first sealing member is positioned proximate to the outer circumferential channel on a first side, and wherein the second sealing member is positioned proximate to the outer circumferential channel on a second side.

5. A method for flushing a catheter connector, comprising: securing the conduit to the housing; rotating the cap while maintaining a fixed position of the housing to position the outlet port of the cap in a top dead center position; A vacuum is applied to the outlet port.

6. A delivery system comprising: A first conduit coupler, the first conduit coupler comprising: a housing having a first conduit connection cavity, a plurality of passages, and an outer circumferential channel, wherein the plurality of passages each connect the first conduit connection cavity to the outer circumferential channel; a cap rotatably coupled to the housing, wherein the cap has an outlet port in fluid communication with an outer circumferential passage; and one or more seals providing a seal between the housing and the cap, the seal directing fluid flow from the outer peripheral passageway to the outlet port; wherein the cap is rotatable to position the outlet port in a vertical orientation without rotating the housing; a first conduit connected to the first conduit connection cavity of the first conduit coupler; A second conduit coupler, the second conduit coupler comprising: a housing having a second conduit connection cavity, a plurality of passages, and an outer circumferential channel, wherein the plurality of passages each connect the second conduit connection cavity to the outer circumferential channel; a cap rotatably coupled to the housing, wherein the cap has an outlet port in fluid communication with an outer circumferential passage; and one or more seals providing a seal between the housing and the cap, the seal directing fluid flow from the outer peripheral passageway to the outlet port; wherein the cap is rotatable to position the outlet port in a vertical orientation without rotating the housing; a second conduit connected to the second conduit connection cavity of the second conduit coupler; Wherein the second conduit extends through the first conduit coupler and the first conduit.

7. The delivery system of claim 6, further comprising a pusher element positioned within the second conduit.

8. The delivery system of claim 7, wherein a valve implant or repair device is removably connected to the pusher element.

9. The delivery system of any one of claims 6-8, wherein the outlet port of the first catheter coupler is coupled to a pressure sensor.

10. The delivery system of any one of claims 6-9, wherein the outlet port of the second catheter coupler is coupled to a pressure sensor.

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