Apparatus and method for positioning guidewire

Abstract

A method for positioning a guidewire may include disposing an inner shaft at least partially within a catheter lumen of a catheter such that the inner shaft is positioned at a proximal limit of longitudinal movement of the inner shaft relative to the catheter; advancing the guidewire into the shaft lumen of the inner shaft until the guidewire is located at a predetermined longitudinally offset distance from the catheter; locking the advanced guidewire relative to the inner shaft when the inner shaft is at the proximal limit; and positioning the guidewire at least partially by advancing the inner shaft.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 62 / 961,440, filed on January 15, 2020, which is incorporated herein by reference in its entirety. Technical Field

[0002] The present invention generally relates to devices and methods for positioning a guidewire. Background Art

[0003] In many medical procedures such as minimally invasive procedures, a guidewire is typically navigated through a body lumen (e.g., a vascular system). For example, many cardiovascular procedures such as stent placement, heart valve procedures, etc. typically require placement of one or more guidewires that facilitate advancement and positioning of other devices (e.g., catheters). However, correct execution of guidewire placement may be challenging. For example, a guidewire must be flexible enough to pass through a potentially tortuous path; however, this flexibility also makes it more difficult to position the guidewire with precise control. Certain types of procedures with dynamically moving targets (such as cardiac procedures involving a beating heart) may present even greater challenges to guidewire placement.

[0004] Conventional guidewire placement systems typically include many components to enable precise control of the guidewire, and these complex systems are difficult to use and require a high level of skill to operate successfully.Therefore, there is a need for new and improved devices and methods for positioning a guidewire. Summary of the invention

[0005] Devices and methods for positioning a guidewire such as in a patient are described herein. In some variations, a device for positioning a guidewire includes: a catheter lumen; an inner shaft, which is at least partially arranged in the catheter lumen and includes a shaft lumen configured to receive the guidewire; and a locking mechanism configured to lock the guidewire relative to the inner shaft to maintain at least a predetermined longitudinal offset distance between the guidewire and the catheter. The inner shaft and the catheter may be capable of engaging to limit the proximal longitudinal movement of the inner shaft in the catheter lumen. In addition, in some variations, the distal end of the catheter may be curved.

[0006] In some variations, the inner shaft and / or the catheter may include one or more features to define the proximal limit of the longitudinal movement of the inner shaft in the catheter lumen. For example, the inner shaft may include a first feature, and the catheter may include a second feature, wherein the first feature and the second feature may be capable of engaging to at least partially define the proximal limit of the longitudinal movement of the inner shaft in the catheter lumen. The first feature, the second feature, or both may include a stopper. For example, in some variations, the first feature in the inner shaft may include a first protrusion extending radially outward, and the second feature in the catheter may include a second protrusion extending radially inward to interfere with (e.g., abut) the first protrusion. In some variations, the first protrusion may include an open (e.g., part) ring or a closed ring arranged around a portion of the inner shaft, and the second protrusion may include a wall configured to abut the open ring or the closed ring.

[0007] In some variations, the locking mechanism may include a shaft housing (e.g., a handle) coupled to the inner shaft. In these variations, the guidewire positioning device may also include a collet configured to tighten the shaft housing around the inner shaft and the guidewire, thereby clamping the guidewire to the inner shaft.

[0008] In some variations, a method for positioning a guidewire includes: disposing an inner shaft at least partially within a catheter lumen of a catheter so that the inner shaft is positioned at a proximal limit of longitudinal movement of the inner shaft relative to the catheter; advancing the guidewire into the shaft lumen of the inner shaft until the guidewire is located at a predetermined longitudinal offset distance relative to the catheter; locking the advanced guidewire relative to the inner shaft when the inner shaft is at the proximal limit of longitudinal movement; and positioning the guidewire at least partially by advancing the inner shaft.

[0009] In some variations, disposing the inner shaft at least partially within the lumen of the catheter may include engaging a first feature of the inner shaft with a second feature of the catheter. The first feature may, for example, be disposed on a distal portion of the inner shaft, and the second feature may be disposed on a proximal portion of the catheter, wherein the first feature and the second feature may engage (e.g., abut each other) to define a proximal limit of longitudinal movement of the inner shaft. For example, the first feature, the second feature, or both may include a stop.

[0010] In some modifications, advancing the guidewire may include advancing the guidewire until the distal end of the guidewire extends distally beyond the distal end of the catheter, such as exceeding a predetermined longitudinal offset distance. Once advanced to such a position, the guidewire may be locked when the inner shaft is at the proximal limit of longitudinal movement (when the distal end of the guidewire extends distally beyond the distal end of the catheter), thereby substantially preventing the distal end of the guidewire from moving proximally into the catheter.

[0011] The guide wire can be locked relative to the inner shaft in any suitable manner. For example, in some variations, the inner shaft can be coupled to a shaft housing (e.g., a handle), and locking the guide wire relative to the inner shaft can include compressing the shaft housing around the inner shaft and the guide wire. For example, compressing the shaft housing can include tightening a chuck around at least a portion of the shaft housing.

[0012] After advancing and locking the guidewire, the guidewire can be moved by moving the inner shaft. In some variations, positioning the guidewire may include alternately advancing the inner shaft and the catheter, thereby providing support and / or protection for the guidewire using the catheter during guidewire positioning. Alternatingly advancing the inner shaft and the catheter may, for example, include: advancing the inner shaft until the distal end of the guidewire encounters an obstacle; advancing the catheter to reduce the distance between the distal end of the guidewire and the distal end of the catheter; and further advancing the inner shaft. During the alternating advancement of the inner shaft and the catheter, at least the predetermined longitudinal offset distance between the guidewire and the catheter can be maintained. In other words, the guidewire can be substantially prevented from being completely withdrawn into the catheter. In some variations, after the guidewire and the guidewire positioning device are placed at a certain position, the guidewire can be unlocked and withdrawn from the inner shaft through the shaft lumen. At least a portion of the remainder of the guidewire positioning device can be retained, and in some variations, the method may also include advancing a second guidewire into the guidewire positioning device (e.g., so that one or more other catheter devices are placed in the same position, such as on a second guidewire). Alternatively, in some variations, the guidewire positioning device may be withdrawn, leaving the guidewire in place (eg, to facilitate placement of one or more other catheter devices in the same location, such as over the guidewire).

[0013] The devices and methods described herein may be used in any suitable application or procedure involving guidewire placement. In an exemplary variation, the device and method may be used to advance a catheter into a ventricle (e.g., left ventricle) of the heart. The device and method may, for example, be used to advance a catheter into the ventricle to reshape (e.g., reverse model) the ventricle. In this example, the method may include advancing a catheter into the left ventricle of the heart, and positioning the guidewire may include alternately advancing the inner shaft and the catheter into the subvalvular space of the mitral valve behind the chordae tendineae of the left ventricle. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Figures 1A to 1H Schematic representations of exemplary variations of devices for positioning a guidewire are depicted.

[0015] Figure 2 A flowchart representation of an exemplary variation of a method for positioning a guidewire is depicted.

[0016] FIG. 3A to FIG. 3F A schematic representation of a method for positioning a guidewire is depicted.

[0017] Figure 4AA proximal portion of an exemplary variation of a guidewire positioning device is depicted in which the inner shaft of the device is at a distal portion of its range of longitudinal motion.

[0018] Figure 4B Depicted Figure 4A The proximal portion of a guidewire positioning device is depicted in FIG, wherein the inner shaft of the device is at the proximal portion of its range of longitudinal motion.

[0019] Figure 4C Depicted Figure 4A A partial detailed view of the guidewire positioning device depicted in FIG.

[0020] Figure 5A is a side view of a distal portion of an exemplary variation of a guidewire positioning device.

[0021] Figure 5B yes Figure 5A Another side view of the distal portion of the guidewire positioning device depicted in .

[0022] Figure 6 Exemplary variations of guide catheter devices are depicted.

[0023] Fig. 7A and Figure 7B A schematic representation of a portion of an exemplary variation of a method for positioning a guidewire is depicted.

[0024] FIG. 8A to FIG. 8E Schematic representations of exemplary variations of locking mechanisms in guidewire positioning devices are depicted. DETAILED DESCRIPTION

[0025] Examples of various aspects and variations of the invention are described herein and illustrated in the accompanying drawings. The following description is not intended to limit the invention to these embodiments, but rather to enable those skilled in the art to make and use the invention.

[0026] Described herein are exemplary variations of the device and method for locating (e.g., advancing) guidewire. In some variations, the device and method for locating guidewire can be used to make the guidewire pass in the patient (e.g., in the cardiovascular system such as the chamber of the heart, in the blood vessel, etc.). As described below, the device and method described herein can enable the user to advance the guidewire in a reliable, safe and easy-to-use manner. For example, the catheter device can provide a simpler threading (navigational) control and support of the guidewire arranged in the lumen of the catheter device, and / or help prevent the undesirable withdrawal or retraction of the guidewire to the catheter device during the advancement of the guidewire in the patient, which would otherwise interfere with the positioning process. These features can, for example, increase the simplicity and safety of the procedure during guidewire positioning.

[0027] Device for positioning guidewire In some variations, the device for positioning the guide wire may include: a catheter including a catheter lumen; an inner shaft, which is at least partially arranged in the catheter lumen and includes a shaft lumen configured to receive the guide wire; and a locking mechanism configured to lock the guide wire relative to the inner shaft. The inner shaft and the catheter may be capable of engaging so as to limit the longitudinal movement of the inner shaft in at least one direction within the catheter lumen (e.g., limiting proximal longitudinal movement). In some variations, the locking mechanism may be configured to lock the guide wire relative to the inner shaft in a manner that at least maintains a predetermined longitudinal offset distance between the guide wire and the catheter.

[0028] The catheter may include an elongated body with a proximal end and a distal end. The catheter may also include a catheter lumen, which is in the elongated body and is configured to receive an inner shaft therein, so as to allow the longitudinal and / or rotational movement of the inner shaft in the catheter. Generally, the elongated body may be sized to be suitable for being pushed in a body passage such as a vascular system and / or a cardiac chamber (e.g., left ventricle or right ventricle) therein. The catheter may include a catheter housing (e.g., handle), which may be coupled (e.g., using epoxy bonding, by one or more suitable fasteners and / or mechanical interference fits, etc.) to the proximal portion of the catheter so that the longitudinal and / or rotational movement of the catheter housing may affect the longitudinal and / or rotational movement of at least a portion of the elongated body. The catheter housing may, for example, be formed (e.g., molded) with ergonomics and / or friction grips to enable easy manipulation.

[0029] In some variations, the distal end of the catheter may have a curved shape, which may be designed to be used for easier threading and / or non-invasive advancement around a curved surface (e.g., ventricular tissue, vascular system). For example, when the guidewire is advanced from the catheter, the curved distal end of the catheter may be positioned to point in a direction away from the tissue to help prevent the perforation caused by the guidewire to the tissue when the guidewire is extending or advancing outside the catheter. In addition, the distal end of the catheter may be increased in diameter and terminated in a rounded end without sharp edges to improve the non-invasive properties of the device. However, the various shapes and sizes of the catheter may depend at least in part on the intended application of the guidewire positioning device. For example, in some variations in which the guidewire positioning device is used to position the guidewire in the left ventricle, the catheter in the guidewire positioning device may have sufficient length to extend from at least the femoral artery entry point to the left ventricle, bypass the space under the valve, and come out of the outflow tract to optionally re-cross the patient's aortic arch.

[0030] The inner shaft may include an elongated body having a proximal end and a distal end, and may be arranged in a catheter lumen (e.g., in a telescopic manner). The inner shaft may also include an axle lumen configured to receive a guide wire and allow longitudinal and / or rotational movement of the guide wire therein. In addition, a shaft housing (e.g., a handle) may be coupled (e.g., bonded with epoxy, using one or more suitable fasteners and / or mechanical interference fits, etc.) to a proximal portion of the inner shaft so that the longitudinal and / or rotational movement of the shaft housing may affect the longitudinal and / or rotational movement of the inner shaft in the catheter.

[0031] The locking mechanism can be configured to lock the position of the guide wire relative to the inner shaft. For example, after the guide wire is locked relative to the inner shaft, the longitudinal and / or rotational motion of the inner shaft (for example, via the shaft housing of the proximal part of the inner shaft) can affect the longitudinal and / or rotational motion of the guide wire in the guide wire positioning device. In some variations, the locking mechanism may include a shaft housing connected to a part of the inner shaft, wherein the shaft housing can be tightened around the inner shaft and the guide wire, thereby locking the guide wire relative to the inner shaft by a compressive force. For example, the shaft housing can be engaged with a collet nut or other mechanism, which clamps around a part of the shaft housing to tighten the shaft housing around the inner shaft and the guide wire, and the inner shaft and the guide wire are locked or otherwise fixed together. The collet nut can, for example, utilize a thread or engage the shaft housing in any suitable manner. However, the locking mechanism may include any suitable structure (for example, a clamping type fixture, etc.) for fixing the guide wire relative to the inner shaft.

[0032] In some variations, the guidewire positioning device may also include one or more stop features, which are configured to limit the longitudinal movement of the inner shaft in the catheter lumen. For example, in some variations, the catheter and / or the inner shaft (and / or another structure connected thereto) may include one or more stops. In some variations, the inner shaft may include a first feature, and the catheter may include a second feature that can engage with the first feature, wherein the first feature and / or the second feature include a stop, which provides the proximal limit of the longitudinal movement of the inner shaft in the catheter lumen. For example, the inner shaft may include at least one protrusion (e.g., an outer ring) extending radially outward, and the catheter may include at least one protrusion (e.g., an inner ring or a suitable wall) extending radially inward, wherein the radially outward protrusion and the radially inward protrusion may abut each other to limit the stroke. In an exemplary variation, the distal portion of the inner shaft may include at least one protrusion, which is configured to abut at least one protrusion at the proximal portion of the catheter at the proximal limit of the range of the longitudinal movement of the inner shaft. Additionally or alternatively, the limitation of longitudinal movement may be formed by any suitable stop feature (e.g., a tether, band, other tensioning device, magnet, etc.) positioned at a preset desired position from the distal end of the catheter (or sized such as a tensioning device having a preset desired length to limit the position of the inner shaft relative to the catheter).

[0033] As further described herein, in some modifications, when the distal end of the guide wire extends distally beyond the distal end of the catheter to reach a predetermined longitudinal offset distance, the guide wire can be locked, and the inner shaft is at the proximal limit of longitudinal movement in the catheter lumen. In these modifications, the longitudinal and / or rotational movement of the inner shaft can control the longitudinal and / or rotational movement of the guide wire locked, but the guide wire locked can be basically prevented from being fully retracted into the catheter lumen by its distal end, thereby improving safety and ease of use when the guide wire is positioned in the patient.

[0034] In some modifications, the guide wire can be retracted into the catheter lumen by unlocking the guide wire from the inner shaft (for example, to allow the guide wire to be removed from the catheter by the proximal portion of the catheter). For example, the locking mechanism can be disengaged or otherwise unlocked, so that the guide wire is unlocked from the inner shaft. However, in addition or alternatively, in some modifications, the stopper can be a "soft stopper", which can be overcome with a sufficiently large force, or in the case of the complete retraction of the desired guide wire (for example, when the guide wire is not unlocked from the inner shaft) a clutch (for example, a rod, a latch, etc.) is disengaged (or otherwise removed). Further, in some modifications, the stopper can be movable between the stopper structure in which the stopper limits the motion of the inner shaft and the permissive (permissive) structure in which the stopper does not limit the motion of the inner shaft. The stopper can be switched between the stopper structure and the permissible (permissible) structure by, for example, a rod, a latch, a squeezing mechanism or any suitable mechanism.

[0035] Figure 1A A schematic representation of an exemplary variation of a device 100 for positioning a guidewire is depicted. The guidewire positioning device 100 may include: a catheter 110 including a catheter lumen 116 extending between a proximal portion 112 and a distal portion 114; and an inner shaft 120 disposed at least partially within the catheter lumen 116, the inner shaft 120 including a shaft lumen 126 configured to receive a guidewire (not shown). The inner shaft 120 may have a limited longitudinal travel range within the catheter lumen 116, wherein the travel of the inner shaft 120 may be limited by a proximal limit of longitudinal motion and / or a distal limit of longitudinal motion. The guidewire positioning device 100 may also include a locking mechanism 140 configured to lock the guidewire relative to the inner shaft so that the movement of the guidewire (e.g., longitudinal and / or rotational positioning) may be controlled by a user manipulating the inner shaft via a connected handle or the like.

[0036] In some variations, the guidewire positioning device 100 may include one or more stops 130 configured to limit the longitudinal movement of the inner shaft 120 within the catheter lumen 116. The stop(s) 130 may include one or more features of the inner shaft 120 and / or the catheter lumen 116. For example, Figure 1A As shown in , the catheter 110 may include a stop feature 112a at a proximal portion 112 of the catheter 110, and the inner shaft 120 may include a stop feature 124a at a distal portion 124 of the inner shaft 120. Generally, when the inner shaft 120 moves proximally, the inner shaft stop feature 124a may engage (e.g., abut) the catheter stop feature 112a, thereby preventing the inner shaft 120 from moving further proximally.

[0037] In some variations, the catheter stop feature 112a may include one or more radially inward projections. The one or more radially inward projections may be integrally formed (e.g., molded) with at least a portion of the catheter 110, or may be formed separately and subsequently coupled to the catheter 110 (e.g., coupled to the inner surface of the catheter lumen 116 using an adhesive such as an epoxy, using threads, using an interference fit, etc.). In some variations, the inner shaft stop feature 124a may include one or more radially outward projections, which may be integrally formed with the inner shaft 120 or formed separately and subsequently coupled to the inner shaft 120 (e.g., coupled to the outer surface of the inner shaft 120 using an adhesive, threads, an interference fit, etc.).

[0038] In some variations, the stop 130 may be selectively transitioned between a stop configuration in which the stop restricts movement of the inner shaft and a permissive configuration in which the stop does not restrict movement of the inner shaft. The stop 130 may be switched between the stop configuration and the permissive configuration in any suitable manner. For example, radial protrusions in the catheter and / or the inner shaft may be selectively movable in radially inward and / or outward directions (e.g., such as being slidable in radial directions along tracks or slots, or being radially inflatable and / or deflable, etc.), such as by means of a rod, a latch, a squeezing operation, or the like. In order to transition the stop 130 to the stop configuration, one or more radial protrusions in the catheter stop feature 112a may be controlled to move radially inward, and / or one or more radial protrusions in the inner shaft stop feature 124a may be controlled to move radially outward, so as to create physical interference between the stop features 112a and 124a. For example, in some variations, such as Figure 1E and Figure 1F In the variation shown in FIG. 1 , the radial protrusion in the catheter stop feature 112a can be controlled to move radially inward to allow the catheter to stop from the configuration ( Figure 1E ) to the stop configuration ( Figure 1F ). Additionally or alternatively, such as Figure 1G and Figure 1H As shown in FIG. 1 , the radial protrusion in the inner shaft stop feature 124a can be controlled to move radially outward to allow the inner shaft stop feature 124a to move radially outward from the allowable configuration ( Figure 1G ) to the stop configuration ( Figure 1H ).

[0039] Conversely, to convert the stop 130 to the enabling configuration, one or more radial protrusions in the catheter stop feature 112a may be controlled to move radially outward, and / or one or more radial protrusions in the inner shaft stop feature 124a may be controlled to move radially inward to create a physical gap between the stop features 112a and 124a. Figure 1E and Figure 1F , the radial protrusion in the catheter stop feature 112a can be controlled to move radially outward to move from the stop configuration ( Figure 1F ) to allow constructs ( Figure 1E ). Additionally or alternatively, reference Figure 1G and Figure 1H , the radial protrusion in the inner shaft stop feature 124a can be controlled to move radially inward to move from the stop configuration ( Figure 1H ) to allow constructs ( Figure 1G ). It will be appreciated that in some variations, the radial protrusion(s) in both stop features 112a and 124a may be movable in such a manner, and in other variations, it may be sufficient that only the radial protrusion(s) in either the catheter stop feature 112a or the inner shaft stop feature 124a may be movable so as to switch between the stopping configuration and the allowing configuration.

[0040] The catheter stop feature(s) 112a and the inner shaft stop feature(s) 124a may have any suitable shape and structure for engaging and forming the stop 130. For example, Figure 1A As shown in , the catheter stop feature(s) 112a and / or the inner shaft stop feature(s) 124a may include rings, partial rings, fingers (e.g., equally or unequally spaced) that may project radially inward (e.g., for the catheter stop feature 112a) or radially outward (e.g., for the inner shaft stop feature 124a). Figure 1A As shown in , the abutment surfaces of the stop features 112a and 124a can be generally orthogonal to the longitudinal axis of the catheter lumen 116 and the inner shaft 120.

[0041] In some variations, the abutment surfaces of stop features 112a and 124a may be at any suitable angle. For example, Figure 1B An exemplary variation of a stopper 130 including an inclined or tapered abutment surface is shown. Figure 1BAs shown in , the proximal portion 112 of the catheter 110 may include a narrowed funnel-shaped stop feature 112a that is configured to engage a correspondingly flared stop feature 124a on the distal portion 124 of the inner shaft 120. When the inner shaft 120 is withdrawn proximally, the inclined inner shaft stop feature 124a abuts or otherwise engages the catheter stop feature 112a, thereby preventing further proximal movement of the inner shaft 120 relative to the catheter 110.

[0042] Additionally or alternatively, in a process such as Figure 1C In some variations shown in , the stopper 130 may include a compressible material or other suitable deformable structure. For example, one or both of the stop features 112a and 124a may include a compressible material or other suitable deformable structure. Figure 1A and Figure 1B In the variation shown in FIG. 1 , the inner shaft stop feature 124a can be configured to abut the catheter stop feature 112a to limit further proximal movement of the inner shaft 120 relative to the catheter 110. Figure 1C In the exemplary variation shown in , the stop 130 can be a "soft stop" in that the proximal limit can be overcome if the inner shaft 120 is moved proximally with sufficient proximal force. Figure 1C 12a, but it should be understood that in some variations, the compressible material may additionally or alternatively be in the inner shaft stop feature 124a. The compressible material may, for example, include foam, epoxy, an inflatable cushion or balloon, and / or the like. In some variations in which the compressible material includes an inflatable structure, the structure may be selectively inflated and / or deflated to transition the stop between a stopping configuration and an enabling configuration, similar to that described above.

[0043] In some variations, stop 130 may comprise an engagement between inner shaft 120 and catheter 110 that does not involve mechanical interference. Figure 1D An exemplary variation of a stopper 130 comprising one or more magnets or magnetic materials is illustrated, wherein magnetic repulsion can limit the longitudinal travel of the inner shaft 120 in the catheter 110. For example, the inner shaft stop feature 124a can include a magnet or magnetic material, and the catheter stop feature 112a can similarly include a magnet or magnetic material. The stop features 112a and 124a can be mutually magnetically repelling, such that when the inner shaft 120 is withdrawn proximally (and the inner shaft stop feature 124a approaches the catheter stop feature 112a), the magnetic repulsion prevents further proximal movement of the inner shaft 120. For example, one or more of the stop features 112a and / or 124a can include permanent magnets or magnetic materials, electromagnetic materials, etc.

[0044] The stop described herein for limiting the longitudinal movement of the inner shaft (e.g., Figures 1A to 1D) can be combined in any suitable manner. For example, Figure 1C The compressible material described may have a Figure 1B As another example, such as those involving mechanical interference (e.g., the above description of Figures 1A to 1C Any of the stop variations described) may also include magnetic material to assist the stop with magnetic repulsion.

[0045] The guidewire positioning device 100 may also include a locking mechanism 140 configured to lock the guidewire in the shaft lumen to the inner shaft. After the guidewire is locked to the inner shaft via the locking mechanism 140, the guidewire can be controlled by moving the inner shaft within the catheter. The locking mechanism 140 may, for example, clamp or wedge the guidewire against the inner shaft and / or a feature (e.g., a handle or hub) fixed to the inner shaft. The locking mechanism 140 may be arranged at or near the proximal portion of the inner shaft so that it is accessible outside the patient's body when the distal portion of the guidewire positioning device is within the patient's body. In some variations, the locking mechanism 140 may include a shaft housing (e.g., a handle) that is compressible over the inner shaft and the guidewire contained therein, thereby locking the guidewire and the inner shaft to move together (e.g., longitudinally and / or rotationally). As Fig. 8A As shown in , the shaft housing or other portion of the locking mechanism 140 may, for example, include a collet mechanism 842 that can be radially compressed using a collet nut 843, a sleeve, or any suitable mechanism. The collet mechanism 842 can, for example, be arranged around the proximal portion of the inner shaft (e.g., when the distal portion of the guidewire positioning device is in the patient's body, it can be accessed outside the patient's body) and is configured to be compressed using the collet nut 843.

[0046] The locking mechanism 140 may additionally or alternatively include any suitable variation of a locking feature. Figure 8B In another example shown in , the locking mechanism 140 may include a longitudinally movable member 844, such as a slidable or rolling wedge member that is longitudinally movable (e.g., distally and proximally) between a locked position and an unlocked position, wherein in the locked position, the slidable or rolling wedge member compresses the inner shaft (or a housing fixedly coupled thereto) against the guide wire 850, thereby locking the guide wire and the inner shaft to move together. The longitudinally movable member 844 and / or the inner shaft 820 may include one or more stops or the like to help fix the member 844 in the locked position or the unlocked position. In some variations, the longitudinally movable member 844 may be spring loaded to bias toward the locked position (and, for example, temporarily retracted to the unlocked position to open the inner shaft lumen to allow the guide wire to be advanced into the inner shaft).

[0047] As Figure 8CIn another example shown in , the locking mechanism 140 may include a transversely movable member 846 (e.g., a thumb screw, a set screw, other threaded member, etc.) that is movable in a radial direction to clamp or wedge the inner shaft (or a housing fixedly coupled thereto) to the guidewire to lock the guidewire and the inner shaft together. A plurality of transversely movable members 846 may be arranged circumferentially around the inner shaft to clamp on the guidewire in a plurality of radial directions, and these plurality of transversely movable members may be independently or synchronously controlled by mating features, etc.

[0048] As Fig.8D In another example shown in , the locking mechanism 140 may include one or more compression spring-loaded members 847 that may be biased to clamp onto the inner shaft 820. When the guidewire 850 is loaded into the inner shaft 820, the spring-loaded members 847 may be retracted (e.g., by depressing a rod or other suitable mechanism) to open the inner shaft lumen and allow advancement of the guidewire 850, and then the spring-loaded members 847 may be released to clamp and lock the guidewire in place, thereby locking the guidewire and the inner shaft together. Although the spring-loaded members 847 are Fig.8D 847 is shown as a laterally movable member, it should be understood that in other variations, the spring loaded member 847 may alternatively be longitudinally movable. Fig.8D Two members 847 are shown in FIG. 8 , but it should be understood that in other variations, any suitable number of spring-loaded members may be arranged circumferentially about the inner shaft and may be independently or synchronously controlled, similar to that described above.

[0049] As Fig. 8E In another example shown in , the locking mechanism 140 may include one or more rotatable cam mechanisms 848 with a variable radius, so that the cam mechanism rotates to a locked rotational position (e.g., with a longer radius directed transversely to the inner shaft 820) may cause the cam mechanism to clamp or otherwise compress the inner shaft 820 against the guide wire 850, thereby locking the guide wire and the inner shaft together. Similar to the above, any suitable number of cam mechanisms may be arranged around the inner shaft 820 and may be independently or synchronously movable. In addition, in some variations, the cam mechanism may be spring-loaded to bias the locking mechanism toward the locked rotational position.

[0050] Any of the above-described locking mechanisms 140 may be combined together and / or used with any other suitable locking mechanism for locking the inner shaft and guidewire to move together.

[0051] Methods for positioning the guidewire Figure 2A flow diagram of an exemplary method 200 for positioning a guidewire is depicted. The method 200 may include: arranging an inner shaft at least partially within a catheter lumen of a catheter such that the inner shaft is positioned at a limit (e.g., a proximal limit) of longitudinal movement of the inner shaft relative to the catheter (210); advancing the guidewire into the shaft lumen of the inner shaft until the guidewire is at a predetermined position relative to the catheter (220); locking the guidewire relative to the inner shaft when the inner shaft is at the limit of longitudinal movement (230); and positioning the guidewire at least partially by advancing the inner shaft (240). In some variations, the guidewire may be advanced to a predetermined position relative to the catheter at a predetermined longitudinal offset distance before locking the guidewire relative to the inner shaft. For example, the guidewire may be positioned such that a distal end of the guidewire extends distally beyond the distal end of the catheter by a predetermined offset distance. When the guidewire is in this distally extending position and the inner shaft is at the proximal limit of its longitudinal movement, the guidewire may be locked relative to the inner shaft. In this example, longitudinal and / or rotational movement of the inner shaft, such as by a user, can control corresponding longitudinal and / or rotational movement of the locked guidewire, but can substantially prevent the locked guidewire from fully retracting its distal end into the catheter lumen, thereby improving the safety and ease of positioning the guidewire within the patient's body.

[0052] In some variations, method 200 may involve the use of a guidewire positioning device such as described herein. FIG. 3A to FIG. 3F Various aspects of method 200 are shown and described in FIG. 3A to FIG. 3F Describes the above Figure 1A A guidewire positioning device is shown and described.

[0053] like Figure 3A As shown in , method 200 may include disposing an inner shaft 320 at least partially within a catheter lumen 316 of a catheter 310, wherein the catheter lumen 316 may extend, for example, between a proximal portion 312 and a distal portion 314. The inner shaft 320 may be configured to move longitudinally (e.g., telescopically) within the catheter lumen 316. The inner shaft 320 may also include a shaft lumen 326 for receiving a guidewire (not shown) to be positioned. During a procedure in which guidewire placement is desired, a user (e.g., a physician or other practitioner) may move the inner shaft 320 in a proximal direction until the inner shaft 320 encounters a proximal limit of its range of longitudinal motion within the catheter lumen at a stop 330, as shown. Figure 3B For example, arranging the inner shaft can include engaging a first stop feature (e.g., at a distal portion 324 of the inner shaft) with a second stop feature (e.g., at a proximal portion 312 of the catheter). When the inner shaft 320 is arranged in this manner, a guide wire can be present within the shaft lumen 326, or a guide wire can be inserted into the shaft lumen 326 after the inner shaft 320 is positioned at its proximal limit.

[0054] like Figure 3C , a guidewire 350 may be disposed within the inner shaft lumen 326. The guidewire may be any suitable type of guidewire that is of sufficient size for use in a related procedure (e.g., delivery of an implant, catheter, or other suitable device). In some variations, the guidewire 350 may have an atraumatic distal end (e.g., blunt, curved, such as in a "J" shape, etc.), which may, for example, reduce damage to tissue during advancement outside the catheter.

[0055] The guidewire 350 may be advanced to a predetermined desired position. For example, advancing the guidewire may include advancing the guidewire until the distal end of the guidewire extends distally beyond the distal end of the catheter. In some variations, the guidewire may be advanced until its distal end extends distally beyond the distal end of the catheter by a longitudinal offset distance (d), such as Figure 3D The distance (d) can be any suitable distance, such as between about 0.1 cm and about 36 cm, between about 0.1 cm and about 20 cm, between about 0.1 cm and about 15 cm, between about 0.1 cm and about 10 cm, between about 0.1 cm and about 5 cm, between about 0.1 cm and about 4 cm, between about 0.1 cm and about 3 cm, between about 1 cm and about 4 cm, between about 1 cm and about 4 cm, etc.

[0056] When the guidewire 350 is at a predetermined desired position, the guidewire 350 can be locked to the inner shaft 320 or otherwise fixed relative to the inner shaft 320. For example, the locking mechanism 340 can be configured to couple the guidewire 350 relative to the inner shaft, as described in further detail herein and in Figure 3D Schematically shown in . In some variations, the method may include: when the inner shaft is at the proximal limit and the guide wire 350 extends distally beyond the distal end of the catheter, the guide wire is locked relative to the inner shaft. Therefore, in these variations, because the guide wire (fixed relative to the inner shaft) still extends its distal end beyond the distal end of the catheter when the inner shaft is in its most proximal position, the locked guide wire is basically prevented from moving completely proximally into the catheter. Then, by longitudinally and / or rotationally moving (e.g., twisting or otherwise advancing) the inner shaft, the locked guide wire can be positioned (e.g., in a body lumen, in other tissues such as a cardiac chamber, etc.) as desired, thereby reducing the risk of the guide wire being unintentionally withdrawn into the guide wire.

[0057] In some variations, the method of positioning the guidewire may include alternately advancing the inner shaft (as described above, wherein the guidewire is fixed in position relative to the inner shaft) and the catheter. Alternating advancement of the inner shaft and the catheter may improve control of the guidewire, for example by providing structural support to the guidewire and / or by protecting the guidewire by surrounding a substantial portion of the guidewire as the guidewire is generally advanced. For example, Figure 3EA configuration is illustrated in which the guidewire 350 is advanced beyond a predetermined longitudinal offset distance (d) by advancing the inner shaft 320 distally. In some variations, the guidewire 350 may be advanced to another predetermined spacing distance (e.g., between about 1 cm and about 5 cm), or until the guidewire 350 encounters an obstruction (e.g., an anatomical structure such as trabeculations, muscle bands, and / or other obstructions along the ventricular wall). Figure 3E In the configuration shown in FIG. 3 , the guidewire 350 has been moved in a distal direction, such as within a body lumen or otherwise toward a suitable target location. Figure 3D Another configuration is shown in which the catheter 310 has been advanced, reducing the distance between the distal end of the guidewire 350 and the distal end of the catheter 310. The alternating inner shaft advancement ( Figure 3E ) and catheter advancement ( Figure 3F ) to further advance the guidewire and / or catheter to the desired target location.

[0058] In some variations, after the guidewire 350 and catheter 310 are positioned at (one or more) desired target locations, the guidewire 350 can be removed from the catheter 310, leaving the catheter 310 at the target location to perform any desired functions of the catheter. Alternatively, the guidewire 350 can be unlocked from the inner shaft 320, and the guidewire positioning device (including the catheter 310 and the inner shaft 320) can be removed, leaving the guidewire 350 at the target location. For example, after the guidewire positioning device is removed, other devices can be threaded on the placed guidewire 350.

[0059] Additionally or alternatively, the guidewire may be removed and replaced by a second guidewire that may be inserted into the placed catheter, such as for guiding placement of other implants, catheters, etc. over the second guidewire. The second guidewire may, for example, have a different size (e.g., outer diameter) suitable for use with other catheters or other devices.

[0060] For the sake of explanation, this article mainly describes the following in a specific sequential order. FIG. 3A to FIG. 3F Various aspects of the method for positioning the guidewire are described. However, it should be understood that in some variations, at least some of the steps may be performed in parallel or in another suitable order. For example, in some variations, the guidewire 350 may be advanced to a predetermined position within the shaft lumen 326 before the inner shaft 320 is arranged at its proximal limit.

[0061] Example In some variations, the devices and methods described herein can be used to position or otherwise thread a guidewire in a cardiovascular system. For example, the devices and methods described herein can be used to position a guidewire for positioning one or more catheters and / or implantable devices. As described in further detail below, an illustrative example of where such guidewire positioning can be performed is a procedure for attaching an implantable device to a ventricular wall to reshape the ventricle. Exemplary implantable devices for reshaping the ventricle are described in detail in U.S. Patent No. 8,343,173, U.S. Patent No. 8,641,727, U.S. Patent Application Publication No. 2018 / 0140421, and U.S. Patent Application Publication No. 2018 / 0154111, each of which is incorporated herein by reference as a whole. However, it should be understood that the devices and methods for positioning the guidewire can be used or performed in combination with any suitable procedure (such as a procedure in a tricuspid valve, pulmonary valve or aortic valve repair, LAA closure, or right ventricle).

[0062] FIG. 4A to FIG. 4C An exemplary variation of a guidewire positioning device 400 is depicted. The guidewire positioning device 400 may be used, for example, to access a subvalvular space in a left ventricle of a patient's heart and facilitate placement of a guidewire between the cord and tendon and the endocardium. The device 400 may include: a catheter 410 including a catheter lumen; an inner shaft 420 at least partially disposed within the catheter lumen and including a shaft lumen configured to receive a guidewire for positioning; and a locking mechanism 440 configured to lock the guidewire relative to the inner shaft. The catheter 410 and / or the inner shaft 420 may, for example, be slidably coupled such that the inner shaft 420 may be longitudinally and / or rotationally movable within the catheter 410. For example, Figure 4A The device 400 is illustrated in a collapsed configuration, with the inner shaft 420 in a more distal position within the catheter lumen. Figure 4B The device 400 is illustrated in an extended configuration, wherein the inner shaft 420 is in a more proximal position within the catheter lumen. In some variations, the guidewire positioning device 400 may have a working length of between about 100 cm and about 200 cm, between about 130 cm and about 140 cm, or about 137 cm, which may be long enough to traverse the distance from the femoral artery entry point into the left ventricle, around the left ventricle, out of the outflow tract, and across the aortic arch.

[0063] The catheter 410 may include an elongated body having a proximal portion and a distal portion (e.g., the catheter 410 may include a hypotube). The catheter lumen may extend within the elongated body, between the proximal portion and the distal portion of the catheter 410. In some variations, the elongated body of the catheter 410 may have a length between about 40 cm and about 50 cm or about 45 cm, or any suitable length depending on the application. One or more markers may be arranged along the elongated body to facilitate tracking the catheter position in the patient's body when manipulating the guidewire positioning device. For example, the catheter may include one or more radiopaque markers of a radiopaque material (e.g., platinum) visible under fluoroscopy or other suitable guided imaging. In some variations, the radiopaque marker may include an annular or band-shaped marker around the elongated body at various longitudinal positions (e.g., one or more positions near the distal end 414 of the catheter 410 to help visualize the catheter end 410).

[0064] In some variations, a proximal portion (e.g., a proximal end) of the elongated body may be coupled to a catheter handle 412 or other housing to enable longitudinal and / or rotational control of the catheter 410. For example, the handle 412 may be coupled to the catheter 410 using an epoxy or other suitable adhesive and / or with a mechanical interference fit, etc. Figure 4A As shown in , the handle 412 may include gripping elements such as ribs and / or friction features (eg, a rubberized grip) to improve ergonomics and control of the catheter 410 using the handle 412 .

[0065] In some variations, device 400 may include a hub 408, which may, for example, provide a fluid pathway into and / or out of catheter 410 and / or inner shaft 420. For example, Figure 4C As shown in FIG. 4 , the hub 408 can be coupled to the handle 412 (e.g., using threads, a mechanical interference fit, etc.). The irrigation tube 407 can be coupled to a port on the hub 408 so that a fluid (e.g., saline) can be introduced into the hub 408, into one or more slots (e.g., Figure 4C ) and is subsequently introduced into the catheter lumen and / or inner shaft for flushing the lumen(s) of the device 400. In some variations, such as Figure 4CAs shown in the detailed view of , the engagement between the hub 408 and the handle 412 may include at least one seal 408a (e.g., an O-ring or other suitable seal) to form a fluid seal between the hub 408 and the handle 412. Additionally or alternatively, at least one retaining ring 408b may be disposed at the interface between the hub 408 and the handle 412. In some variations, the device 400 may also include a hemostatic valve 409, which includes a rotating seal that can be opened and / or closed to help maintain hemostasis in the patient. For example, the hemostatic valve 409 may include a rotatable element threadedly coupled to the proximal portion of the hub 408, wherein selective rotation of the rotatable element may compress or release one or more seals 409a (e.g., a silicone gasket). One or more washers (e.g., Teflon washers) or other suitable load distribution elements may also be disposed in the hemostatic valve.

[0066] In some variations, at least a portion of catheter 410 may be configured to be disposed within introducer assembly 402, which may include one or more valves that may selectively allow trapped air to escape from introducer assembly 402, such as through prep tube 406. When guidewire device 400 is in use, a proximal portion of prep tube 406 may be positioned outside the patient's body to allow air to escape from the interior of introducer assembly 402 and help maintain, for example, hemostasis.

[0067] In some variations, the distal portion of catheter 410 may include a distal tip region that includes one or more preformed bends (eg, bends preformed during manufacturing). Figure 4CAs shown in , the distal end region may include one or more contours and / or bends, which may be configured to facilitate the catheter to pass around curved tissue during catheter advancement. In some variations, the distal portion of the catheter may be preformed during manufacturing by a suitable process such as molding, extrusion, thermoforming, plastic deformation by bending, etc. For example, the distal portion of the catheter may be bent or contoured without the practitioner actively actuating using a control line or the like. The distal end region may, for example, have one or more preformed bends to facilitate positioning in the subannular groove (e.g., the junction of the left ventricular wall and the mitral annulus) behind / around the chordae tendineae. For example, the distal end of the catheter 410 may include a terminal curvature radius of about 0.3 inches and about 0.7 inches or about 0.5 inches in diameter. In some variations, the nominal diameter is 0.48 inches (e.g., the tolerance range is about between about 0.31 inches and 0.65 inches) The terminal curvature radius is configured to easily manipulate around obstacles and return to the outflow tract from the left ventricle during advancement. Additionally, in some variations, the distal portion of the catheter may have a non-invasive nature because the distal tip of the catheter may be rounded and / or the distal portion of the catheter (e.g., the curved portion) may increase in diameter toward the distal end such that the distal tip outer diameter is greater than the diameter of the remainder of the elongated body of the catheter (e.g., the central or proximal portion). For example, in some variations, the tip outer diameter may be approximately 0.110 inches, and the remainder of the elongated body may have an outer diameter of at most approximately 0.080 inches, which is less than the tip outer diameter.

[0068] like Figure 5A and Figure 5B As shown in, the distal portion 514 of the catheter 510 (which may be similar to the catheter 410) may include one or more bends oriented generally in a single plane. However, in other variations, the distal portion of the catheter may include one or more contours and / or bends oriented in multiple planes. In some variations, the distal portion of the catheter (e.g., catheter 410, 510) may include a material that is more flexible than the rest of the elongated body of the catheter, which, when the catheter is advanced in the patient, may, for example, help reduce the risk of tissue perforation and / or other injuries. For example, although in some variations the majority of the elongated body of the catheter may include braided reinforced PEBAX, which ranges from about Shore D 72 to Shore D 35 from distal to proximal, respectively, in terms of hardness, the distal portion of the catheter itself may include PEBAX without braided reinforcement, which has a hardness less than or equal to about 35 D.

[0069] As described herein, the inner shaft 420 can be slidably disposed within the catheter lumen. In some variations, the inner shaft 420 can be configured to have a longitudinal range of travel within the catheter lumen. For example, Figure 4CAs shown in , the inner shaft 420 may have a proximal limit to its longitudinal movement due to one or more stops 430. Figure 4C As shown in , the distal portion of the inner shaft 420 may include an outer sleeve or other outward projection that is configured to engage with a proximal wall or other inward projection at the proximal portion of the catheter 410. In other words, the inner shaft 420 may be withdrawn proximally ( Figure 4B ), until the distal portion of the inner shaft 420 interferes with the proximal portion of the catheter 410 or stops against the proximal portion of the catheter 410. Figure 4C An exemplary variation of the stop 430 is shown in FIG. 1 , but it should be understood that the stop 430 may include any suitable combination of features (e.g., in the catheter 410, in the inner shaft 420, in the catheter handle 412, in the hub 408, etc.) for limiting the movement of the inner shaft 420. For example, the above description of Figures 1A to 1D Any stopper described may be included as part of device 400. In some variations, similar to a catheter, the inner shaft may include one or more markers to facilitate positioning of the inner shaft in the patient's body when the guidewire positioning device is manipulated. In some variations, one or more markers may be arranged along the inner shaft to facilitate tracking the position of the inner shaft in the patient's body when the guidewire positioning device is manipulated. For example, the inner shaft 420 may include one or more radiopaque markers of a radiopaque material (e.g., platinum) visible under fluoroscopy or other suitable guided imaging. In some variations, the radiopaque marker may include an annular or band-shaped marker surrounding the inner shaft at various longitudinal positions.

[0070] The inner shaft 420 may include an elongated body having a proximal portion and a distal portion (e.g., the inner shaft 420 may include a hypotube). In some variations, the elongated body of the inner shaft 420 may have a length between about 20 cm and about 30 cm, or about 25 cm, or any suitable length depending on the application. The shaft lumen may extend within the elongated body between the proximal portion and the distal portion of the catheter 420. As described above, the shaft lumen may be configured to receive a guidewire (e.g., via a guidewire introducer 460, such as Figure 4A and Figure 4B ). The specific dimensions of the inner shaft may depend on the specific application of the device. For example, in some variations, the shaft lumen may be configured to receive a guidewire having an outer diameter of approximately 0.035" and / or approximately 0.018", with a working length suitable for placement around the subvalvular space of the ventricle into the descending aorta (e.g., from a femoral artery entry point).

[0071] In some variations, a proximal portion (e.g., a proximal end) of the inner shaft elongated body may be coupled to a shaft handle 442 or other housing to enable longitudinal and / or rotational control of the inner shaft 420. For example, the handle 442 may be coupled to the inner shaft 420 using epoxy or other suitable adhesives and / or using a mechanical interference fit, etc. Figure 4A As shown in , the handle 442 can include a gripping element to help improve the ergonomics and / or control of the inner shaft 420.

[0072] In some variations, device 400 may include a locking mechanism 440 configured to lock the position of the guidewire relative to inner shaft 420. For example, Figure 4A As shown in, the locking mechanism 440 may include a collet (e.g., a portion of the inner shaft handle 442) and a collet nut 444, which is configured to tighten the locking mechanism 440 around the inner shaft 420 and the guide wire positioned therein. For example, the collet nut 444 may be threadedly engaged with the handle 442 so that rotating the collet nut 444 pushes the engagement between the collet nut 444 and the handle 442 to clamp around the inner shaft 444, thereby clamping and fixing the guide wire position therein. Similar to the handle 442, the collet nut 444 may include a housing including one or more suitable gripping features to help improve the ergonomics and / or control of the collet nut 444. However, the device 400 may include any suitable locking mechanism 440 for functionally coupling the actuation of the inner shaft 420 to the actuation of the guide wire.

[0073] The guidewire positioning device 400 can be used in conjunction with one or more suitable devices. Figure 4C As shown in the schematic diagram of , the guidewire positioning device 400 can be advanced within a guide catheter 404. The guide catheter 404 can be positioned, for example, near the region of the ventricular wall where the device is to be implanted, and / or between the chordae tendineae and the endocardium. The diameter of the catheter 410 can be smaller than the diameter of the guide catheter 404, so that the catheter 410 can be slidably advanced within the lumen of the guide catheter 404. Figure 6 Exemplary variations of suitable guide catheters are described in further detail.

[0074] In use, the guidewire positioning device 400 can be prepared and used for positioning of a guidewire as follows. A user can at least partially loosen the hemostasis valve 409 and slide the inner shaft 420 in a proximal direction (e.g., to Figure 4B ) until the inner shaft 420 reaches the proximal limit of its movement due to the stop 430. The catheter lumen and the inner shaft lumen can be flushed by filling the catheter 410 and the inner shaft 420 with saline or other suitable fluid via the flush tube 407. For example, the fluid can flow through the flush tube 407, into the hub 408, and into the catheter 410 and / or the inner shaft 420 through one or more slots 428.

[0075] A suitable guidewire (e.g., a J-tip guidewire) can then be inserted into the guidewire introducer 460 and advanced until the distal tip of the guidewire extends beyond the distal end of the catheter 410 by a predetermined offset distance. For example, in some variations, the predetermined offset distance (d) can be approximately 3 cm or less. The predetermined offset distance (d) can be confirmed by fluoroscopy (e.g., observing and measuring the distance between (one or more) radiopaque markers and / or other features of the device), echocardiographic imaging or other suitable imaging methods, by (one or more) distance markings at the proximal end of the guidewire relative to the proximal portion of the device (e.g., the collet nut 444), and the like. After the guidewire introducer is removed, the collet nut 444 can be tightened (e.g., by rotation) to secure the guidewire to the inner shaft handle 442. Thus, the handle 442 can be used to advance and / or torque the secured guidewire. However, when the device 400 is in Figure 4B 430). In other words, the guidewire affixed in this manner is substantially prevented from being withdrawn proximally into the catheter lumen. In addition, the guidewire is substantially prevented from moving to a position where the distance between its distal end and the distal end of the catheter 410 is less than a predetermined offset distance.

[0076] The introducer assembly 402 can be moved distally along the device 400 (e.g., along the catheter 410), and the distal end of the catheter 410 and the guidewire can be withdrawn into the introducer assembly 402. The introducer assembly 402 can then be inserted into a portion of the guide catheter 404 (e.g., the hub of the guide catheter 404, not shown), and one or more valves can be opened to allow any trapped air to escape from the introducer assembly 402 through the preparation tube 406. The device 400 (e.g., the catheter 410) can be advanced through the guide catheter to the desired distance, and the preparation tube 406 can be removed from the assembly.

[0077] The guidewire positioning device 400 can then be advanced through the guide catheter to facilitate placement of the guidewire along the ventricular wall region where the device is to be implanted (e.g., at least a portion of the circumference around the left ventricle) and / or between the chordae tendineae and the endocardium. In some variations, advancement of the guidewire positioning device 400 through the guide catheter can be performed under fluoroscopic guidance, echocardiographic imaging, and / or other suitable imaging methods. In addition, during advancement of the guidewire positioning device 400, the distal end of the catheter 410 can be twisted so that it is directed toward the mitral valve.

[0078] like Fig. 7A and Figure 7BAs shown in , the inner shaft handle portion 442 can be moved distally and forwardly (thereby advancing the guidewire 450 distally and forwardly) until an obstruction (e.g., a trabeculae, muscle bands, or other obstructions along the left ventricular wall) is encountered. Fig. 7A As shown in , the guidewire 450 may encounter ventricular wall tissue. Once an obstruction is encountered, the inner shaft handle 442 remains stable to hold the guidewire 450 in place while the catheter handle 412 moves distally and forward (thereby advancing the catheter 410 forward) until the distal end of the catheter 410 is just proximal to the obstruction (or when the distance between the distal end of the catheter 410 and the distal end of the guidewire 450 decreases to a predetermined offset distance (d) ( Figure 7B )). If the inner shaft 420 is not already at the proximal limit of its travel after the catheter 410 is advanced over the guidewire 450 in this manner, the guidewire 450 may be further withdrawn proximally until the inner shaft 420 is at the proximal limit of its travel. Fig. 7A and Figure 7B The process shown in to alternately advance guidewire 450 and catheter 410 to track at least a portion of the circumference of the left ventricular wall. In some variations, guidewire 450 and / or catheter 410 may be positioned along the subannular groove so that the distal end of the guidewire leaves the outflow tract and optionally recrosses the aortic arch. Therefore, the end of the catheter can be manipulated to pass the guidewire around one or more various obstacles during guidewire advancement. In some variations, guidewire 450 and / or catheter 410 may be positioned below the mitral valve plane or annulus, such as downward to or along the papillary muscle insertion on the ventricular wall (e.g., downward to about 25 to about 30 mm below the mitral valve plane).

[0079] In addition, the position of the guidewire 450 can be confirmed (e.g., using fluoroscopy, echocardiography, and / or other suitable imaging methods). Once the guidewire 450 and / or device 400 are positioned in the desired position, the guidewire 450 can then be unlocked from the inner shaft 410, thereby allowing the guidewire 450 and the device 400 to be separated. In some variations, the device 400 can be withdrawn proximally on the placed guidewire 450, thereby leaving the guidewire 450 in place to facilitate positioning other catheters and devices in the left ventricle. In other variations, the guidewire 450 can be withdrawn from the placed device 400 and replaced by a second guide 450 (e.g., the second guide 450 can have another suitable size to facilitate positioning other catheters and devices in the left ventricle).

[0080] Therefore, as described herein, guidewire positioning device 400 and methods using it can facilitate positioning of guidewires in a safer and easier to use manner than other conventional devices and methods. For example, the devices and methods described herein substantially prevent guidewires from being inadvertently withdrawn into a catheter, which inadvertent withdrawal would otherwise interfere with the positioning process.

[0081] Kits The present invention also describes a kit including a guidewire positioning device and one or more guidewires. The guidewire positioning device may include: a catheter including a catheter lumen; an inner shaft at least partially disposed within the catheter lumen and including a shaft lumen configured to receive the guidewire; and a locking mechanism configured to lock the guidewire relative to the inner shaft to maintain at least a predetermined longitudinal offset distance between the guidewire and the catheter. The inner shaft and the catheter may be capable of engaging to limit proximal longitudinal movement of the inner shaft within the catheter lumen.

[0082] In some variations, the kit may further include a guide catheter. Figure 6 Describe an exemplary variation of a guide catheter 601, in which a guidewire positioning device can be advanced during use in the process of placing a guidewire. The guide catheter 601 may include an elongated body 603 and a distal portion 605 including one or more preformed bends 607. The preformed bend 607 may have a contour and / or bend corresponding to the contour and / or bend of the patient's vascular system, so that advancing and / or aligning the guide catheter along the contour and / or bend of the patient's vascular system automatically positions the most distal end 609 of the guide catheter at or near the mitral annulus and / or subannular groove area in the left ventricle. In some variations, the distal portion 605 of the guide catheter 601 may include a steerable, deflectable end portion that allows the curvature of the distal portion to be adjusted (e.g., by using a deflection knob on the proximal handle of the guide catheter).

[0083] In some variations, the kit may also include one or more implants for remodeling (e.g., reverse remodeling) a ventricle and / or one or more devices for delivering the implants. The implants and / or devices for delivering the implants may be configured for advancement over a guidewire (or another guidewire that can be positioned using a guidewire positioning device). For example, a kit may include an implant that can be implanted in a left ventricle that requires remodeling, such as the implants described in U.S. Pat. No. 8,343,173 and U.S. Pat. No. 8,641,727, each of which is incorporated herein by reference in its entirety. In addition, the kit may include: a multi-window catheter, such as the multi-window catheter described in U.S. Patent No. 8,790,367 and U.S. Patent Application Publication No. 2018 / 0154111; a locking device, such as the locking device described in U.S. Patent No. 9,636,106; a tightening and / or locking catheter, such as the tightening and / or locking catheter described in U.S. Patent No. 8,795,298 and U.S. Patent Application Publication No. 2018 / 0140421; and / or a cutting catheter, such as the cutting catheter described in U.S. Provisional Patent Application Serial No. 62 / 847,279 filed on July 17, 2019, each of which is incorporated herein in its entirety by this reference, and / or another suitable anchor delivery catheter for use in an anchor for delivering an implant. The kit may also include any suitable delivery catheter and / or other implant devices, etc.

[0084] For the purpose of explanation, the foregoing description uses specific nomenclature to provide a comprehensive understanding of the present invention. However, it will be apparent to those skilled in the art that specific details are not required in order to practice the present invention. Therefore, for the purpose of illustration and description, the foregoing description of specific embodiments of the present invention is presented. They are not intended to be exhaustive or to limit the present invention to the precise form disclosed; obviously, in view of the above teachings, many modifications and variations are possible. The embodiments are selected and described in order to best explain the principles of the present invention and its practical application, so that other technical personnel in the field can best utilize the present invention and various embodiments with various modifications as suitable for the specific purpose envisioned. It is intended that the following claims and their equivalents define the scope of the present invention.

Claims

1. A method for positioning a guide wire, the method comprising: disposing the inner shaft at least partially within the lumen of the catheter; engaging the inner shaft and the catheter so as to limit proximal longitudinal movement of the inner shaft within the lumen of the catheter; advancing a guidewire into the shaft lumen of the inner shaft until the guidewire is located at a predetermined longitudinal offset distance relative to the catheter; locking the advanced guidewire to the inner shaft when the inner shaft is at the proximal limit; and The guidewire is advanced at least in part by advancing the inner shaft.

2. The method according to claim 1, wherein: Deploying the inner shaft includes engaging a first feature of the inner shaft with a second feature of the catheter.

3. The method according to claim 2, wherein: The first feature is disposed on a distal portion of the inner shaft, and wherein the second feature is disposed on a proximal portion of the catheter, and the first feature and the second feature engage to define a proximal limit of longitudinal movement of the inner shaft.

4. The method according to claim 3, wherein: At least one of the first feature and the second feature includes a stop.

5. The method according to claim 1, wherein: Advancing the guidewire includes advancing the guidewire until a distal end of the guidewire extends distally beyond a distal end of the catheter.

6. The method according to claim 5, wherein: Locking the guidewire includes locking the guidewire to the inner shaft when the inner shaft is at the proximal limit and when the distal end of the guidewire extends distally beyond the distal end of the catheter, thereby substantially preventing the distal end of the guidewire from moving proximally into the catheter.

7. The method according to claim 1, wherein: Positioning the guidewire includes alternately advancing the inner shaft and the catheter.

8. The method according to claim 7, wherein: While the inner shaft and the catheter are alternately advanced, at least the predetermined longitudinal offset distance between the guidewire and the catheter is maintained.

9. The method according to claim 7, wherein: Alternatingly advancing the inner shaft and the catheter includes: advancing the inner shaft until the distal end of the guidewire encounters an obstruction; advancing the catheter to reduce the distance between the distal ends of the guidewire and the catheter; and further advancing the inner shaft.

10. The method of claim 7, further comprising advancing the catheter into a left ventricle of the heart, and positioning the guidewire comprises alternately advancing the inner shaft and the catheter around the subvalvular space of the mitral valve behind chordae tendineae of the left ventricle.

11. The method of claim 1 , further comprising unlocking the guidewire and withdrawing the guidewire from the inner shaft.

12. The method of claim 10, further comprising delivering an implant to the subvalvular space.

13. The method according to claim 12, wherein: The implant includes a plurality of anchors.

14. A kit comprising: one or more guide wires; A device for positioning the one or more guide wires, the device comprising: a catheter comprising a lumen; an inner shaft disposed at least partially within the catheter lumen and comprising a shaft lumen configured to receive a guidewire, wherein the inner shaft and the catheter are engageable to limit proximal longitudinal movement of the inner shaft within the catheter lumen; and A locking mechanism is disposed at a proximal portion of the inner shaft and is configured to lock the guidewire to the inner shaft to maintain at least a predetermined longitudinal offset distance between the guidewire and the catheter.

15. The kit of claim 14, further comprising one or more implants configured for delivery to a subvalvular space of the heart.

16. The kit of claim 15, wherein: The one or more implants include a plurality of anchors.

17. The kit of claim 14, further comprising a guide catheter.

18. The kit of claim 17, wherein: The guide catheter includes an elongated body and a distal portion having one or more pre-formed bends.

19. The kit of claim 14, wherein: The inner shaft includes a first feature and the catheter includes a second feature, and wherein the first feature and the second feature are engageable to define a proximal limit of longitudinal movement of the inner shaft within the catheter lumen.

20. The kit of claim 19, wherein: At least one of the first feature and the second feature includes a stop.

21. The kit of claim 19, wherein: The first feature comprises a first protrusion extending radially outward, and wherein the second feature comprises a second protrusion extending radially inward.

22. The kit of claim 21, wherein: The first protrusion includes a ring disposed around a portion of the inner shaft, and wherein the second protrusion includes a wall configured to abut the ring.

23. The kit of claim 19, wherein: The catheter includes a catheter housing including the second feature.

24. The kit of claim 14, wherein: The locking mechanism includes a shaft housing coupled to the inner shaft.

25. The kit of claim 14, wherein: The distal end of the catheter is curved.

Images