Multi-sensor pressure guidewire and connectors for structural heart procedures

Abstract

A guidewire is disclosed comprising a distal tip, a distal shaft, and a proximal shaft, and a distal sensor configured to measure a distal pressure and transmit a distal sensor signal through a distal fiber; and a proximal sensor housing connected distally to the distal shaft on one end and connected to the proximal shaft on another end, the proximal sensor housing partially enclosing a portion of the distal fiber, a tip of a proximal fiber, and a proximal sensor connected to the proximal fiber and configured to measure a proximal pressure. A guidewire connector and a guidewire coupler, as well as methods of manufacturing thereof are also provided.

Description

File No. : P6314PC00MULTI-SENSOR PRESSURE GUIDEWIRE AND CONNECTORS FOR STRUCTURAL HEART PROCEDURESTECHNICAL FIELD

[0001] The present disclosure relates to pressure guidewires for coronary, peripheral and structural heart procedures. More specifically, it relates to pressure guidewires for sensing the blood pressure in multiple points.BACKGROUND

[0002] Guidewires are known for delivering catheters to many vascular locations in the body. Guidewires were initially used mainly in coronary and peripheral interventions but have recently been proposed also for structural heart procedures.

[0003] A heart has four valves, which maintain the flow of blood: mitral, tricuspid, pulmonary and aortic valves. In order to determine the strength needed to open the valve, two measurements of pressure may be performed: one pressure measurement on one side of the valve and another pressure measurement on the other side of the valve. These measurements allow to obtain the pressure gradient required to open the valve.

[0004] Usually, to obtain several measurements of pressure along a blood vessel or in a particular point of the heart, fluid-filled catheters are used in combination with an external pressure sensor. To measure a valve gradient, two of those catheters are required in order to obtain simultaneous pressure from both sides of the valves. Additional steps and the use of several devices to perform this measurement is a major inconvenience and is the main reason why invasive hemodynamic gradient measurement is now avoided by many physicians during aortic valve procedures. In percutaneous procedure of other valves, it might be impossible to have a secondary access for an additional catheter to measure pressure on one side of the valve during the intervention. This is the case for transseptal mitral valve implantations, where it is difficult to measure pressure in the left atrium with a catheter. Similarly, with the currently available devices, it may be not only inconvenient, but also sometimes impossible to measure pressure around pulmonary valves. Using the conventional fluid-filled pressure sensors may be also difficult, because they may suffer from leaks, air bubbles, errors from incorrect height adjustment, over- and under-damping, and other undesirable characteristics.File No. : P6314PC00

[0005] Therefore, it would be useful to develop techniques and devices that would allow simultaneous measurements of blood pressure in different positions of the same blood vessel without having to use any adjunct device such as fluid-filled catheter and external pressure sensor.SUMMARY

[0006] It is an object of the present disclosure to provide a multi-sensor pressure guidewire and connectors therefor for coronary, peripheral, and structural heart procedures and methods of manufacturing of the multi-sensor pressure guidewire and the connectors.

[0007] According to one aspect of the disclosed technology, there is provided a guidewire comprising: a distal tip, a distal shaft, and a proximal shaft attached to a guidewire connector; a distal sensor housing having a distal pressure sensor therein, the distal pressure sensor being configured to measure a distal pressure and configured to transmit a distal sensor signal through a distal fiber from and towards the distal pressure sensor, the distal sensor housing being connected to the distal tip on one end and to the distal shaft on another end, the distal shaft having the distal fiber located therein and running towards the distal pressure sensor; and a proximal sensor housing connected distally to the distal shaft on one end and connected to the proximal shaft on another end, the proximal sensor housing partially enclosing a portion of the distal fiber, a tip of a proximal fiber, and a proximal sensor connected to the proximal fiber and configured to measure a proximal pressure. In at least one embodiment, the guidewire connector has a keyed surface. The guidewire connector may be made directly within the proximal shaft of the guidewire. The keyed surface may be implemented on a tube welded or glued over the shaft. The keyed surface may be located on the proximal shaft, extending from a guidewire facet to between 1 mm and 10 mm distally. The keyed surface may be located distal to a guidewire proximal end, and a tube portion of the guidewire proximal end has a circular cross-section. The keyed surface may be located at between 1 millimeter (mm) and 10 mm distal to the guidewire proximal end.

[0008] The guidewire connector may comprise: a shaft having an outside shaft surface and comprising at least the distal fiber and the proximal fiber located within a connector shaft lumen; and the keyed surface located on the outside shaft surface, the keyed surface being oriented at a predetermined angle with a virtual plane formed by central axes of the distal fiber and the proximal fiber for aligning the distal fiber and the proximal fiber with receiving fibers of a receiving connector. The keyed surface may be flat forming a flat keyed surface. The keyed surface may further comprise a bump or a spine. The keyed surface may have a groove. The keyed surface may have a V-groove. The keyed surface may be concave forming a recess within the shaft, the recess configured to receive therein at least partially an alignment device therein, the keyed surface having a concave surfaceFile No. : P6314PC00 radius that is equal to or less than a radius of a curvature of an aligning surface of the alignment device. The alignment device may be an aligning ball.

[0009] The guidewire connector may comprise: an insert having a body with at least two longitudinal fiber bores, each fiber bore being configured to receive one of the proximal fiber and the distal fiber therein, and an insert key on an outer surface; and a connector tube being coaxial with the insert and configured to envelope the insert and a portion of a shaft, the connector tube having a connector tube key configured to abut the insert key to restrict rotational movement of the insert relative to the connector tube and the proximal shaft. The proximal pressure sensor and the distal pressure sensor may be located at different longitudinal locations in one double sensor housing. The double sensor housing may comprise at least one temperature sensor. The guidewire may further comprise another sensor housing having a third pressure sensor or a temperature sensor therein. The proximal shaft, the distal shaft, or both the proximal and the distal shaft may have an electrical insulating layer. The guidewire may further comprise a coil or a sleeve over the proximal shaft or the distal shaft or over both the proximal and the distal shaft. The proximal sensor housing may be welded to the proximal shaft and the distal shaft, and the distal sensor housing may be welded to the distal shaft and the distal tip. The guidewire may further comprise an intermediate sensor and an intermediate sensor fiber, the intermediate sensor being a temperature sensor or a pressure sensor. The intermediate sensor may be located in an intermediate sensor housing attached to an intermediate shaft section attached on another side to the proximal sensor housing. The intermediate sensor may be located in the distal housing or the proximal housing. In at least one embodiment, the proximal fiber and the distal fiber are electric wires, the proximal sensor and the distal sensor are piezoelectric sensors, and the distal sensor signal and the proximal sensor signal are electrical signals. In at least one embodiment, the proximal fiber and the distal fiber are optical fibers, and the proximal pressure sensor and the distal pressure sensor are optical sensors, and the distal sensor signal and the proximal sensor signal are optical signals.

[0010] The guidewire may further comprise a temperature sensor and a temperature sensor fiber configured to transmit a temperature signal from the temperature sensor. The temperature sensor may be located in the distal sensor housing. The temperature sensor may be located in the proximal sensor housing which has a radiopaque marker or in the distal sensor housing which has a radiopaque marker. The guidewire may further comprise a distancing device configured to distance the proximal sensor from the distal fiber running within the proximal sensor housing. The distancing device may be a sensor ring embracing the proximal fiber and having an outside diameter larger than a sensor head. The distancing device may be a distancing ring that encircles at least partially the distal fiber within the proximal sensor housing.File No. : P6314PC00

[0011] The guidewire may further comprise an intermediate shaft positioned between the proximal sensor housing and the proximal shaft. The intermediate shaft may be connected to the proximal shaft via a shaft union tube. The intermediate shaft may be more flexible compared to the proximal shaft, the intermediate shaft being configured to bend sharply. A shaft union tube may be attached to the proximal shaft and to the intermediate shaft, the intermediate shaft being more flexible compared to the proximal shaft. The intermediate shaft, the shaft union tube, and the proximal shaft may be connected by an adhesive having a conductive material. The intermediate shaft may be made of nitinol. The distal shaft may be more flexible than the proximal shaft. A diameter of the intermediate shaft may be less than the diameter of the proximal shaft. The guidewire may further comprise a prebent shaft section.

[0012] According to another aspect of the disclosed technology, there is provided a connector for a guidewire having at least two fibers located longitudinally therein, the connector comprising: a shaft having an outside shaft surface and a lumen, having portions of the at least two fibers located longitudinally within the lumen; and a keyed surface located on the outside shaft surface, the keyed surface being oriented at a pre-determined angle with a virtual plane formed by central axes of two fibers of the at least two fibers for aligning the at least two fibers with fibers of another connector. The keyed surface may be implemented on a tube welded or glued over the shaft. The keyed surface may be flat forming a flat keyed surface. The keyed surface may have a spine or a bump. The keyed surface may have a groove. The keyed surface may have a V-groove. The keyed surface may be concave forming a recess within the shaft, the recess configured to receive therein at least partially an alignment device therein, the keyed surface having a concave surface radius that is less than a radius of a curvature of an aligning surface of the alignment device. The alignment device may be an aligning ball.

[0013] In at least one embodiment, the connector comprises: an insert having a body with at least two longitudinal fiber bores, each fiber bore being configured to receive one of the at least two fibers therein, and an insert key on an outer surface; and a connector tube being coaxial with the insert and configured to envelope the insert and a portion of the shaft, the connector tube having a connector tube key configured to abut the insert key to restrict rotational movement of the insert relative to the connector tube and the proximal shaft.

[0014] In at least one embodiment, the connector may be a guidewire connector, and the other connector may be a receiving connector having receiving fibers therein. The connector may be made directly within a proximal shaft of the guidewire. The keyed surface may be located on a proximal shaft distally from a guidewire facet. The keyed surface may be located distal to a guidewire proximalFile No. : P6314PC00 end, and a tube portion of the guidewire proximal end has a circular cross-section. The keyed surface may be located at between 1 millimeter (mm) and 10 mm distal to the proximal end. In at least one embodiment, the connector may be a receiving connector, and the other connector may be a guidewire connector having guidewire fibers therein.

[0015] According to another aspect of the disclosed technology, there is provided an assembly comprising the receiving connector and a guidewire coupler having aligning devices configured to abut keyed surfaces of the receiving connector and the guidewire connector simultaneously to align and restrict rotational movement of the guidewire fibers relative to the receiving fibers.

[0016] According to a further aspect of the disclosed technology, there is provided a guidewire comprising: a distal tip, a distal shaft, and a proximal shaft attached to a guidewire connector; a distal sensor housing having a temperature sensor therein, the temperature sensor being configured to measure a distal temperature and configured to transmit a temperature signal through a distal fiber from and towards the temperature sensor, the distal sensor housing being connected to the distal tip on one end and to the distal shaft on another end, the distal shaft having the distal fiber positioned within a distal shaft lumen located in the distal shaft and running towards the temperature sensor; and a proximal sensor housing connected distally to the distal shaft on one end and connected to the proximal shaft on another end, the proximal sensor housing partially enclosing a portion of the distal fiber, a tip of a proximal fiber, and a proximal sensor connected to the proximal fiber and configured to measure a proximal pressure. The distal sensor housing may also have a distal pressure sensor configured to measure a distal blood pressure and configured to transmit a distal pressure signal through another distal fiber.

[0017] According to a further aspect of the disclosed technology, there is provided a connecting sleeve for aligning a guidewire connector having a first keyed surface with a receiving connector having a second keyed surface, the connecting sleeve having a bore therein for receiving, coaxially, the guidewire connector therein, and a first sleeve opening on a side wall, the first sleeve opening being configured to receive a first alignment device therein to pass through the first sleeve opening and to abut the keyed surface of the guidewire connector to lock a rotation of the guidewire connector relative to the connecting sleeve; and a second sleeve opening on the side wall of the connecting sleeve, the second sleeve opening being configured to receive a second alignment device therein to pass through the second sleeve opening and to abut another keyed surface of the receiving connector to lock a rotation of the receiving connector relative to the connecting sleeve. The first sleeve opening may be a groove, and the alignment device may be a connecting slit. The first alignment device or the second alignment device may be spring-loaded, or both the first alignmentFile No. : P6314PC00 device and the second alignment device may be spring-loaded. The first alignment device or the second alignment device may have a rounded tip, or both the first alignment device and the second alignment device have a rounded tip. In at least one embodiment, the second alignment device may be the same component as the first alignment device. For example, the first alignment device and the second alignment device may be combined in one alignment device, such as, for example, a long spine, that fits both the guidewire connector and receiving connector.

[0018] According to a further aspect of the disclosed technology, there is a provided a guidewire coupler for coupling a guidewire connector and a receiving connector, the guidewire coupler comprising the connecting sleeve, the first alignment device and the second alignment device. In at least one embodiment, the first alignment device has a first aligning surface and the second alignment device has a second aligning surface, both configured to abut and fix the keyed surface of the guidewire connector and the receiving keyed surface of the receiving connector with respect to the connecting sleeve. The first alignment device, or the second alignment device may be spring- loaded, or both the first alignment device and the second alignment device may be spring-loaded. The first alignment device or the second alignment device may comprise a spring-loaded rounded component, or both the first alignment device and the second alignment device may comprise spring- loaded rounded components.

[0019] According to a further aspect of the disclosed technology, there is provided a fiber optic interface cable assembly comprising the guidewire coupler and a portion of the receiving connector located in the connecting sleeve. A connecting sleeve for aligning the guidewire connector with the receiving connector is also described, the connecting sleeve having a bore therein for receiving the guidewire connector therein, and an alignment surface configured to mate with the keyed surface of the guidewire connector and with another keyed surface of the receiving connector simultaneously. In at least one embodiment, the connecting sleeve has a bore therein for receiving the guidewire connector therein, and an alignment surface configured to mate with the keyed surface of the guidewire connector and with the receiving connector simultaneously.

[0020] According to another aspect of the disclosed technology, there is provided a connector assembly comprising: an insert having a body with at least two longitudinal fiber bores, each fiber bore being configured to receive a fiber therein, and an insert key on an outer surface; and a connector tube being coaxial with the insert and configured to envelope the insert and a portion of a shaft, the connector tube having a connector tube key which is complementary to the insert key. The connector tube key may be a slit and the insert key may be an insert spine. The connector tube key and the insert key may be visual indicators that allow aligning the connector tube and the insertFile No. : P6314PC00 visually or using automated cameras during assembly. The insert may be manufactured by a three- dimensional (3D) printer. The shaft may be a guidewire shaft of a guidewire or a receiver shaft of a receiver connector.

[0021] According to another aspect of the disclosed technology, there is provided a method for assessing regurgitation using a temperature-pressure guidewire having a temperature sensor located in a sensor housing having a radiopaque marker, the method comprising: receiving temperature measurements from the temperature sensor before and after an injection of a liquid into aorta over a valve to determine a temperature decrease due to the injection of the liquid; based on two angiography images, a first angiography image being obtained before injecting the liquid into aorta over the valve and a second angiography image being obtained after injecting the liquid into aorta, determining a distance between the temperature sensor and the valve; and in response to the temperature decrease being more than a pre-determined threshold of the temperature decrease, determining a level of the regurgitation. In at least one embodiment, the method further comprises determining and alerting a user whether to increase or to decrease the distance between the temperature sensor and the valve in order to determine the level of the regurgitation. The liquid may be a contrast or a saline solution. The liquid may be at a temperature colder than the body temperature of the patient. For example, the liquid may have a room temperature or lower.

[0022] According to another aspect of the disclosed technology, there is provided a method of manufacturing of a guidewire connector and a receiving connector which are configured to couple a guidewire with an output cable using a guidewire coupler, the method comprising: placing two or more fibers parallel to each other inside a tube along a tube longitudinal axis and gluing the fibers to the tube therein; grinding out a segment of the tube to manufacture a keyed preform with a keyed surface; and cutting the keyed preform approximately in a middle of the keyed surface and perpendicular to the tube longitudinal axis to obtain the guidewire connector having a guidewire connector keyed surface and the receiving connector having a receiving connector keyed surface. The method may further comprise attaching the guidewire connector to a shaft of the guidewire and attaching the receiving connector to the output cable. The fibers may be optical fibers or electric wires.

[0023] In at least one embodiment, a method of use of the guidewire connector and the receiving connector, each manufactured according to the method of manufacturing of a guidewire connector and a receiving connector, comprises: aligning the guidewire connector and the receiving connector such that the guidewire connector keyed surface of the guidewire connector and the receivingFile No. : P6314PC00 connector keyed surface each abuts a corresponding aligning surface of a corresponding alignment device of the guidewire coupler.

[0024] According to a further aspect of the disclosed technology, there is provided an alignment jig for aligning of fibers with respect to a keyed surface in a guidewire connector, the alignment jig comprising: a jig block having a ferrule cavity configured to receive at least two ferrules on one side of the jig block and a keyed alignment ferrule on another side, the keyed alignment ferrule having a bore therein for receiving, coaxially with the bore, at least a portion of the guidewire connector with the keyed surface, the keyed alignment ferrule having an alignment ferrule key and the guidewire connector having the keyed surface, wherein each one of the keyed surface of the guidewire connector, the alignment ferrule key and a jig key receives a portion of a locking element which is configured to fix rotation positions of the guidewire connector with respect to the alignment jig. The keyed alignment ferrule may have a groove for receiving the portion of a jig spine therein, the jig spine being configured to enter and abut a connector groove of the guidewire connector to lock the circular orientation of the guidewire connector with respect to the jig block.

[0025] According to a further aspect of the disclosed technology, there is provided a guidewire coupler for connecting and aligning a guidewire connector with a receiving connector, the guidewire coupler comprising: a connection tube having a bore therein for receiving therein, coaxially, at least a portion of the guidewire connector at one end and at least a portion of the receiving connector at another end; a first opening on a side of the connection tube for receiving a first alignment device for abutting a first keyed surface of the guidewire connector; and a second opening for receiving a second alignment device, configured to abut a second keyed surface of the receiving connector.

[0026] The first opening may be a groove and the first alignment device may be a spine. The second opening may be a groove and the second alignment device may be a spine. Both the first and second openings may be grooves and the first alignment device and the second alignment device may be spines. The first opening and the second opening may form one side opening, and the first alignment device and the second alignment device may form one alignment device configured to abut simultaneously the first and the second keyed surfaces. At least one of the first and second openings may be a window opening and the alignment device may be a spring-loaded rounded component configured to pass therethrough. The connection tube may have a cross-section other than round. An interface cable assembly is also disclosed according to a further aspect of the disclosed technology, the interface cable assembly comprising the guidewire coupler and a portion of the receiving connector located coaxially therein, wherein a rotation of the receiving connector is locked by an alignment device.File No. : P6314PC00

[0027] According to another aspect of the disclosed technology, there is provided a method of manufacturing of a connector for a guidewire using an alignment jig comprising a connector tube and at least two fiber ferrules, the method comprising: placing at least two fiber ferrules on one side of the alignment jig and the connector or a shaft on another side of the alignment jig, and locking a rotational position of the connector relatively to the alignment jig, the connector having a fiber ferrule side looking towards the fiber ferrules and an outer side looking outside of the alignment jig; threading at least two fibers inside the connector or the shaft along a longitudinal axis of the connector, each one of the at least two fibers being also threaded through a bore of one corresponding fiber ferrule; gluing the at least two fibers at the fiber ferrule side of the connector to attach the at least two fibers stretching from the at least two fiber ferrules to the connector on the ferrules side; and cutting and grinding the at least two fibers at the ferrule side of the connector. In at least one embodiment, the locking of the rotational position of the connector relatively to the alignment jig comprises placing a portion of a locking element into a keyed surface of the connector and another portion of the locking element into an alignment ferule key of the alignment jig. The locking element may be a jig spine, the alignment ferule key may be a jig groove, and the keyed surface may comprise a groove. The connector may be a guidewire connector or a receiving connector.

[0028] According to a further aspect of the disclosed technology, there is provided a method of manufacturing of a connector for a guidewire, the method comprising: inserting a portion of a shaft into a portion of a longitudinal insert bore of a connector tube, the connector tube having a connector tube key on a side wall; passing each one of at least two fibers, exiting the shaft and the connector tube attached thereto, through a corresponding longitudinal fiber bore in a keyed insert, the keyed insert having therein at least two longitudinal fiber bores located longitudinally and an insert key on an outer surface of the insert; placing the keyed insert coaxially with the connector tube attached to a portion of the shaft of the guidewire and inserting the keyed insert into the connector tube to envelope, by the connector tube, in addition to the portion of the shaft, the keyed insert, the connector tube having a connector tube key configured to receive the insert key therein to prevent rotation of the keyed insert relative to the connector tube; and gluing the at least two fibers to the keyed insert at an insert facet and cut the at least two fibers at or in a vicinity of the insert facet. The connector may be a receiving connector or a guidewire connector.

[0029] According to another aspect of the disclosed technology, there is provided a guidewire comprising a distal tip, a distal shaft, and a proximal shaft, and a distal sensor configured to measure a distal pressure and transmit a distal sensor signal through a distal fiber; and a proximal sensor housing connected distally to the distal shaft on one end and connected to the proximal shaft on another end, the proximal sensor housing partially enclosing a portion of the distal fiber, a tip of aFile No. : P6314PC00 proximal fiber, and a proximal sensor connected to the proximal fiber and configured to measure a proximal pressure. A guidewire connector and a guidewire coupler, as well as methods of manufacturing thereof are also provided.BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Further features and advantages of the present disclosure will become apparent from the following detailed description, taken in combination with the appended drawings, in which:

[0031] Fig 1A schematically illustrates a diagnostic system that uses a multi-sensor pressure guidewire adapted for facilitating delivery of a structural heart device and measuring pressure, in accordance with at least one embodiment of the present disclosure;

[0032] Fig. 1B is a schematic diagram of the multi-sensor pressure guidewire located in a heart and placed therein via an aortic valve, in accordance with at least one embodiment of the present disclosure;

[0033] Fig. 1 C is a schematic diagram of the multi-sensor pressure guidewire located in the heart and placed therein via a mitral valve, in accordance with at least one embodiment of the present disclosure;

[0034] Fig. 1 D is a schematic diagram of the multi-sensor pressure guidewire located in the heart and placed therein via a tricuspid valve, in accordance with at least one embodiment of the present disclosure;

[0035] Fig. 2A is a sectional view of the multi-sensor pressure guidewire having two sensors, in accordance with at least one embodiment of the present disclosure;

[0036] Fig 2B is a cross-sectional view of the multi-sensor pressure guidewire of Fig. 2A along the line A-A;

[0037] Fig. 2C is a cross-sectional view of the multi-sensor pressure guidewire of Fig. 2A along the line B-B;

[0038] Fig 2D illustrates a side view of the multi-sensor pressure guidewire of Fig. 2A, in accordance with at least one embodiment of the present disclosure;

[0039] Fig 2E is a sectional view of the multi-sensor pressure guidewire having two pressure sensors located in one double sensor housing, in accordance with at least one embodiment of the present disclosure;File No. : P6314PC00

[0040] Fig. 3A is a schematic side view of a multi-sensor pressure guidewire having three sensors, including an intermediate sensor, in accordance with at least one embodiment of the present disclosure;

[0041] Fig. 3B is a cross-sectional view of the multi-sensor pressure guidewire of Fig. 3A along the line C-C;

[0042] Fig. 3C is a cross-sectional view of the multi-sensor pressure guidewire of Fig. 3A along the line D-D;

[0043] Fig. 4A is a schematic side view of a proximal pressure sensor housing for a proximal sensor of the multi-sensor pressure guidewire of Fig. 2A, in accordance with at least one embodiment of the present disclosure;

[0044] Fig. 4B is a cross-sectional view of a sensor with a ring, in accordance with at least one embodiment;

[0045] Fig. 4C illustrates a side view of a portion of a proximal pressure sensor housing, in accordance with at least one embodiment;

[0046] Fig. 4D illustrates a cross-sectional view of a distal pressure sensor housing for a distal sensor of the multi-sensor pressure guidewire of Fig. 2A, in accordance with at least one embodiment of the present disclosure;

[0047] Figs. 5A-5C schematically illustrate a multi-sensor guidewire with various configurations of a shaft, in accordance with various embodiments of the present disclosure;

[0048] Fig 5D illustrates a multi-sensor guidewire with a temperature sensor and a pressure sensor, accordance with at least one embodiment of the present disclosure;

[0049] Fig. 5E illustrates a multi-sensor guidewire with a temperature sensor and two pressure sensors, accordance with at least one embodiment of the present disclosure;

[0050] Fig 5F schematically illustrates a multi-sensor guidewire, which is capable to sharply bend, in accordance with at least one embodiment of the present disclosure;

[0051] Fig 6A schematically illustrates a receiver connector, in accordance with at least one embodiment of the present disclosure;

[0052] Fig. 6B illustrates an interface cable handler with a guidewire coupler, in accordance with at least one embodiment of the present disclosure;File No. : P6314PC00

[0053] Fig. 6C illustrates a cross-sectional view of interface cable handler of Fig. 6B with the guidewire coupler, in accordance with at least one embodiment of the present disclosure;

[0054] Fig. 7A is a perspective view of a guidewire connector of the multi-sensor pressure guidewire of Fig. 2A, in accordance with at least one embodiment of the present disclosure;

[0055] Fig 7B is a side view of a guidewire connector and a receiving connector which are connected to each other using a flat alignment mechanism of a guidewire coupler, in accordance with at least one embodiment of the present disclosure;

[0056] Fig. 7C is a top view of the guidewire connector and the receiving connector of Fig. 7B, in accordance with at least one embodiment of the present disclosure;

[0057] Fig. 7D illustrates a cross-sectional side view of a preform used for manufacturing of a matching pair of the guidewire connector and the receiving connector for the multi-sensor pressure guidewire, in accordance with at least one embodiment of the present disclosure;

[0058] Fig. 7E is a cross-sectional top view of the guidewire connector of the preform of Fig. 7D;

[0059] Fig. 7F is a cross-sectional view of the guidewire connector along the line E-E of the preform of Fig. 7D;

[0060] Fig 8A illustrates a cross-sectional side view of an alternative preform for manufacturing the guidewire connector and the matching receiving connector, in accordance with at least one embodiment of the present disclosure;

[0061] Fig 8B illustrates a cross-sectional view along the line F-F of the alternative preform of Fig. 8A;

[0062] Fig 8C illustrates a cross-sectional view of another embodiment of the preform having an angle alpha between a line formed by the axes of fibers and the keyed surface of between 0 and 90, in accordance with at least one embodiment of the present disclosure;

[0063] Fig 8D illustrates a method of manufacturing of the guidewire connector, in accordance with at least one embodiment of the present disclosure;

[0064] Fig. 9A illustrates a perspective view of a portion of a shaft with a circular distal crosssection and a keyed proximal end for manufacturing of the guidewire connector, in accordance with at least one embodiment of the present disclosure;File No. : P6314PC00

[0065] Fig 9B is a cross-sectional view along the line G-G of the tube of Fig. 9A with fibers and a centering device while manufacturing of the guidewire connector, in accordance with at least one embodiment of the present disclosure;

[0066] Fig 90 is a cross-sectional view along the line H-H of Fig. 9B of the tube of Fig. 9A;

[0067] Fig. 10 is a perspective view of the guidewire connector with a keyed tube and a union tube installed, in accordance with at least one embodiment of the present disclosure;

[0068] Fig 11A illustrates a perspective view of a keyed portion of the machined guidewire connector with a spring-loaded alignment device, in accordance with at least one embodiment of the present disclosure;

[0069] Fig. 11 B illustrates a cross-sectional view along lines K-K of the keyed portion of the machined guidewire connector with the spring-loaded alignment device of Fig. 11 A, in accordance with at least one embodiment;

[0070] Fig. 12A illustrates a cross-sectional view of an alignment device positioned on top of a concave keyed surface of the guidewire connector for facilitating an alignment of the guidewire connector and fibers located therein with the receiving connector and fibers located therein, in accordance with at least one embodiment of the present disclosure;

[0071] Fig. 12B illustrates a perspective view of a guidewire connector, a receiving connector, and a guidewire coupler configured to connect the guidewire connector with the receiving connector, in accordance with at least one embodiment of the present disclosure;

[0072] Fig. 12C illustrates a perspective view of the guidewire connector connected to the receiving connector using the guidewire coupler of Fig. 12B, in accordance with at least one embodiment of the present disclosure;

[0073] Fig. 13A illustrates a perspective view of the guidewire connector having a groove, in accordance with at least one embodiment of the present disclosure;

[0074] Fig. 13B illustrates a perspective view of the guidewire connector having a V-groove, in accordance with at least one embodiment of the present disclosure;

[0075] Fig. 13C illustrates a perspective view of the guidewire connector having a spine, in accordance with at least one embodiment of the present disclosure;

[0076] Fig. 14A illustrates a perspective view of an alignment jig, in accordance with at least one embodiment of the present disclosure;File No. : P6314PC00

[0077] Fig. 14B illustrates a top plane view of the alignment jig of Fig. 14A;

[0078] Fig 14C illustrates a perspective view of the alignment jig of Fig. 14A with the guidewire connector and fibers, in accordance with at least one embodiment of the present disclosure;

[0079] Fig. 14D illustrates another perspective view of the alignment jig of Fig. 14A with the guidewire connector and fibers, in accordance with at least one embodiment of the present disclosure;

[0080] Fig 14E illustrates a top view of the alignment jig of Fig. 14A with the guidewire connector and fibers, in accordance with at least one embodiment of the present disclosure;

[0081] Fig 14F illustrates the guidewire connector with a groove for the multi-sensor guidewire before assembly, in accordance with at least one embodiment of the present disclosure;

[0082] Fig. 14G illustrates a keyed alignment ferule, in accordance with at least one embodiment of the present disclosure;

[0083] Fig. 14H illustrates a keyed alignment ferule, in accordance with another embodiment of the present disclosure;

[0084] Fig 15A illustrates a perspective partially exploded view of an interface cable assembly illustrating internal components of the interface cable assembly and a proximal end of the guidewire, in accordance with at least one embodiment of the present disclosure;

[0085] Fig. 15B illustrates a perspective exploded view of the interface cable assembly of Fig. 15A;

[0086] Fig 15C illustrates a perspective back view of the interface cable assembly of Fig. 15A;

[0087] Fig 16 illustrates a method of manufacturing of the guidewire connector, in accordance with at least one embodiment of the present disclosure;

[0088] Fig. 17A illustrates a keyed insert, in accordance with at least one embodiment of the present disclosure;

[0089] Fig 17B illustrates a connector assembly with the keyed insert of Fig. 17A, in accordance with at least one embodiment of the present disclosure;

[0090] Fig. 17C illustrates the connector assembly with the keyed insert of Fig. 17B;

[0091] Fig 18 illustrates a method of manufacturing of the guidewire connector, in accordance with at least one embodiment of the present disclosure; andFile No. : P6314PC00

[0092] Fig 19 illustrates a method for assessing regurgitation, in accordance with at least one embodiment of the present disclosure.

[0093] It will be noted that throughout the appended drawings, like features are identified by like reference numerals.DETAILED DESCRIPTION

[0094] The technology will now be described more fully hereinafter with reference to the accompanying figures, in which the technology is illustrated. The foregoing may, however, be embodied in many different forms and should not be construed as limited to the illustrated realizations set forth herein.

[0095] In the present description, it is understood that terms such as “first”, “second”, “third”, and the like, are words of convenience and are not to be construed as limiting terms.

[0096] In the present description, the expression “at least one of A, B or C” means one or more of A or one or more of B, or one or more of C, or a combination of A and B, or a combination of B and C, or a combination of A and C, or a combination of A, B, and C. When used herein, the expression “at least one of A or B” means at least one of A or at least one of B, or a combination of one or more A and a combination of one or more B. When used herein, the expression “A and / or B” means only A, or only B, or both A and B. When used herein, the expression “A, B and / or C” means only A, or only B, or only C, or both A and B, or both A and C, or both B and C, or A and B and C.

[0097] Various aspects of the present disclosure generally address one or more of the problems of measuring the blood pressure at two or more different positions of a blood vessel simultaneously.

[0098] The present description provides a system and a method for measuring the blood pressure with two or more sensors simultaneously and a method for manufacturing a multi-sensor pressure guidewire for structural heart procedures.

[0099] During structural heart procedures, a downstream pressure curve and an upstream pressure curve can be used to determine a condition of a heart valve, a status of blood flow through a heart valve and, in some cases, to determine how and when to treat a patient. Depending on the valve to be treated and the approach, in some implementations, a downstream pressure curve may be provided by a pigtail catheter connected to an external pressure sensor, a pressure guidewire or another device capable of sensing pressure. The upstream pressure curve may be provided by a pressure guidewire or another device capable of sensing pressure upstream to the downstream pressure measurement. In other implementations, both the downstream and upstream pressureFile No. : P6314PC00 curves may be provided by pigtail catheters connected to external pressure sensors, pressure guidewires or other devices capable of sensing pressure.

[0100] For example, some methods for evaluating a heart valve include accessing a blood flow passage of a patient at an access point. The access point may be a femoral artery, radial artery, femoral vein, radial vein, left ventricle apex, or otherwise. A pressure guidewire may be advanced through the access point to a location adjacent to a treatment site of the patient, for example the heart valve to be assessed, treated, or replaced. For example, a pressure sensing device separate from the pressure guidewire may be advanced to the opposite side of the treatment site, e.g., to the side of a heart valve opposite to the side of the valve where a pressure guidewire is located. For example, the pressure sensing device may be located towards a distal tip of the pressure guidewire. The pressure sensing device may comprise or may be disposed in an aortic pigtail catheter, a guide catheter, a pressure guidewire, or another device capable of sensing pressure. Treatment devices, such as a balloon or replacement heart valve, may be advanced over the pressure guidewire.

[0101] Various implementations are possible in order to sense the pressure at two points simultaneously such as, for example, on two sides of the valve. For example, a pressure sensing device may sense pressure on a first side of the heart valve, e.g. in the aorta, pulmonary artery or atrium, and the pressure guidewire may sense pressure on a second side of the heart valve, e.g. in the left ventricle or the right ventricle. In some implementations, the pressure sensing device may sense pressure in a heart chamber and the pressure guidewire may sense pressure in a blood flow passage on an opposite side of a heart valve, e.g., in a second heart chamber or in the aorta or pulmonary artery. The pressure sensing device may be positioned from aorta, the vena cava or the apex of the ventricle. It may be possible, for example, to position the pressure guidewire in the left ventricle to sense pressure therein and position the pressure sensing device in the aorta (through arterial access) to sense pressure therein to evaluate the aortic valve. Another example may include positioning the pressure sensing device in the left ventricle to sense pressure therein and positioning the pressure guidewire in the left atrium (through transseptal access) to sense pressure therein to evaluate the mitral valve. The pressure measurements may be used to measure a valve state condition, such as pressure gradient across the heart valve and / or valve regurgitation.

[0102] Multi-sensor pressure guidewire as described herein may permit measuring the pressure simultaneously at two different positions. For example, one sensor of the multi-sensor pressure guidewire described herein may sense pressure on the first side of the heart valve, and the second sensor of the multi-sensor pressure guidewire may sense pressure on the second side of the heart valve. The multi-sensor pressure guidewire as described herein may have more than two sensors.File No. : P6314PC00Several sensors may be located in one multi-sensor pressure guidewire along the length of the multisensor pressure guidewire.

[0103] Having several sensors in one guidewire may help to simplify the manipulation of the sensors and improve accuracy of the pressure measurements. The multi-sensor pressure guidewire as described herein may also allow to decrease the number of vascular accesses necessary for an intervention, effectively decreasing risks of adverse events (bleeding, etc.) related to percutaneous accesses and manipulations. Using the multi-sensor guidewire, it may be possible to eliminate the vascular access dedicated to the catheter measuring blood pressure on one side of a heart valve. Other applications, such as measurement of a patent foramen ovale (PFO) closure, transeptal puncture, Mitraclip monitoring, monitoring of left ventricular outflow tract obstruction (also referred to as “LVOT obstruction monitoring”) may benefit from using the multi-sensor pressure guidewire as described herein. In peripheral intervention, a guidewire with multiple sensors as described herein may allow to provide the gradient measurement of a stenosis without having to use any adjunct device such as fluid-filled catheter and external pressure sensor. Two pressure values, measured at different locations using the technology described herein, may be added to improve the accuracy of the boundary conditions for computer fluid dynamics (CFD) simulation, which may be used for determining a blood flow and calculating various parameters such as, for example, pressure values, flowrate, stroke volume, etc.

[0104] The multi-sensor pressure guidewire may also have a temperature sensor, which may permit monitoring valve regurgitation or measuring flow.

[0105] Fig 1A illustrates a diagnostic system 100 that may be used in the vasculature of a patient, in accordance with at least one embodiment of the present disclosure. For example, the diagnostic system 100 may help to determine the hemodynamics conditions of a heart valve through blood pressure measurement before or after a catheter valve intervention. Hemodynamics conditions may provide confirmation of intervention success or indication for interventions such as balloon dilation (e.g., valvuloplasty), valve replacement or other catheter intervention.

[0106] The diagnostic system 100 comprises a multi-sensor pressure guidewire 200 (also referred to herein as a “pressure guidewire 200” or a “guidewire 200”), having pressure sensors 231 , 232, that is configured to be coupled to a monitor assembly 104 (which may also be referred to as a “console 104”). The diagnostic system 100 may have a connection 102 (indicated by a dashed double-line) that facilitates connection to and disconnection of the pressure guidewire 200 from the monitor assembly 104. The connection to and disconnection from the monitor assembly 104 is useful in allowing a clinician to use the pressure guidewire 200 for assessing the hemodynamics conditionsFile No. : P6314PC00 of the heart valve. The pressure guidewire 200 may also be used for delivering a treatment device, such as, for example, a balloon catheter or a valve delivery system.

[0107] An output cable 108 (which may be referred to as a “fiber optic cable 108” when the pressure sensors 231 , 232 of the multi-sensor pressure guidewire 200 are optical sensors or an “electric cable 108” when the pressure sensors 231 , 232 are piezoelectric sensors) may be used to couple the pressure guidewire 200 with the monitor assembly 104 by way of a handle 110. Such output cable 108 is connected to the guidewire 200 by a guidewire coupler 140 (also referred to herein as a “multiple-fiber guidewire coupler 140”).

[0108] The pressure sensors 231 , 232 are configured to measure the blood pressure and generate sensor signals (electrical sensor signals if the pressure sensors 231 , 232 are electrical or optical sensor signals if the pressure sensors 231 , 232 are optical sensors) to be transmitted to the monitor assembly 104. The monitor assembly 104 has a receiving unit and a processor 105 configured to receive and use the sensor signals to generate a guidewire data describing various characteristics of the heart and vascular system of a patient. The guidewire data may be then displayed on a monitor of the monitor assembly 104.

[0109] The pressure guidewire 200 may take any suitable form. For example, the pressure guidewire 200 may have a proximal segment 133 that is positioned outside the patient and a distal segment 135 that may be advanced through the vasculature of the patient by, for example, an access catheter 120. The pressure guidewire 200 may be configured to have the flexibility to navigate the tortuous vasculature while maintaining structural integrity for pushability and torqueability. The pressure guidewire 200 may also have a more rigid design to allow for an optimal support when delivering interventional devices to the treatment site. The distal end (distal segment 135) of the pressure guidewire 200 may be soft and atraumatic for advancement in the vasculature, or it may be pre-shaped in a pigtail design (as it is shown in Fig. 1A) for safety and stability in heart chambers.

[0110] The diagnostic system 100 with the pressure guidewire 200 as described herein may be used to measure the performance of an existing or replacement aortic valve. Fig. 1 B illustrates schematic diagram of the multi-sensor pressure guidewire 200 deployed in a heart around the aortic valve, in accordance with at least one embodiment of the present disclosure. For example, as shown in Fig. 1 B, the guidewire 200 may be inserted using access catheter(s) (illustrated in Fig. 1 A) through the arterial vasculature, aortic valve and into the left ventricle using a transfemoral or other approach. In some variations, the access catheter 120 may be configured to provide such access or may be configured to track a guidewire or a device that has provided such access. The access catheter 120 or a separate delivery catheter exchanged with the access catheter 120 may be used to advance aFile No. : P6314PC00 valve dilation balloon, replacement valve, and / or other device to the treatment site. The pressure guidewire 200 may extend through the access catheter 120 to the left ventricle LV. The pressure sensors 231 , 232 are schematically depicted by circles one the pressure guidewire 200. One pressure sensor (a proximal sensor 231) of the pressure guidewire 200 thus located in the aorta AO may provide pressure signals that may be used to generate a downstream pressure curve, while another sensor (for example, distal pressure sensor 232) located with the pressure guidewire 200 in the left ventricle LV provides pressure signals that may be used to generate an upstream pressure curve.

[0111] The diagnostic system 100 with the pressure guidewire 200 as described herein may be used to measure the performance of an existing or replacement mitral valve. Fig. 1C illustrates schematic diagram of the multi-sensor pressure guidewire 200 deployed in a heart around the mitral valve, in accordance with at least one embodiment of the present disclosure. For example, as shown in Fig. 1C, the guidewire 200 may be inserted using access catheters through the venous vasculature, left atrium, mitral valve and into the left ventricle through a transseptal approach. One pressure sensor (for example, the proximal sensor 231 in Fig. 1C) of the pressure guidewire 200 located in the left atrium LA may provide pressure signals that may be used to generate an upstream pressure curve, while another sensor (for example, the distal pressure sensor 232) located with the pressure guidewire 200 in the left ventricle LV provides pressure signals that may be used to generate a downstream pressure curve.

[0112] Fig. 1 D illustrates the use of the pressure guidewire 200 for determining pressure signals around the tricuspid valve. As can be seen in Fig. 1 D, the guidewire 200 may be inserted using access catheters through the venous vasculature, right atrium, tricuspid valve and into the right ventricle through a transfemoral or other approach. For example, one pressure sensor (the proximal sensor 231) of the pressure guidewire 200 thus located in the right atrium RA may provide pressure signals that may be used to generate an upstream pressure curve, while another sensor (for example, the distal pressure sensor 232) located with the pressure guidewire 200 in the right ventricle RV provides pressure signals that may be used to generate a downstream pressure curve.

[0113] Fig. 2A illustrates a schematic view of the multi-sensor pressure guidewire 200 (also referred to herein as a “guidewire 200” or a “pressure guidewire 200”), in accordance with at least one embodiment of the present disclosure. Each pressure sensor of the multi-sensor pressure guidewire 200 may be an optical or electrical sensor, such as, for example, an optical sensor based on Fabry Perot cavity interferometry (so-called “Fabry-Perot sensor”) or a piezoelectric pressure sensor. The guidewire 200 may have pressure sensors that may be similar, for example, to aFile No. : P6314PC00 structure of pressure sensors described in patent documents WO 2020 / 236492 and WO 2006 / 066393A1 , incorporated herein by reference in their entirety.

[0114] In the embodiments having electrical sensor(s) and, for example, piezoelectric sensors, the terms “fiber” and “fibers” used herein refer to electric wire(s). In the embodiments having optical sensor(s), the terms “fiber” and “fibers” used herein refer to optical fiber(s).

[0115] Figs. 2A, 2B illustrate the embodiment of the guidewire 200 having two sensors. The guidewire 200 comprises a hollow shaft (tube) 210 which comprises a proximal shaft section 211 (also referred to herein as a “proximal shaft 211”) and a distal shaft section 212 (also referred to herein as a “distal shaft 212”), a distal tip 214, and a guidewire connector 300 (also referred to herein as a “guidewire connecting section 300” or a “multiple-fiber guidewire connector 300” or “guidewire plug 300”).

[0116] The distal tip 214 provides an atraumatic interaction with blood vessels, valves and heart chambers’ walls. The distal tip 214 also may provide stability or anchoring of the guidewire 200 in heart chambers. The distal tip 214 may have a pre-shaped pigtail configuration, as illustrated in Fig. 1A. In some embodiments, the distal tip 214 may have a hemispherical shape. The distal tip 214 may be formed as a pre-shaped guidewire with a corewire inner part and a coiled external section. Various configurations of a distal tip were discussed, for example, in patent publications US 2022 / 0361762 A1 and US 2022 / 0192520 A1 , incorporated herein by reference in their entirety.

[0117] Pressure sensors, such as a proximal sensor 231 and a distal sensor 232 are located along the length of the distal segment 135 of the pressure guidewire 200. As illustrated in Fig. 2A, the distal sensor 232 is located closer to the distal tip 214 than the proximal sensor 231. The distance between the proximal and distal pressure sensors 231 , 232 (which may be referred to as a “sensor distance”) may be, for example, at least 1 centimeter (cm), between 1 cm and 5 cm, at least 5 cm, between 5 cm and 10 cm, at least 10 cm, between 10 cm and 15 cm, and, in some embodiments, longer than 15 cm. In at least one embodiment, the sensor distance between the proximal and distal sensors 231 , 232 may be between 5 and 10 cm, which may provide the most convenient interspace for measuring the pressure around a heart’s valve. In at least one embodiment, pressure sensors 231 and 232 are positioned in different sensor housings (such as a proximal sensor housing 221 and a distal sensor housing 222 illustrated in Fig. 2A), and are therefore capable to provide measurements of the blood pressure at two different positions along the length of the pressure guidewire 200. The sensor housings 221 , 222 provide contact between the blood and the sensors 231 , 232. The proximal pressure sensor 231 is configured to measure a proximal pressure, is connected to a proximal fiber 251. The proximal pressure sensor 231 is configured to transmit aFile No. : P6314PC00 proximal sensor signal through a proximal fiber 251 from and towards the proximal pressure sensor231. The distal pressure sensor 232 is configured to measure a distal pressure and configured to transmit a distal sensor signal through a distal fiber 252 from and towards the distal pressure sensor232. The proximal pressure sensor 231 receives from the guidewire connector 300, generates, modifies and transmits back to the guidewire connector 300 a proximal pressure signal via the proximal fiber 251. The distal pressure sensor 232 receives from the guidewire connector 300, generates, modifies and transmits back to the guidewire connector 300 a distal pressure signal via the distal fiber 252. Depending on the type of each one of the pressure sensors 231 , 232, the corresponding proximal and distal fibers 251 ,252 are electrical wires or optical fibers. The proximal and distal fibers 251 , 252 which are configured to transmit, as the distal pressure signal and the proximal pressure signal, an electrical signal or an optical signal, respectively. In other words, when the pressure sensors 231 , 232 are optical sensors, the corresponding fibers are the optical fibers transmitting optical signals, and when the pressure sensors 231 , 232 are electrical sensors, the corresponding fibers are electrical wires which transmit electrical signals.

[0118] In some embodiments, two pressure sensors 231 , 232 are located in one double sensor housing 280, as illustrated in Fig. 2E, which is long enough to allow for two pressure sensors 231 , 232, and which provides a same-housing sensor distance 284 between the two pressure sensors 231 , 232. The distance between the two pressure sensors 231 , 232 when located in one sensor housing may be, for example, at least 1 cm, between 1 cm and 5 cm, at least 5 cm, between 5 cm and 10 cm, and, in some embodiments, between 5 cm and 15 cm. In some embodiments, the samehousing sensor distance 284 between the proximal and distal sensors 231 , 232 in one double sensor housing 280 may be approximately 7 cm. The guidewire having the double sensor housing 280 may also have another sensor housing with a third sensor.

[0119] Figs. 3A, 3B illustrate a schematic side view and a cross-sectional view, respectively, of a pressure guidewire 201 having three pressure sensors, in accordance with at least one embodiment of the present disclosure. For example, the distal sensor 232 may be positioned near the distal tip 214 of the guidewire 201. Intermediate sensor(s) 233 may be located in between of the proximal sensor 231 and distal sensor 232, as illustrated in Fig. 3A. For example, the pressure sensors 231 , 232, 233 may be positioned at any distance apart. Preferably, each pair of neighboring sensors has between them the sensor distance of approximately 5 centimeters, at least 1 cm, between 1 cm and 5 cm, at least 5cm, between 5 cm and 10 cm, at least 10 cm, between 10 cm and 15 cm, and, in some embodiments, longer than 15 cm. In some embodiments, the sensor distance between two neighboring sensors may be approximately 7 cm, which may provide the most convenient distance for measuring the pressure around a heart’s valve.File No. : P6314PC00

[0120] The distance between the neighboring sensors is provided in order to provide space for two separate sensor housings and to be capable to provide measurements of the blood pressure at two different positions along the length of the pressure guidewire 201. The distance between neighboring proximal and intermediate sensors 231 , 233 (which may be referred to as “proximal- intermediate sensor distance”) may be different from the distance between the intermediate and distal sensors 233, 232 (which may be referred to as “intermediate-distal sensor distance”).

[0121] Still referring to Fig. 3A, in at least one embodiment, the multiple-sensor guidewire 201 may have more than one intermediate sensors 233 and corresponding intermediate sensor housings 223, and therefore more than one intermediate shaft sections 213 forming, together with the sensor housings 221 , 222, 223 one shaft 210 which is attached to the distal tip 214. The intermediate sensor 233 is connected to an intermediate sensor fiber 253 running inside the shaft 210 towards the guidewire connector 300. Each shaft section 211 , 212, 213 is connected to a corresponding sensor housing 221 , 222, 223 that allows the pressure sensor 231 , 232, 233 located therein to get in contact with blood to measure the pressure. In some embodiments, one or more temperature sensors may be also located in the one or more sensor housing 221 , 222, 223. Thus, in between of the proximal and distal shaft sections 211 , 212, there may be located one or more intermediate shaft sections 213, and each may be attached to at least one intermediate sensor housing 223, each having one or two sensors 233 therein, where one of guidewire fibers of a set of guidewire fibers 251 , 252, 253, etc. running inside the shafts terminates, while the other fiber(s) of the set of fibers located within the shaft, continue propagating towards the distal tip 214 of the pressure guidewire 200.

[0122] For each pressure sensor, a corresponding fiber runs towards the pressure sensor. As illustrated in Fig. 2A, a proximal fiber 251 runs towards the proximal sensor 231 and a distal fiber 252 runs towards the distal sensor 232. For the guidewires with more than two pressure sensors, such as the guidewire 201 illustrated in Figs. 3A-3C, a corresponding intermediate fiber 253 runs from the guidewire connector 300 towards the corresponding intermediate sensor 233. The guidewire 201 in Figs. 3A-3C has the intermediate fiber 253 that runs towards the intermediate sensor 233.

[0123] Referring to Figs. 2A, 4A, the proximal sensor housing 221 comprises one sensor head 241 where one corresponding fiber 251 ends with a sensor fiber portion 248. The other fiber, such as distal fiber 252, continues running through the shaft 210 within the shaft lumen 216 in the distal shaft 212 (the corresponding portion of the shaft lumen 216 may be also referred to as a “distal shaft lumen”) towards the distal tip 214. Referring to Figs. 2A, 2B, the proximal fiber 251 and the distal fiber 252 run within the shaft lumen 216 in the proximal shaft 211 (the corresponding portion of the shaft lumen 216 may be referred to as a “proximal shaft lumen”). Referring to Figs. 2A, 2C, the distalFile No. : P6314PC00 fiber 252 runs within a distal shaft lumen located in the distal shaft 212 towards the distal sensor housing 222 with only one distal fiber 252 inside. Referring to Fig. 3A, when the guidewire 201 has more than two pressure sensors, the intermediate sensor housings 223 of the intermediate sensors 233, have structures similar to the one illustrated in Fig. 4A, except for carrying the remaining other intermediate fibers, towards other intermediate sensor housings, and towards the distal tip 214.

[0124] Referring now again to Fig. 4A, the proximal sensor housing 221 is bonded or welded to the proximal and distal shaft sections 211 , 212. The proximal sensor housing 221 also allows blood to get in contact with the proximal pressure sensor 231 while the distal pressure sensor fiber 252 runs through the proximal sensor housing 221 and in the distal shaft 212. In such an embodiment of the two-sensor guidewire 200, two fibers 251 , 252 (also referred to herein as the proximal fiber 251 and the distal fiber 252) are located inside the lumen 216 of the proximal shaft 211.

[0125] The proximal sensor housing 221 is connected distally to the distal shaft 212 on one end and connected to the proximal shaft 211 on another end, and the proximal sensor housing 221 comprises and partially encloses a portion of the distal fiber 252, a tip of the proximal fiber 251 and a proximal sensor 231 connected to the proximal fiber 251 and configured to measure a proximal pressure.

[0126] Referring now also to Fig. 2B, the shaft has a shaft internal diameter (which may be also referred to herein as “shaft ID” or “a shaft lumen diameter”) which allows for the passage of two fibers 251 , 252. The outside diameter d of the fibers 251 , 252 (leading to the corresponding sensors) may be between about 80 micrometers (pm) to 150 pm. Thus, the shaft ID may be in the range of 160pm (0.0063”) to 350pm (0.0138”). The shaft ID may vary and may be selected based on the number of fibers located inside the shaft and the diameter of each fiber.

[0127] Stiffness and kink resistance of the shaft 210, of shaft sections 211 , 212, and of the sensor housing 221 , 222 are of major importance for structural application, therefore the outside diameter (OD) and the material of the shaft 210 and of the sensor housing 221 , 222 need to be selected to meet these requirements. High yield material such as stainless steel (SS) 304, SS 17- 7PH, MP35N or Chrome cobalt alloy may be used as a material of the shaft 210. Similar material may be used for manufacturing of the sensor housing 221 , 222. The sensor housings 221 , 222 may have even higher requirements with regard to kink resistance compared to the shaft sections 211 , 212, because the sensor housings 221 , 222 are relatively short with even bigger outside diameter than the outside diameter of the shaft sections 211 , 212.

[0128] A coil, an electrical insulation and / or a coating layer, illustrated in Figs. 2A-3B as a shaft outside layer 260 (also referred to herein as a “covering layer 260”) may cover the shaft 210. ForFile No. : P6314PC00 example, the shaft outside layer 260 may comprise an electrical insulation layer 261 and / or a coating layer covering the shaft 210. This shaft outside layer 260 may be used for lubricity but also to maintain a constant outside diameter of the guidewire 200. The shaft outside layer 260 may have an electrical insulation property to allow for electrical insulation of the shaft 210. The proximal shaft 211 or the distal shaft 212 or both the proximal shaft 211 and the distal shaft 212 may have an electrical insulating layer 261. Electrical insulation of the shaft 210 is particularly important when the pressure guidewire 201 is intended to be used for rapid pacing. In some embodiments, the shaft outside layer 260 may comprise an electrical insulating layer. The electrical insulating layer 261 (which is illustrated in Figs. 2A-2C) may act as a lubricious material to allow passage of the access catheter 120 over the guidewire 200. This electrical insulating layer 261 may be also easily cleanable before and after the guidewire 200 is used in contact with blood. For example, the electrical insulating layer 261 may be made of: perfluoroalkoxy alkanes (PFA), polytetrafluoroethylene (PTFE), polyether ether ketone (PEEK), polyamide, polyether block amide (such as, for example, PEBAX™) with or without additive, etc.

[0129] In at least one embodiment, the shaft ID of the pressure guidewire 200 needs to be reduced and / or minimized to improve stiffness and kink resistance. This brings dimension considerations in the integration of the pressure sensors into the guidewire 200, because fibers 251 , 252 coming out of the proximal shaft 211 are located close together, and positioning the fibers 251 , 252 too close to each other would make difficult to install a free-floating sensor inside the proximal sensor housing 221. Such optical pressure sensors 231 , 232 are sensitive to physical contact to the diaphragm 249, so contact of the diaphragm 249 of the proximal sensor 231 (and an intermediate sensor for the embodiment with three and more sensors) with the distal pressure sensor fiber 252 (in other terms, with the fiber running towards another pressure sensor, such as the distal pressure sensor 232, located closer to the distal tip than the proximal sensor 231) needs to be avoided. In other words, as the two fibers run close together in the shaft 210, to maintain and to improve the kink resistance, a special care should be taken to avoid the fiber 252 getting in contact with the diaphragm 249 (Fig. 4A) of the optical pressure sensor 231. A distancing device (such as, for example, a positioning ring 243 of Fig. 4A and other devices described below) may be located in the proximal sensor housing 221 and configured to distance the proximal sensor 231 from the distal fiber 252 running within the proximal sensor housing 221.

[0130] In at least one embodiment, each one of the pressure sensors 231 , 232, 233 comprises a sensor head 241 . The sensor head 241 is configured to measure the blood pressure and then send the optical or electrical signal back through the respective fiber towards the monitor assembly 104. The sensor head 241 may be implemented in various ways. A non-limiting example of the sensorFile No. : P6314PC00 head 241 is illustrated in Fig. 4B. Other non-limiting examples of the sensor head 241 have been described in U.S. patent No. 7,689,071 , which is incorporated herein in its entirety. In some nonlimiting examples, the sensor may be an optical sensor or a piezoelectric sensor. The optical sensor 231 , 232, 233 may be based on a Fabry-Perot cavity or on a fiber Bragg grating (FBG).

[0131] For example, as illustrated in Fig. 4B, the sensor head 241 may comprise a recessed cavity 440 defining a first surface 449 and a diaphragm 249 located on a distal facet of the sensor head 241 , the diaphragm 249 may define a second surface such that both the first and second surfaces are separated by a distance and form a Fabry-Perot cavity. The Fabry-Perot cavity formed with the diaphragm 249 in this non-limiting example of the sensor head may react to blood pressure and allow for pressure measurement.

[0132] For the proximal sensor 231 , a sensor fiber portion 248 may be also positioned within (inserted into) a distancing device such as, for example, a positioning ring 243 (also referred to as a “sensor ring 243”) to allow proper alignment and positioning of the sensor head 241 . The positioning ring 243 may be made of a glass and may be referred to as a “glass ring”. Alternatively, another distancing device may be used to distance the proximal sensor 231 from the distal fiber 252 running within the proximal sensor housing 221 . The glass ring 243 may be the same or different for the distal sensor 231 and the proximal sensor 232. A thermal adhesive 245 may be used to attach the fiber 251 to the positioning ring 243.

[0133] Referring also to Fig. 4A, the proximal sensor 231 is located in the proximal sensor housing 221 which has a proximal sensor window 225 that allows the proximal pressure sensor 231 to get in contact with blood. The sensor glass ring 243 is used to secure the pressure sensor 241 at the end of the fiber. It may help for concentricity and perpendicularity positioning of the sensor head 241 . The glass ring 243 may be also used to make sure that the sensor’s head 241 is free floating in the sensor housing.

[0134] As seen in Figs. 4A-4B, proximal pressure sensor 231 has a sensor head 241 that is glued on a positioning ring 243. The proximal fiber 251 is inserted in this positioning ring 243 to allow proper alignment and positioning of the fiber tip within the sensor head 241. The separation of the sensor head 241 (and therefore the diaphragm 249) from the distal fiber 252 may be controlled by having the positioning ring 243 with larger outside diameter 472 than the outside diameter 470 of the sensor head 241. The positioning ring 243 ensures that the diaphragm 249 avoids any contact with the distal fiber 252. In at least one embodiment, a second ring may be located on the distal fiber 252, proximal to the sensor glass head 241 , and the second ring may have larger outside diameter than the distal fiber 525 in order to avoid the contact of the diaphragm 249 with the distal fiber 252.File No. : P6314PC00

[0135] As illustrated in Fig. 4C, in addition to or instead of the ring 247 (of Fig. 4A), the proximal sensor housing 221 may have another (second) fiber attaching element 256, such as, for example and without limitation, a hook, a notch, or another ring 256, which attaches the second fiber 252 to the corresponding sensor housing while simultaneously distancing the distal fiber 252 from the sensor head 241 of the proximal sensor 231 to ensure that the distal fiber 252 and the proximal sensor 231 do not touch each other. For example, the fiber attaching element 256 may be a distancing ring which embraces the distal fiber 252 at least partially within the proximal sensor housing 221. For example, the distal fiber 252 may be fixed to the fiber attaching element 256, threaded though the fiber attaching element 256 (for example, when the fiber attaching element 256 is a distancing ring which encircles the distal fiber within the proximal sensor housing 221), or hooked loosely to the fiber attaching element 256, allowing longitudinal movement of the distal fiber 252 while restricting the distal fiber 252 to have any contact with the sensor head 241 . The fiber attaching element 256 may be attached to the internal wall of the proximal sensor housing 221. Such fiber attaching element 256 may force the distal fiber 252 to bend (induce a curve in the distal fiber 252) inside the proximal sensor housing 221 , preventing it from touching the proximal sensor 231 and to ensure that the distal fiber 252 and the proximal sensor 231 do not touch each other.

[0136] Fig. 4D illustrates a cross-sectional view of a distal sensor 232 in the distal sensor housing 222, in accordance with at least one embodiment of the present disclosure. The distal sensor housing 222 allows the distal pressure sensor 232 to get in contact with blood through a distal sensor window 226. As illustrated in Fig. 4D, the distal fiber 252 is connected to the diaphragm 249 of the distal sensor 232 and transmits light towards and away from the diaphragm 249 to detect the blood pressure.

[0137] The distal shaft 212 is, as the proximal shaft 211 , made of high yield strength material. The shaft ID of the distal shaft 212 may be smaller than the shaft ID of the proximal shaft 212, as there is only one fiber 252 inside. The OD of both distal shaft 212 and proximal shaft 211 may be uniform over the entire length of the pressure guidewire 200. Alternatively, the distal shaft 212 (and, in some embodiments, along with the proximal shaft 211) may be grinded at specific locations to allow for a reduction of the stiffness along the length of the pressure guidewire 200. In some embodiments, the distal shaft 212 along the whole length of the distal shaft 212 may be grinded to reduce stiffness. In some embodiments, to have a uniform OD over the whole length of the pressure guidewire 200, the distal shaft 212 may be covered by a covering layer, an insulation layer or a metallic coil. Although the guidewire 200 as described herein may be used without coil, the construction permits adding the coil to cover the shaft.File No. : P6314PC00

[0138] In at least one embodiment, stiffness of the shaft 210 gradually decreases towards the distal tip 114 of the guidewire 201. For example, when manufacturing, the metal tubing may be grinded and / or tapered making the outside diameter narrower towards the distal tip 114. For example, the shaft 210 may be made of metal tubings. As described above, the shaft 210 has an outside layer which may be a coating. The coating preferably provides electrical insulation for rapid pacing thus providing an electrical insulating layer 261. Preferably, the coating may be made of polytetrafluoroethylene (PTFE) or Pebax™.

[0139] Figs. 5A-5C schematically illustrate guidewires 500, 501 , 502 with various configurations of the shaft 210 and its proximal shaft section 211 and distal shaft section 212 of Fig. 2A, in accordance with various embodiments of the present disclosure. In at least one embodiment, shaft sections may have at least two tubings positioned coaxially.

[0140] As illustrated in Fig. 5A, the proximal shaft section 211 has proximal core tubing 262 and a proximal outer tubing 263. The distal shaft section 212 has distal core tubing 266 and a distal outer tubing 267. For example, the proximal and distal core tubings 262, 266 may have outer diameter (OD) of 0.024 inches (SS304). The two outer tubings 263, 267 provide stiffness to the shaft 210 by the stiffness profile. For example, the stiffness profile of the outer provides a more kink- resista nt alloy such as 17-7PH). In some embodiments, the proximal outer tubing 263 may be tapered (for example, the OD may be 0.028”). In at least one embodiment, the distal outer tubing 267 is tapered towards the distal sensor housing. For example, thickness of the distal outer tubing 267 may be approximately 0.024" around the distal sensor housing.

[0141] Fig. 5B illustrates another embodiment of the guidewire 501 , where the proximal shaft 211 has a core tubing 262 which is tapered on the outside (for example, from OD 0.028" or more on one side of the core tubing 262 to OD 0.026" on the other side of the core tubing 262). Proximal sensor housing 221 has an internal diameter (ID) larger than the ID of the distal sensor housing 222 (for example, 0.026" instead of 0.024"). In at least one embodiment, distal shaft section 212 (or, if more than two sensors are used, intermediate shaft section 213) is tapered (for example, with OD being 0.026" on one side and 0.024" or lower on the other side). The proximal sensor housing 221 is not as thick as the distal sensor housing 222 in order to maintain the overall OD of the guidewire 201 (OD in any point of length of the guidewire 201) below a given specification (for example 0.035"), depending on the application.

[0142] Fig. 5C illustrates another embodiment of the guidewire 502, which has a combined intermediate section 510 of the shaft, which is drilled and grinded. Such combined intermediate section 510 may have two sensors 231 , 232 in two housings 321 , 322 located on the extreme portionsFile No. : P6314PC00 of the combined intermediate section 510. In other words, section 510 may comprise two housings 321 , 322. Such configuration has higher-quality joints, less components, but may be more expensive to manufacture. The combined intermediate section 510 may be coated with the outside coating described above after assembly, with proximal and distal sensor windows masked. To assembly such an embodiment of the guidewire 502, distal sensor is pre-inserted in a shaft of the combined intermediate section 510, then both fibers 251 , 252 are inserted in proximal shaft section 511 at the same time. Then joints with the housings 321 , 322 are made to assemble the guidewire 502.

[0143] In some embodiments, the multi-sensor pressure guidewire has a temperature sensor and a pressure sensor and may be referred to as “temperature-pressure guidewire 503”, as illustrated in Fig. 5D. For example, a pressure sensor 531 may be operated while located in the left ventricle LV (see Figs. 1 B-1 D), while a temperature sensor 550 may be also located in the left ventricle LV. Such a temperature-pressure guidewire 503 may permit to perform an assessment of valve regurgitation. For example, the pressure sensor 531 of such a temperature-pressure guidewire 503 may be the same as described above.

[0144] The temperature sensor 550 may be preferably positioned in a distal housing 522 and measure a distal temperature, while the pressure sensor 531 may be positioned in the proximal housing 521 , as illustrated in Fig. 5D. Alternatively, the temperature sensor 550 may be positioned in the proximal housing 521 and measure a proximal temperature, and the pressure sensor 531 may be positioned in the distal housing 522. The temperature sensor 550 and the pressure sensor 532 may be located in the same sensor housing, at approximately the same position (less than 1 cm apart) or separated by a given distance (in a structure similar to the one illustrated in Fig. 2E). A temperature sensor fiber 254 is configured to a temperature signal from the temperature sensor 550 towards the connector 300. In at least one embodiment, the guidewire with the temperature sensor 550 and the pressure sensor 532 has the same construction as described herein for the guidewire with two pressure sensors 231 , 232.

[0145] In at least one embodiment, as illustrated in Fig. 5E, the guidewire, which is referred to herein as temperature-pressure guidewire 503, may comprise two pressure sensors (such as pressure sensors 531 , 532) separated by a given distance as described above and configured to measure the proximal pressure and the distal pressure in order to assess heart valve gradient, in addition to a third sensor, the temperature sensor 550 configured to measure the temperature. The temperature sensor 550 may be positioned near the distal pressure sensor 532 in one distal housing 522, in order to simultaneously measure the distal pressure and the distal temperature and to provide data (based on the distal pressure signal and the temperature signal generated by the distal pressureFile No. : P6314PC00 sensor 532 and the temperature sensor 550, respectively) to assess valve regurgitation. The distal pressure and the distal temperature may thus be transmitted as the distal pressure signal and the temperature signal via two different distal fibers: the distal fiber 252 and another distal fiber - the temperature sensor fiber 254. In some embodiments, the temperature-pressure guidewire 503 as illustrated in Fig. 5E may have the distal pressure sensor 532 configured to measure a distal pressure and the temperature sensor 550 configured to measure the distal temperature in one distal housing 522. When more than one sensor is located in the same housing, for example, the distal housing, each fiber 252, 254 may have a corresponding distancing ring that encircles at least partially the distal fiber within the distal sensor housing in order to restrict the distal fiber 252 from having any contact with the temperature sensor fiber 254.

[0146] The temperature sensor 550 of the temperature-pressure guidewire 503 non-limiting examples of which are illustrated in Figs. 5D, 5E, may be used to quantify the regurgitation. A liquid may be injected in the aorta over the valve. The liquid may be, for example, a contrast or a saline solution. In at least one embodiment, the liquid is at a temperature colder (cooler) than the body temperature of the patient, and may be referred to as a “cold liquid”. For example, the liquid may have a room temperature or lower. In some embodiments, the liquid may have 4 degrees Celsius (°C). The more valve regurgitation there is, the more liquid goes in the left ventricle, and the bigger decrease in temperature may be sensed (measured). The distance between the temperature sensor 550 and the valve may be determined and controlled by corresponding indications to the operator. For this, the housing which has the temperature sensor 550 inside (for example, the distal housing 522 in Fig. 5D) may be radiopaque and / or have at least one radiopaque marker, and an angiography image may be used to calculate a distance between the temperature sensor 550 and the valve. For example, the housing with the temperature sensor 550 may have, inside or on the outside surface of the housing, a radiopaque marker. In some embodiments, the temperature sensor 550 may be located in the proximal sensor housing 221 with the radiopaque marker. The temperature sensor 550 may be located in the proximal sensor housing 221 which has the radiopaque marker thereon and / or therein. In some embodiments, temperature sensor 550 may be located in the distal sensor housing 222 with the radiopaque marker inside the distal sensor housing 222 or thereon. The temperature sensor 550 may be located in the distal sensor housing 222 which has the radiopaque marker thereon and / or therein.

[0147] During a valve regurgitation assessment, data from the pressure sensor may be used either as an indicator of sensor positioning (indicating on which side of the valve the sensor is located based on the pressure waveform), or as an additional indicator of regurgitation through detection ofFile No. : P6314PC00 pressure change (e.g. slope of the pressure waveform during a specific phase of the cardiac cycle may be used to quantify regurgitation).

[0148] The processor 105, using an regurgitation assessment routine, may determine and indicate, for example on the monitor assembly 104 and / or using a sound signal, to the operator of the temperature-pressure guidewire 503 where to position the temperature sensor 550 by providing feedback (for example, an alarm or an indication on the display 104) when the position of the temperature sensor 550 is appropriate for taking measurements of the temperature. During the regurgitation assessment, the system 100 which uses the temperature-pressure guidewire 503 may instruct the user to pull the temperature-pressure guidewire 503 until the system 100 determines that the temperature sensor 550 is just below the valve, and requests the operator to stop pulling or pushing the temperature-pressure guidewire 503.

[0149] Using the temperature-pressure guidewire 503, the system 100 may perform a method for assessing regurgitation using the temperature-pressure guidewire 503 having the temperature sensor 550 located in the sensor housing 522 which is radiopaque. The temperature sensor 550 may be located in the sensor housing 522 which has the radiopaque marker thereon and / or therein. The temperature sensor 550 obtains and transmits temperature measurements to the processor 105 before and after the injection of the liquid into aorta over the valve. The processor 105 then determines a temperature decrease due to the injection of the cold liquid. A distance between the temperature sensor and the valve may then be determined by the processor 105 based on two angiography images: the first angiography image obtained before injecting the liquid into aorta over the valve and the second angiography image obtained after injecting the liquid into aorta. The level of regurgitation may then be determined if temperature decrease due to the injection of the liquid is more than a pre-determined threshold of the temperature decrease. In at least one embodiment, the method 1900 for assessing regurgitation, illustrated in Fig. 19, comprises: receiving temperature measurements at step 1910 from the temperature sensor 550 before and after an injection of the liquid into aorta over the valve to determine the temperature decrease due to the injection of the liquid; based on two angiography images, the first angiography image being obtained before injecting the liquid into aorta over the valve and the second angiography image being obtained after injecting the liquid into aorta, determining at step 1912 a distance between the temperature sensor and the valve; and in response to the temperature decrease being more than a pre-determined threshold of the temperature decrease, determining the level of regurgitation at step 1914. In at least one embodiment, the liquid that is injected is a cold liquid, such that the temperature of the liquid is colder than the temperature of the body of the patient, as discussed above. The liquid may be, for example, the contrast or another liquid such as, for example, the saline solution. In at least one embodiment,File No. : P6314PC00 the method for assessing regurgitation may further comprise determining and alerting the user whether to increase or to decrease the distance between the temperature sensor 550 and the valve in order to determine the level of regurgitation.

[0150] To use the guidewire 200 in some applications, where vascular access is more challenging, with sharper bends in the guidewire shaft, the guidewire 200 needs to withstand sharp bending during use. This necessity may arise not only in mitral, tricuspid, and pulmonary valve applications, but also in some challenging aortic valve and / or pediatric applications. To accommodate for this sharp bending in such applications, the guidewire 200 may be improved as follows. Such an alternative improved embodiment of the guidewire 200 - a sharply bending guidewire 560 - is schematically illustrated in Fig. 5F.

[0151] As illustrated in Fig. 5F, in addition to the proximal guidewire connector 300, distal tip 214, proximal and distal sensor housings 221 , 222 and proximal and distal shafts 211 , 212 of the pressure guidewire 200 illustrated in Fig. 2A, the sharply bending guidewire 560 illustrated in Fig.5F has an intermediate shaft 213 (which may be also referred to as an “intermediate shaft section 213”) and a shaft union tube 270 that may be used to join the proximal shaft 211 to the intermediate shaft 213. The intermediate shaft 213 of the sharply bending guidewire 560 is flexible and is configured to bend sharply and run from the shaft union tube 270 to the proximal sensor housing 221 . The sharply bending guidewire 560 may also have an intermediate shaft outside layer 561 which is more flexible than the proximal shaft 211. The intermediate shaft outside layer 561 may be a coil, an electrical insulation and / or coating layer covering the intermediate shaft 213.

[0152] In the sharply bending guidewire 560, the proximal shaft tube 211 that is stiff, has two fibers 251 , 252 running inside, and has an electrical insulation and / or coating layer 260 covering the proximal shaft 211. The proximal shaft tube 211 is stiff, which may be achieved by using a stiffer material such as, for example, stainless steel, and / or by making larger core OD of the proximal shaft tube 211. Material and OD are the main parameters that determine stiffness of the proximal shaft tube 211.

[0153] The proximal sensor housing 221 allows the proximal pressure sensor 231 to get in contact with blood on the proximal side of the heart valve. The distal shaft 212 is running from the proximal sensor housing 221 to the distal sensor housing 222 with only one fiber (distal fiber 252) inside. A coil, an electrical insulation and / or coating layer may cover the distal shaft 212. The distal sensor housing 222 allows the distal pressure sensor 232 to get in contact with blood on the distal side of the heart valve. The distal tip 214 may have a spiral shape as illustrated in Fig. 1A or any other atraumatic shape.File No. : P6314PC00

[0154] Both intermediate shaft 213 and distal shaft 212 of the sharply bending guidewire 560 may have different stiffness compared to the proximal shaft and compared to each other. The additional flexibility of the intermediate shaft 213 or distal shaft 212 may be obtained by reduction of diameter or by the use of a different material, having lower stiffness, compared to the stiff proximal shaft 211. Additional flexibility of the intermediate shaft would allow it to be sharply bent.

[0155] Alternatively, in at least one embodiment, the guidewire 200, 560 may have a pre-bent shaft section. For example, the intermediate shaft 213 may be pre-bent. In at least one embodiment, a pre-bent curved shaft section (not illustrated) may be located in the intermediate shaft 213 of the guidewire 560. This pre-bent shaft section of the intermediate shaft 213 of the guidewire 560 may be stiff in order to support guiding stiff catheters, such as valve delivery catheters, into sharply bending blood vessels, while conforming to the anatomy. There may be a variety of intermediate shafts 213 having different curves, shapes and bending patterns of the pre-bent curved shaft section(s). The user may choose the shape of the intermediate shaft 213 before attaching it to the guidewire 560. In at least one embodiment, the pre-bent shaft section may be located in the proximal shaft 211 (and not in a distinct intermediate shaft 113) of the guidewire 200. In other words, the guidewire 200 may have a pre-bent shaft section, which may be located in the proximal shaft 211 .

[0156] Kink resistance is another important aspect as a kink would make the advancement of a catheter over the sharply bending guidewire 560 difficult. To obtain the flexibility with good kink resistance, a kink- resista nt material with low Young modulus may be used. For example, such kinkresistant material may be nitinol. Using nitinol allows keeping dimensions of the intermediate shaft 213 and distal shaft 212 similar to dimensions of the proximal shaft 211 but having an additional flexibility and kink resistance compared to the proximal shaft 211. The proximal shaft 211 may be made of stainless steel. In at least one embodiment, the proximal shaft 211 may be welded to the intermediate shaft 213.

[0157] In an alternative embodiment, the proximal shaft 211 is connected to the intermediate shaft 213 via the shaft union tube 270 (Fig. 5F). The proximal shaft 211 and the intermediate shaft 213 may be glued, brazed or welded to the shaft union tube 270.

[0158] The guidewire 200, 560 as described herein may be able to conduct electricity to allow for rapid pacing of the heart. This function necessitates a good electrical conduction through the guidewire 200, 560. This may be achieved by welding the components together. In at least one embodiment, the proximal sensor housing 221 is welded to the proximal shaft 21 land the distal shaft 212, and the distal sensor housing 222 is welded to the distal shaft 212 and the distal tip 214 to allow electrical conduction between these components of the guidewire 200. Similarly, in the sharplyFile No. : P6314PC00 bending guidewire 560, the shaft union tube 270 may be also welded to the intermediate shaft 213 and the proximal shaft 211 , and the proximal sensor housing 221 is welded to the intermediate shaft 213 instead of the proximal shaft 211 to allow electrical conduction. Using a conventional adhesive may be problematic because the conventional adhesive is not an electrical conductor. An electrically conductive adhesive may be used to ensure the electrical conduction. For example, the electrically conductive adhesive may be manufactured by adding a conductive material into an adhesive. Such electrically conductive adhesive may be used in the guidewire 200. In at least one embodiment, the intermediate shaft 213, the shaft union tube 270, and the proximal shaft 211 are connected by an adhesive having a conductive material therein. Commercially available medical conductive adhesive may also be used.

[0159] Alternatively, to keep the electrical conductivity of the guidewire 200, 560 while using nonconductive adhesive, a stainless-steel coil may be positioned over the intermediate shaft 213 and / or the distal shaft 212. This stainless-steel coil may provide the electrical conductivity between the proximal shaft 211 and the tip 114. This stainless-steel coil may be welded to the shaft union tube 270 and / or proximal sensor housing 221 and / or distal sensor housing 222 to ensure electrical conduction. Alternatively, an electrically conductive flexible sleeve may be positioned over the intermediate shaft 213 and the distal shaft 212. For example, the electrically conductive flexible sleeve may be made of a polymer. The coil or a sleeve may be added to the shafts 211 , 212, 213 (attached over the distal shaft 212, the proximal shaft 211 and, where applicable, the intermediate shaft 213) for lubrication and smooth advancement of the guidewire within the catheter.

[0160] In at least one embodiment, two sensors (such as pressure sensors 231 , 232) may be designed with a different Fabry-Perot reference cavity length. Such sensors may be implemented, for example, using microelectromechanical systems (MEMS) technology. Two signals from these two sensors may thus travel through the same fiber and be analyzed and converted independently. For example, the two signals from the sensors may correspond to two distinct wavelength peaks. In at least one embodiment, the two sensors may be installed on the same fiber in the guidewire 200, or on two distinct fibers that connect to a single fiber having the fiber core with larger diameter in a monofiber guidewire connector. The guidewire connector Fiber of the monofiber guidewire connector does not need a specific alignment with a receiver fiber of the of the receiving connector 160, other than concentricity. When using the monofiber guidewire connector, an alignment key or angular positioning at the connector might be not needed.

[0161] A diameter of the monofiber in the monofiber guidewire connector may need to be at least twice as large as a diameter of the optical fibers 251 , 252 described above with reference to Fig. 2A,File No. : P6314PC00 for example, in order to receive the optical signal from these two fibers 251 , 252. Losses of the light coming from the sensors 231 , 232 may be thus reduced.

[0162] For the guidewire 200 with at least two sensors 231 , 232 and at least two corresponding fibers 251 , 252, the output cable 108 brings at least two receiver fibers 151 , 152 from the monitor assembly 104 towards the guidewire coupler 140, as illustrated in Figs. 1A, 2A, and 6A. When the guidewire 200 has more than two fibers therein, the output cable 108 has matching number of fibers. During the operation, the guidewire coupler 140 holds together a guidewire connector 300 of the guidewire 200 and a receiving connector 160 (also referred to herein as “female receiving connector 160”). During the operation, the guidewire 200 is maintained sterile and may need to receive a device, such as a stent, heart valve or a balloon over the shaft 210. For example, in some applications, during the operation, when the distal tip 114 of the pressure guidewire 200 is already inside the vasculature, the guidewire coupler 140 may need to be opened in order to separate the guidewire 200 from the guidewire coupler 140 and to insert a device over the guidewire 200, such as, for example, a valve delivery device or a stent, over the guidewire connector 300 towards the distal segment 135 of the pressure guidewire 200. Therefore, to be able to use the guidewire 200 by receiving the light (and / or the electrical signal) back from the sensors 231 , 232 and to have a possibility to operationally connect and disconnect the guidewire coupler 140 with / from the pressure guidewire 200, the guidewire coupler 140 needs to provide a low-loss connection of the light (and / or the electrical signal) between the matching fibers of the guidewire connector 300 and the output cable 108 (which may be the fiber optic cable or the electric cable when the sensors 231 , 232 are piezoelectric sensors). The receiver fibers 151 , 152 of the receiving connector 160 need to be removably connected to two fibers 251 , 252 running within the guidewire 200.

[0163] The guidewire coupler 140 is configured to connect, join, and align the fibers running in the guidewire connector 300 and the receiving connector 160, and the fibers of the guidewire connector 300 and the receiving connector 160 need to be aligned to reduce and minimize the losses of light in the guidewire coupler 140. The receiving connector 160, the guidewire coupler 140 and at least a portion of the output cable 108 together form an interface cable 109 (Fig. 1A), which may be referred to as a fiber optic interface cable 109 (or “FOIC 109”) when the sensors 231 , 232 are optical sensors and the fibers 251 , 252 are optical fibers.

[0164] Figs. 6B-6C illustrate the guidewire coupler 140 that may be used to connect the guidewires 200, 201 as described herein to output cable 108, in accordance with at least one embodiment of the present disclosure. In at least one embodiment, the guidewire coupler 140 and the receiving connector 160 may be attached to each other during the manufacturing and before use,File No. : P6314PC00 such that during the operation, the user only needs to insert the guidewire connector 300 into the guidewire coupler 140 to connect to the receiving connector 160, which is already positioned and attached to in the guidewire coupler 140. The guidewire coupler 140 may be similar to the one described in patent publication WO 2013 / 029157A1 , incorporated herein by reference in its entirety. The output cable 108 is thus terminated with the guidewire coupler 140 of Fig. 6C that is embedded within the interface cable handle 610 of Fig. 6B. The guidewire coupler 140 is configured to receive the guidewire connector 300 of the guidewire 200, 201 via the opening 620 within an alignment mechanism 625 and to align the guidewire connector 300 of the guidewire 200, 201 with the optical fibers 166 of the output cable 108. The guidewire coupler 140 is connected to a female receiving connector 160 that, together with the alignment mechanism 625, help aligning the optical fibers of the guidewire 200, 201 with the optical fibers of the output cable 108. The alignment mechanism 625 may be spring-loaded. The guidewire coupler 140 may facilitate insertion and connection of the guidewire connector 300 by the user. To achieve this, the guidewire coupler 140 may have a prealignment mechanism. For example, the geometry at the opening 620 of the guidewire coupler 140 may help guide proper alignment of the guidewire connector 300 when pushed inside the guidewire coupler 140. Rotational alignment may be provided by rotation, by the user, of a rotating component 615 of the interface cable handle 610 around a guidewire axis 303.

[0165] As illustrated in Fig. 2A, the guidewire connector 300 is located at the proximal end of the guidewire 200, that is opposite to the distal tip 114. In some embodiments, the guidewire connector 300 is a portion of the guidewire 200 in the proximal segment of the guidewire 200. The guidewire connector 300 may be attached to the proximal shaft 211 of the guidewire 200, 201 , or may be integral with the proximal shaft 211 of the guidewire 200. For example, a connector outer diameter (COD) may be approximately 0.035”.

[0166] To provide low losses when the guidewire connector 300 is connected with the receiving connector 160, the orientation and the position of the guidewire fibers 251 , 252 in the guidewire connector 300 and at least at the guidewire facet 310 need to be compatible and aligned with the position and the orientation of the receiver fibers 151 , 152 located in the corresponding portion and at least at the receiver facet 161 of the receiving connector 160. In at least one embodiment, the guidewire fibers 251 , 252 need to have such specific position and orientation within a short distance from the guidewire facet 310, and that short distance may be, for example, about three times a fiber diameter or less than 0.5 mm. Each guidewire fiber 251 or 252 needs to be positioned concentrically with and receive a signal (optical or electrical) from one of the receiver fibers 151 , 152. The guidewire connector 300 and the receiving connector 160 need to match, align, and therefore to have low loss when connected, in order to be implemented in a disposable product, which may comprise, forFile No. : P6314PC00 example, the guidewire 300 and the guidewire coupler 140. In addition, the guidewire connector 300 may need to be produced in volume.

[0167] Referring also to Fig. 2B, in the guidewire connector 300 of the guidewire 200, the optical fibers 251 , 252 may be aligned (in other words, the fiber’s central cores may be aligned) on one specific alignment plane 290 and positioned relative to an angular reference on the guidewire 200 and in the output cable 108. In most of the applications, alignment of each guidewire fiber 251 , 252, 253 on the guidewire connector 300 relative to the respective fiber on the female receiving connector 160 (receiving fiber 151 , 152, 153) needs to be within approximately 10 pm (or, for example, between 5 pm and 15 pm) of concentricity to ensure adequate signal transmission. Such precision of the alignment may be achieved, for example, by using the guidewire connector 300 as described herein.

[0168] In at least one embodiment, there is an additional separation provided by a spacing (distance) between the fibers 251 , 252. Such spacing may or may not be needed depending on the tolerancing (if the ID of the wire tubing constrain them sufficiently or does not allow separation) and possible crosstalk between fibers. The diameter of the cores of the receiver fibers 151 , 152, 153 in the receiving connector 160 may be larger than the guidewire fibers 251 , 252, 253 in the guidewire 200. This allows for looser tolerancing, for example: the guidewire fibers 251 , 252 with smaller cores would not need to be perfectly aligned with thicker fiber cores of the receiver fibers 151 , 152 to have all the light to be transmitted to thicker fibers of the optical interface cable 108. Some incoming light from the receiving connector 160 to the guidewire 200 may be lost, but not when the light is received by the receiving connector 160 from the guidewire 200. In other words, a portion of the incoming light from the receiving connector 160 to the guidewire 200 may be lost, but not the other way around. The fibers of the interface cable 109 may have larger cores in a relatively short adapter closer to the receiving connector 160, and the fibers of the output cable 108 may have smaller core diameter (for example, standard fiber core diameter) after that relatively short adapter, closer to the monitor assembly 104.

[0169] In at least one embodiment, to reduce coupling losses of the light (or electrical signal, if the fibers 251 , 252 are electric wires) between the guidewire connector 300 to the receiving connector 160, in at least one embodiment, the guidewire connector 300 has a guidewire key. Similarly, the interface cable 109, and specifically the receiving connector 160 of the interface cable 109 also has a receiver key, such that when the interface cable 109 is connected to the guidewire connector 300, the guidewire fibers 251 , 252 are aligned with the receiver fibers 151 , 152 of the receiving connector 160 to reduce and minimize losses of the connection. The guidewire key may be implemented in a keyed portion of the guidewire connector 300. In at least one embodiment, such keyed portion hasFile No. : P6314PC00 at least one keyed surface that may be, for example, flat, convex, concave, or have a groove and / or a spine, and / or a notch. The guidewire fibers 251 , 252 at a guidewire facet 310, and in particular central axes of the guidewire fibers 251 , 252, of the guidewire connector 300 are positioned and aligned in relation to the key in a specific manner. For example, when there are two fibers 251 , 252, the alignment plane 290 of the fibers 251 , 252 (which is a virtual plane formed by central axes of the fibers 251 , 252) may be parallel, perpendicular, or at a pre-determined angle to the keyed surface of the guidewire connector 300 (which may be, for example, flat and / or have a key groove as described below). The receiver key of the receiving connector 160 needs to ensure that the receiver fibers 151 , 152 are located at the same position at and in the vicinity of the receiver facet 161 to minimize losses in transmission of the signal from the guidewire connector 300 to the receiving connector 160 and vice versa.

[0170] In other words, the guidewire key is located on the guidewire connector 300 for aligning the fibers 251 , 252 of the guidewire connector 300 with receiving fibers 151 , 152 of the matching receiving connector 160, where the guidewire keyed surface (the keyed surface of the guidewire connector 300) and a receiving keyed surface (the keyed surface of the receiving connector 160) are configured to simultaneously mate with two opposite portions (two ends) of the guidewire coupler 140 such that two or more fibers 251 , 252 inside the connectors (the guidewire connector 300 and the receiving connector 160) align and connect to each other inside the guidewire coupler 140 to transmit the light (when the fibers 251 ,252 are the optical fibers) or the electrical signal (when the fibers 251 , 252 are the electric wires) from the guidewire connector 300 to the receiving connector 160. The guidewire keyed surface and / or the receiving keyed surface may be located on an outside shaft surface of the connectors 300, 160. The guidewire keyed surface and / or the receiver keyed surface may be oriented at a pre-determined angle with the virtual plane formed by central axes of two fibers (of at least two fibers of the guidewire connector 300) for aligning all fibers of the guidewire connector 300 with the matching receiving connector 160 and receiving fibers 151 , 152 thereof. Different types of the keys of two connectors may orient rotationally the fiber therein, especially in the vicinity of the front facets 310, 161 of the connectors 300, 160 such that the fibers in both connectors align 300, 160. The pre-determined angle may be, for example, 0 degrees, 90 degrees, 45 degrees, between about 0 and 45 degrees, between 0 degrees or 90 degrees. The pre-determined angle may be, for example, other than 0 degrees or 90 degrees.

[0171] Fig. 7A illustrates a perspective view of the guidewire connector 300 having a keyed surface 702 which is flat and is referred to herein as a “flat keyed surface”, in accordance with at least one embodiment of the present disclosure. In some embodiments, the guidewire connector 300 may be made directly on the proximal shaft 211 of the guidewire 300. The keyed surface 702 may beFile No. : P6314PC00 located on the proximal shaft 211 but distally from the proximal end 905 of the guidewire connector 300 (or distally from the guidewire facet 310 when the guidewire connector 300 is located directly on the proximal shaft 211 of the guidewire 200 as in Fig. 2A). In at least one embodiment, the keyed surface 702 may start (in other words, have one end) in the proximal end 905. For example, the keyed surface 702 may start on the guidewire facet 310. In at least one embodiment, the keyed surface 702 may extend for between 1 mm and 10 mm distally from the guidewire facet 310. In other words, the keyed surface 702 may be between 1 mm and 10 mm extending from the guidewire facet 310. For example, the keyed surface 702 may be 3 mm long. In at least one embodiment, the keyed surface 702 is located on the proximal shaft 211 , extending from the guidewire facet 310 to between 1 and 10 mm distally.

[0172] The receiver connector 160 may have a similar shape and construction as the guidewire connector 300. In the embodiment illustrated in Fig. 7A, the key, and in particular, the keyed surface is implemented by the flat keyed surface 702 which is located on a portion of the guidewire connector 300. In other words, in the guidewire connector 300 as illustrated in Fig. 7A (which may also be referred to as a “flat connector 300”), at least one section of a connector shaft 701 that carries the fibers 251 , 252 in a connector shaft lumen 916, is removed. For example, in the guidewire connector 300, at least two points of the keyed surface 702 may lie on an imaginary chord which forms a predetermined angle with the imaginary plane formed by the central axes of the guidewire fibers 251 , 252 in the guidewire connector 300 (see Figs. 7F, 8B, 8C) and receiver fibers 151 , 152 in the receiving connector 160. The pre-determined angle may be, for example, between 0 degrees and 90 degrees. In some embodiments, the guidewire connector 300 may have more than one keyed surface 702.

[0173] Figs. 7B (side view) and 7C (top view) illustrate the guidewire connector 300 and the matching receiving connector 160 which are connected to each other using the flat alignment mechanism 625 of the guidewire coupler 140, in accordance with at least one embodiment. The guidewire connector 300 may be manufactured by using a connector shaft 710 to obtain a keyed preform 700 (Fig. 7D), where the fibers (two or more) are glued inside the keyed preform 700 parallel to the keyed preform’s central axis prior to cutting this keyed preform 700, for example, in a middle of the keyed surface of the perpendicular to the connector shaft 710 (and therefore keyed preform 700) in 2 separate pieces, which helps improving the precision of the alignment. Fig. 7D illustrates a cross-sectional side view and Fig. 7E illustrates a cross-sectional top view of the keyed preform 700 (intermediate product) for manufacturing the guidewire connector 300 and the matching receiving connector 160, in accordance with at least one embodiment of the present disclosure.File No. : P6314PC00

[0174] Fig. 7F illustrates a cross-sectional view of the guidewire connector 300 along the lines E-E of Fig. 7D. In such an embodiment, the central axes 771 , 772 of the fibers 251 , 252, respectively are located in a fiber plane 755 which is oriented parallel (or approximately parallel) to the keyed surface 702 (which may be flat, as illustrated in Figs. 7A-7E). In other embodiments, the fibers 251 , 252 may be located such that at an angle alpha between the fiber plane 755, 855 and the keyed surface 702, 802 is between 0 and 360 degrees. Such a guidewire connector 300 with an inclined fiber plane 880 may be manufactured, preferably, together with the receiving connector 160 from one keyed preform 700, 800. Fig. 8C illustrates a cross-sectional view of the embodiment of an alternative keyed preform 800 having the angle alpha between a line representing the fiber place 880 formed by the axes 871 , 872 of fibers 851 , 852 and the keyed surface 802, where the alpha is between 0 and 90 degrees.

[0175] Figs. 8A and 8B illustrate a side view and a cross-sectional view of an alternative keyed preform 800 for manufacturing the guidewire connector 300 and the matching receiving connector 160, where two fibers 851 and 852 are arranged within the alternative keyed preform 800 vertically, such that the central axes 871 , 872 of the fibers 851 , 852 are located in a plane perpendicular to the keyed surface 802. The guidewire connector 300 may be thus manufactured as the keyed preform 800 with the fiber inserted. Position (location) of the fibers 251 , 252 is secured to the connector shaft 710 with an adhesive prior to a cutting step. When using the technology as described herein, the guidewire connector 300 of the guidewire 200, 201 as described herein may be manufactured at low cost and with a high level of reliability.

[0176] Figs. 7D, 8A illustrate keyed preforms 700, 800 (which may be also referred to as “preforms” or “keyed tubes”), in accordance with embodiments of the method of manufacturing the connector 300. The keyed preforms 700, 800 have keyed surfaces 702, 802 that may be obtained by grinding a segment of the tube, while leaving a keyed tube thickness 707 between the lumen 216 and the keyed surface 702, 802 illustrated in Figs, 7F, 8B, 8C. There may be more than one keyed surfaces 702, 802 on the preform prior to cutting, and the keyed surfaces 702, 802 may be located further away from the cut plane (for example, located along the line 790) of the keyed preform 700, 800.

[0177] Cutting the keyed preforms 700, 800 to obtain the guidewire connector 300 and the receiving connector 160 may be done, for example, along the line 790 (Figs. 7D, 8A) using a smooth diamond blade with high spindle speed but low advancement. This creates a mirror image on the front facets of the guidewire connector 300 and the receiving connector 160, and in particular a mirrored positioning of the fibers, on both sides of the cut where the location (in other words, theFile No. : P6314PC00 central axes) of both fibers 251 , 252 match 100% the location (in other words, the central axes) of receiving fibers 151 , 152 located in the matching receiving connector 160 obtained as a result of cutting the preforms 700, 800. The position of each fiber 251 , 252 relative to the tube and / or to the keyed surface 702, 802 (in other words, the position of the central axes of the fibers relative to the tube or the keyed surfaces), is not important because the positions of the fiber central aces of the receiving connector portion 722, 822 matches the positions of the fiber central axes in the guidewire connector portion 721 , 721 .

[0178] The diamond blade cutting might provide a polished surface that may need an additional polishing step. An additional surface polishing step may be performed to ensure a connector with optimal optical quality. As the two pieces of the cut keyed preform 700, 800 (portions 721 , 722 in Fig. 7D and portions 821 , 822 in Fig. 8A) match only with each other, they may be paired and may not be paired with any other connector.

[0179] The keyed preform 700, 800 for manufacturing the guidewire connector 300 and the receiving connector 160 may be manufactured on the proximal side of the guidewire 200, directly on the guidewire shaft 211 or on a short section of a tube that may be fixed on the proximal side of the guidewire 200. This means that the guidewire fibers 251 , 252 glued in the keyed preform 700 are already assembled in the guidewire 200 prior to the step of cutting the keyed preform 700 to manufacture the guidewire connector 300, and that there is an excess length of the guidewire 200 located on the proximal side of the keyed preform 700 for connecterization.

[0180] Once the keyed preform 700 is cut into two parts along the lines 790, the proximal part is assembled within receiving connector 160 and connected to the output cable 108 that transmits the optical signal from the console 104 to the guidewire 200 and vice-versa. Standard connection technique may be used to connect both fibers from the output cable 108 to the receiving connector 160, such as, for example, fiber fusion, gel connection or even zirconia ferule assembly.

[0181] Fig 8D illustrates a method 1800 of manufacturing of the guidewire connector 300 and / or a receiving connector 160, as illustrated, for example, in Figs. 7A, 7E, and in accordance with at least one embodiment of the present disclosure. At step 1810, the fibers 251 , 252 are glued inside a connector shaft. The connector shaft may be, for example, a separate shaft, or a proximal portion of the shaft 210 of the guidewire 200. At step 1812, a segment of the connector shaft is grinded to manufacture a key in the keyed preform 700, 800 which may be provided, for example, by the keyed surface 702, 802 (Figs. 7D and 8A) of the keyed preform 700, 800. For example, as illustrated in Fig. 7D, the keyed surface 702 may be obtained by grinding the connector shaft. At step 1814, the keyed preform 700, 800 is cut along a plane, which is perpendicular to the keyed preform 700, 800, and isFile No. : P6314PC00 illustrated with the line 790 in Figs. 7D and 8A, to obtain the guidewire connector 300 and the receiving connector 160. In some embodiments, the keyed surface 702 may be polished after the fibers 251 , 252 have been glued into the keyed preform 700. At step 1816, one portion of the keyed preform 700, 800 is assembled in the guidewire (guidewire connector). At step 1818, another portion of the keyed preform 700, 800 is assembled in the guidewire coupler 140 (receiving connector 160). At step 1820, during use, the guidewire 200 and its guidewire connector 300 is connected with the receiving connector 160 using the keyed guidewire coupler 140 which is adapted simultaneously to the guidewire connector 300 and the receiving connector 160.

[0182] Manufacturing a matching pair of the guidewire connector 300 and receiving connector 160 by cutting of the keyed preform 700, 800 may be cumbersome for a mass production of the pressure guidewire 200 and the system 100.

[0183] To manufacture the guidewire connectors 300 and receiving connectors 160 with consistent fiber positions in mass production, fiber centering devices may be used. In such a method of manufacturing of the connectors 300, 160, a short (relatively short) piece of a keyed tube 900 illustrated in Fig. 9A may be used. The keyed tube 900 may be a tube having any type of the key, such as, for example and not limited to a keyed surface (such as, for example, a flat surface), a groove, a spine, etc. In some embodiments, the key may be the keyed surface having a groove and / or a spine. In at least one embodiment, illustrated in Fig. 9A, the keyed tube 900 has a distal circular cross-section (at a distal end 932) and a keyed proximal end 931 . The key (the keyed feature) may be also located distal to the guidewire proximal end 905, leaving the tube portion of the guidewire proximal end (proximal to the front facet of the guidewire connector 300) with a circular cross-section. The key (keyed feature) may be located, for example, between 1 millimeter (mm) and 10 mm distal to the front facet of the proximal end. The key may be located, for example, between 1 cm and 10 cm distal to the proximal end. In this case, the matching alignment key of the guidewire coupler 140 is manufactured accordingly, to ensure proper alignment of the connector key with the matching alignment key of the guidewire coupler 140. In the non-limiting example illustrated in Figs. 9A-9C, the keyed proximal end 931 of the keyed tube 900 has one segment of the keyed tube 900 peeled off (or grinded) to obtain the keyed surface 702. For example, the key may be implemented by a groove, which may be, for example, a straight groove, as illustrated in Fig. 13A. In at least one embodiment, the key may be implemented by an additional (keyed) tube that is laser cut with a groove and welded or glued over the proximal end of the guidewire 200. Such an embodiment of the guidewire connector 300 (which may be also referred to as a “tubular guidewire connector”) make the alignment easier and improves the precision of the alignment.File No. : P6314PC00

[0184] Referring to Fig. 9B, fibers 251 , 252 may be fed through the keyed tube 900 and inserted in a centering device 980. The centering device 980 may precisely hold fibers 251 , 252 on the proximal side of the keyed tube 900 while also precisely securing the position of the keyed tube 900. Tension may be required on the fibers 251 , 252 to ensure that the fibers 251 , 252 are perfectly rectilinear from the proximal holding point 991 to the distal holding point 992. Positions of the fibers 251 , 252 are then secured on the keyed tube 900 using an adhesive. The centering device 980 may be a machined tool with two perfectly aligned holes, a precise hole and forcing fiber to both sides, or a slot with a spacing fiber tool. The centering device 980 may be also a positioning device with a micro-displacement motor and a camera, automated or manually operated. Following the gluing step, the guidewire connector 300 may be removed from the centering device 980 (from the alignment setup). The guidewire proximal end 905 of the guidewire connector 300 may then be polished using standard optical polishing technique. The guidewire proximal end 905 may have a flat or slightly curved surface achieved by polishing. The receiving connector 160 may be manufactured in a similar manner: by feeding the receiving fibers 151 , 152 through the keyed tube, and using the centering device 980 which holds precisely the receiving fibers 151 , 152, while also precisely securing the position of the keyed tube. When manufacturing the matching receiving connector 160, positions of the guidewire fibers 251 , 252 on the guidewire facet and on the proximal side need to align (for example, core centers of the fibers need to approximately coincide, with a minimal deviation) with positions of the receiving fibers on the receiver facet 161 of the matching receiving connector 161.

[0185] The keyed tube 900 may be attached to (joined with) the pressure guidewire 300 before or after the fiber alignment and gluing step, if it is an additional piece. Alternatively, this keyed tube 900 may be directly the shaft 210 of the guidewire 200, 201. The joining method needs to avoid providing any mechanically weak region that would allow losses of the light, because the proximal part of the pressure guidewire 300 may be roughly manipulated during the use of the pressure guidewire 300 in the system 100. In at least one embodiment, the maximum OD of the tube 900 may be approximately 0.035 inch, similar to the maximum OD of the guidewire 300. The maximum OD of the tube 900 may be, for example, 0,028 inch, 0,018 inch, or 0,014 inch.

[0186] The best method to join the keyed tube 900 to the pressure guidewire 300 may be by using a union tube 1015 as, for example, in Fig. 10, where a guidewire connector 1000 with a keyed tube 1001 and the union tube 1015 installed are illustrated, in accordance with at least one embodiment of the present disclosure. The keyed tube 1000 has a keyed portion 1010 which has two opposite keyed surfaces 1011 , 1012. While the OD of the union tube 1015 may have any value, the OD for the guidewire application may be approximately equal to or less than 0.035” to be able to advance the catheter or an interventional device (such as a valve delivery system) over the guidewireFile No. : P6314PC00200. The OD 1020 of the internal keyed tube 1001 may be, for example, in the range of approximately 0.025” to approximately 0.030”, in order to provide sufficient thickness for the wall of the union tube 1015 to make the junction with the pressure guidewire. This union tube 1015 may be glued or welded to the keyed tube 1001 on one side and the guidewire 200 on the other side using standard welding or gluing technique known in the art. The proximal end of the pressure guidewire 300 and the distal end of the keyed tube 900 (or the keyed tube 1001) may be also grinded to obtain a thicker wall on the union tube 1015 while respecting the OD constraints, which may be desirable in some applications.

[0187] The keyed portion 910, 1010 of the guidewire connector 300 has the keyed surface 702, 1011. In at least one embodiment, the keyed surface 702, 1011 may have a longitudinal alignment feature. For example, the longitudinal alignment feature may be a spine or a bump (for example, an optional bump 1013 is illustrated in Fig. 10), which may be, for example, of circular convex shape, that is configured to mate with an alignment surface of the alignment device. Similarly, the receiving connector 160 may also have the receiving keyed surface (flat or curved, preferably the same shape as the keyed surface of the guidewire connector 300) and may have optionally a spine or a bump thereon. For example, the longitudinal alignment feature may “click” when the guidewire connector 300 is pushed inside the guidewire coupler 140 towards the receiving connector 160. The keyed surface 702 may be distal to the proximal end 905 of the guidewire 200 requiring the matching alignment key of the guidewire coupler 140 to be positioned accordingly, to ensure proper alignment.

[0188] In order to improve the alignment of the connector 300 and the receiving connector 160, other solutions described herein may be used. In at least one embodiment, an alignment device with, for example, a coupler alignment feature (also referred herein as an “alignment key”) is integrated in the guidewire coupler 140. Two ferules may be held concentrically using a split sleeve and the alignment feature may be incorporated in such an assembly.

[0189] In at least one embodiment, the alignment device has a shape which matches or is complemental with the shape of the keyed surface(s) 1011 , 1012 of the keyed portion 1010 of the guidewire connector 300, the receiving connector 160 or both, such that when one or more alignment devices are abutting the keyed surface of the guidewire connector 300, the matching receiving connector 160, or both, the keyed tube 900, 1001 of the guidewire connector 300 does not rotate around its central axis and with respect to the guidewire coupler 140 and the receiving connector 160, and an alignment between the fibers of the guidewire connector 300 and the matching receiving connector 160 may be provided. In some embodiments, the alignment device has at least one alignment surface configured to mate with one of the keyed surfaces 1011 , 1012 or both (or more)File No. : P6314PC00 keyed surfaces 1011 , 1012 of the guidewire connector 300 (while abutting at least partially one of the keyed surfaces 1011 , 1012 or two or more keyed surfaces 1011 , 1012 in order to lock a rotational position of the guidewire connector 300 relative to the alignment device).

[0190] Fig 11 A illustrates the guidewire connector 300 with a flat alignment surface 702 and an alignment device 1100, according to at least one embodiment of the present disclosure. For instance, the flat alignment surface with the flat keyed surface 702, 1011 as illustrated in Figs. 9A, 10 needs the alignment device 1100 with a matching flat alignment surface. The alignment device 1100 has a mechanism which helps the user aligning the key (keyed surface 702) at a proper angle in the guidewire coupler 140 of the interface cable 109, and then locking the key in place to lock the rotational position (restrict rotational movement) of the connector 300 with respect to the alignment device 1100 and therefore to the fibers 251 , 252. For example, a spring-loaded mechanism may perform this function. The flat alignment device 1100 may be spring-loaded. A non-limiting example of the spring-loaded alignment device 110 is illustrated, for example, in Fig. 11 B with springs 1105) that are capable to adjust positioning of the alignment device 110 to adapt to discrepancies of the outer dimensions of the keyed portion 910 (in other words, to adjust the distance between the keyed surface 702 and the inner diameter of the ferrule that may accommodate the keyed portion 910). Due to the use of spring-loaded alignment device 1100, the connectors 300 may be manufactured in high volume and may be reliably (in other terms, with low losses) connected to receiving connectors 160. Spring load of the alignment device 1100 may be implemented using a conventional spring or by using compressive material such as, for example, rubber.

[0191] As discussed above, the keyed surface 702 may have other shapes than just a flat surface 702, 802, 1011 , 1012 as illustrated in Figs. 7A, 8A, 10. In at least one embodiment, the keyed portion of the connector 300 may have the keyed surface having a convex form or a concave form which may be, for example, circular. Fig. 12A illustrates a cross-sectional view of an alignment device 1240 positioned on top of a concave keyed surface 1211 of the guidewire connector 300 for facilitating an alignment of the guidewire connector 300 and guidewire fibers 251 , 252 located therein with the receiving connector 160 and the receiving fibers 151 , 152 located therein, in accordance with at least one embodiment of the present disclosure.

[0192] Fig 12B illustrates a perspective view of the guidewire connector 300, a receiving connector 160, and a guidewire coupler 140 configured to connect the guidewire connector 300 with the receiving connector 160, in accordance with at least one embodiment of the present disclosure. The guidewire coupler 140 (also illustrated in Fig. 1A) may have one or more aligning devices 1240, 1248 and a connecting sleeve 1245 for aligning the guidewire connector 300 with the receivingFile No. : P6314PC00 connector 160. The connecting sleeve 1245 has a bore therein for receiving the guidewire connector 300 therein, and a first sleeve opening on a side wall. The first sleeve opening (for example, a sleeve opening 1247 in Fig. 12B) receives a first alignment device (for example, the spring-loaded rounded component 1240) therein to pass through the first sleeve opening and to abut the keyed surface 1211 of the guidewire connector 300 to lock a rotation of the guidewire connector 300 with respect to the connecting sleeve 140.

[0193] The connecting sleeve 1245 also has a second sleeve opening 1249 on the side wall of the connecting sleeve 1245, the second sleeve opening being configured to receive a second alignment device (for example, the spine 1248) therein to pass through the second sleeve opening 1249 and to abut another keyed surface of the receiving connector 160 to lock a rotation of the receiving connector 160 with respect to (relative to) the connecting sleeve 1245. In at least one embodiment, the second alignment device may be the same component as the first alignment device. For example, the first alignment device and the second alignment device may be combined in one alignment device, such as, for example, a long spine that fits both the keyed surface of the guidewire connector 300 (guidewire keyed surface) and another keyed surface (receiving keyed surface) of the receiving connector 160. In at least one embodiment, the connecting sleeve 1245 has a bore therein for receiving the guidewire connector 300 and the receiving connector 160 therein, and one alignment surface (and / or one alignment device) configured to mate with the keyed surface (guidewire keyed surface) of the guidewire connector 300 and with the another keyed surface (receiving keyed surface) of the receiving connector 160 simultaneously.

[0194] The guidewire coupler 140 may have a first alignment device 1240 for the first sleeve opening 1247 of the guidewire connector 300 and a second alignment device for the second sleeve opening 1249 of the receiving connector 160. One or both of the first and / or the second sleeve openings 1240, 1249 may be, for example, a slit for receiving a spine (as the alignment device) therein. One or both of the first and / or second sleeve openings may be configured to receive a rounded component (having a tip with a spherical shape) therein as the alignment device. The rounded component may be, for example, spring-loaded. The alignment device is configured to abut the keyed surface(s) 1211 , 163 of the guidewire connector 300 and / or the receiving connector 140, and lock the guidewire connector 300 rotationally relatively to the connecting sleeve 1245.

[0195] In a non-limiting example of the connecting sleeve illustrated in Figs. 12B, 12C, the first and second alignment devices are a spring-loaded rounded component 1240 and a spine 1248, respectively, the first and second sleeve openings are a sleeve opening 1247 and a connecting slit 1249, and the keyed surface of the guidewire connector 300 is a concave keyed surface 1211 (whichFile No. : P6314PC00 may be, for example, a circular concave keyed surface 1211) and another keyed surface (of the receiving connector 160) has the connecting slit 1249.

[0196] The guidewire connector 300 in Fig. 12A has the concave keyed surface 1211 , and it may be used with the spring-loaded rounded component 1240, such as, for example, a ball tip of a spring-loaded set screw, as an alignment device. The connecting sleeve 1245 of Fig. 12B (which is located in the guidewire coupler 140 in Fig. 1A) may be used to align the guidewire connector 300 with the receiving connector 160, as shown in Fig. 12B. To ensure access to the keyed tube 1200, the connecting sleeve 1245 may be machined to provide the sleeve opening 1247 (machined sleeve window) to allow the passage of the spring-loaded rounded component 1240 therethrough. In the embodiment illustrated in Figs. 12B and 12C, the alignment reference for the receiving connector 160 in the machined connecting sleeve 1245 is a receiving connector groove 163 with a spine 1248. For example, such alignment reference may be used in the guidewire coupler 140 with the receiving connector 160 assembled therein for the convenience of the use. As illustrated in Fig. 12C, the spine 1248 sits in the receiving connector groove 163 which is received in a connecting slit 1249 of the connecting sleeve 1245. Any other key feature may be used for the receiving connector subassembly, such as another convex or concave surface on the connecting sleeve 1245 or on the receiving connector 160.

[0197] In at least one embodiment, a method of use of the guidewire connector 300 and the receiving connector 160 may comprise aligning the guidewire connector 300 and the receiving connector 160, after the receiving connector 160 has already been mounted in the guidewire coupler 140 or before that or simultaneously, such that a guidewire connector keyed surface 1211 of the guidewire connector 300 and a receiving connector keyed surface 163 each abuts a corresponding aligning surface of the corresponding alignment device (for example, the aligning devices 1240, 1249 in Fig. 12C) of the guidewire coupler 140.

[0198] In some embodiments, after the receiving connector 160 has been installed in the guidewire coupler 140, the guidewire 300 may be rotated manually by the user or by a machine (by a mechanism, mechanically) into the connecting sleeve 1245 until the alignment device (for example, the spring-loaded rounded component 1240 of Fig. 12B), clicks into and abuts the keyed surface (for example, the concave keyed surface 1211) of the guidewire 300, and locks itself therein, as shown in Fig. 12C. The user may rotate the keyed tube 1200 (illustrated with arrow 1255) to find the locking position inside the guidewire coupler 140. Another mechanism may push the guidewire 300 longitudinally, along the guidewire axis 303, to force contact with the receiving connector 160 andFile No. : P6314PC00 lock it into place, to ensure appropriate optical (or electrical) signal transmission between the fibers of the guidewire connector 300 and the receiving connector 160.

[0199] The spring-loaded rounded component 1240, which may be a set screw, may have a tip with an aligning ball 1230. The aligning ball 1230 may be made of a plastic or a metal. To ensure proper alignment using a concave keyed tube 1200 and a spring-loaded rounded component 1240, the radius of curvature of the keyed surface 1211 of the keyed tube 1200 is smaller than the radius of the aligning ball 1230 to allow for two points of contact with the ball’s tip. This ensures that there is only one rotational position that may be achieved for the guidewire connector 300 in the ferrule assembly. Fig. 12A illustrates the spring-loaded aligning ball 1230 on top, with the concave keyed tube 1200 with the circular concave keyed surface 1211. Diameter of the concave keyed surface 1211 is smaller than the diameter of the aligning ball 1230 to allow for two points of contacts 1231a, 1232b. The keyed surface may be thus concave, forming a recess within the shaft, the recess configured to receive (mate with) at least partially the aligning ball 1230 (or another alignment device having a tip with a convex shape), and the concave keyed surface having a concave surface radius that is equal to or less than a radius of a curvature of an aligning surface of the aligning device, in other words, the convex surface of the tip of the alignment device (for example, the aligning ball 1230).

[0200] In at least one embodiment, a similar mechanism with a concave keyed surface of the guidewire connector 300 and a spring-loaded rounded component (or another alignment device with a convex aligning surface) may also be used in an alignment jig described below (see, for example, the alignment jig 1410 in Fig. 14A) during assembly of the guidewire 200 for the purpose of aligning the fibers with the keyed surface of the guidewire connector 300.

[0201] In at least one embodiment, the keyed portion of the guidewire connector 300 may have a guidewire connector groove or a guidewire connector spine (protuberance) for alignment, as long as the total diameter of the guidewire connector 300 is approximately equal to or less than 0.035”. Similarly, the keyed portion of the receiving connector 160 may have a receiving connector groove or a receiving connector spine (protuberance). For example, the groove or the spine may be located on the flat surface, and the groove or a spine may be positioned parallel to the central axis 303 of the keyed tube of the guidewire connector 300 and / or the receiving connector 160 (as illustrated in Fig. 12B). A non-limiting example of a guidewire connector straight groove 1310 is illustrated in Fig. 13A, a non-limiting example of a guidewire connector V-groove 1315 is illustrated in Fig. 13B, and a nonlimiting example of the guidewire spine 1350 is illustrated in Fig. 13C. The receiving connector 160 may have similar construction. The key may be implemented on a short laser-cut tube, and, forFile No. : P6314PC00 example, welded over the keyed tube. Fig. 13A illustrates the guidewire connector 300 having a guidewire connector groove 1310, in accordance with at least one embodiment of the present disclosure. In at least one embodiment, a portion of the guidewire connector 300 may have a guidewire connector V-shaped groove 1315 as illustrated in Fig. 13B, while the guidewire coupler 140 may have a matching corresponding guidewire coupler key (for example, a V-shaped guidewire coupler, and / or for example, a fin). The V-shape of the guidewire connector V-shaped groove 1315 helps the user to find the guidewire connector V-shaped groove 1315 with the corresponding coupler key when rotating the guidewire connector V-shaped groove 1315 inside the guidewire coupler 140. Straight grooves are depicted in figures for simplicity, but other shapes and mechanisms may be used (for example, and without limitation, a curved V-shaped groove of the guidewire coupler). Similarly, for the guidewire spine 1350 of Fig. 13C, the guidewire coupler 140 may have a matching groove (for example, a coupler V-groove). Inside the guidewire coupler 140, there may be similar connector tubing as the one on the guidewire connector 300, in addition to the V-shaped key. This connector tubing inside the guidewire coupler 140 may be fixed to the V-shaped key, and thus does not need to have a V-shape (without rotation by the user).

[0202] Figs. 14A, 14B illustrate a perspective view and a top plane view, respectively, of an alignment jig 1410, in accordance with at least one embodiment of the present disclosure. The alignment jig 1410 may be used to align fibers 251 , 252 inside the guidewire connector 300 with respect to the guidewire connector keyed surface (that has a groove and / or a spine, etc.) that the guidewire connector 300 has. Figs. 14C, 14D illustrate perspective views and Fig. 14E illustrates a top plane view of the guidewire 200 with guidewire connector 300 and fiber ends 1425 of the fibers 251 , 252 inserted into the alignment jig 1410.

[0203] In at least one embodiment, the fiber ends 1425 may be held separately by two fiber ferules 1415 illustrated in Figs. 14A, 14B in an alignment jig 1410 for alignment with two fiber ferrules 1415. Alternatively, the fiber ends 1425 may be held in an alignment tool 1410 by one dual-hole ferule (not shown).

[0204] The alignment jig 1410 has a jig block 1412 which has a ferrule cavity 1420 configured to receive two fiber ferrules 1415 on one side and a keyed alignment ferule 1430 (which may be also referred to as a “guidewire connector tube 1430”) on another side. The keyed alignment ferule 1430 is a hollow cylinder with a bore therein for receiving, coaxially with the bore, and at least partially the guidewire connector 300. The keyed alignment ferule 1430 has an alignment ferule key configured to receive a locking element. In Figs. 14A-14D, the keyed alignment ferule 1430 has the alignment ferule key which is, in the embodiment illustrated in Fig. 4D, an alignment ferule groove 1450 locatedFile No. : P6314PC00 on one side of the hollow cylinder of the grooved alignment ferule 1430, while the locking element is a jig spine 1427. The keyed alignment ferule 1430 in the non-limiting embodiment illustrated in Figs. 14A-14D may be also referred to as “a grooved alignment ferule 1430”.

[0205] The alignment ferule 1430 is configured to receive coaxially the at least a portion of the guidewire connector 300. Figs. 14A-14D illustrate a non-limiting example of using the alignment jig 1410 with the alignment ferule groove 1450 of the keyed alignment ferule 1430, and other shapes of the guidewire connector keyed surface of the guidewire connector 300 and therefore of the alignment ferrule key and another jig key and another locking element may be used.

[0206] An alignment jig 1410 for aligning of fibers 251 , 252 with respect to the keyed surface in the guidewire connector comprised a jig block having a ferrule cavity configured to receive at least two ferrules on one side of the jig block and a keyed alignment ferrule on the other side, the keyed alignment ferrule having a bore therein for receiving, coaxially with the bore, at least a portion of the guidewire connector with a keyed surface, the keyed alignment ferrule having an alignment ferrule key and the guidewire connector having a keyed surface, wherein each one of the keyed surface of the guidewire connector, the alignment ferrule key and a jig key receives a portion of a locking element which is configured to fix rotation positions of the guidewire connector with respect to the alignment jig. The keyed alignment ferrule 1430 may have a groove for receiving the portion of the jig spine therein, the jig spine 1427 being configured to enter and abut the connector groove 1310 of the guidewire connector 300 to lock the circular orientation (in other words, to lock the rotation orientation to prevent rotation, restrict rotational movement) of the guidewire connector 300 with respect to the jig block 1410 around its central axis 303, to prevent rotation of the guidewire connector 300 around its central axis 303, and therefore to prevent rotation of fibers 251 , 252 around the central axis 303 of the guidewire connector 300.

[0207] As illustrated in Fig. 14D, the grooved alignment ferule 1430 has a groove 1450 (also referred to herein as an “alignment ferrule groove 1450”) which is aligned with the jig spine 1427. For example, the jig spine 1427 may be received by both an alignment ferrule key (which is a jig groove 1429 in Fig. 14D) of the alignment jig 1410 and by the alignment ferrule groove 1450. Alternatively, the jig spine 1427 may be simply made in the ferrule cavity 1420 of the alignment jig 1410. In Fig. 14D, the shaft tube 211 is illustrated as being cut to show the fibers 251 , 252 inside the guidewire 200, which extend towards sensors 231 , 232. The central axes of at least two fiber ferrules 1415 and preferably all three ferules 1415, 1430 may lie on one common reference plane, and therefore the fiber ends 1425 may be precisely aligned on a common plane. This may be achieved due to uniformity of two fiber ferrules 1415 and a ferrule cavity 1420 (Fig. 14C) configured to receive and hold the threeFile No. : P6314PC00 ferules 1415, 1430 therein, the ferrule cavity 1420 being adapted to provide such one common reference plane. The fiber ferrules 1415 and therefore fiber ends 1425 are separated by an angle 1440. This angle 1440 between the fiber ends 1425 allows to manipulate the fiber ends 1425 in individual fiber ferules 1415 for precise alignment. When exiting from the guidewire 200 to the alignment jig 1410, as illustrated in Figs. 14B, the fiber ends 1425 may “lean against” the inner wall of the guidewire tubing. A proximal end 1433 of the guidewire 200 may extend from the grooved alignment ferule 1430. Glue may be added at and around the proximal end 1433 of the guidewire to fix the fiber ends 1425 in place.

[0208] Positioning fiber ferules 1415 in the alignment tool 1410, relative to the reference groove(s) or another key, is easier than positioning and clamping the fiber ends 1425 directly. This may be done using two ferules 1415 at an angle or with a dual-hole ferule or another dual-hole part, such as, for example, a precision-printed dual-hole part. Instead of sitting on a fixed plane, the ferrules 1415 may be clamped, together or each clamped individually, on high-precision adjustable stages or other mobile component that allow refining the alignment of the fibers inside the guidewire connector 300. Adjustment may be in the X, Y axis or an angular adjustment. High-precision camera or other vision tool may help this task. The same alignment tool 1410 may be used to mount the matching receiving connector 160.

[0209] Fig 14F illustrates the guidewire connector 300 for the multi-sensor guidewire 200 before assembly, with the groove 1310 for alignment and fiber ends 1425 of the fibers 251 , 252 which are loose, to be positioned in the alignment jig 1410 for gluing in place. Fibers 251 , 252 (with fiber ends 1425) are glued in at the proximal end 1433 of the guidewire 200, then cut. The shaft tube 211 extends towards the distal end of the guidewire 200, with fibers 251 , 252 run inside the guidewire 200 towards the sensors 231 , 232.

[0210] Other shapes and / or mechanisms may be used for the alignment of the fibers 251 , 252 with the groove 1310 during fabrication. For example, referring to Fig. 14A, instead of the ferrules 1415, the alignment jig 1410 may have a clamp 1330 that directly clamps the two fiber ends 1425 on a fixed plane relative to the keyed alignment ferrule 1430 as illustrated in Fig. 14G. The clamp 1330 is configured to maintain the fiber ends 1425 closely in place under tension, ensuring a consistent alignment relative to the keyed feature (keyed surface, for example) of the guidewire connector 300 (in this case, a groove in the grooved alignment ferule 1430).

[0211] Alternatively, the alignment jig 1410 may have two or more clamps 1330, each clamp holding one fiber end 1425. In some embodiments, those clamps 1330 may be mounted on high- precision adjustable stages or other mobile components that allow refining the alignment of the fiberFile No. : P6314PC00 ends 1425 inside the guidewire connector 300. Adjustment may be in the X, Y axis or an angular adjustment. A high-precision camera or another vision tool may be used to improve the precision of the alignment. Instead of the clamp 1330 of Fig. 14G, the alignment jig 1410, may have two grooves 1371 , or the alignment ferule 1430 as illustrated, for example, in Fig. 14H, where each groove 1371 has the diameter of approximately the diameter of the fibers 251 , 252. A weight may be laid on top of the fibers 251 , 252 that sit in the grooves 1371 , ensuring stable positioning and allowing to maintain tension through friction while the fibers 251 , 252 are glued at the guidewire proximal end 905.

[0212] Referring to Fig. 1A and 15 A, in at least one embodiment, the guidewire coupler 140 for connecting the guidewire connector 300 with the receiving connector 160 may comprise the connection tube 1510 having a bore therein for receiving, coaxially, at least a portion of the guidewire connector 300 on one side and a receiving connector 160; and at least one opening (for example, the connector slit 1517 in Fig. 15A) for receiving at least one alignment device (for example, the guidewire coupler spine 1515 in Fig. 15A), the at least one alignment device configured to abut simultaneously the keyed surfaces of the guidewire connector 300 and the receiving connector 160.

[0213] Fig. 15A illustrates a perspective view of an interface cable assembly 1500 (also referred to herein as “fiber optic interface cable assembly 1500” or a “FOIC assembly 1500” when at least one fiber 251 , 252 located in the interface cable assembly 1500 is an optical fiber) with a guidewire connector 300, in a simplified view, in accordance with at least one embodiment of the present disclosure. In some embodiments, the interface cable assembly 1500 is the same as the interface cable 109 of Fig. 1A, and in some other embodiments, the interface cable 109 comprises interface cable assembly 1500 and an additional portion of the output cable 108. An arrow 1525 in Fig. 15A illustrates the direction of insertion of the proximal end of the guidewire 200 into the interface cable assembly 1500. Fig. 15B illustrates an exploded perspective view of the interface cable assembly 1500. The interface cable assembly 1500 comprises a portion of the output cable 108, the receiving connector 160, and the guidewire coupler 140 (illustrated in Fig. 1A) which corresponds to the connection tube 1510 in the interface cable assembly 1500 illustrated in Figs. 15A-15C. The receiver fibers 151 , 152 extend towards the external console (for example, handle 100, Fig. 1A).

[0214] To obtain the interface cable assembly 1500, first, a receiving connector sub-assembly 1505 needs to be assembled. The receiving connector sub-assembly 1505 is illustrated in Fig. 15B and corresponds to the receiving connector 160 of Fig. 1A with a receiving connector groove 1311. The receiving connector sub-assembly 1505 may have the same tubes as the guidewire connector 300 and may be assembled using the same alignment jig 1410 discussed above with respect to the guidewire connector 300 and illustrated in Fig. 14A.File No. : P6314PC00

[0215] The connection tube 1510 has a hollow tubular shape and is configured to receive partially in its orifice 1530 (also referred to herein as a “bore 1530”) the guidewire connector 300 on one end and the connector sub-assembly 1505 on another end. The connection tube 1510 has a connector slit 1517 positioned on the side of the connection tube 1510 and extending along the length of the connection tube 1510. The connector slit 1517 is a longitudinal slit running lengthwise on the side of the connection tube 1510. The guidewire coupler spine 1515, which is received in the connector slit 1517, is complementary to the guidewire connector groove 1310 of the guidewire connector 300 and to the receiving connector groove 1311 of the connector sub-assembly 1505. In some embodiments, the guidewire coupler spine 1515 is placed and is located in the connector slit 1517 of the connection tube 1510. The receiving connector groove 1311 is another longitudinal slit running lengthwise on the side of at least a portion of the tube of connector sub-assembly 1505. Similarly, the guidewire connector groove 1310 is a longitudinal groove running longitudinally on the side of at least a portion of the guidewire connector 300. When the guidewire connector 300, the connection tube 1510 and connector sub-assembly 1505 are positioned coaxially, the guidewire connector groove 1310 and the receiving connector groove 1311 are parallel to each other. The connector slit 1517 may be positioned radially with respect to the central axis of the connector subassembly 1505, as illustrated in Figs. 15B, 15C. In some embodiments, the connection tube 1510 has a cross-section of its outer surface other than round (in other words, out-of-round, for example, rectangular, square, obround, polyhedron, etc.). In some embodiments, the connection tube 1510 as illustrated in Fig. 15A may be used as the alignment ferule 1430 of the alignment jig 1410 of Fig. 14A.

[0216] After assembling of the connector sub-assembly 1505, the connector sub-assembly is inserted half-way into a connection tube 1510, to obtain the interface cable assembly 1500. In at least one embodiment, the guidewire coupler spine 1515 may first be assembled with the connection tube 1510, and then the guidewire connector 300 and the receiving connector 160 are slid into the connection tube 1510. The guidewire coupler spine 1515 allows locking the rotational orientation of the connector sub-assembly 1505, guidewire connector 300, and the fibers 151 , 152 therein relatively to (with respect to) the guidewire coupler spine 1515. Thus, the fibers 151 , 152 of the receiving connector 160 become aligned to the guidewire fibers 251 , 252 of the guidewire connector 300.

[0217] Fig. 15C illustrates a back perspective view of the interface cable assembly 1500. The arrow 1525 illustrates the direction of insertion of the proximal end of the guidewire 200 until the proximal end (and the front guidewire facet 310) of the guidewire connector 300 abuts the receiver facet 161 of the receiving connector 160.File No. : P6314PC00

[0218] The connection tube 1510 is similar to the grooved alignment ferule 1430 of the alignment jig 1410, but the material and dimensions may be different to manufacture the grooved alignment ferule 1430 to adjust for low cost and ease of use. Using the same fiber alignment jig 1410 for both the guidewire 200 (and therefore guidewire connector 300) and the connector sub-assembly 1505 may improve alignment accuracy between the two assemblies when connected and thus improve performance of the interface cable assembly 1500.

[0219] Fig 16 illustrates a method 1600 of manufacturing of a guidewire connector using the alignment jig 1410 comprising the keyed alignment ferule 1430 and two or more fiber ferrules 1415, as illustrated, for example, in Figs. 14A, 14B, and in accordance with at least one embodiment of the present disclosure. At step 1610, the two or more fiber ferrules 1415 are placed on one side of the alignment jig 1410, and the keyed alignment ferule 1430 with the guidewire connector 300 or the shaft 211 therein on another side of the alignment jig 1410, and the rotational position (in other words, angular position or rotational orientation) of the guidewire connector 300 relatively to the alignment jig 1410 is locked by the alignment device (which may be, for example, the jig spine 1427). The guidewire connector 300 has a fiber ferrule side looking towards the fiber ferrules 1415 and a guidewire side looking outside of the alignment jig 1410. The two or more fibers 1425 (which are end portions of the fibers 251 , 252 of Fig. 2A, for example) are then placed inside the guidewire connector 300 or the shaft 211 located in the keyed alignment ferule 1430, along the longitudinal axis of the keyed alignment ferule 1430 or the shaft 211. The fiber ends 1425 may need to be stretched tense between the guidewire connector 300 and two or more fiber ferrules 1415, each one of the fibers 1425 being threaded through a bore of one corresponding fiber ferrule 1415.

[0220] At step 1620, the fiber ends 1425 are glued at the fiber ferrule side of the guidewire connector 300 to attach them to the guidewire connector 300 while they stretch from the fiber ferrules 1415 to the guidewire connector 300 on the ferrules side and are therefore positioned parallel to the ferrule cavity 1420 such that their rotational orientation with respect to the alignment jig 1420, the guidewire connector 300 and the guidewire connector’s keyed surface is removably fixed. This alignment permits to repeatedly obtain guidewire couplers 300 and receiving connectors 160 with similar (and identical) rotational orientation of the fibers 251 , 252 at the guidewire facet 310 relatively to the keyed surface of the guidewire connector 300. At step 1630, the fiber ends 1425 are cut at the ferrule side of the guidewire connector 300. The fibers 251 , 252 are then grinded at the guidewire facet 310 (on the ferrule side of the guidewire connector 300). Similar steps 1640-1660, as illustrated in Fig. 16, may be used to manufacture a receiving connector 160, where the receiving fibers 151 , 152 are then grinded at the receiver facet 161.File No. : P6314PC00

[0221] In some embodiments, the locking of the rotational position of the guidewire connector 300 relatively to the alignment jig 1410 may be ensured by placing a portion of the locking element (for example, the jig spine 1427) into the keyed surface (for example, the guidewire connector groove 1310) of the guidewire connector 300 and another portion of the jig spine 1427 into an alignment ferule key (in the embodiment illustrated in Fig. 14D, the jig groove 1429) of the alignment jig 1410. Fig. 14D illustrates the alignment jig 1410 where the locking element is the jig spine 1427, the alignment ferule key is the jig groove 1429, and the keyed surface is the groove (the guidewire connector groove 1310).

[0222] Fig. 17A illustrates a keyed insert 1700 (also referred to herein as an “insert 1700”), in accordance with at least one embodiment of the present disclosure. Figs. 17B and 17C illustrate a perspective view and a side view of the connector assembly 1710 having the insert 1700, in accordance with at least one embodiment of the present disclosure. The connector assembly 1710 of Figs. 17B, 17C comprises a portion of the proximal shaft 211 and a connector assembly 1710. The connector assembly 1710 with the insert 1700 may be used to manufacture the guidewire connector 300 and / or the receiving connector 160 for the multi-sensor guidewire 200 described herein. The connector assembly 1710 comprises the insert 1700 and a connector tube 1720. The insert 1700 has a body with two or more fiber bores 1705, each for one fiber 251 , 252, etc. of the guidewire 200, depending on the number of fibers in the guidewire 200. The body of the insert 1700 may have, for example, a cylindrical shape, or, for example, hexagonal or square shape. When the connector assembly 1710 is provided for the guidewire connector 300, the shaft tube 211 extends towards the distal end of the guidewire 200, and fibers 251 , 252 run loosely inside the shaft tube 211. The insert 1700 may be manufactured for the guidewire connector 300 and / or the receiving connector 160. The insert 1700 has an insert key, which may be, for example, an insert spine 1707 as illustrated in Fig. 17A. The insert key is located on an external (side) surface of the insert 1700.

[0223] Fig. 17B illustrates a perspective view of the connector assembly 1710 which has the insert 1700, a connector tube 1720, and a shaft tube 211. The connector tube 1720 covers (envelopes) the insert 1700 and is shown with a degree of transparency for illustration purpose. The connector tube 1720 is a tube that has an inner diameter compatible to receive therein the insert 1700 such that the external surface of the insert 1700 abuts the internal surface of the connector tube 1720, and they are positioned coaxially. The connector tube 1720 receives therein coaxially a portion of the shaft 211 and the insert 1700. The insert 1700 may or may not be in contact with the shaft tube 211. There may be a gap between the insert 1700 and the shaft tube 211. The connector tube 1720 has a connector tube key (which may be, for example, a slit 1725 as illustrated in Fig. 17B) configured to match (being complementary to) the insert key (which may be the insert spine 1707 as illustratedFile No. : P6314PC00 in Fig. 17A), such that when the connector tube key and the insert spine 1707 are matched, they at least partially abut each other and thus prevent rotation of the connector tube 1720 relative to the insert 1700.

[0224] For example, the connector tube 1720 may be a partially slitted tube. In other words, the connector tube 1720 may have a slit 1725 that is located on a side wall of the connector tube 1720 and runs, for example, parallel to the longitudinal axis of the connector tube 1720, on at least a portion of the connector tube 1720. As illustrated in Figs. 17A, 17B, the insert key may be, for example, the insert spine 1707 which extends along the length (at least partially) of the insert 1700, while the connector tube key may be, for example, the slit 1725 of the connector tube 1720 which is configured to receive therein the insert spine 1707 to lock the rotational position (in other words, to restrict the rotational movement) of the connector tube 1720 with respect to the insert 1700 (in other words, to prevent rotation of the connector tube 1720 with respect to the insert 1700 and therefore to the fibers 251 , 252), as illustrated in Fig 17B. The combination of the insert key and the connector tube key allows locking (fixing) the rotational orientation of the insert 1700 relative to the shaft of the guidewire 200, guidewire connector 300 (or the receiving connector 160 if the connector assembly is provided of the receiving connector 160), and therefore, align the position of the fiber bores 1705 relative to the connector tube key of the connector tube 1720 (for example, slit 1725 of the connector tube 1720, shown in Fig 17B), which allows locking the rotational orientation of the fiber bores 1705 and therefore the fibers running therein with respect to the receiving connector 160 when the connector assembly 1710 is inserted into the guidewire coupler 140, and when the at least one alignment device of the guidewire coupler 140 locks the rotation of the guidewire connector 300 and receiving connector 160 with respect to the guidewire coupler 140. The guidewire coupler 140 or the connection tube 1510 (not shown in Fig. 17C) having the at least one alignment device (key) allows insertion of the guidewire connector 300 and the receiving connector 160 using slots 1725a, 1725b illustrated in Fig. 17C. Another additional connector key, different from the connector tube key (such as the slit 1725 that is used for the insert 1700), may be used for locking the rotational position of the guidewire connector 300 and the receiving connector 160 with respect to the guidewire coupler 140 or the connection tube 1510. For example, there may be two keys on the guidewire connector 300, similar to each other or different, having their relative position fixed relative to one another, the keys having two different purposes: one key (insert key) being for positioning the insert 1700, and the other key (the additional insert key) for insertion into and fixing rotation in the guidewire coupler 140 (or the connection tube 1510).

[0225] Other shapes of the insert key and the connector tube key may be used, such as a V- shape or other geometries of the keys discussed above, in order to align the fiber bores 1705 of theFile No. : P6314PC00 insert 1700 with the keyed reference provided by the connector tube’s key 1707 of the connector assembly 1710. In at least one embodiment, the insert 1700 may have the connector tube key and the insert key which are visual indicators that allow aligning the connector tube and the insert visually or using automated cameras during the assembly. An insert visual indicator may be, for example, a mark, a dot, a line or other reference element that may be detected as a reference during the assembly. One or more insert visual indicators may be aligned with one or more connector visual indicators of the guidewire connector 300 (connector visual reference) during the assembly, using high precision camera or other tools. Alternatively, the fiber bores 1705 may serve as a visual reference and be directly aligned with the connector tube key (keyed reference) of the connector assembly 1710 (for example, the guidewire connector 300 or the receiving connector 160) during the assembly.

[0226] As illustrated in Figs. 17A, 17B, the slit 1725 is located on a side of the connector tube 1720 and helps aligning the insert 1700 with respect to the connector tube 1720. The insert 1700 constrains the position of the fibers 251 , 252 relatively to the keyed reference of the guidewire connector 300, such as the slit 1725 in Fig. 17B. Therefore, if the insert 1700 is used to assemble the guidewire connector 300, there is no need for using the alignment jig 1410 of Figs. 14A-14C during the assembly. The receiving connector 160 of the interface cable assembly 1500 may be made with a similar insert 1700, also eliminating the need for using the alignment jig 1410 to manufacture the interface cable assembly 1500.

[0227] The insert 1700 may be printed using a three-dimensional (3D) printer. Manufacturing of the insert 1700 and other parts of the connector assembly 1710 using the 3D printer allows for precise large-volume production of the parts. An outer shell 1735 of the shaft (for example, the shaft tube 211 of the guidewire 200), for example, may be a coating, coil, or other tubing. The insert 1700 may be made, for example, of a biomedical plastic. If the surface of the insert 1700 is not compatible with blood, the insert 1700 may be fully encompassed inside the biocompatible metallic tubes of the guidewire 200, with biocompatible glue (which may then be polished) covering the proximal end, allowing light transmission, but preventing any contact of the printed part of the insert 1700 with the blood. The glue or other biomedical coating may cover any surface of the insert 1700 that would otherwise be left exposed. A grooved alignment ferule 1430 of Fig. 14A, which may have similar structure to the insert 1700, may be manufactured in a similar manner as the insert 1700 and may be used in the alignment jig 1410. A dual hole ferule manufactured in a similar manner may also replace the two fiber ferules 1415 of the alignment jig 1410 in Fig. 14A. Same or similar insert as the insert 1700 may be used in the interface cable 109. As noted above, straight grooves are depicted in the drawings for simplicity, but other shapes and / or mechanisms (such as V-shape of the groove)File No. : P6314PC00 may be used for alignment of the fibers 251 , 252, 151 , 152 of the guidewire connector 300 and the receiving connector 160 when inserting of the guidewire connector 300 into the interface cable 109.

[0228] Fig 18 illustrates the method 1850 of manufacturing and use one or two connector assemblies 1710, in accordance with at least one embodiment. A first connector assembly 1710a may correspond to the guidewire connector 300, and a second connector assembly 1710b may correspond to the receiving connector 160 as illustrated in Fig. 17C. To manufacture the first connector assembly 1710a, at step 1852 of method 1850a, the guidewire fibers 251 , 252 are passed through the keyed insert 1700, and in particular each one of two or more fibers 251 , 252, exiting the proximal shaft 211 of the guidewire 200 (see, for example, Fig. 2A), is passed through a corresponding longitudinal fiber bore 1705 in the keyed insert 1700. At step 1854, a first connector tube 1720a is placed coaxially with the insert 1700 to envelop the insert 1700 (also referred to herein as the first insert 1700a) and, simultaneously, a portion of the shaft 211 of the guidewire 200. In some embodiments, the first connector tube 1720 may be placed first on a portion of the shaft 211 and may be attached thereto by, for example, being preferably either glued or welded, or soldered. Then the first insert 1700a is pushed, while having the fibers 251 , 252 in its bores 1705, towards the shaft 211 and into the first connector tube 1720a. The first insert spine 1707a thus enters the first insert’s slit 1725a locking the rotational position of the first insert 1700a relative to the first connector tube 1720a. Prior to inserting the first insert 1700a into the first connector tube 1720a, a glue may be applied such that the first connector tube 1720a is glued to the insert 1700a at step 1856 after the insert 1700a is installed. For example, the glue may be a heat-activated glue, and the heat may be applied after the first insert 1700a is installed in the first connector tube 1720a to glue. The first connector tube 1720a may be also glued to the proximal shaft 211 of the guidewire before or after the installation of the first insert 1700a in the first connector tube 1720a. Alternatively, the first connector tube 1720a and the first insert 1700a may be attached to each other by welding (preferably) or soldering after the first insert 1700 has been installed in the first connector tube 1720a. For example, laser welding may be used. As illustrated in Fig. 17B, the connector tube 1720 has the connector tube key (for example, the slit 1725) configured to receive the insert key 1707 (for example, the insert spine 1707) to prevent rotation of the insert 1700 relative to the connector tube 1720. The connector tube key (for example, the slit 1725) may be also configured to receive a portion of the alignment device of the guidewire coupler 140 to prevent rotation of the connector assembly 1710 relative to the guidewire coupler 140. Alternatively, the connector tube 1720 and / or the insert 1700 may have an additional connector key for receiving a portion of the alignment device of the guidewire coupler 140. At step 1858, fibers 251 , 252 are glued to the insert 1700 at the insert facet 1701. The at least two fibers 251 , 252 areFile No. : P6314PC00 then cut and, optionally, polished at the insert facet 1701 to obtain the first connector assembly 1710a.

[0229] The second connector assembly 1710b, corresponding to the receiving connector 160, may be manufactured using method 1850b of Fig. 18, which is similar to the method 1850a. At step 1862, the receiver fibers 151 , 152 are passed through a second keyed insert 1700b. At step 1864, this second keyed insert 1700b is inserted into the second connector tube 1720b. In some embodiments, the second connector tube 1720b may be placed first on a portion of a second shaft (for example, the second shaft may be of the receiving connector), and then the second insert 1700b is pushed, while having the fibers 151 , 152 in its bores 1705, towards the second shaft and into the second connector tube 1720b. The second insert spine 1707b thus enters the second insert’s slit 1725b locking the rotational position of the second insert 1700b relative to the second connector tube 1720b. At step 1866, the second connector tube 1720a may be glued or welded to the second insert spine 1707b as discussed above for the first connector assembly 1710a. At step 1868, the receiver fibers 151 , 152 are glued in place and then cut, and optionally polished. At step 1870, during the use, the first connector assembly 1710a is connected with the second connector assembly 1710b using the keyed guidewire coupler 140 using, for example, first and second slits 1725a, 1725b formed in the connector assemblies 1710a, 1710b that may receive therein at least a portion of one or two different alignment device(s) of the guidewire coupler 140. In method 1850, the connector tube 1720 and the keyed insert 1700 for the connector assembly 1710 may be manufactured as one single component which may receive therein a portion of the shaft 211 as the connector tube 1720 does in Fig. 17B, making steps 1862, 1864 unnecessary in some embodiments.

[0230] In at least one embodiment, the method 1850 of manufacturing the connector 160, 300 for the guidewire 200 comprises: inserting a portion of a shaft into a portion of a longitudinal insert bore of a connector tube, the connector tube having a connector tube key on a side wall; passing each one of at least two fibers, exiting the shaft and the connector tube attached thereto, through a corresponding longitudinal fiber bore in a keyed insert, the keyed insert having therein at least two longitudinal fiber bores located longitudinally and an insert key on an outer surface of the insert; placing the keyed insert coaxially with the connector tube attached to a portion of the shaft of the guidewire and inserting the keyed insert into the connector tube to envelope, by the connector tube, in addition to the portion of the shaft, the keyed insert, the connector tube having a connector tube key configured to receive the insert key therein to prevent rotation of the keyed insert relative to the connector tube; and gluing the at least two fibers to the keyed insert at an insert facet and cut the at least two fibers at or in a vicinity of the insert facet.File No. : P6314PC00

[0231] In at least one embodiment, the guidewire connector 300 and the receiving connector 160 may be manufactured by two different methods and still be compatible with each other. For example, the guidewire connector 300 may be manufactured using the method 1600 (Fig. 16), and the receiving connector 160 may be manufactured using the method 1850 (Fig. 18), or vice-versa, and both the guidewire connector 300 and the receiving connector 160 may be still compatible with one guidewire coupler 140 and its aligning device (same or different keys, and different methods of manufacturing).

[0232] As noted above, the technology described herein may be implemented with fibers 151 , 152, 153, 251, 252, 253 being electric wires and / or optical fibers. The electric wires may run within the guidewire 200 (Figs. 1A, 2A) towards the sensors 231 , 232, 233, where the sensors 231, 232, 233, are electric sensors, such as, for example, piezoelectric sensors.

[0233] While preferred embodiments have been described above and illustrated in the accompanying drawings, it will be evident to those skilled in the art that modifications may be made without departing from this disclosure. Such modifications are considered as possible variants comprised in the scope of the disclosure.

Claims

File No. : P6314PC00CLAIMS:

1. A guidewire comprising: a distal tip, a distal shaft, and a proximal shaft attached to a guidewire connector; a distal sensor housing having a distal pressure sensor therein, the distal pressure sensor being configured to measure a distal pressure and configured to transmit a distal sensor signal through a distal fiber from and towards the distal pressure sensor, the distal sensor housing being connected to the distal tip on one end and to the distal shaft on another end, the distal shaft having the distal fiber located therein and running towards the distal pressure sensor; and a proximal sensor housing connected distally to the distal shaft on one end and connected to the proximal shaft on another end, the proximal sensor housing partially enclosing a portion of the distal fiber, a tip of a proximal fiber, and a proximal sensor connected to the proximal fiber and configured to measure a proximal pressure.

2. The guidewire of claim 1 , wherein the guidewire connector has a keyed surface.

3. The guidewire of claim 1 or 2, wherein the guidewire connector is made directly within the proximal shaft of the guidewire.

4. The guidewire of any one of claims 2 to 3 wherein the keyed surface is implemented on a tube welded or glued over the shaft.

5. The guidewire of any one of claim 2 to 4, wherein the keyed surface is located on the proximal shaft, extending from a guidewire facet to between 1 mm and 10 mm distally.

6. The guidewire of any one of claims 2 to 4, wherein the keyed surface is located distal to a guidewire proximal end, and a tube portion of the guidewire proximal end has a circular cross-section.

7. The guidewire of claim 6, wherein the keyed surface is located at between 1 millimeter (mm) and 10 mm distal to the guidewire proximal end.

8. The guidewire of any one of claims 2 to 7, wherein the guidewire connector comprises: a shaft having an outside shaft surface and comprising at least the distal fiber and the proximal fiber located within a connector shaft lumen; and the keyed surface located on the outside shaft surface, the keyed surface being oriented at a pre-determined angle with a virtual plane formed by central axes of the distal fiber and the proximal fiber for aligning the distal fiber and the proximal fiber with receiving fibers of a receiving connector.

9. The guidewire of any one of claims 2 to 8, wherein the keyed surface is flat forming a flat keyed surface.File No. : P6314PC0010. The guidewire of any one of claims 2 to 9, wherein the keyed surface further comprises a bump or a spine.

11. The guidewire of any one of claims 2 to 10, wherein the keyed surface has a groove.

12. The guidewire of any one of 2 to 11 , wherein the keyed surface has a V-groove.

13. The guidewire of claim 2 or 12, wherein in the keyed surface is concave forming a recess within the shaft, the recess configured to receive therein at least partially an alignment device therein, the keyed surface having a concave surface radius that is equal to or less than a radius of a curvature of an aligning surface of the alignment device.

14. The guidewire of claim 13, wherein the alignment device is an aligning ball.

15. The guidewire of claim 1 or 2, wherein the guidewire connector comprises: an insert having a body with at least two longitudinal fiber bores, each fiber bore being configured to receive one of the proximal fiber and the distal fiber therein, and an insert key on an outer surface; and a connector tube being coaxial with the insert and configured to envelope the insert and a portion of a shaft, the connector tube having a connector tube key configured to abut the insert key to restrict rotational movement of the insert relative to the connector tube and the proximal shaft.

16. The guidewire of any one of claims 1 to 15, wherein the proximal pressure sensor and the distal pressure sensor are located at different longitudinal locations in one double sensor housing.

17. The guidewire of claim 16, wherein the double sensor housing comprises at least one temperature sensor.

18. The guidewire of claim 16, further comprising another sensor housing having a third pressure sensor or a temperature sensor therein.

19. The guidewire of any one of claims 1 to 18, wherein the proximal shaft, the distal shaft, or both the proximal and the distal shaft have an electrical insulating layer.

20. The guidewire of any one of claims 1 to 19, further comprising a coil or a sleeve over the proximal shaft or the distal shaft or over both the proximal and the distal shaft.

21. The guidewire of any one of claims 1 to 20, wherein the proximal sensor housing is welded to the proximal shaft and the distal shaft, and the distal sensor housing is welded to the distal shaft and the distal tip.

22. The guidewire of any one of claims 1 to 21 , further comprising an intermediate sensor and an intermediate sensor fiber, the intermediate sensor being a temperature sensor or a pressure sensor.File No. : P6314PC0023. The guidewire of claim 22, wherein the intermediate sensor is located in an intermediate sensor housing attached to an intermediate shaft section attached on another side to the proximal sensor housing.

24. The guidewire of claim 22, wherein the intermediate sensor is located in the distal housing or the proximal housing.

25. The guidewire of any one of claims 1 to 24, wherein the proximal fiber and the distal fiber are electric wires, the proximal sensor and the distal sensor are piezoelectric sensors, and the distal sensor signal and the proximal sensor signal are electrical signals.

26. The guidewire of any one of claims 1 to 24, wherein the proximal fiber and the distal fiber are optical fibers, and the proximal pressure sensor and the distal pressure sensor are optical sensors, and the distal sensor signal and the proximal sensor signal are optical signals.

27. The guidewire of any one of claims 1 to 26 further comprising a temperature sensor and a temperature sensor fiber configured to transmit a temperature signal from the temperature sensor.

28. The guidewire of claim 27, wherein the temperature sensor is located in the distal sensor housing.

29. The guidewire of claim 27, wherein the temperature sensor is located in the proximal sensor housing which has a radiopaque marker or in the distal sensor housing which has a radiopaque marker.

30. The guidewire of any one of claims 1 to 29 further comprising a distancing device configured to distance the proximal sensor from the distal fiber running within the proximal sensor housing.

31. The guidewire of claim 30, wherein the distancing device is a sensor ring embracing the proximal fiber and having an outside diameter larger than a sensor head.

32. The guidewire of claim 30, wherein the distancing device is a distancing ring that encircles at least partially the distal fiber within the proximal sensor housing.

33. The guidewire of any one of claims 1 to 32, further comprising an intermediate shaft positioned between the proximal sensor housing and the proximal shaft.

34. The guidewire of claim 33, wherein the intermediate shaft is connected to the proximal shaft via a shaft union tube.

35. The guidewire of claim 33 or 34, wherein the intermediate shaft is more flexible compared to the proximal shaft, the intermediate shaft being configured to bend sharply.File No. : P6314PC0036. The guidewire of claim 35, wherein a shaft union tube is attached to the proximal shaft and to the intermediate shaft, the intermediate shaft being more flexible compared to the proximal shaft.

37. The guidewire of any one of claims 33 to 36, wherein the intermediate shaft, the shaft union tube, and the proximal shaft are connected by an adhesive having a conductive material.

38. The guidewire of claim 33, wherein the intermediate shaft is made of nitinol.

39. The guidewire of any one of claims 1 to 32, wherein the distal shaft is more flexible than the proximal shaft.

40. The guidewire of any one of claims 33 to 39, wherein a diameter of the intermediate shaft is less than the diameter of the proximal shaft.

41. The guidewire of any one of claims 1 to 32, further comprising a pre-bent shaft section.

42. A connector for a guidewire having at least two fibers located longitudinally therein, the connector comprising: a shaft having an outside shaft surface and a lumen, having portions of the at least two fibers located longitudinally within the lumen; and a keyed surface located on the outside shaft surface, the keyed surface being oriented at a pre-determined angle with a virtual plane formed by central axes of two fibers of the at least two fibers for aligning the at least two fibers with fibers of another connector.

43. The connector of claim 42, wherein the keyed surface is implemented on a tube welded or glued over the shaft.

44. The connector of claim 42, wherein the keyed surface is flat forming a flat keyed surface.

45. The connector of any one of claims 42 to 44, wherein the keyed surface has a spine or a bump.

46. The connector of any one of claims 42 to 44, wherein the keyed surface has a groove.

47. The connector of claim 43, wherein the keyed surface has a V-groove.

48. The connector of claim 42, wherein in the keyed surface is concave forming a recess within the shaft, the recess configured to receive therein at least partially an alignment device therein, the keyed surface having a concave surface radius that is less than a radius of a curvature of an aligning surface of the alignment device.

49. The connector of claim 48, wherein the alignment device is an aligning ball.

50. The connector of claim 42, wherein the connector comprises:File No. : P6314PC00 an insert having a body with at least two longitudinal fiber bores, each fiber bore being configured to receive one of the at least two fibers therein, and an insert key on an outer surface; and a connector tube being coaxial with the insert and configured to envelope the insert and a portion of the shaft, the connector tube having a connector tube key configured to abut the insert key to restrict rotational movement of the insert relative to the connector tube and the proximal shaft.

51. The connector of any one of claims 42 to 50, wherein the connector is a guidewire connector, and the other connector is a receiving connector having receiving fibers therein.

52. The connector of claim 51 , wherein the connector is made directly within a proximal shaft of the guidewire.

53. The connector of claim 51 , wherein the keyed surface is located on a proximal shaft distally from a guidewire facet.

54. The connector of claim 51 , wherein the keyed surface is located distal to a guidewire proximal end, and a tube portion of the guidewire proximal end has a circular crosssection.

55. The connector of claim 54, wherein the keyed surface is located at between 1 millimeter (mm) and 10 mm distal to the proximal end.

56. The connector of any one of claims 42 to 50, wherein the connector is a receiving connector, and the other connector is a guidewire connector having guidewire fibers therein.

57. An assembly comprising the receiving connector of claim 56 and a guidewire coupler having aligning devices configured to abut keyed surfaces of the receiving connector and the guidewire connector of claim 51 simultaneously to align and restrict rotational movement of the guidewire fibers relative to the receiving fibers.

58. A guidewire comprising: a distal tip, a distal shaft, and a proximal shaft attached to a guidewire connector; a distal sensor housing having a temperature sensor therein, the temperature sensor being configured to measure a distal temperature and configured to transmit a temperature signal through a distal fiber from and towards the temperature sensor, the distal sensor housing being connected to the distal tip on one end and to the distal shaft on another end, the distal shaft having the distal fiber positioned within a distal shaft lumen located in the distal shaft and running towards the temperature sensor; andFile No. : P6314PC00 a proximal sensor housing connected distally to the distal shaft on one end and connected to the proximal shaft on another end, the proximal sensor housing partially enclosing a portion of the distal fiber, a tip of a proximal fiber, and a proximal sensor connected to the proximal fiber and configured to measure a proximal pressure.

59. The guidewire of claim 58 wherein the distal sensor housing also has a distal pressure sensor configured to measure a distal blood pressure and configured to transmit a distal pressure signal through another distal fiber.

60. A connecting sleeve for aligning a guidewire connector having a first keyed surface with a receiving connector having a second keyed surface, the connecting sleeve having a bore therein for receiving, coaxially, the guidewire connector therein, and a first sleeve opening on a side wall, the first sleeve opening being configured to receive a first alignment device therein to pass through the first sleeve opening and to abut the keyed surface of the guidewire connector to lock a rotation of the guidewire connector relative to the connecting sleeve; and a second sleeve opening on the side wall of the connecting sleeve, the second sleeve opening being configured to receive a second alignment device therein to pass through the second sleeve opening and to abut another keyed surface of the receiving connector to lock a rotation of the receiving connector relative to the connecting sleeve.

61. The connecting sleeve of claim 60, wherein the first sleeve opening is a groove, and the alignment device is a connecting slit.

62. The connecting sleeve of claim 60 or 61 , wherein the first alignment device or the second alignment device is spring-loaded, or both the first alignment device and the second alignment device are spring-loaded.

63. The connecting sleeve of any one of claims 60 to 62, wherein the first alignment device or the second alignment device has a rounded tip, or both the first alignment device and the second alignment device have a rounded tip.

64. A guidewire coupler for coupling a guidewire connector and a receiving connector, the guidewire coupler comprising the connecting sleeve of any one of claims 60 to 63, the first alignment device and the second alignment device.

65. The guidewire coupler of claim 64 wherein the first alignment device has a first aligning surface and the second alignment device has a second aligning surface, both configured to abut and fix the keyed surface of the guidewire connector and the receiving keyed surface of the receiving connector with respect to the connecting sleeve.File No. : P6314PC0066. The guidewire coupler of claim 65, wherein the first alignment device, or the second alignment device is spring-loaded, or both the first alignment device and the second alignment device are spring-loaded.

67. The guidewire coupler of claim 66, wherein the first alignment device or the second alignment device comprises a spring-loaded rounded component, or both the first alignment device and the second alignment device comprise spring-loaded rounded components.

68. A fiber optic interface cable assembly comprising the guidewire coupler of any one of claims 64 to 67 and a portion of the receiving connector located in the connecting sleeve.

69. A connecting sleeve for aligning the guidewire connector of any one of claims 51 to 55 with the receiving connector, the connecting sleeve having a bore therein for receiving the guidewire connector therein, and an alignment surface configured to mate with the keyed surface of the guidewire connector and with another keyed surface of the receiving connector simultaneously.

70. A connector assembly comprising: an insert having a body with at least two longitudinal fiber bores, each fiber bore being configured to receive a fiber therein, and an insert key on an outer surface; and a connector tube being coaxial with the insert and configured to envelope the insert and a portion of a shaft, the connector tube having a connector tube key which is complementary to the insert key.

71. The connector assembly of claim 70, wherein the connector tube key is a slit and the insert key is an insert spine.

72. The connector assembly of claim 70 or 71 , wherein the connector tube key and the insert key are visual indicators that allow aligning the connector tube and the insert visually or using automated cameras during assembly.

73. The connector assembly of any one of claims 70 to 72, wherein the insert is manufactured by a three-dimensional (3D) printer.

74. A method for assessing regurgitation using a temperature-pressure guidewire having a temperature sensor located in a sensor housing having a radiopaque marker, the method comprising: receiving temperature measurements from the temperature sensor before and after an injection of a liquid into aorta over a valve to determine a temperature decrease due to the injection of the liquid;File No. : P6314PC00 based on two angiography images, a first angiography image being obtained before injecting the liquid into aorta over the valve and a second angiography image being obtained after injecting the liquid into aorta, determining a distance between the temperature sensor and the valve; and in response to the temperature decrease being more than a pre-determined threshold of the temperature decrease, determining a level of the regurgitation.

75. The method for assessing regurgitation of claim 74, the method further comprising determining and alerting a user whether to increase or to decrease the distance between the temperature sensor and the valve in order to determine the level of the regurgitation.

76. A method of manufacturing of a guidewire connector and a receiving connector which are configured to couple a guidewire with an output cable using a guidewire coupler, the method comprising: placing two or more fibers parallel to each other inside a tube along a tube longitudinal axis and gluing the fibers to the tube therein; grinding out a segment of the tube to manufacture a keyed preform with a keyed surface; and cutting the keyed preform approximately in a middle of the keyed surface and perpendicular to the tube longitudinal axis to obtain the guidewire connector having a guidewire connector keyed surface and the receiving connector having a receiving connector keyed surface.

77. The method of claim 76 further comprising attaching the guidewire connector to a shaft of the guidewire and attaching the receiving connector to the output cable.

78. The method of claim 76 wherein the fibers are optical fibers or electric wires.

79. A method of use of the guidewire connector and the receiving connector each manufactured according to any one of claims 74 to 78, the method comprising: aligning the guidewire connector and the receiving connector such that the guidewire connector keyed surface of the guidewire connector and the receiving connector keyed surface each abuts a corresponding aligning surface of a corresponding alignment device of the guidewire coupler.

80. An alignment jig for aligning of fibers with respect to a keyed surface in a guidewire connector, the alignment jig comprising:File No. : P6314PC00 a jig block having a ferrule cavity configured to receive at least two ferrules on one side of the jig block and a keyed alignment ferrule on another side, the keyed alignment ferrule having a bore therein for receiving, coaxially with the bore, at least a portion of the guidewire connector with the keyed surface, the keyed alignment ferrule having an alignment ferrule key and the guidewire connector having the keyed surface, wherein each one of the keyed surface of the guidewire connector, the alignment ferrule key and a jig key receives a portion of a locking element which is configured to fix rotation positions of the guidewire connector with respect to the alignment jig.

81. The alignment jig of claim 80, wherein the keyed alignment ferrule has a groove for receiving the portion of a jig spine therein, the jig spine being configured to enter and abut a connector groove of the guidewire connector to lock the circular orientation of the guidewire connector with respect to the jig block.

82. A guidewire coupler for connecting and aligning a guidewire connector with a receiving connector, the guidewire coupler comprising: a connection tube having a bore therein for receiving therein, coaxially, at least a portion of the guidewire connector at one end and at least a portion of the receiving connector at another end; a first opening on a side of the connection tube for receiving a first alignment device for abutting a first keyed surface of the guidewire connector; and a second opening for receiving a second alignment device, configured to abut a second keyed surface of the receiving connector.

83. The guidewire coupler of claim 82, wherein the first opening is a groove and the first alignment device is a spine, or the second opening is a groove and the second alignment device is a spine, or both the first opening and the second opening are grooves and the first alignment device and the second alignment device are spines.

84. The guidewire coupler of claim 82, wherein the first opening and the second opening form one side opening and the first alignment device and the second alignment device form one alignment device configured to abut simultaneously the first and the second keyed surfaces.

85. The guidewire coupler of claim 82, wherein at least one of the first and second openings is a window opening and the alignment device is a spring-loaded rounded component configured to pass therethrough.

86. The guidewire coupler of claim 82, wherein the connection tube has a cross-section other than round.File No. : P6314PC0087. An interface cable assembly comprising the guidewire coupler of claim 82 and a portion of the receiving connector located coaxially therein, wherein a rotation of the receiving connector is locked by an alignment device.

88. A method of manufacturing of a connector for a guidewire using an alignment jig comprising a connector tube and at least two fiber ferrules, the method comprising: placing at least two fiber ferrules on one side of the alignment jig and the connector or a shaft on another side of the alignment jig, and locking a rotational position of the connector relatively to the alignment jig, the connector having a fiber ferrule side looking towards the fiber ferrules and an outer side looking outside of the alignment jig; threading at least two fibers inside the connector or the shaft along a longitudinal axis of the connector, each one of the at least two fibers being also threaded through a bore of one corresponding fiber ferrule; gluing the at least two fibers at the fiber ferrule side of the connector to attach the at least two fibers stretching from the at least two fiber ferrules to the connector on the ferrules side; and cutting and grinding the at least two fibers at the ferrule side of the connector.

89. The method of claim 88, wherein the locking of the rotational position of the connector relatively to the alignment jig comprises placing a portion of a locking element into a keyed surface of the connector and another portion of the locking element into an alignment ferule key of the alignment jig.

90. The method of claim 89, wherein the locking element is a jig spine, the alignment ferule key is a jig groove, and the keyed surface comprises a groove.

91. The method of any one of claims 88 to 90, wherein the connector is a guidewire connector.

92. The method of any one of claims 88 to 90, wherein the connector is a receiving connector.

93. A method of manufacturing of a connector for a guidewire, the method comprising: inserting a portion of a shaft into a portion of a longitudinal insert bore of a connector tube, the connector tube having a connector tube key on a side wall; passing each one of at least two fibers, exiting the shaft and the connector tube attached thereto, through a corresponding longitudinal fiber bore in a keyed insert, the keyed insert having therein at least two longitudinal fiber bores located longitudinally and an insert key on an outer surface of the insert;File No. : P6314PC00 placing the keyed insert coaxially with the connector tube attached to a portion of the shaft of the guidewire and inserting the keyed insert into the connector tube to envelope, by the connector tube, in addition to the portion of the shaft, the keyed insert, the connector tube having a connector tube key configured to receive the insert key therein to prevent rotation of the keyed insert relative to the connector tube; and gluing the at least two fibers to the keyed insert at an insert facet and cut the at least two fibers at or in a vicinity of the insert facet.

94. The method of claim 93, wherein the connector is a receiving connector.

95. The method of claim 93, wherein the connector is a guidewire connector.

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