# US 2019/0167197 A1 · Systems and methods for intra-procedural cardiac pressure monitoring

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- Number: US 2019/0167197 A1
- Document ID: US20190167197A1
- Status: Published application
- Kind: A1
- Application number: 16/321,221
- Filed: 2017-07-27
- Published: 2019-06-06
- Earliest claimed: 2016-07-28
- Assignees: Evalve, Inc.
- Applicants: Evalve, Inc.
- Inventors: Chad J. Abunassar; Brandon W. Chu; Patricia H. Ho; Koji J. Kizuka; Benjamin L. Lee; Tamer M. Mahmoud; Sean A. Mcniven; Scott C. Mosher; Santosh V. Prabhu; Lauren G. Troxler; Dylan T. Van Hoven
- Web page: https://patentgrep.com/patent/US20190167197A1

## CPC

- A61B 5/6869: {Heart}
- A61B 5/02158: {provided with two or more sensor elements}
- A61B 5/6852: {Catheters}
- A61B 17/0057: {Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect (sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009)}
- A61B 17/064: Surgical staples, {i.e. penetrating the tissue}
- A61B 17/12122: {within the heart (for closing a cardiac septal defect A61B17/0057)}
- A61B 17/12172: {having a pre-set deployed three-dimensional shape (methods of manufacturing A61B2017/00526)}
- A61B 17/122: Clamps or clips, e.g. for the umbilical cord {(for the vas deferens A61F6/206)}
- A61F 2/246: {Devices for obstructing a leak through a native valve in a closed condition}
- A61F 2/2466: {Delivery devices therefor}
- A61B 17/12177: {comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated}
- A61B 2017/00022: {Sensing or detecting at the treatment site}
- A61B 2017/00243: {cardiac}
- A61B 2017/00575: {for closure at remote site, e.g. closing atrial septum defects}
- A61B 2017/00592: {Elastic or resilient implements}
- A61B 2017/00606: {Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening}
- A61B 2017/0649: {Coils or spirals}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

The present disclosure relates to delivery devices and interventional devices configured to enable monitoring of pressure and other hemodynamic properties before, during, and/or after a cardiac procedure. A guide catheter includes a routing lumen or a routing groove for routing a sensor wire to a desired location during a cardiac procedure. A guide catheter includes one or more pressure sensors positioned to provide desired pressure measurements when the guide catheter is deploying an interventional device. An interventional device may also include one or more associated sensors for providing hemodynamic information before, during, and/or after deployment.

## Claims

### Claim 1

A delivery device configured for delivering an interventional device to a targeted treatment area within a body, the delivery device comprising:
an outer guide catheter having a proximal end and a distal end;
an inner sleeve positioned radially within the outer guide catheter and configured to be translatable within the outer guide catheter;
a delivery catheter positioned radially within the inner sleeve and configured to be translatable within the inner sleeve, the delivery catheter being configured to enable delivery of an interventional device through the inner sleeve and outer guide catheter to a targeted treatment area within a body; and
at least one sensor coupled to one or more of the outer guide catheter, inner sleeve, or delivery catheter, the at least one sensor being configured to enable monitoring of one or more hemodynamic properties of the targeted treatment area during deployment of an interventional device using the delivery device.

### Claim 2 (depends on 1)

The delivery device of claim 1, wherein the at least one sensor is configured to measure blood pressure.

### Claim 3 (depends on 1)

The delivery device of claim 1, wherein the at least one sensor is configured to measure blood flow.

### Claim 4 (depends on 1)

The delivery device of claim 1, wherein the at least one sensor includes one or more sensor wires routed through one or more wall lumens, each wall lumen disposed through a wall of the outer guide catheter, inner sleeve, or delivery catheter.

### Claim 5 (depends on 4)

The delivery device of claim 4, wherein the one or more sensor wires are routed through the delivery catheter so as to be distally extendable beyond the delivery catheter.

### Claim 6 (depends on 4)

The delivery device of claim 4, wherein the one or more sensor wires are routed through the inner sleeve so as to be distally extendable beyond the inner sleeve.

### Claim 7 (depends on 4)

The delivery device of claim 4, wherein the one or more sensor wires are routed through the outer guide catheter so as to be distally extendable beyond the outer guide catheter.

### Claim 8 (depends on 4)

The delivery device of claim 4, wherein the at least one sensor includes one or more attached sensors each attached to a point on the outer guide catheter, inner sleeve, or delivery catheter.

### Claim 9 (depends on 1)

The delivery device of claim 1, wherein the at least one sensor includes one or more attached sensors each attached to a point on the outer guide catheter, inner sleeve, or delivery catheter.

### Claim 10 (depends on 9)

The delivery device of claim 9, wherein the one or more attached sensors are each attached to a distal end of the outer guide catheter, inner sleeve, or delivery catheter.

### Claim 11 (depends on 9)

The delivery device of claim 9, wherein the one or more attached sensors are attached to the outer guide catheter.

### Claim 12 (depends on 9)

The delivery device of claim 9, wherein the one or more attached sensors are attached to the inner sleeve.

### Claim 13 (depends on 9)

The delivery device of claim 9, wherein the one or more attached sensors are attached to the delivery catheter.

### Claim 14 (depends on 9)

The delivery device of claim 9, wherein the one or more attached sensors include a plurality of sensors each attached so as to be at a different longitudinal position when the delivery device is extended into a deploying configuration.

### Claim 15 (depends on 1)

The delivery device of claim 1, wherein the at least one sensor includes a plurality of sensors, the plurality of sensors being arranged such that each sensor is positioned at a different section of the targeted treatment area when the delivery device is in a deploying configuration.

### Claim 16 (depends on 1)

The delivery device of claim 1, wherein one or more of the outer guide catheter or the inner sleeve include a steering mechanism, the steering mechanism including one or more pullwires each routed through a wall lumen of the outer guide catheter or inner sleeve.

### Claim 17 (depends on 16)

The delivery device of claim 16, wherein the targeted treatment area is a mitral valve, and wherein the delivery system is configured to enable delivery of an interventional tool to the mitral valve through a transfemoral approach.

### Claim 18

A delivery device for delivering an interventional device to a targeted treatment area within a body, the delivery device comprising:
a steerable outer guide catheter having a proximal end and a distal end;
a steerable inner sleeve positioned radially within the outer guide catheter and configured to be translatable within the outer guide catheter;
a delivery catheter positioned radially within the inner sleeve and configured to be translatable within the inner sleeve, the delivery catheter being configured to enable delivery of an interventional device through the inner sleeve and outer guide catheter to a targeted treatment area within a body; and
at least one pressure sensor coupled to one or more of the outer guide catheter, inner sleeve, or delivery catheter, the at least one pressure sensor being configured to enable monitoring of blood pressure at the targeted treatment area during deployment of an interventional device using the delivery device.

### Claim 19 (depends on 18)

The delivery device of claim 18, wherein the steerable outer guide catheter and the steerable sleeve each include a steering mechanism including one or more pullwires routed through respective wall lumens of the steerable outer catheter and steerable sleeve.

### Claim 20

A delivery device for delivering an interventional device to a mitral valve, the delivery device comprising:
a steerable outer guide catheter having a proximal end and a distal end;
a steerable inner sleeve positioned radially within the outer guide catheter and configured to be translatable within the outer guide catheter;
a delivery catheter positioned radially within the inner sleeve and configured to be translatable within the inner sleeve, the delivery catheter being configured to enable delivery of an interventional device through the inner sleeve and outer guide catheter to a targeted treatment area within a body; and
a plurality of pressure sensors coupled to one or more of the outer guide catheter, inner sleeve, or delivery catheter, the plurality of pressure sensors being arranged so as to enable monitoring of blood pressure at different areas near the mitral valve during deployment of an interventional device.

### Claim 21

A delivery device configured for delivering an interventional device to a targeted treatment area within a body, the delivery device comprising:
one or more routing catheters having respective proximal and distal ends, the one or more routing catheters being configured to transmit an interventional device to a targeted area, each of the one or more routing catheters including a catheter wall having one or more routing channels formed therein, each routing channel longitudinally extending along at least a portion of the routing catheter; and
one or more sensor wires each positioned within a respective routing channel so as to be translatable within the routing channel relative to the routing catheter, each sensor wire configured to enable monitoring of one or more hemodynamic properties of the targeted treatment area.

### Claim 22 (depends on 21)

The delivery device of claim 21, wherein the delivery device includes an outer guide catheter, an inner sleeve positioned translatably within the outer guide catheter, and a delivery catheter positioned translatably within the inner sleeve, wherein one or more of the outer guide catheter, inner sleeve, or delivery catheter are configured as the one or more routing catheters.

### Claim 23 (depends on 21)

The delivery device of claim 21, wherein the one or more routing channels include a routing lumen formed within a respective catheter wall so as to enclose a corresponding sensor wire.

### Claim 24 (depends on 23)

The delivery device of claim 23, wherein the routing lumen has a diameter of about 1 to 1.5 F.

### Claim 25 (depends on 23)

The delivery device of claim 23, wherein the one or more routing catheters include a routing catheter having a wall thickness of about 0.0200 to 0.0250 inches.

### Claim 26 (depends on 23)

The delivery device of claim 23, wherein the routing lumen is formed with an ovoid cross-sectional shape.

### Claim 27 (depends on 26)

The delivery device of claim 26, wherein the routing lumen has a major axis of about 0.014 to 0.026 inches and a minor axis of about 0.012 to 0.020 inches.

### Claim 28 (depends on 23)

The delivery device of claim 23, wherein the one or more routing catheters include a routing catheter having a keying component for locking a rotational relationship between the routing catheter and a component received within the routing catheter.

### Claim 29 (depends on 28)

The delivery device of claim 28, wherein the keying component includes one a plurality of asymmetrically radially spaced notches, wherein the routing lumen is formed in a section of the catheter wall having greater circumferential distance between adjacent notches than at least one other distance between another set of adjacent notches.

### Claim 30 (depends on 21)

The delivery device of claim 21, wherein the one or more routing channels include a routing groove formed within an exterior of a respective catheter wall so as to receive a corresponding sensor wire within a thickness of the catheter wall.

### Claim 31 (depends on 30)

The delivery device of claim 30, wherein the routing groove is configured to maintain the sensor wire within the groove through one or more extending sections that partially wrap around the sensor wire to prevent the sensor wire from dislocating from the groove.

### Claim 32 (depends on 31)

The delivery device of claim 31, wherein the one or more extending sections are configured to resiliently hold the sensor wire within the groove and to flex outwardly upon outward radial force to allow the sensor wire to be dislocated from the groove.

### Claim 33 (depends on 30)

The delivery device of claim 30, wherein the routing groove is configured as a plurality of clips disposed along a plurality of discrete sections of the routing catheter.

### Claim 34 (depends on 21)

The delivery device of claim 21, wherein the one or more routing catheters include a routing catheter having a plurality of additional lumens for housing pullwires for enabling steering of the routing catheter.

### Claim 35 (depends on 21)

The delivery device of claim 21, wherein the one or more routing catheters include a routing catheter having a distal exit point disposed at a soft distal tip of the routing catheter, the distal exit point enabling a respective sensor wire to exit a respective routing channel and extend distally from the distal exit point.

### Claim 36 (depends on 21)

The delivery device of claim 21, wherein the one or more routing catheters include a routing catheter having a proximal exit point disposed adjacent to a routing catheter handle, the proximal exit point enabling a respective sensor wire to exit a respective routing channel and extend proximally from the proximal exit point.

### Claim 37 (depends on 21)

The delivery device of claim 21, wherein the one or more routing channels include a routing channel formed through a jacketing process that includes forming a jacketing material around a mandrel and removing the mandrel to form the routing channel.

### Claim 38 (depends on 21)

The delivery device of claim 21, wherein the one or more routing channels include a routing channel that extends only across a distal section of a respective routing catheter.

### Claim 39

A delivery device configured for delivering an interventional device to a targeted treatment area within a body, the delivery device comprising:
one or more routing catheters having respective proximal and distal ends, the one or more routing catheters being configured to transmit an interventional device to a targeted area within a body, each of the one or more routing catheters including a catheter wall having one or more routing lumens formed therein, each routing lumen longitudinally extending along at least a portion of the routing catheter and having a diameter of about 1 to 1.5 F; and
one or more pressure wires each positioned within a respective routing channel so as to be translatable within the routing channel relative to the routing catheter, each pressure wire configured to enable monitoring of pressure at the targeted treatment area.

### Claim 40

A delivery device configured for delivering an interventional device to a targeted treatment area within a body, the delivery device comprising:
one or more routing catheters having respective proximal and distal ends, the one or more routing catheters being configured to transmit an interventional device to a targeted area within a body, each of the one or more routing catheters including a catheter wall having one or more routing grooves formed therein, each routing groove longitudinally extending along at least a portion of the routing catheter, at least one routing groove including one or more extending sections that partially wrap around a sensor wire to prevent the sensor wire from dislocating from the groove; and
one or more pressure wires each positioned within a respective routing channel so as to be translatable within the routing channel relative to the routing catheter, each pressure wire configured to enable monitoring of pressure at the targeted treatment area.

### Claim 41

An interventional spacer assembly configured for delivery to a targeted treatment area within a body, the spacer assembly comprising:
a spacer device having a proximal end and a distal end, the spacer device being configured for placement within a heart valve to provide a surface for coaptation of valve leaflets;
an anchoring trackwire attached to the distal end of the spacer device and extending distally therefrom, the anchoring trackwire being configured to enable anchoring into a section of myocardium when the spacer device is deployed in the valve in order to orient the spacer device relative to the valve; and
one or more sensors associated with the spacer device to enable monitoring of hemodynamic properties near the heart valve during and after deployment of the spacer device.

### Claim 42 (depends on 41)

The spacer assembly of claim 41, wherein the spacer device is configured for placement within a mitral valve.

### Claim 43 (depends on 42)

The spacer assembly of claim 42, wherein the one or more sensors includes a ventricular sensor positioned distally relative to the spacer device so as to reside within a left ventricle upon deployment of the spacer device in the mitral valve, and an atrial sensor positioned proximally relative to the spacer device so as to reside within a left atrium upon deployment of the spacer device in the mitral valve.

### Claim 44 (depends on 41)

The spacer assembly of claim 41, wherein the spacer device is fillable with one or more of a saline fluid or a foam.

### Claim 45 (depends on 41)

The spacer assembly of claim 41, wherein the one or more sensors include at least one sensor that is integrally attached to the spacer device.

### Claim 46 (depends on 41)

The spacer assembly of claim 41, wherein the one or more sensors include at least one sensor that is decoupled from the spacer device.

### Claim 47 (depends on 46)

The spacer assembly of claim 46, wherein the at least one sensor that is decoupled from the spacer device is crimpable, and wherein the crimpable sensor is attached to the anchoring trackwire through a crimping action.

### Claim 48 (depends on 41)

The spacer assembly of claim 41, wherein the one or more sensors are configured to measure pressure.

### Claim 49

An interventional spacer assembly configured for delivery to a mitral valve, the spacer assembly comprising:
a spacer device having a proximal end and a distal end, the spacer device being configured for placement within a mitral valve to provide a surface for coaptation of mitral valve leaflets;
a trackwire attached to the spacer device and extending at least distally therefrom, the trackwire being configured to enable anchoring into a section of myocardium of a left ventricle when the spacer device is deployed in the mitral valve in order to properly orient the spacer device relative to the mitral valve; and
a pair of pressure sensors associated with the spacer device and positioned on opposite sides of the spacer device to enable monitoring of pressure on either side of the mitral valve during and after deployment of the spacer device.

### Claim 50 (depends on 49)

The spacer assembly of claim 49, wherein the pair of pressure sensors are integrally attached to the spacer device.

### Claim 51 (depends on 49)

The spacer assembly of claim 49, wherein the pair of pressure sensors are decoupled from the spacer device, and wherein an atrial pressure sensor is attached to a section of the trackwire extending proximally from the spacer device and a ventricular pressure sensor is attached to a section of the trackwire extending distally from the spacer device.

### Claim 52 (depends on 51)

The spacer assembly of claim 51, wherein the pair of pressure sensors are crimpably attached to the trackwire.

### Claim 53

A method for delivering a spacer device to a mitral valve for deployment of the spacer device at the mitral valve, comprising:
delivering a tracking wire to the mitral valve by passing the tracking wire through a septum to cross into a left atrium;
passing the tracking wire through the mitral valve and anchoring the tracking wire in myocardium of a left ventricle; and
using the tracking wire to guide a spacer assembly to deploy the spacer assembly within the mitral valve, the spacer assembly including a spacer device configured to allow coaptation of mitral valve leaflets against the spacer device, and one or more sensors enabling monitoring of one or more hemodynamic properties in the vicinity of the spacer device.

### Claim 54 (depends on 53)

The method of claim 53, wherein the spacer assembly is delivered to the mitral valve as an integrated unit including the spacer device and the one or more sensors.

### Claim 55 (depends on 53)

The method of claim 53, wherein deploying the spacer assembly includes guiding a ventricular sensor using the trackwire to position the ventricular sensor within the left ventricle, coupling the ventricular sensor to the trackwire, and guiding the spacer device to the mitral valve using the trackwire.

### Claim 56 (depends on 55)

The method of claim 55, wherein deploying the spacer assembly further includes guiding an atrial sensor using the trackwire to position the atrial sensor within the left atrium, and coupling the atrial sensor to the trackwire.

### Claim 57 (depends on 56)

The method of claim 56, wherein the ventricular sensor and the atrial sensor are coupled to the trackwire by a crimping action.

### Claim 58 (depends on 53)

The method of claim 53, wherein the one or more sensors include one or more pressure sensors.

### Claim 59 (depends on 53)

The method of claim 53, wherein the one or more sensors include one or more flow sensors.

### Claim 60 (depends on 53)

The method of claim 53, wherein the one or more sensors include an atrial sensor and a ventricular sensor disposed on opposite sides of the spacer device.

### Claim 61

An interventional chord replacement assembly configured for attachment to a targeted heart valve, the chord replacement assembly comprising:
a chord replacement device having a proximal end and a distal end, the chord replacement device being configured for attachment to a heart valve to tether the heart valve to a section of myocardium of the heart;
one or more sensors coupled to the chord replacement device to enable monitoring of hemodynamic properties associated with the heart valve during and after deployment of the chord replacement device; and
an access component configured to be positioned outside the heart and configured to enable adjustment of the length of the cord replacement device.

### Claim 62 (depends on 61)

The chord replacement assembly of claim 61, wherein the chord replacement assembly is configured for attachment to a mitral valve, and wherein the one or more sensors includes an atrial sensor configured to be positioned in a left atrium upon attachment of the device to the mitral valve.

### Claim 63 (depends on 61)

The chord replacement assembly of claim 61, wherein the one or more sensors includes at least one sensor configured to monitor pressure.

### Claim 64 (depends on 63)

The chord replacement assembly of claim 63, wherein the one or more sensors includes an atrial sensor positioned above a mitral valve to measure left atrial pressure when the chord replacement device is attached to the mitral valve, and a ventricular sensor positioned below the mitral valve to measure left ventricular pressure when the chord replacement device is attached to the mitral valve.

### Claim 65 (depends on 61)

The chord replacement assembly of claim 61, wherein the access component is engageable with a tensioning tool to enable tensioning or loosening of the chord replacement device.

### Claim 66

A method for attaching a chord replacement device to a mitral valve, the method comprising:
delivering a chord replacement device to the mitral valve;
attaching a proximal end of the chord replacement device to a leaflet of the mitral valve;
anchoring a distal end of the chord replacement device to myocardium located at an apex of a left ventricle, the distal end of the chord replacement device extending through the myocardium to couple to an access component disposed on an exterior of the myocardium, the access component being coupled to the chord replacement device so as to enable adjustment to the length of the chord replacement device;
receiving hemodynamic information from one or more sensors coupled to the chord replacement device; and
based on the received hemodynamic information, adjusting the length of the chord replacement device.

### Claim 67 (depends on 66)

The method of claim 66, wherein the hemodynamic information is received by a controller coupled to the access component, the controller being operable to automatically adjust the length of the chord replacement device based on the received hemodynamic information.

### Claim 68 (depends on 67)

The method of claim 67, wherein the hemodynamic information comprises blood pressure measurements.

### Claim 69 (depends on 67)

The method of claim 67, wherein the controller is operable to automatically adjust the length of the chord replacement device by actuating a tension spool.

### Claim 70 (depends on 66)

The method of claim 66, wherein the adjusting the length of the chord replacement device is accomplished using a tensioning tool configured to engage with the access component.

### Claim 71

An interventional assembly configured for deployment at a targeted heart valve, the interventional assembly comprising:
an adjustable interventional device configured for deployment at the targeted heart valve to reduce a level of regurgitation at the heart valve, the adjustable interventional device including a connector that extends, when the interventional device is deployed at the heart valve, into a ventricular area to attach to myocardium in the ventricular area;
an actuator component disposed external to the myocardium and opposite the connector, the connector extending through the myocardium to couple with the actuator component;
one or more sensors coupled to the adjustable interventional device, the one or more sensors being configured to gather hemodynamic information; and
a controller communicatively associated with the one or more sensors and with the actuator component, the controller being configured to receive hemodynamic information from the one or more sensors and, in response, direct the actuator component to adjust the adjustable interventional device according to the hemodynamic information.

### Claim 72 (depends on 71)

The interventional assembly of claim 71, wherein the one or more sensors include at least one sensor configured to monitor pressure.

### Claim 73 (depends on 71)

The interventional assembly of claim 71, wherein the adjustable interventional device is a chord replacement device.

### Claim 74 (depends on 73)

The interventional assembly of claim 73, wherein the actuator component is configured to adjust the tension of the chord replacement device by actuating a tension spool.

### Claim 75 (depends on 74)

The interventional assembly of claim 74, wherein the controller is configured to direct the actuation component to tighten the chord replacement device upon receiving hemodynamic information indicating a level of regurgitation as exceeding a predetermined threshold.

### Claim 76 (depends on 71)

The interventional assembly of claim 71, wherein the actuator component is configured as a fluid port, and wherein the adjustable interventional device is configured as an adjustable spacer.

### Claim 77 (depends on 76)

The interventional assembly of claim 76, further comprising a fluid reservoir in fluidic communication with the fluid port, the fluid reservoir being configured to provide fluid for adding to the spacer and to store fluid withdrawn from the spacer, and wherein the connector is configured as a conduit for transporting the fluid between the spacer and the fluid reservoir.

### Claim 78 (depends on 77)

The interventional assembly of claim 77, wherein the controller is configured to direct the fluid port to add fluid to or withdraw fluid from the spacer in response to receiving hemodynamic information indicating exceedance of a predetermined threshold.

### Claim 79 (depends on 78)

The interventional assembly of claim 78, wherein the controller is configured to direct the fluid port to add fluid to the spacer in response to receiving hemodynamic information indicating that a level of regurgitation exceeds a predetermined threshold

### Claim 80 (depends on 71)

The interventional assembly of claim 71, wherein the one or more sensors include an atrial sensor and a ventricular sensor.

### Claim 81

An interventional occluder assembly configured for deployment at a targeted treatment site, the occluder assembly comprising:
an occluder device configured to occlude a defect at the treatment site;
one or more sensors extending from the occluder device, the one or more sensors being configured to measure one or more hemodynamic properties; and
a connector disposed between the occluder device and the one or more sensors, the connector being configured in size and shape to direct the one or more sensors from the occluder device to one or more desired hemodynamic measurement areas when the occluder device is deployed.

### Claim 82 (depends on 81)

The occluder assembly of claim 81, wherein the occluder device is configured as a left atrial appendage occluder.

### Claim 83 (depends on 82)

The occluder assembly of claim 82, wherein the one or more sensors extend from the occluder device, when the occluder device is deployed in a left atrial appendage, so as to position at least one of the one or more sensors above the mitral valve.

### Claim 84 (depends on 81)

The occluder assembly of claim 81, wherein the occluder device is configured as a septal occluder.

### Claim 85 (depends on 84)

The occluder assembly of claim 84, wherein the one or more sensors extend from the occluder device, when the occluder device is deployed in a septal defect, so as to position at least one of the one or more sensors above the mitral valve.

### Claim 86

An interventional tissue fixation assembly, comprising:
a tissue fixation clip including a pair of distal elements rotatably joined to a coupling member and a pair of proximal elements resiliently biased toward the distal elements, the distal elements being configured to receive the proximal elements so as to enable the grasping of tissue therebetween;
one or more mounts configured to be attachable to the clip; and
one or more sensors configured to be attachable to the one or more mounts, the one or more sensors being configured to measure one or more hemodynamic properties.

### Claim 87 (depends on 86)

The tissue fixation assembly of claim 86, wherein the one or more mounts include a distal mount configured to couple to a distal side of the clip and to extend distally from the clip.

### Claim 88 (depends on 87)

The tissue fixation assembly of claim 87, wherein the one or more mounts include a proximal mount configured to couple to a proximal side of the clip and to extend proximally from the clip.

### Claim 89 (depends on 86)

The tissue fixation assembly of claim 86, wherein the one or more mounts include a proximal mount configured to couple to a proximal side of the clip and to extend proximally from the clip.

### Claim 90 (depends on 89)

The tissue fixation assembly of claim 89, wherein the clip includes a connector extending proximally from the coupling member, the connector including a proximal coupler configured to receive the proximal mount.

### Claim 91 (depends on 90)

The tissue fixation assembly of claim 90, wherein the proximal coupler is also configured for detachably coupling to a delivery mechanism, such that the clip may be deployed by the delivery mechanism and detached from the delivery mechanism prior to receiving the proximal mount.

### Claim 92 (depends on 90)

The tissue fixation assembly of claim 90, wherein the proximal coupling of the neck portion is proximally flared to define a neck in the connector.

### Claim 93 (depends on 89)

The tissue fixation assembly of claim 89, wherein the proximal mount includes an orifice enabling threading of the proximal mount upon a guidewire.

### Claim 94

An interventional mitral valve fixation assembly, comprising:
a mitral valve fixation clip including a pair of distal elements rotatably joined to a coupling member and a pair of proximal elements resiliently biased toward the distal elements, the distal elements being configured to receive the proximal elements so as to enable the grasping of mitral valve leaflets therebetween;
a distal mount coupled to the coupling member and extending distally from the coupling member;
a proximal mount joined to the clip member and extending proximally from the clip; and
one or more pressure sensors mounted in each of the distal mount and the proximal mount, the one or more sensors being configured to measure left atrial and left ventricular pressure during and/or after deployment of the fixation clip.

### Claim 95 (depends on 94)

The mitral valve fixation assembly of claim 94, further comprising a connector joined to the coupling member and extending proximally from the coupling member, the connector including a proximal coupler configured to engage with the proximal mount to enable attachment of the proximal mount.

### Claim 96 (depends on 95)

The mitral valve fixation assembly of claim 95, wherein the proximal mount and the connector are connectable via a snap-fitting mechanism.

### Claim 97

A method for deploying a tissue fixation device at a heart valve, the method comprising:
using a delivery catheter, delivering a tissue fixation clip to the heart valve and passing the tissue fixation clip from a proximal side through the heart valve to a distal side;
positioning a pair of distal elements on a distal side of heart valve tissue;
lowering a pair of proximal elements onto a proximal side of the heart valve tissue so as to grasp the heart valve tissue between the distal elements and the proximal elements;
decoupling the delivery catheter from the tissue fixation clip; and
delivering a proximal mount to the proximal side of the deployed clip and attaching the proximal mount to the clip, the proximal mount including one or more sensors for measuring one or more hemodynamic properties.

### Claim 98 (depends on 97)

The method of claim 97, wherein the tissue fixation clip includes a connector extending proximally from a body of the clip and providing coupling of the clip to the delivery catheter.

### Claim 99 (depends on 98)

The method of claim 98, wherein the delivery catheter is decoupled from the clip by detaching from the connector, and wherein the proximal mount is attached to the clip by attaching to the connector.

### Claim 100 (depends on 97)

The method of claim 97, wherein the tissue fixation clip includes a distal mount extending distally from the clip, the distal mount including one or more sensors for measuring one or more hemodynamic properties.

### Claim 101

An interventional annuloplasty assembly configured for deployment at a targeted treatment site, the annuloplasty assembly comprising:
an annuloplasty device having a lumen;
a plurality of anchors positionable within the lumen so as to anchor the annuloplasty device along a plurality of corresponding positions;
a connecting wire connecting the plurality of anchors such that tensioning of the connecting wire brings the plurality of anchors closer together to tighten the annuloplasty device; and
one or more sensors coupled to the connecting wire of the annuloplasty device, the one or more sensors being configured to measure one or more hemodynamic properties at a targeted treatment site upon deployment of the annuloplasty assembly at the targeted treatment site.

### Claim 102 (depends on 101)

The annuloplasty assembly of claim 101, wherein the annuloplasty device is configured for placement around at least a portion of a perimeter of an annulus of an atrioventricular cardiac valve.

### Claim 103 (depends on 102)

The annuloplasty assembly of claim 102, wherein the one or more sensors are configured to protrude, when the annuloplasty device is deployed, atrially and/or ventricularly.

### Claim 104 (depends on 101)

The annuloplasty assembly of claim 101, wherein the plurality of anchors are configured as helical screws.

### Claim 105 (depends on 101)

The annuloplasty assembly of claim 101, wherein the one or more sensors are attached to respective anchors.

### Claim 106 (depends on 101)

The annuloplasty assembly of claim 101, wherein the one or more sensors are threaded through by the connecting wire.
