Treatment system with steerable catheter

Abstract

A steerable sheath assembly is disclosed, comprising an elongated tubular sheath with a handle assembly at its proximal end featuring a bending mechanism to curve the distal portion of the sheath. The assembly may include a hemostasis valve with one or more valve members, and a catheter tool passage extending from the hemostasis valve's proximal end through the handle assembly to the sheath's distal end. A rotatable connection mechanism may link the hemostasis valve to the handle assembly, enabling rotation of the handle and sheath while maintaining a fixed longitudinal connection with the hemostasis valve.

Description

SPECIFICATIONTREATMENT SYSTEM WITH STEERABLE CATHETERRELATED APPLICATIONS

[0001] This application claims benefit of and priority to U.S. Provisional Application Serial No. 63 / 605,329 filed December 1 , 2023 entitled Heart Valve Therapy Removal Device, which is hereby incorporated herein by reference in its entirety.BACKGROUND

[0002] Minimally invasive cardiac procedures often utilize catheters, which are flexible, thin tubes inserted into the body to access the heart. However, navigating the complex vascular structures and precisely targeting specific areas within the heart can be challenging. Traditional catheters lack the maneuverability needed for certain delicate procedures, which can lead to suboptimal outcomes or increased procedure times.

[0003] To address these challenges, the development of advanced steerable sheaths has become crucial. Steerable sheaths offer enhanced control and flexibility, allowing surgeons to navigate complex anatomical pathways with greater ease and precision and deploy catheters and similar tools at a target location. This innovation may be particularly beneficial for intricate cardiac procedures where accurate positioning and manipulation of instruments are vital.SUMMARY

[0004] In some aspects, the techniques described herein relate to a steerable sheath assembly, including: a sheath including an elongated tubular structure; a handle assembly connected to a proximal portion of the sheath and having a bending mechanism that selectively curves a distal portion of the sheath; a hemostasis valve including one or more valve members; a catheter tool passage extending from a proximal end of the hemostasis valve, through the handle assembly, and to a distal end of the sheath; and, arotatable connection mechanism connecting the hemostasis valve with the handle assembly allowing the handle mechanism and the sheath to rotate relative to the hemostasis valve, while maintaining a longitudinally-fixed connection between the hemostasis valve and the handle assembly.

[0005] In some aspects, the techniques described herein relate to a steerable sheath assembly, wherein the rotatable connection mechanism includes a tube with a circumferentially enlarged region and a space to accommodate the circumferentially enlarged region.

[0006] In some aspects, the techniques described herein relate to a steerable sheath assembly, wherein the tube is fixed to the hemostasis valve and wherein the space is located within the handle assembly.

[0007] In some aspects, the techniques described herein relate to a steerable sheath assembly, wherein a proximal end of the sheath is located within the hemostasis valve.

[0008] In some aspects, the techniques described herein relate to a steerable sheath assembly, wherein the proximal end of the sheath includes a first retaining member having a diameter larger than a distal opening of a housing of the hemostasis valve.

[0009] In some aspects, the techniques described herein relate to a steerable sheath assembly, wherein the hemostasis valve further includes: a circumferential valve member within a valve cavity, having a ring shape body with a circular flap extending radially inward from the ring shape body; a cross-slit valve member within the valve cavity and located distally of the circumferential valve member; the cross-slit valve member having crossing slits forming a cross shape; and, a dome valve member within the valve cavity and located distally of the cross-slit valve; the dome valve member having a concave or dome shape extending proximally within the valve cavity and having a passage through the dome shape.

[0010] In some aspects, the techniques described herein relate to a steerable sheath assembly, wherein the hemostasis valve further includes a passage into the valve cavitywhere the connection and cavity are in communication with a proximal side of the dome valve member.

[0011] In some aspects, the techniques described herein relate to a steerable sheath assembly, wherein the handle assembly includes a housing, a hand actuator accessible from outside of the housing, a spur gear coupled to the hand actuator, a first rack gear engaged with the spur gear and longitudinally movable within the housing, a second gear rack engaged with the spur gear on a side opposite of the first rack gear and longitudinally movable within the housing, a first clamp connected to the first gear rack, a second clamp connected to the second gear rack; a first wire connected to the first clamp and to a distal portion of the sheath; and, a second wire connected to the second clamp and to the distal portion of the sheath.

[0012] In some aspects, the techniques described herein relate to a steerable sheath assembly, further including a support structure including a bottom support, a first mounting area connected to the bottom support and shaped to engage the steerable sheath assembly, a second mounting area connected to the bottom support and shaped to engage the steerable sheath assembly, and a gap between the first mounting area and the second mounting area, where the handle assembly fits substantially within the gap and is rotatable within the gap.

[0013] In some aspects, the techniques described herein relate to a hemostasis valve, including: a valve housing having a first opening on a proximal side of the valve housing and a second opening on a distal side of the valve housing; the valve housing forming a valve cavity; a circumferential valve member within the valve cavity, having a ring shape body with a circular flap extending radially inward from the ring shape body; a cross-slit valve member within the valve cavity and located distally of the circumferential valve member; the cross-slit valve member having crossing slits forming a cross shape; and, a dome valve member within the valve cavity and located distally of the cross-slit valve; the dome valve member having a concave or dome shape extending proximally within the valve cavity and having a passage through the dome shape.

[0014] In some aspects, the techniques described herein relate to a hemostasis valve, further including a third opening into the valve cavity and in communication with a proximal side of the dome valve member.

[0015] In some aspects, the techniques described herein relate to a hemostasis valve, wherein the cross-slit valve includes a plurality of distally facing ridges.

[0016] In some aspects, the techniques described herein relate to a hemostasis valve, further including angled surfaces adjacent to and on each side of the distally facing ridges.

[0017] In some aspects, the techniques described herein relate to a hemostasis valve, further including a first retaining member located adjacent to the dome valve member.

[0018] In some aspects, the techniques described herein relate to a hemostasis valve, further including a second retaining member longitudinally and distally spaced apart from the first retaining member by one or more lateral arms.

[0019] In some aspects, the techniques described herein relate to a hemostasis valve, further including a handle assembly connected to a proximal portion of the sheath and having a bending mechanism that selectively curves a distal portion of the sheath.

[0020] In some aspects, the techniques described herein relate to a hemostasis valve, wherein the bending mechanism includes a worm and a worm gear configured to prevent back drive of a hand actuator.

[0021] In some aspects, the techniques described herein relate to a steerable sheath assembly, including: a sheath including an elongated tubular structure; a handle assembly connected to a proximal portion of the sheath and including a housing and a deflection mechanism; the deflection mechanism at least partially located within the handle assembly and including a hand actuator accessible from outside of the housing, a worm coupled to the hand actuator, and a worm gear coupled to the worm; a first wire connected to the deflection mechanism and to a distal portion of the sheath; a second wire connected to the deflection mechanism and to the distal portion of the sheath; and,a catheter tool passage extending through the handle assembly and to a distal end of the sheath.

[0022] In some aspects, the techniques described herein relate to a steerable sheath assembly, wherein the hand actuator is a knob, lever, slider member, thumbwheel, or trigger.

[0023] In some aspects, the techniques described herein relate to a steerable sheath assembly, wherein the deflection mechanism further includes a spur gear coupled to the worm gear.

[0024] In some aspects, the techniques described herein relate to a steerable sheath assembly, wherein the deflection mechanism further includes a first rack gear engaged with the spur gear and longitudinally movable within the housing, a second gear rack engaged with the spur gear on a side opposite of the first rack gear and longitudinally movable within the housing, a first clamp connected to the first gear rack, and a second clamp connected to the second gear rack.

[0025] In some aspects, the techniques described herein relate to a steerable sheath assembly, further including a first elongated recess which the first clamp is positioned in and longitudinally slidable in; and a second elongated recess which the second clamp is positioned in and longitudinally slidable in.

[0026] In some aspects, the techniques described herein relate to a steerable sheath assembly, further including a first angled recess connected to the first elongated recess and opening at the sheath, where the first wire is located within the first elongated recess and the first angled recess; and a second angled recess connected to the second elongated recess and opening at the sheath, where the second wire is located within the second elongated recess and the second angled recess.

[0027] In some aspects, the techniques described herein relate to a steerable sheath assembly, wherein the first wire and the second wire extend respectively extend throughthe first angled recess and the second angled recess, then between an outer tubular layer and an inner tubular layer of the sheath.

[0028] In some aspects, the techniques described herein relate to a steerable sheath assembly, wherein the first wire and the second wire have a round diameter, an oval diameter, a flat / rectangular diameter, or a curved / arc diameter.

[0029] In some aspects, the techniques described herein relate to a steerable sheath system, including: a steerable sheath assembly including a sheath including an elongated tubular structure, a handle assembly connected to a proximal portion of the sheath and having a bending mechanism that selectively curves a distal portion of the sheath; a catheter tool passage extending through the handle assembly and to a distal end of the sheath; and, a support structure including a bottom support, a first mounting area connected to the bottom support and shaped to engage the steerable sheath assembly, a second mounting area connected to the bottom support and shaped to engage the steerable sheath assembly, and a gap between the first mounting area and the second mounting area, where the handle assembly fits substantially within the gap and is rotatable within the gap.

[0030] In some aspects, the techniques described herein relate to a steerable sheath system, further including a catheter tool support platform including an elongated surface located proximal of the second mounting area.

[0031] In some aspects, the techniques described herein relate to a steerable sheath system, further including a rotatable connection mechanism connecting a hemostasis valve with the handle assembly, allowing the handle mechanism and the sheath to rotate relative to the hemostasis valve, while maintaining a longitudinally-fixed connection between the hemostasis valve and the handle assembly.

[0032] In some aspects, the techniques described herein relate to a steerable sheath system, wherein the first mounting area is positioned to engage a first location distal ofthe handle assembly and wherein the second mounting area is positioned to engage a second location proximal of the handle assembly.

[0033] In some aspects, the techniques described herein relate to a steerable sheath system, wherein either the first mounting area or the second mounting area further includes a rotation lock mechanism configured to selectively prevent the handle assembly from rotating when engaged.

[0034] In some aspects, the techniques described herein relate to a steerable sheath system, wherein the first mounting area is positioned closer to the bottom support than the second mounting area.

[0035] In some aspects, the techniques described herein relate to a steerable sheath system, wherein the first mounting area is positioned at about a same height as the second mounting area.

[0036] In some aspects, the techniques described herein relate to a steerable sheath system, wherein the first mounting area is positioned further from the bottom support than the second mounting area.

[0037] In some aspects, the techniques described herein relate to a steerable sheath system, wherein the first mounting area and the second mounting area are movable between an elevated position and a non-elevated position.

[0038] In some aspects, the techniques described herein relate to a support structure for a first steerable sheath system, including: a bottom support; a first mounting area connected to the bottom support and shaped to engage a first steerable sheath assembly; a second mounting area connected to the bottom support and shaped to engage the first steerable sheath assembly; and, a first longitudinal gap between the first mounting area and the second mounting area, where a handle assembly of the first steerable sheath system fits substantially within the first longitudinal gap and is rotatable within the first longitudinal gap.

[0039] In some aspects, the techniques described herein relate to a support structure, further including a first catheter tool support platform including an elongated surface located proximal of the second mounting area.

[0040] In some aspects, the techniques described herein relate to a support structure, wherein either the first mounting area or the second mounting area further includes a rotation lock mechanism configured to selectively prevent a handle assembly of the first steerable catheter system from rotating when engaged.

[0041] In some aspects, the techniques described herein relate to a support structure, wherein the first mounting area is positioned closer to the bottom support than the second mounting area.

[0042] In some aspects, the techniques described herein relate to a support structure, further including: a third mounting area connected to the bottom support and shaped to engage a second steerable sheath assembly; a fourth mounting area connected to the bottom support and shaped to engage the second steerable sheath assembly; and, a second longitudinal gap between the first mounting area and the second mounting area, where a handle assembly of the second steerable sheath system fits substantially within the second longitudinal gap and is rotatable within the second longitudinal gap.BRIEF DESCRIPTION OF THE DRAWINGS

[0043] The following figures are included to illustrate certain example aspects of the present disclosure and should not be viewed as exclusive or limiting. The subject matter disclosed is capable of considerable modifications, alterations, combinations, and equivalents in form and function, as will occur to one having ordinary skill in the art and having the benefit of this disclosure. The present disclosure references the drawings as follows:

[0044] Fig. 1 illustrates a side view of a steerable sheath assembly 100.

[0045] Fig. 2 illustrates a side view of a steerable sheath assembly 100.

[0046] Fig. 3 illustrates a side view of a steerable sheath assembly 100.

[0047] Fig. 4 illustrates a side view of a steerable sheath assembly 100.

[0048] Fig. 5 illustrates an end view of a steerable sheath assembly 100.

[0049] Fig. 6 illustrates an end view of a steerable sheath assembly 100.

[0050] Fig. 7 illustrates a perspective view of a steerable sheath assembly 100.

[0051] Fig. 8 illustrates a side cross sectional view of a steerable sheath assembly100.

[0052] Fig. 8 illustrates a cross-sectional view of the handle assembly 102 and the hemostasis valve 104.

[0053] Fig. 9 illustrates a cross-sectional perspective view of the hemostasis valve 104.

[0054] Fig. 10 illustrates an exploded view of the hemostasis valve 104.

[0055] Figs. 11 and 12 illustrate cross sectional views of seals of the hemostasis valve 104.

[0056] Fig. 13 illustrates a perspective view of seals of the hemostasis valve 104.

[0057] Fig. 14 illustrates a partially disassembled view of the handle assembly 102.

[0058] Fig. 15 illustrates a partially disassembled view of the handle assembly 102.

[0059] Fig. 16 illustrates a partially disassembled view of the handle assembly 102.

[0060] Fig. 17 illustrates a view of a wire clamp assembly 150.

[0061] Fig. 18 illustrates a partially disassembled view of the handle assembly 102.

[0062] Fig. 19 illustrates view of a reinforcement sleeve 130 of the sheath 106.

[0063] Fig. 20 illustrates a side view of a distal region 156 of a sheath 106.

[0064] Fig. 21 illustrates a side view of a support structure 160 for a steerable sheath assembly 100 which supports the steerable sheath assembly 100 in a way to allow rotation of the handle assembly 102 while preventing the hemostasis valve 104 from rotating.

[0065] Fig. 22 illustrates the support structure 160 supporting the steerable sheath assembly 100 and a catheter tool system 180 with a catheter hub 182.

[0066] Fig. 23 illustrates a distal end of a tissue cutting catheter 184.

[0067] Fig. 24 illustrates a distal end distal end of a snare catheter 186.

[0068] Fig. 25 illustrates a distal end of a cutting loop catheter 188.

[0069] Fig. 26 illustrates a distal end of a capture basket catheter 190.

[0070] Figs. 27, 28, 29, and 30 illustrate an example procedure with the steerable sheath assembly 100 and the catheter tool system 180.

[0071] Fig. 31 illustrates a side view of a support structure 160’ for two steerable sheath assemblies 100, 100’ (or an alternative second device) provides support in a way to allow rotation of the handle assemblies 102, 102’ while preventing the hemostasis valves 104, 104’ from rotating.DETAILED DESCRIPTION

[0072] It will be appreciated by persons skilled in the art that the present disclosure is not limited to what has been particularly shown and described herein. A variety of modifications and variations are possible in view of the teachings herein without departing their scope, spirit, or intent.

[0073] While different examples may be described in this specification, it is specifically contemplated that any of the features from the different examples can be used andbrought together in any combination. In other words, the features of different examples can be mixed and matched with each other. Hence, while every permutation of features from different examples may not be explicitly shown or described, it is the intention of this disclosure to cover any such combinations, especially as may be appreciated by one of skill in the art.

[0074] The terminology used in this disclosure should be interpreted in a permissive manner and is not intended to be limiting. In the drawings, like numbers refer to like elements. Unless otherwise noted, all of the accompanying drawings are not to scale. Unless otherwise noted, the term “about” or “substantially” is defined to mean plus-or- minus 5% of a stated value.

[0075] The terms distal or distally generally refer to a direction or area towards an end of a device within a patient (e.g., away from a physician / clinician), while the terms proximal or proximally refer to a direction or area toward an end of a device that remains outside of a patient (e.g., toward or closer to a physician / clinician or handle / hub of a device).

[0076] Ranges stated in this specification should be understood to include every incremental whole number and incremental decimal value between beginning and ending range values.

[0077] The term catheter tool is used in this specification to mean any elongated device that may be inserted through a hemostasis valve, a sheath, and / or at least partially into a patient. Examples of such tools include guidewires, catheters, sheaths, introducers, and similar devices.

[0078] The present disclosure is generally directed to a treatment system. In some examples, the treatment system may be used for heart treatment procedures, such as procedures in which a heart is accessed via one or more catheter tools. Specific heart treatments may include removal of heart therapy devices such as heart valve leaflet clips, cutting or modification of heart valve leaflets, or implantation of heart valve therapydevices such as valves, leaflet clips, annuloplasty rings, and similar devices. The treatment system or any of its components may also be used for procedures outside the heart, such as within other locations within vessels for various treatment procedures. While use in a heart is primarily described, it should be understood that use with any other vessels or cavities is also specifically contemplated.

[0079] One component of the treatment system may include a steerable sheath assembly. In some examples, the steerable sheath assembly may include a steerable sheath and a hemostasis valve. The hemostasis valve may be physically connected to a proximal end of a handle of the steerable sheath such that the steerable sheath may rotate relative to the hemostasis valve while maintain the axial or proximal / distal distance between the two components. In other words, the steerable sheath (the handle and a tubular sheath portion) may rotate relative to the hemostasis valve without substantially pulling away longitudinally or disconnecting from the hemostasis valve. This may allow the user to rotate the handle and tubular sheath portion during a procedure without rotating the hemostasis valve and any catheter tools within the steerable sheath. Keeping the hemostasis valve stationary with an aspiration / access port (e.g., a luer fitting) facing upwards allows better capture and removal of air bubbles that accumulate after multiple tool exchanges. If the hemostasis valve rotates with the sheath, the bubbles can accumulate in positions that cannot be cleared with a syringe via the aspiration / access port. Additionally, maintaining a fixed rotational position (especially with regard to an aspiration port on a top of the hemostasis valve) may allow air bubbles to be more reliably removed during and after exchanges of tools. If the hemostasis valve rotates with the steerable sheath, any air bubbles may accumulate in locations within the valve that aspiration of the valve may not be able to easily remove. In other words, preventing rotation of the hemostasis valve

[0080] The hemostasis valve may have an outer housing composed of clear or mostly clear materials. This may allow the user to view air bubbles that may have accumulated (e.g., during catheter tool exchanges) and cause the physician to aspirate (e.g., via a syringe connected to an aspiration port) to remove the air bubbles.

[0081] The hemostasis valve may comprise a plurality of different valve seals that further maintain hemostasis and prevent blood leakage. In some examples, the hemostasis valve comprises a circumferential valve member, a cross-slit valve member, and a dome valve member. In some examples, a chamber or cavity of the hemostasis valve may be pressurized on one side of the dome valve. The circumferential valve member may help create a seal around any catheter tools passing through the hemostasis valve. The cross-slit valve member may help maintain hemostasis, particularly when no catheter tools are positioned therethrough. Additionally, the dome valve member may help maintain hemostasis, particularly when no catheter tools are positioned therethrough. If the steerable sheath is positioned in a patient and the proximal handle is raised to a height above the patient’s chest, creating higher pressure due to “column height”, the dome valve member may prevent the “column” from dropping and pulling in air. This feature also makes it easier to prep devices as they can be filled with fluid and can be held vertically without the fluid rushing out.

[0082] The steerable sheath assembly may further include a handle portion that includes a mechanism for bending a distal portion of the steerable sheath. The mechanism may be configured to maintain the curvature of the distal portion after a physician has adjusted it, without the need for a discrete lock or brake. In some examples, the mechanism may include a rotating adjustment member such as a knob, thumbwheel, or similar member that is connected to a worm drive assembly. The rotating adjustment member may be attached to or form a worm that is engaged with a worm gear. In such an arrangement, the worm may be rotated to drive rotation of the worm gear, but it is much more difficult for force on the worm gear to drive rotation of the worm and therefore the rotating adjustment member. Since the worm gear is further coupled to mechanisms (e.g., gear racks, wires) to cause movement of the distal portion of the steerable sheath, the rotating adjustment member tends to remain in a rotational position set by the physician, despite any counter force caused by the distal portion of the steerable sheath. In other words, the worm drive assembly tends to maintain the curvature of the distal portion of the steerable catheter via the worm drive assembly without the need to a lock or brake assembly.

[0083] The steerable sheath assembly may also include a support structure or stand which supports the steerable sheath assembly in a way that allows a user to rotate the handle and tubular sheath portion while maintaining the hemostasis valve in a rotationally fixed position. The support structure may include a rotation lock mechanism to selectively limit rotation of the handle and tubular sheath, as well as a proximal platform for supporting any catheter tools positioned within the steerable sheath assembly.

[0084] Figs. 1-7 illustrate various aspects of a steerable sheath assembly 100. Figs. 1 -4 illustrate various side views of the steerable sheath assembly 100, Fig. 5 illustrates a proximal end view of the steerable sheath assembly 100, Fig. 6 illustrates a distal end view of the steerable sheath assembly 100, and Fig. 7 illustrates a perspective view of the steerable sheath assembly 100. These figures are discussed concurrently below.

[0085] In some examples, the steerable sheath assembly 100 comprises a handle assembly 102, a sheath 106, and a hemostasis valve 104. The hemostasis valve 104 is connected to a proximal end of the handle assembly 102, and the sheath 106 is connected to a distal end of the handle assembly 102. Each of these components have a passage therethrough such that, when connected, form a single main catheter tool passage between a proximal end and a distal end of the steerable sheath assembly 100. This allows a user to advance one or more of catheter tools through the steerable sheath assembly 100 during a procedure.

[0086] The handle assembly 102 may comprise a mechanism that moves a distal region and / or tip of the sheath 106 out of axial alignment with at least some of a proximal region of the sheath 106. The handle assembly 102 may include a hand actuator exposed from or at least partially outside of the housing of the handle assembly 102. The hand actuator is moved by a user’s thumb and / or fingers and causes the distal reg ion / tip of the sheath 106 to move out of axial alignment. In some examples, the hand actuator is a rotatable knob 108 as seen in the figures. However, other adjustment mechanisms may also be used, such as levers, slider members, thumbwheels, triggers, or any other part that moves relative to the other components of the handle assembly 102.

[0087] In some examples, the handle assembly 102 moves or bends the distal portion / tip of the sheath 106 out of axial alignment towards at least one direction (e.g., between a generally axially oriented position and a bent position towards a first direction). In some examples, the handle assembly 102 moves or bends the distal portion / tip of the sheath 106 out of axial alignment towards at least a first direct or towards a second direction (e.g., between a generally axially oriented position and a bent first position towards a first direction or between the generally axially oriented position and a bent second position towards a second direction). The first direction and the second direction may be opposite to each other or in non-opposite positions (e.g., perpendicular to each other). While the examples discussed in this disclosure describe the ability to bend in only a first direction and a second direction, it is also contemplated that the handle assembly 102 may be configured to bend the distal portion / tip of the sheath 106 in three, four, or more directions.

[0088] As seen best in Fig. 7, the handle assembly 102 is connected to the hemostasis valve 104 such that the two components are unable to axially or proximally / distally pull away or separate from each other while also allowing the two components to rotate relative to each other. This may allow the user to rotate the handle assembly 102 during use so that the distal portion / tip of the sheath 106 may be bent in a desired direction. While rotating the handle assembly 102, the hemostasis valve 104 may remain rotationally stationary relative to the user and any catheter tools within the steerable sheath assembly 100, which may maintain a better hemostasis seal and allow any catheter tools within the steerable sheath assembly 100 to remain rotationally stationary while the handle assembly 102 is rotated.

[0089] As seen in Fig. 5, the hemostasis valve 104 may include a proximal opening 112 within an outer housing 114 of the hemostasis valve 104 that opens into an interior of the hemostasis valve 104. Any catheter tools may be advanced through the proximal opening 112 and through the main passage of the steerable sheath assembly 100.

[0090] In some examples, the hemostasis valve 104 may include a connection or passage into the inner chamber 114A or cavity of the outer housing 114. In one example, the connection / passage is a luer fitting 110 that opens into an inner cavity of the hemostasis valve 104. The luer fitting 110 may allow for air removal, injection of saline, heparin, or similar fluids. Typically, the inner chamber 114A is initially filled with fluid to help remove air within. During a procedure, placing a catheter tool through the hemostasis valve 104 may introduce air bubbles within the inner chamber 114A. These bubbles may rise to the top of the inner chamber 114A, allowing the physician to aspirate them out of the hemostasis valve 104 (e.g., via a syringe attached to the luer fitting 110). In some examples, the outer housing 114 may be composed of a clear, translucent, or semi-translucent material that allows the physician to see into the inner chamber 114A and therefore see any bubbles that have been introduced and should be removed.

[0091] Fig. 8 illustrates a cross-sectional view of the handle assembly 102 and the hemostasis valve 104. Fig. 9 illustrates a cross-sectional perspective view of the hemostasis valve 104, Fig. 10 illustrates an exploded view of the hemostasis valve 104, Figs. 11 and 12 illustrate cross sectional views of seals of the hemostasis valve 104, and Fig. 13 illustrates a perspective view of seals of the hemostasis valve 104. These figures are discussed concurrently below.

[0092] As previously discussed, the handle assembly 102 is connected to and rotates relative to the hemostasis valve 104 via a connection mechanism that also maintains the components in a longitudinally fixed position (i.e. , they are unable to axially / longitudinally pull away from each other during normal use). A variety of different mechanisms are possible. In one example, the hemostasis valve 104 may include a tube 116 with a circular and circumferentially enlarged portion 116A (Fig. 8) extending from the outer housing 114 and that is positioned within a space or groove 134 within the handle assembly 102. The space or groove 134 may have a relatively larger size to accommodate the enlarged portion of the tube 116 but may have an opening out of the handle assembly 102 smaller than or of a smaller diameter than the circumferentially enlarged portion 116A to prevent the enlarged portion 116A from moving axially out ofthe handle assembly 102 while allowing rotation of the handle assembly 102 and groove 134 relative to the enlarged portion 116A. The tube 116 may include a passage that is part of the catheter tool passage of the steerable sheath assembly 100 and through which catheter tools pass through during use. The tube 116 may also include a passage extending therethrough.

[0093] In some examples, a proximal end of the sheath 106 may be located within with hemostasis valve 104. Hence, the handle assembly 102 and the hemostasis valve 104 may rotate relative to each other without pulling away from each other. Additionally, the proximal end of the sheath 106 (e.g., distal ends of the reinforcement sleeve 130 and outer tubular layer 132) may rotate within and relative to the hemostasis valve 104. This may help seal and prevent leakage from the catheter tool passage, especially near the rotational interface of the connection mechanism.

[0094] In some examples, the reinforcement sleeve 130 is composed of a metal, such as stainless steel which interfaces with an O-ring 131 of the hemostasis valve 104. The metal composition of the reinforcement sleeve 130 helps create a tight seal relative to the O-ring 131 to prevent leakage, particularly as the reinforcement sleeve 130 rotates relative to the O-ring 131. The remaining components within the hemostasis valve 104 may remain stationary relative to each other (i.e., they do not rotate with the handle assembly 102).

[0095] While the reinforcement sleeve 130 is shown as having a uniform diameter within the hemostasis valve 104, in alternative examples a proximal end of the sheath 106 may increase in diameter larger than the passage through the valve housing 114 to further prevent the sheath 106 from pulling out of the hemostasis valve 104.

[0096] In other examples, the tube 116 may instead be located on the handle assembly 102 and the space or groove 134 may be located in the hemostasis valve 104. Similar variations are also possible, such as both the handle assembly 102 and the hemostasis valve 104 each having a space or groove 134, and a separate tube 116 with enlargements on each end and positioned into each of the space or grooves 134. Othermechanisms between the handle assembly 102 and hemostasis valve 104 may include mating ridges and grooves, attraction via magnetic force such as with two or more magnets or a magnet and a ferrous metal, or similar mechanisms.

[0097] The hemostasis valve 104 may include one or more seals or valve members that help allow catheter tools to pass through the hemostasis valve 104 while preventing or minimizing blood leakage, hemostasis pressure loss, and air infiltration. Note, the terms seal and valve member are used interchangeably for some components, and may mean components and may mean a structure that allows passage of a catheter tool and either partially or fully closes around or against the catheter tool and partially or fully closes when a catheter tool is removed. A variety of different shaped seals or valve members may be used.

[0098] In one specific example, the hemostasis valve 104 may include a plurality of seals or valve members. As seen best in Figs. 9-13, the hemostasis valve 104 may include a circumferential valve member 118, a cross-slit valve member 120, and a dome valve member 124 that are all axially aligned with each other and within the passage through the hemostasis valve 104 to partially or fully close off the passage.

[0099] In the present example, the circumferential valve member 118 is located most proximally, the cross-slit valve member 120 is positioned distally of the circumferential valve member 118, and the dome valve member 124 is positioned distally of the crossslit valve member 120. However, these valve members may alternatively be positioned in any order. The circumferential valve member 118, the cross-slit valve member 120, and the dome valve member 124 may all be composed of resilient materials, such as silicone, rubber, or flexible polymers.

[0100] The circumferential valve member 118 may have a shape that creates a seal around one or more catheter tools to minimize blood leakage and air ingress. In other words, the circumferential valve member 118 may only seal the main passage when a catheter tool is positioned through the hemostasis valve 104. In some examples, the circumferential valve member 118 may have a circular or ring shape body 118B with acircular flap 118A extending radially inward from the circular or ring shape body 118B of the circumferential valve member 118. In some examples, the circular flap 118A may be angled distally as seen in the figures, and in other examples, the circular flap 118A may be angled proximally or may be vertically aligned (i.e. , straight / planar) relative to the other portions of the circumferential valve member 118.

[0101] The cross-slit valve member 120 may have a shape that helps create closure force for the cross-slit valve member 120 under positive hemostasis pressure from the patient’s vascular system when no catheter tools are positioned therethrough. In some examples, this may be achieved with a cross-slit valve member comprising a valve body having distally facing ridges 120A in a pattern of a cross or X where each ridge has a slit along its length, thereby creating cross slits. Both sides of each ridge on the distal surface of the cross-slit valve member 120 (the left in the figures) may include angled surfaces 120B extending away from each side of each ridge 120A, as seen bests in Figs. 11 and 13, which may allow any pressure from the distal side of the passage to help force the slits closed or against any catheter tools positioned through the slits. In some examples, the angled surfaces 120B may form planes with an angle less than a side of the ridge 120A and greater than an angle perpendicular to the side of the ridge 120A.

[0102] The dome valve member 124 may have a shape that helps prevent air ingress into the main passage of the steerable sheath assembly 100 and hold a vacuum distally of the dome valve member 124. In some examples, this may be achieved with a valve body having a concave or dome shape 124A that extends proximally relative to radially outer portions of the valve’s body. The dome shape 124A may have an opening, aperture, slit, or other shaped passage through it for allowing catheter tools to pass through. The concave or dome shape 124A may help maintain a closed configuration when no catheter tools are positioned therethrough.

[0103] A retaining support 122 may be included to help maintain the position of one or more of the circumferential valve member 118, the cross-slit valve member 120, and / or the dome valve member 124. In some examples seen in the figures, the retaining support122 may have a generally tubular shape with recessed areas 122A that accommodate or form a mating arrangement with the dome valve member 124 (e.g., on a distal portion of the retaining support 122) and with the cross-slit valve member 120 (e.g., on a proximal portion of the retaining support 122). Recesses, grooves, ridges, and similar shapes may be included to help retain these components. The retaining support 122 may be composed of a rigid material, such as a polymer or metal.

[0104] In some examples, positive pressure may be created and maintained within an inner chamber 114A of the outer housing 114 of the hemostasis valve 104. In one example, the luer fitting 110 creates a passage into the inner chamber 114A and may be further connected to a fluid supply (e.g., saline) that may be charged or injected therein. The hemostasis valve 104 may also be structured such that this positive fluid pressure occurs on a distal side of the dome valve member 124 (e.g., on its inner domed surface) while an outer side of the dome valve member 124, cross-slit valve member 120, and circumferential valve member 118 are relatively more isolated from this pressure. When injecting through the luer fitting 110, the dome valve member 124 may open relatively easily as the pressure is applied to its concave surface, opening its slit / aperture. When aspirating via the luer fitting 110, the pressure may be higher on its convex side, closing the slit / aperture. The cross-slit valve member 120 acts in an opposite manner.

[0105] During use, air bubbles may be located within the inner chamber 114A, particularly from introducing one or more catheter tools through the hemostasis valve 104. In some examples, these air bubbles may be visualized within the inner chamber 114A if the outer housing 114 is composed of a clear, translucent, or semi-translucent material. The air bubbles may be aspirated out of the inner chamber 114A via a port, such as the luer fitting 110 which opens into the inner chamber 114A. For example, a syringe may be attached to the luer fitting 110 for aspirating. The hemostasis valve 104 may be typically oriented so that the luer fitting 110 is positioned on a top of the hemostasis valve 104 and therefore any air bubbles rise to a location near the luer fitting 110. As discussed later, the steerable sheath assembly 100 may be supported during use by a support structure 160 that, in some examples, may be angled upwards in a proximal direction. Insuch cases, positioning the luer fitting 110 near a proximal portion of the inner chamber 114A may allow any air bubbles to rise near the luer fitting 110 so they can be aspirated out of the inner chamber 114A.

[0106] In the present example, the dome valve member 124 may be positioned distally against a first retaining member 126. The first retaining member 126 is axial ly / longitudinally spaced apart proximally from a second retaining member 128 by one or more of a lateral arm 127, which allows a radial gap or gaps between the first retaining member 126 and second retaining member 128. In one example, only a single lateral arm 127 may be included for separating the first retaining member 126 and second retaining member 128. This lateral arm 127 may further be located at a side as seen in the figures or bottom orientation so that any air bubbles that are introduced rise to a top of the inner chamber 114A (i.e., the lateral arm 127 is positioned so as to not interfere with air bubbles rising towards luer fitting 110). Alternatively, a plurality of arms may also be possible (e.g., 2, 3, 4, 5, 6, or more arms). Alternatively, the first retaining member 126 and the second retaining member 128 may be a single tubular member with a plurality of apertures or openings into its inner passage.

[0107] Returning to the handle assembly 102, the handle assembly 102 may have an outer housing. In some examples, this housing has an elongated shape with a rectangular cross section across its longitudinal axis, as seen in the figures. However, other shapes are also possible, such as an elongated shape with a round cross section, or a cubical shape.

[0108] In some examples, the housing of the handle assembly 102 may comprise several housing components that connect to each other (e.g., two or more components). In the present example shown in the figures (e.g., Figs. 1-8), the housing of the handle assembly 102 may comprise three main housing components: a bottom housing component 138, a middle housing component 140, and a top housing component 136.

[0109] The bottom housing component 138 may generally have an axially elongated shape (e.g., with a rectangular cross section perpendicular to the longitudinal axis) andmay have spaces and supports within it to accommodate the various components of the handle assembly 102, as discussed later in this specification.

[0110] The middle housing component 140 connects on top of the bottom housing component 138 and has a similar axially elongated shape (e.g., with a rectangular cross section perpendicular to the longitudinal axis) and may have spaces and supports within it to accommodate the various components of the handle assembly 102, as discussed later in this specification.

[0111] The top housing component 136 connects on top of the middle housing component 140 and has a similar axially elongated shape (e.g., with a rectangular cross section perpendicular to the longitudinal axis) and may have spaces and supports within it to accommodate the various components of the handle assembly 102 as discussed later in this specification, as well as may act as a top cover to the middle housing component 140.

[0112] Figs. 14-18 illustrate various views of the handle assembly 102 with various components hidden to better view how the internal components function. Specifically, Fig. 14 illustrates the handle assembly 102 with the bottom housing component 138 removed / hidden, Figs. 15 and 16 illustrates the handle assembly 102 with the bottom housing component 138 and middle housing component 140 removed / hidden, Fig. 17 illustrates a magnified view of only a wire clamp assembly 150, and Fig. 18 illustrates the handle assembly 102 with the top housing component 136 removed / hidden. These figures are discussed concurrently below.

[0113] As previously discussed, the handle assembly 102 deflects or bends a distal end of the sheath 106 when the user actuates a deflection mechanism within the handle assembly 102. A variety of different mechanisms may be used to cause this deflection and one such example is illustrated in the figures.

[0114] Generally, the deflection mechanism of the handle assembly 102 longitudinally moves one or more wires that are connected to the sheath 106 (e.g., two wires).Typically, the distal portion of the sheath 106 creates resistance and counter force to bending. In other words, as the distal portion of the sheath 106 is bent, it tends to create force to return to its axial configuration. The handle assembly 102 may comprise a deflection mechanism that prevents the distal portion of the sheath 106 from returning to its axial position and rotating the knob 108 by itself and without explicit user adjustment. In some examples, this may be achieved with a worm drive mechanism that allows rotational movement of the knob 108 to cause deflection of the distal portion of the sheath 106 but prevents “back drive” or force from the distal portion of the sheath 106 from causing rotation of the knob 108. In other words, the knob 108 generally stays in any rotation position despite counter force from the distal end of the sheath 106.

[0115] As best seen in Fig. 14, the handle assembly 102 may comprise one example of the worm drive mechanism. The knob 108 may be connected to an axle 144 which includes a worm 144A (e.g., a helical gear thread extending along the axle 144). The axle 144 is supported within the handle assembly 102 (e.g., by the bottom housing component 138) such that the worm 144A is engaged with a worm gear 146A (e.g., a gear with teeth extending radially from a rotational center or axle) that is adjacent and perpendicularly arranged relative to it. Hence, as the knob 108 rotates either clockwise or counterclockwise to rotate the axle 144 and worm 144A, the worm gear 146A also rotates. When force is generated at the distal portion of the sheath 106 from deflection, the worm gear 146A is unable to “back drive” the worm 144A. In that respect, the worm 144A may drive the worm gear 146A but the worm gear 146A may not drive the worm 144A. Again, without the worm 144A and worm gear 146A, tension from the distal portion of the sheath 106 would otherwise cause the knob 108 to rotate without the physician holding it.

[0116] The worm gear 146A may be connected to spur gear 146B (e.g., by a common axle supported within the bottom housing component 138), allowing the spur gear 146B to rotate with the worm gear 146A. Opposite sides of the spur gear 146B may be engaged with a first rack gear 148A and a second gear rack 148B. As the spur gear 146B rotates in a first direction, it longitudinally moves the first rack gear 148A distally and the secondgear rack 148B proximally, and as the spur gear 146B rates in a second direction, it longitudinally moves the first rack gear 148A proximally and the second gear rack 148B distally. Hence, the first rack gear 148A and second gear rack 148B are simultaneously movable in opposite longitudinal directions within the handle assembly 102.

[0117] As best seen in Figs. 15, 16, and 17, the first rack gear 148A and second gear rack 148B are each connected to a wire clamp assembly 150. Each wire clamp assembly 150 may include two clamp members 150A that may be adjusted relative to each other (e.g., via screws) to engage / pinch / clamp a wire 142 placed therebetween. The two clamp members 150A may be connected to one of the first rack gear 148A and second gear rack 148B via a fin 150B extending from the body of the wire clamp assembly 150. Alternatively, the two clamp members 150A may be directly fixed to one of the first rack gear 148A and second gear rack 148B. Hence, as the first rack gear 148A and second gear rack 148B longitudinally move, they also longitudinally move each wire clamp assembly 150.

[0118] Each wire clamp assembly 150 may be restricted from moving in any location / position / direction other than along a longitudinal portion along a length of the handle assembly 102. In some examples and as best seen in Figs. 14 and 18, an elongated recess 140A may be included on the left and right side of the handle assembly 102. Each elongated recess 140A may be sized to fit the wire clamp assembly 150 and prevent it from movement other than along the length of each elongated recess 140A. In the present example, each 140A may be formed by the middle housing component 140. However, other housing components, internal or external, may also form each of the elongated recess 140A.

[0119] Each elongated recess 140A may also include a groove 140C through which the fin 150B may extend through to connect to either the first rack gear 148A or second gear rack 148B. In that respect, the first rack gear 148A or second gear rack 148B may be on opposite upper / lower sides of portions of the middle housing component 140 relative to each wire clamp assembly 150.

[0120] An angled recess OB may also be connected or continued from each elongated recess 140A and angled towards the sheath 106 which may extend between proximal and distal ends of the handle assembly 102. As seen best in Fig. 18, each wire 142 may be clamped at wire clamp assembly 150, may be positioned along the elongated recess 140A, along angled recess OB, and into or along the sheath 106.

[0121] The sheath 106 may comprise an elongated tubular structure with at least one main passage 135 between its proximal portion (seen in Figs. 18 and 19) and its distal portion (seen in Fig. 20). The elongated tubular structure may have locations along which each wire 142 may extend. In some examples, the elongated tubular structure may at least include an outer tubular layer 132 and an inner tubular layer 133 positioned within the outer layer 132, between which one or more wire passages are created for each wire 142. Alternatively, the elongated tubular structure may include a single layer with passages molded or formed within the single layer between the proximal portion and the distal portion. Alternatively, each wire 142 may be positioned on an outer surface of the outer tubular layer 132.

[0122] In some examples, the sheath 106 may include a reinforcement sleeve 130 at a proximal portion of the of the sheath 106 to provide added rigidity, particularly within the handle assembly 102. In some examples, the reinforcement sleeve 130 may be composed of a metal, such as stainless steel. Since a proximal portion of the reinforcement sleeve 130 is positioned within the hemostasis valve 104, the metal or stainless steel may allow for tight tolerances / sealing between the reinforcement sleeve 130 and the O-ring 131 , especially when the reinforcement sleeve 130 rotates relative to the O-ring 131 and the remaining components of the hemostasis valve 104.

[0123] In the present example and as best seen in Figs. 18 and 19, the reinforcement sleeve 130 may be positioned over the outer tubular layer 132 at least within the handle assembly 102 and optionally extending distally out of the handle assembly 102. In examples where the steerable sheath assembly 100 is used with the support structure 160, the rotation lock mechanism (e.g., screw 164A) may engage against the outer distalportion of this reinforcement sleeve 130 without crushing the main passage 135. The reinforcement sleeve 130 may also help reinforce the interface at which a wire 142 passes into the wire passages of the sheath 106. For example and as seen in Fig. 19, the reinforcement sleeve 130 may include a wire aperture 130A for each wire 142 (e.g., two wire apertures 130A) that are each positioned over openings into the wires passages created between the outer tubular layer 132 and the inner tubular layer 133. This may help protect the outer tubular layer 132 from movement of each wire 142.

[0124] The reinforcement sleeve 130 may also include one or a plurality of apertures 130B (Fig. 19) that allow portions of the handle assembly 102 to engage or retain the reinforcement sleeve 130 and therefore the sheath 106. Additionally, a plurality of smaller apertures 130C may be included to help adhesive bond the reinforcement sleeve 130 with portions of the handle assembly 102.

[0125] Each wire 142 may connect to a location at the distal portion of the sheath 106, such as at a distal end or near the distal end of the sheath 106. In the present example, a wire anchor ring 154 is located at or near the distal end of the sheath 106 and each of the 142 (e.g., 2 wires) may be fixed to the wire anchor ring 154. The wire anchor ring 154 may be composed of a rigid material, such as metal (e.g., a radiopaque metal), or a rigid polymer. The distal ends of each of the wire 142 may be tied, welded, adhered or otherwise attached to the wire anchor ring 154. In one example, a single wire may be used, where each free end of the wire 142 is clamped at a wire clamp assembly 150 and the remaining length of the wire 142 passes distally within a first wire passage, through one or more openings of the wire anchor ring 154, and then proximally within a second wire passage.

[0126] The distal portion of the sheath 106 may include a region that increases flexibility and bendability. In the example of Fig. 20, distal region 156 may have a higher amount of flexibility than proximal portions of the sheath 106. The distal region 156 may also include structural features that help prevent kinking or other undesirable positions, such as a structural coil 156A that is connected to the outer tubular layer 132, the innertubular layer 133, or other layers of the sheath 106. In one example, the structural coil 156A is composed of Nitinol wire.

[0127] In the example of Fig. 20, a first wire 142 and a second wire 142 are positioned on opposite longitudinal sides of the sheath 106 (e.g., about 180 degrees from each other) and are both connected to the wire anchor ring 154. Hence, as the knob 108 of the handle assembly 102 is rotated, one wire 142 may move proximally while the other wire 142 moves distally, causing the distal region 156 to bend. Depending on the direction the knob 108 is rotated, the distal region 156 may bend or curve in directions generally opposite to each other (e.g. , 180 degrees) as seen by the dashed lines in Fig. 20 and first direction 151 and opposite direction 153. The amount the knob 108 is rotated may increase the bend or curvature angle of the distal region 156.

[0128] Some or all of the wires 142 may have a generally round diameter, an oval diameter, a flat / rectangular diameter, or a curved / arc diameter (e.g., to match the curvature of the sheath 106). The some or all of the wires 142 may be composed of material such as a metal or polymer.

[0129] As previously discussed, a physician may rotate the handle assembly 102 so that the distal region 156 of the sheath 106 may be bent or curved in a desired direction. For example, the sheath 106 may be rotated and then bent to a desired amount so that the distal opening of the at least one main passage 135 opens toward a desired target location.

[0130] This rotation of the handle assembly 102 may be achieved by holding the handle assembly 102 while the hemostasis valve 104 remains rotationally stationary on a surgical table or while catheter tools passing through the hemostasis valve 104 remain rotationally stationary on a surgical table. However, the steerable sheath assembly 100 may also include a stand or support structure that better allows a physician to rotate the handle assembly 102 without disturbing the hemostasis valve 104 and any catheter tools passing through.

[0131] Figs. 21 and 22 illustrate side views of a support structure 160 for a steerable sheath assembly 100 which supports the steerable sheath assembly 100 in a way to allow rotation of the handle assembly 102 while preventing the hemostasis valve 104 from rotating. The support structure 160 may also be referred to as a support stand or support platform.

[0132] The support structure 160 may include a first mounting area 164 that supports the steerable sheath assembly 100 distal of the handle assembly 102, and a second mounting area 166 that supports the steerable sheath assembly 100 proximal of the handle assembly 102. The first mounting area 164 and second mounting area 166 create a gap 172 between which the handle assembly 102 is unobstructed from rotation. Additionally, the first mounting area 164 and second mounting area 166 are located to position the handle assembly 102 at an elevation in which a physician’s fingers / hand may fit underneath during use (e.g., within an inclusive range of 2 inches to 12 inches).

[0133] In some examples, the first mounting area 164 may be a structure with either a “U” or fork shaped structure (e.g., two upwardly extending fingers 164B in Fig. 22 that create a gap therebetween) or a structure with an aperture therethrough. The gap or aperture may be sized to accept the proximal portion of the sheath 106 near a distal end of the handle assembly 102.

[0134] In some examples, the second mounting area 166 may support a location directly between the handle assembly 102 and hemostasis valve 104, as seen in Figs. 21 and 22, or may support or engage portions of the hemostasis valve 104, such as a bottom surface and / or side surfaces. The second mounting area 166 may be a structure with either a “U” or fork shaped structure (e.g., two upwardly extending fingers that create a gap therebetween), a structure with an aperture therethrough, a lower surface with sidewalls, or similar variations and combinations of the same. The gap or aperture may be sized to accept the proximal portion of the sheath 106 near a distal end of the handle assembly 102.

[0135] In some examples, the support structure 160 may include a rotational lock that may be selectively activated by the physician to prevent rotation of the handle assembly 102. This may help prevent accidental rotation of the steerable sheath assembly 100 during a procedure. In one example see in Figs. 21 and 22, the rotational lock may comprise a screw 164A that screws into and / or clamps a portion of the sheath 106 within or near the first mounting area 164. In other examples, the rotational lock may be positioned at other locations on the support structure 160, such as at or near the second mounting area 166, or between the first mounting area 164 and second mounting area 166.

[0136] The support structure 160 may further include a catheter tool support platform 170 that is positioned proximal of the second mounting area 166 so that any catheter tools extending proximally from the hemostasis valve 104 may be supported during a procedure without undesirable bending. Fig. 22 illustrates the support structure 160 supporting the steerable sheath assembly 100 and a catheter tool system 180 with a catheter hub 182 which may have hemostasis valves 182A on each of its proximal entry ports (e.g., 2) that are similar to the seal arrangements of hemostasis valve 104. The various proximal components of the catheter tool system 180 may be positioned through the hemostasis valve 104. In some examples, the catheter tool support platform 170 is an elongated and generally flat surface. In other examples, the catheter tool support platform 170 may include ridges, walls, varying widths, clamps, and other features to help support and retain any catheter tools in place during a procedure.

[0137] The first mounting area 164, the second mounting area 166, and the catheter tool support platform 170 may all be generally aligned with each other such that the steerable sheath assembly 100 and catheter tool system 180 may remain relatively straight on the support structure 160 during use. The first mounting area 164, the second mounting area 166, and the catheter tool support platform 170 may be angled relative a bottom support 162 or to a surface on which the support structure 160 is placed. In one example, the first mounting area 164 is located lower (i.e., closer to the bottom support 162 or surface) than the second mounting area 166 and catheter tool support platform170 so that the steerable sheath assembly 100 is angled downward during use. This angle may prevent air bubbles from being introduced into the patient by trapping them at the top of the hemostasis valve 104 as this is the highest location of the system. The angle also facilitates a smooth transition into the patients’ femoral vein or other access vessel. In some examples, the first mounting area 164, the second mounting area 166, and the catheter tool support platform 170 are angled downward within an inclusive range of 5 degrees to 45 degrees.

[0138] In other examples, the first mounting area 164, the second mounting area 166, and the catheter tool support platform 170 may be generally parallel to the bottom support 162 or to a surface on which the support structure 160 is placed. In other examples, the first mounting area 164, the second mounting area 166, and the catheter tool support platform 170 may be generally inclined relative to the bottom support 162 or to a surface on which the support structure 160 is placed (e.g., the steerable sheath assembly 100 is angled upwards in a distal direction).

[0139] In some examples, the support structure 160 may include a plurality of legs 168 or similar supports that connect to the catheter tool support platform 170 and the bottom support 162, maintaining the first mounting area 164, the second mounting area 166, and the catheter tool support platform 170 at a fixed angle. In other examples, the support structure 160 may include a structure that allows portions of the first mounting area 164, the second mounting area 166, and the catheter tool support platform 170 to increase and decrease in height (e.g., folding legs). Hence, a physician may begin with the support structure 160 in a relatively flat configuration initially while the steerable sheath assembly 100 and catheter tool system 180 are being loaded or placed on the support structure 160, and then the support structure 160 may be elevated and angled to achieve a more desirable “working” configuration that better allows rotation of the handle assembly 102.

[0140] In some procedures, it may be desirable to have a second proximal steerable sheath assembly that is positioned within the first steerable sheath assembly 100. In other procedures, it may be desirable to be able to selectively rotate the catheter toolsystem 180. In that regard, Fig. 31 illustrates one alternative example of the support structure 160’ that may include a first gap 172 at distal end of the support structure 160’ and a second gap 172’ proximal of the first gap 172. The second gap 172’ may include a third mounting area 164’ and fourth mounting area 166’, as well as a rotation lock mechanism (screw 164A’). The catheter tool support platform 170 may be located proximal of the second gap 172’ and also optionally in between the two gaps 172, 172’. Hence, two separate components such as a first steerable sheath assembly 100 and a second steerable sheath assembly 100’ may be mounted on the support structure 160’, further allowing the handle assembly 102’ to also rotate relative to the hemostasis valve 104’.

[0141] Figures 23-26 illustrate the distal ends of various catheter tools that may be used with the steerable sheath assembly 100. While these catheter tools may work desirably with the steerable sheath assembly 100, it should be understood that a variety of other tools may also be used with the steerable sheath assembly 100. These catheter tools, and an example use with the steerable sheath assembly 100 are described in Figs. 27-30.

[0142] Fig. 23 illustrates a distal end of a tissue cutting catheter 184 with a hook or “J” shaped wire loop 184A in its unconstrained configuration and a plurality (e.g., two) electrodes 184B located on the wire loop 184A. The electrodes 184B may conduct radiofrequency current which, when in proximity or contact with tissue, may cut the tissue. This tool may be particularly useful for cutting chordae and tissue (e.g., leaflet tissue) within a heart.

[0143] Fig. 24 illustrates a distal end distal end of a snare catheter 186 having a wire loop 186A that forms a generally saddle-shape when unconstrained and which may be pulled into the body of the snare catheter 186 to close around an object. This tool may be particularly useful for grabbing a heart valve therapy device, such as a leaflet clip, during a heart valve therapy removal procedure.

[0144] Fig. 25 illustrates a distal end of a cutting loop catheter 188, having a wire loop 188A with a plurality of electrodes 188B. The wire loop 188A may form a generally saddle shape when unconstrained and the electrodes may conduct radiofrequency current for use in cutting tissue. This tool may be particularly useful for placing around a heart valve therapy device such as a leaflet clip and then cutting leaflet tissue to free the heart valve therapy device.

[0145] Fig. 26 illustrates a distal end of a capture basket catheter 190, having a mesh basket 190A with an opening that may be sinched closed. This tool may be particularly useful for capturing a heart valve therapy device such as a leaflet clip that has been removed from valve leaflets.

[0146] The example devices of Figs. 23-26 may be used, in one example, with the catheter hub 182 shown in Fig. 22 in various combinations.

[0147] Figs. 27-30 illustrate an example procedure with the steerable sheath assembly 100 and the catheter tool system 180 with catheters shown in Figs. 23-26 for removing a valve leaflet clip 50 that is attached to mitral valve leaflets 14 of a mitral valve.

[0148] Turning to Fig. 27, initially a left atrium 10 of a heart is accessed via a transeptal procedure. A distal end of the sheath 106 is then advanced across the septum of the heart and into the left atrium above the mitral valve leaflets 14. The tissue cutting catheter 184 may be advanced through the steerable sheath assembly 100 and out the distal end of the sheath 106 such that its wire loop 184A is positioned in the left ventricle 12 of the heart, below the mitral valve leaflets 14. Since an access point from the septal wall to the opening between mitral valve leaflets 14 may be relatively abrupt (e.g., 50-120 degrees), it can be desirable to bend or curve the distal opening of the main passage 135 of the sheath 106 towards the mitral valve leaflets 14. This may be accomplished by rotationally orienting the sheath 106 in a position that the sheath 106 may bend by rotating the handle assembly 102. Next, the knob 108 may be rotated to cause the distal region 156 to bend to a position seen in Fig. 27. The tissue cutting catheter 184 may be activated (e.g., RF current) to help cut the chordae and other tissue that may surround the valve leaflet clip50, thereby allowing the valve leaflet clip 50 to be better accessed. Additionally, other tissue, such as the mitral valve leaflets 14 may also be cut as necessary.

[0149] Turning to Fig. 28, the tissue cutting catheter 184 may be withdrawn from the steerable sheath assembly 100 and the snare catheter 186 and cutting loop catheter 188 may be advanced through the steerable sheath assembly 100. The wire loop 186A of the snare catheter 186 may first be advanced between the mitral valve leaflets 14 and into the left ventricle 12 so that the wire loop 186A is positioned around and then tightened around the valve leaflet clip 50.

[0150] Turning to Fig. 29, the snare catheter 186 may be moved distally away from the mitral valve leaflets 14 to help expose the tissue of the mitral valve leaflets 14 closest to the valve leaflet clip 50. The wire loop 188A of the cutting loop catheter 188 may be moved proximally and immediately above the valve leaflet clip 50, and then the plurality of electrodes 188B of the wire loop 188A may be activated (e.g., with RF current) to cut the tissue of the mitral valve leaflets 14 and thereby release the valve leaflet clip 50.

[0151] Turning to Fig. 29, the cutting loop catheter 188 may be removed from the steerable sheath assembly 100 and replaced with the capture basket catheter 190. The wire loop 186A of the snare catheter 186 may proximally retract the valve leaflet clip 50 into the left atrium 10 and then the mesh basket 190A may be placed over the valve leaflet clip 50 and at least partially cinched closed. The valve leaflet clip 50, the snare catheter 186, and the capture basket catheter 190 may be removed from the heart. In some examples, patients may have two valve leaflet clips 50 and therefore the main passage 135 of the sheath 106 may be large enough in diameter to fully remove a first valve leaflet clip 50 and left in place to allow a new removal device(s) to be introduced to remove the second valve leaflet clip 50. The steerable sheath assembly 100 may also be removed or left in place so that any further procedure may be performed, such as replacement of the mitral valve leaflets 14 with an artificial valve and closing the opening created through the heart septum.

Claims

What is claimed is:1 . A steerable sheath assembly, comprising: a sheath comprising an elongated tubular structure; a handle assembly connected to a proximal portion of the sheath and having a bending mechanism that selectively curves a distal portion of the sheath; a hemostasis valve comprising one or more valve members; a catheter tool passage extending from a proximal end of the hemostasis valve, through the handle assembly, and to a distal end of the sheath; and, a rotatable connection mechanism connecting the hemostasis valve with the handle assembly allowing the handle mechanism and the sheath to rotate relative to the hemostasis valve, while maintaining a longitudinally-fixed connection between the hemostasis valve and the handle assembly.

2. The steerable sheath assembly of claim 1 , wherein the rotatable connection mechanism comprises a tube with a circumferentially enlarged region and a space to accommodate the circumferentially enlarged region.

3. The steerable sheath assembly of claim 2, wherein the tube is fixed to the hemostasis valve and wherein the space is located within the handle assembly.

4. The steerable sheath assembly of claim 3, wherein a proximal end of the sheath is located within the hemostasis valve.

5. The steerable sheath assembly of claim 4, wherein the proximal end of the sheath comprises a first retaining member having a diameter larger than a distal opening of a housing of the hemostasis valve.

6. The steerable sheath assembly of claim 1 , wherein the hemostasis valve further comprises:a circumferential valve member within a valve cavity, having a ring shape body with a circular flap extending radially inward from the ring shape body; a cross-slit valve member within the valve cavity and located distally of the circumferential valve member; the cross-slit valve member having crossing slits forming a cross shape; and, a dome valve member within the valve cavity and located distally of the cross-slit valve; the dome valve member having a concave or dome shape extending proximally within the valve cavity and having a passage through the dome shape.

7. The steerable sheath assembly of claim 6, wherein the hemostasis valve further comprises a passage into the valve cavity where the connection and cavity are in communication with a proximal side of the dome valve member.

8. The steerable sheath assembly of claim 1 , wherein the handle assembly comprises a housing, a hand actuator accessible from outside of the housing, a spur gear coupled to the hand actuator, a first rack gear engaged with the spur gear and longitudinally movable within the housing, a second gear rack engaged with the spur gear on a side opposite of the first rack gear and longitudinally movable within the housing, a first clamp connected to the first gear rack, a second clamp connected to the second gear rack; a first wire connected to the first clamp and to a distal portion of the sheath; and, a second wire connected to the second clamp and to the distal portion of the sheath.

9. The steerable sheath assembly of claim 1 , further comprising a support structure comprising a bottom support, a first mounting area connected to the bottom support and shaped to engage the steerable sheath assembly, a second mounting area connected to the bottom support and shaped to engage the steerable sheath assembly, and a gap between the first mounting area and the second mounting area, where the handle assembly fits substantially within the gap and is rotatable within the gap.

10. A hemostasis valve, comprising:a valve housing having a first opening on a proximal side of the valve housing and a second opening on a distal side of the valve housing; the valve housing forming a valve cavity; a circumferential valve member within the valve cavity, having a ring shape body with a circular flap extending radially inward from the ring shape body; a cross-slit valve member within the valve cavity and located distally of the circumferential valve member; the cross-slit valve member having crossing slits forming a cross shape; and, a dome valve member within the valve cavity and located distally of the cross-slit valve; the dome valve member having a concave or dome shape extending proximally within the valve cavity and having a passage through the dome shape.11 . The hemostasis valve of claim 10, further comprising a third opening into the valve cavity and in communication with a proximal side of the dome valve member.

12. The hemostasis valve of claim 10, wherein the cross-slit valve comprises a plurality of distally facing ridges.

13. The hemostasis valve of claim 12, further comprising angled surfaces adjacent to and on each side of the distally facing ridges.

14. The hemostasis valve of claim 10, further comprising a first retaining member located adjacent to the dome valve member.

15. The hemostasis valve of claim 14, further comprising a second retaining member longitudinally and distally spaced apart from the first retaining member by one or more lateral arms.

16. The hemostasis valve of claim 15, further comprising a handle assembly connected to a proximal portion of the sheath and having a bending mechanism that selectively curves a distal portion of the sheath.

17. The hemostasis valve of claim 16, wherein the bending mechanism comprises a worm and a worm gear configured to prevent back drive of a hand actuator.

18. A steerable sheath assembly, comprising: a sheath comprising an elongated tubular structure; a handle assembly connected to a proximal portion of the sheath and comprising a housing and a deflection mechanism; the deflection mechanism at least partially located within the handle assembly and comprising a hand actuator accessible from outside of the housing, a worm coupled to the hand actuator, and a worm gear coupled to the worm; a first wire connected to the deflection mechanism and to a distal portion of the sheath; a second wire connected to the deflection mechanism and to the distal portion of the sheath; and, a catheter tool passage extending through the handle assembly and to a distal end of the sheath.

19. The steerable sheath assembly of claim 18, wherein the hand actuator is a knob, lever, slider member, thumbwheel, or trigger.

20. The steerable sheath assembly of claim 19, wherein the deflection mechanism further comprises a spur gear coupled to the worm gear.

21. The steerable sheath assembly of claim 20, wherein the deflection mechanism further comprises a first rack gear engaged with the spur gear and longitudinally movable within the housing, a second gear rack engaged with the spur gear on a side opposite ofthe first rack gear and longitudinally movable within the housing, a first clamp connected to the first gear rack, and a second clamp connected to the second gear rack.

22. The steerable sheath assembly of claim 21 , further comprising a first elongated recess which the first clamp is positioned in and longitudinally slidable in; and a second elongated recess which the second clamp is positioned in and longitudinally slidable in.

23. The steerable sheath assembly of claim 22, further comprising a first angled recess connected to the first elongated recess and opening at the sheath, where the first wire is located within the first elongated recess and the first angled recess; and a second angled recess connected to the second elongated recess and opening at the sheath, where the second wire is located within the second elongated recess and the second angled recess.

24. The steerable sheath assembly of claim 22, wherein the first wire and the second wire extend respectively extend through the first angled recess and the second angled recess, then between an outer tubular layer and an inner tubular layer of the sheath.

25. The steerable sheath assembly of claim 18, wherein the first wire and the second wire have a round diameter, an oval diameter, a flat / rectangular diameter, or a curved / arc diameter.

26. A steerable sheath system, comprising: a steerable sheath assembly comprising a sheath comprising an elongated tubular structure, a handle assembly connected to a proximal portion of the sheath and having a bending mechanism that selectively curves a distal portion of the sheath; a catheter tool passage extending through the handle assembly and to a distal end of the sheath; and, a support structure comprising a bottom support, a first mounting area connected to the bottom support and shaped to engage the steerable sheath assembly, a second mounting area connected to the bottom support and shaped to engage the steerablesheath assembly, and a gap between the first mounting area and the second mounting area, where the handle assembly fits substantially within the gap and is rotatable within the gap.

27. The steerable sheath system of claim 26, further comprising a catheter tool support platform comprising an elongated surface located proximal of the second mounting area.

28. The steerable sheath system of claim 27, further comprising a rotatable connection mechanism connecting a hemostasis valve with the handle assembly, allowing the handle mechanism and the sheath to rotate relative to the hemostasis valve, while maintaining a longitudinally-fixed connection between the hemostasis valve and the handle assembly.

29. The steerable sheath system of claim 28, wherein the first mounting area is positioned to engage a first location distal of the handle assembly and wherein the second mounting area is positioned to engage a second location proximal of the handle assembly.

30. The steerable sheath system of claim 29, wherein either the first mounting area or the second mounting area further comprises a rotation lock mechanism configured to selectively prevent the handle assembly from rotating when engaged.

31. The steerable sheath system of claim 29, wherein the first mounting area is positioned closer to the bottom support than the second mounting area.

32. The steerable sheath system of claim 29, wherein the first mounting area is positioned at about a same height as the second mounting area.

33. The steerable sheath system of claim 29, wherein the first mounting area is positioned further from the bottom support than the second mounting area.

34. The steerable sheath system of claim 29, wherein the first mounting area and the second mounting area are movable between an elevated position and a non-elevated position.

35. A support structure for a first steerable sheath system, comprising: a bottom support; a first mounting area connected to the bottom support and shaped to engage a first steerable sheath assembly; a second mounting area connected to the bottom support and shaped to engage the first steerable sheath assembly; and, a first longitudinal gap between the first mounting area and the second mounting area, where a handle assembly of the first steerable sheath system fits substantially within the first longitudinal gap and is rotatable within the first longitudinal gap.

36. The support structure of claim 35, further comprising a first catheter tool support platform comprising an elongated surface located proximal of the second mounting area.

37. The support structure of claim 36, wherein either the first mounting area or the second mounting area further comprises a rotation lock mechanism configured to selectively prevent a handle assembly of the first steerable catheter system from rotating when engaged.

38. The support structure of claim 35, wherein the first mounting area is positioned closer to the bottom support than the second mounting area.

39. The support structure of claim 35, further comprising: a third mounting area connected to the bottom support and shaped to engage a second steerable sheath assembly; a fourth mounting area connected to the bottom support and shaped to engage the second steerable sheath assembly; and,a second longitudinal gap between the first mounting area and the second mounting area, where a handle assembly of the second steerable sheath system fits substantially within the second longitudinal gap and is rotatable within the second longitudinal gap.

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