Patent Description:
The present invention relates generally to cardiac catheters, and more particularly, to a transseptal insertion device which is suitable for facilitating quick and safe transseptal puncture and insertion of a catheter through a cardiac septum to provide access to the left atrium in implementation of a left atrial intervention.

Cardiac catheterization is a medical procedure in which a long thin tube or catheter is inserted through an artery or vein into specific areas of the heart for diagnostic or therapeutic purposes. More specifically, cardiac chambers, vessels and valves may be catheterized.

Cardiac catheterization may be used in procedures such as coronary angiography and left ventricular angiography. Coronary angiography facilitates visualization of the coronary vessels and finding of potential blockages by taking X-ray images of a patient who has received a dye (contrast material) injection into a catheter previously injected in an artery. Left ventricular angiography enables examination of the left-sided heart chambers and the function of the left sided valves of the heart, and may be combined with coronary angiography. Cardiac catheterization can also be used to measure pressures throughout the four chambers of the heart and evaluate pressure differences across the major heart valves. In further applications, cardiac catheterization can be used to estimate the cardiac output, or volume of blood pumped by the heart per minute.

Some medical procedures may require catheterization into the left atrium of the heart. For this purpose, to avoid having to place a catheter in the aorta, access to the left atrium is generally achieved by accessing the right atrium, puncturing the interatrial septum between the left and right atria of the heart, and threading the catheter through the septum and into the left atrium. Transseptal puncture must be carried out with extreme precision, as accidental puncturing of surrounding tissue may cause very serious damage to the heart. In addition, transseptal puncture may require complicated instruments which are not helpful in guaranteeing the precision of the puncture.

The use of devices available today present many challenges for doctors attempting to puncture the interatrial septum and perform cardiac catheterization. Locating the interatrial septum, properly placing the distal end of the puncturing device at the desired location of the septum, safely puncturing the interatrial septum, avoiding accidental punctures, and tracking and maneuvering the catheter post-puncture, are among the many challenges facing those performing cardiac catheterization today.

<CIT> discloses a transseptal puncture system comprising an insertion shaft having a deflection mechanism and a distal balloon.

Accordingly, there is an established need for a transseptal insertion device or shaft that is suitable for facilitating quick and safe transseptal puncturing to provide access to the left atrium in implementation of a left atrial intervention, and a handle that efficiently controls the movements of the transseptal insertion device.

These advantages and others are achieved, for example, by a transseptal puncture system which is suitable for facilitating precise and safe transseptal puncture of a cardiac interatrial septum of a patient.

The transseptal puncture system includes a handle and a transseptal insertion shaft coupled to the handle. The handle includes two twister thread half shells having internal threads, a twister bolt inner placed inside and locked into the two twister thread half shells, a nut inner placed inside the two twister thread half shells, a nut outer placed inside the two twister thread half shells, a first pull wire coupled to the nut inner and a second pull wire coupled to the nut outer, a grip overmold over-molded onto the two twister thread half shells. The nut inner engages with the twister bolt inner. The internal threads of the twister thread half shells engage with the nut outer. The nut inner and nut outer rotate in opposite directions to each other when the two twister thread half shells are turned in a direction. The transseptal insertion shaft includes a sheath that defines one or more lumens therein and has a distal end that is positioned toward the patient when the transseptal insertion shaft is in use, and at least one positioning balloon connected to the distal end of the sheath. Said at least one positioning balloon, when inflated and the transseptal insertion shaft is in use, overhangs and extends past the distal end of the sheath. The sheath includes one or more hypotubes connected to the at least one positioning balloon to inflate the positioning balloon. A proximal end of the transseptal insertion shaft is coupled to the handle. A distal end of the first pull wire is attached to a first side of the transseptal insertion shaft and a distal end of the second pull wire is attached to a second side of the transseptal insertion shaft.

The nut inner pulls the first pull wire when the two twister thread half shells are rotated in a first direction, and the distal end of the transseptal insertion shaft bends toward the first side of the transseptal insertion shaft while the first pull wire is pulled. The nut outer pulls the second pull wire when the two twister thread half shells are rotated in a second direction, and the distal end of the transseptal insertion shaft bends toward the second side of the transseptal insertion shaft while the second pull wire is pulled. The handle further includes a clamp assembly for clamping the first and second pull wires, and a coupler that couples the first pull wire to the nut inner and the second pull wire to the nut outer. The handle may further include a handle inner that is slid onto ends of the nut inner and nut outer. The twister bolt inner and the handle inner may have cavities in which the transseptal insertion shaft is placed. The handle may further include an introducer assembly formed at a proximal end of the handle and one or more tubes connected to the introducer assembly to supply inflation gas to the one or more hypotubes of the sheath to inflate the positioning balloon. The introducer assembly may include a shaft connector that holds the proximal end of the transseptal insertion shaft, and an introducer assembly connector that adheres to the shaft connector, the transseptal insertion shaft and the handle inner. The one or more tubes may include an additional tube that is connected to the one or more hypotubes to remove gas from the positioning balloon to deflate the positioning balloon.

The introducer assembly may include at least one flush port connected to the one or more lumens of the sheath to flush fluid or materials taken from the distal end of the sheath. The at least one flush port may be connected to a flush tube through which suction is applied to flush the fluid or materials.

The transseptal insertion shaft may further include a puncture member movably positioned within the one or more lumens and a puncture member balloon located on the distal end of the puncture member. The puncture member has a distal end that is positioned toward the cardiac interatrial septum of the patient. The distal end of the puncture member is capable of precisely puncturing the cardiac interatrial septum. The puncture member may include at least one puncture member tube connected to the puncture member balloon to inflate and deflate the puncture member balloon. The one or more tubes may include an additional tube connected to the introducer assembly to supply gas to the puncture member tube to inflate the puncture member balloon.

Also disclosed is a handle for controlling movements of a transseptal insertion shaft which is suitable for facilitating precise and safe transseptal puncture of a cardiac interatrial septum of a patient. The handle includes two twister thread half shells having internal threads, a twister bolt inner placed inside and locked into the two twister thread half shells, a nut inner placed inside the two twister thread half shells, a nut outer placed inside the two twister thread half shells, a first pull wire connected to a first side of the transseptal insertion shaft and coupled to the nut inner, a second pull wire connected to a second side of the transseptal insertion shaft and coupled to the nut outer, and a grip overmold over-molded onto the two twister thread half shells. The nut inner engages with the twister bolt inner. The internal threads of the twister thread half shells engage with the nut outer. The nut inner and nut outer rotate in opposite directions to each other when the two twister thread half shells are turned in a direction. A proximal end of the transseptal insertion shaft is coupled to the handle.

The preferred embodiments described herein and illustrated by the drawings hereinafter be to illustrate and not to limit the invention, where like designations denote like elements.

The following detailed description is merely exemplary in nature and is not intended to limit the described embodiments or the application and uses of the described embodiments. As used herein, the word "exemplary" or "illustrative" means "serving as an example, instance, or illustration. " Any implementation described herein as "exemplary or "illustrative" is not necessarily to be construed as preferred or advantageous over other implementations. All of the implementations described below are exemplary implementations provided to enable persons skilled in the art to make or use the embodiments of the disclosure and are not intended to limit the scope of the disclosure, which is defined by the claims. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the inventive concepts defined in the appended claims.

With reference to <FIG>, shown is an embodiment of transseptal insertion device or catheter <NUM>. Shown is the distal end of transseptal insertion device <NUM>, i.e., the end of transseptal insertion device <NUM> with opening through which dilator, catheter, and needle may extend, e.g., to puncture interatrial cardiac septum. As shown in <FIG>, transseptal insertion device <NUM> includes outer sheath or balloon shaft <NUM> and one or more balloons <NUM> located at distal tip <NUM> of transseptal insertion device <NUM>. Sheath <NUM> may contain and define a center lumen <NUM>. Sheath <NUM> may be fabricated from various materials, including, e.g., polymers, including thermoplastics elastomers (TPEs) such as PEBA (e.g., Pebax®), nylons, thermoplastic polyurethanes (TPUs) such as Pellathane®, similar materials and combinations thereof. Sheath <NUM> may be referred to as catheter shaft and used in cardiac catheterizations. After puncture, sheath <NUM> may be inserted through septum into left atrium. Alternatively, sheath <NUM> may contain a separate catheter that is inserted through septum post puncture. Transseptal insertion device <NUM> also includes dilator <NUM>, positioned in center lumen <NUM>, as shown in <FIG>. The one or more balloons <NUM> are preferably sealed, air-tight and water-tight, on both its ends to sheath <NUM>.

With continuing reference to <FIG>, in view shown, overhanging one or more balloons <NUM> are uninflated. Although cross-section of balloons <NUM> shown on top and bottom of distal tip <NUM>, balloons <NUM> preferably extend around circumference of distal tip or end <NUM> of transseptal insertion device <NUM>. Overhanging one or more balloons <NUM> are of form such that balloons <NUM> overhang or extend from distal tip <NUM> of sheath <NUM> when inflated.

In <FIG>, dilator <NUM> is shown positioned within and partially extending out of sheath <NUM>, past distal tip <NUM> of device <NUM>. Overhanging one or more balloons <NUM> are uninflated and dilator <NUM> extends past balloons <NUM>. It is noted that the relative sizes of sheath <NUM> and dilator <NUM> shown are for illustrative purposes as the diameter of dilator <NUM> may be relatively larger or smaller than shown in relation to the diameter of sheath <NUM>, although dilator <NUM> necessarily has a smaller diameter than sheath <NUM>. Although dilator <NUM> is shown to have a pointed end, dilator <NUM> may have a rounded or relatively flat end. Embodiments, as described herein, are designed and intended to puncture septum without use of a needle or other sharp instrument.

With reference now to <FIG>, dilator <NUM> is shown positioned within center lumen <NUM> of sheath <NUM>. Tip of dilator <NUM> is positioned within distal tip <NUM> of transseptal insertion device <NUM> sub-planar to end of transseptal insertion device <NUM>. The position shown is position dilator <NUM> may be in immediately prior to inflation of one or more balloons <NUM>. It is noted that the relative sizes of catheter/sheath <NUM> and dilator <NUM> shown are for illustrative purposes as the diameter of dilator <NUM> may be relatively larger or smaller than shown in relation to the diameter of sheath <NUM>. Ordinarily, dilator <NUM> has smaller diameter or gauge then catheter/sheath <NUM>, although fit of dilator <NUM> in catheter/sheath <NUM> is preferably snug enough so that dilator <NUM> does not move (laterally or axially) relative to position or "wobble" within transseptal insertion device <NUM>. Dilator <NUM> necessarily has a smaller diameter than sheath <NUM>. In embodiments, sheath <NUM> material may be sufficiently malleable to enable larger diameter dilators <NUM>, and other larger diameter devices, to be passed through sheath <NUM>. In such embodiments, sheath <NUM> will stretch to accommodate the larger diameter dilator <NUM> or other device.

With reference to <FIG>, shown is a side perspective view of an embodiment of transseptal insertion device or catheter <NUM>. Shown is the distal end of transseptal insertion device <NUM>, i.e., the end of transseptal insertion device <NUM> with opening through which dilator, catheter, and needle may extend, e.g., to puncture interatrial cardiac septum. As shown in <FIG>, transseptal insertion device <NUM> includes outer sheath or catheter shaft <NUM> and one or more balloons <NUM> located at distal tip <NUM> of transseptal insertion device <NUM>. Sheath <NUM> may contain lumen shaft <NUM> that defines center lumen <NUM>. Sheath <NUM> may be fabricated from various materials, including, e.g., polymers, including thermoplastics elastomers (TPEs) such as PEBA (e.g., Pebax®), nylons, thermoplastic polyurethanes (TPUs) such as Pellathane®, similar materials and combinations thereof. Sheath <NUM> may be referred to as catheter shaft and used in cardiac catheterizations. After puncture, sheath <NUM> may be inserted through septum into left atrium. Alternatively, sheath <NUM> may contain multiple lumen shafts that define multiple lumens separately. Transseptal insertion device <NUM> also includes dilator <NUM>, positioned in center lumen <NUM>. The one or more balloons <NUM> are preferably sealed, air-tight and water-tight, on both their ends to sheath <NUM>. Transseptal insertion device <NUM> includes hypotube <NUM> for inflation or deflation of one or more balloons <NUM>. Hypotube <NUM> may be contained in sheath or catheter shaft <NUM>. Transseptal insertion device <NUM> may further include a port (not shown) connected to hypotube <NUM> to supply gas or fluid to inflate one or more balloons <NUM>, or to remove gas or fluid from one or more balloons <NUM> to deflate balloons <NUM>. Balloons <NUM> may be fully inflated or deflated, or may be inflated or deflated as much as desired. With reference to <FIG>, shown is a front, cross-sectional view of distal end <NUM> of the embodiment of transseptal insertion device <NUM> that shows cross-sectional views of sheath <NUM>, center lumen <NUM>, and hypotube <NUM>.

In the embodiment shown in <FIG>, transseptal insertion device <NUM> may include ultrasound chips or transducers <NUM> for ultrasound imaging or visualizing (see <FIG>2D). The transseptal sheath <NUM> or balloon <NUM> may house (inside or on) an ultrasound chip or transducer which may be used to guide the insertion procedure. Ultrasound chip or transducer emits and receives ultrasound energy, that may be detected by known ultrasound visualization devices, to create an image of the cardiac chambers (e.g., the right atrium, fossa, interatrial septum, left atrium, atrial appendage, mitral valve, ventricle, etc.). Ultrasound chips and transducers are transducers that convert ultrasound waves to electrical signals and/or vice versa. Those that both transmit and receive may also be called ultrasound transceivers; many ultrasound sensors besides being sensors are indeed transceivers because they can both sense and transmit. Such imaging will allow the operator(s) of transseptal insertion device <NUM> to visualize the cardiac chambers and the determine the location of the distal end or tip <NUM> of transseptal insertion device <NUM>, enabling more precise operation of transseptal insertion device <NUM>. Such a ultrasound chips or transducers used may be similar to ultrasound chip or transducer described in <CIT>, or any other ultrasound transducer known to those of ordinary skill in the art that may be fabricated on scale small enough to be deployed on or in sheath <NUM> or balloon <NUM>.

With reference to <FIG>, shown are embodiments of transseptal insertion device <NUM> with ultrasound imaging or visualizing capability. Balloon <NUM> shown includes one or more ultrasound chips or transducers <NUM> deployed in or on balloon <NUM>. Ultrasounds chips or transducers <NUM> may be ultrasound transceivers that both emit and receive waves, convert the ultrasound waves to electrical signals, transmit the electrical signals, e.g., through a wire that runs via sheath <NUM>. Ultrasounds chips or transducers <NUM> may be connected via WiFi or other wireless connection, to an external imaging device that produces images from the received signals (both still and video images).

Ultrasound chips or transducers <NUM> may be affixed to interior or exterior surface of balloon <NUM>. Ultrasound chips or transducers <NUM> may be arranged in a line, disc, or cross-shape. Ultrasound chips or transducers <NUM> may be arranged to be forward facing (e.g., on distal end of balloon facing towards interatrial septum), as shown in <FIG>, or in a different direction/orientation, such as sideways and forward facing (e.g., facing towards interatrial septum and facing perpendicular to the distal or front end), as shown in <FIG>. Indeed, orientation of ultrasound chips or transducers <NUM> may depend on whether balloon <NUM> is inflated or not. When balloon <NUM> is fully inflated, as shown in <FIG>, ultrasound transducer <NUM> may be forward facing (or forward and perpendicularly facing as shown in <FIG>). However, when balloon <NUM> is deflated, ultrasound transducer <NUM> may be folded flat and positioned on side of distal tip <NUM> of sheath <NUM>. Hence, when balloon <NUM> is deflated, ultrasound chip or transducer <NUM> may be side-facing. During inflation ultrasound transducer <NUM> orientation will change as balloon <NUM> inflates (moving from side-facing orientation to forward facing orientation with the ultrasound transducer <NUM> shown in <FIG>). Accordingly, operator(s) of transseptal insertion device <NUM> may vary the inflation of balloon <NUM> to achieve different orientations of ultrasound transducer <NUM> for different imaging views.

Ultrasound chip or transducers <NUM> may emit and/or receive/detect ultrasound waves that may be reflect off of surfaces and structures, e.g., within atrium, and then read by imaging system (not shown), e.g., connected to ultrasound chips or transducers <NUM> via wire or cable extending through, e.g., lumen <NUM> in sheath <NUM>. In this manner, ultrasound chips or transducers <NUM> may enable visualization of the interatrial septum and the left atrial structures.

It is also noted that ultrasound chips or transducers <NUM> may be deployed on distal tip <NUM> of sheath <NUM> (or elsewhere on or in sheath <NUM>). Ultrasound chips or transducers <NUM> may be installed or configured to be forward facing (facing towards distal end of sheath <NUM>). Alternatively, ultrasound chips or transducers <NUM> may be flipped to be rear facing (facing towards proximal end of sheath <NUM>). Varying orientations of ultrasound chips or transducers <NUM> may be implemented.

With reference to <FIG>, shown is transseptal insertion device <NUM> including multiple balloons <NUM>, which surround center lumen shaft <NUM> that defines center lumen <NUM>, and sheath or catheter shaft <NUM> that includes center lumen shaft <NUM> and hypotubes <NUM> connected to multiple balloons <NUM>. <FIG> is a side view of sheath or catheter shaft <NUM>, and <FIG> is a front cross-sectional view of sheath or catheter shaft <NUM>. Balloons <NUM> are in various shapes such as round, cylindrical, spherical, tear drop shaped or pear shaped, and are in various lengths. Balloons <NUM> may be with or without overhang over shaft. Balloons <NUM> are positioned around distal tip or end <NUM>, and may extend around circumference of distal tip or end <NUM>. Multiple balloons <NUM> are connected to one or more hypotubes <NUM>, and inflated or deflated via hypotubes <NUM> that are contained in sheath or catheter shaft <NUM>. Each of balloons <NUM> may be connected to corresponding hypotube <NUM> to independently control the inflation and deflation of balloons <NUM>. Alternatively, balloons <NUM> may share one or more hypotubes <NUM>. Inflation fluid or gas may flow through hypotubes <NUM> to inflate or deflate balloons <NUM>. Outer covering <NUM> may cover the multiple balloons <NUM>.

In between balloons <NUM>, there are one or more ultrasound chips or transducers <NUM> that provide ultrasound imaging or visualizing capability. For illustrative purposes, <FIG> shows ultrasound chips or transducers <NUM> disposed between balloons <NUM>, but ultrasound chips or transducers <NUM> may be deployed in or on balloons <NUM>. Ultrasound chips or transducers <NUM> may be affixed to interior or exterior surface of balloon <NUM>. Ultrasounds chips or transducers <NUM> may be ultrasound transceivers that both emit and receive waves, convert the ultrasound waves to electrical signals, transmit the electrical signals, e.g., through wire <NUM> that runs inside sheath or catheter shaft <NUM>. However, ultrasound chips or transducers <NUM> may be connected wirelessly via WiFi or other wireless connection, to an external imaging device that produces images from the received signals (both still and video images).

Ultrasound chips or transducers <NUM> may be designed in the shape of the balloons <NUM>. The balloons <NUM> may be round, cylindrical, spherical, tear drop shaped or pear shaped with overhang or without overhang. Ultrasound chips or transducers <NUM> may have shapes corresponding to the shapes of balloons <NUM>. Alternatively, one or more ultrasound chips or transducers <NUM> may be deployed in a shape corresponding to the shapes of balloons <NUM>. Depending on the shapes of balloons <NUM>, ultrasound chips or transducers <NUM> may be side facing, front facing or back facing. Ultrasound chips or transducers <NUM> may be arranged in a line, disc, or cross-shape. Ultrasound chips or transducers <NUM> may be arranged to be forward facing (e.g., on distal end of balloon facing towards interatrial septum), or in a different direction/orientation, such as sideways and forward facing (e.g., facing towards interatrial septum and facing perpendicular to the distal or front end).

Orientations of ultrasound chips or transducers <NUM> may depend on whether balloons <NUM> are inflated or not. When balloons <NUM> are fully inflated, ultrasound chips or transducers <NUM> may be forward facing. However, when balloons <NUM> are deflated, ultrasound chips or transducer <NUM> may be folded flat and positioned on side of distal tip <NUM> of center lumen <NUM>. Hence, when balloons <NUM> are deflated, ultrasound chips or transducer <NUM> may be side-facing. During inflation, orientation of ultrasound chips or transducers <NUM> may change as balloons <NUM> inflate (moving from side-facing orientation to forward facing orientation). Accordingly, operator(s) of transseptal insertion device <NUM> may vary the inflation of balloons <NUM> to achieve different orientations of ultrasound chips or transducers <NUM> for different imaging views.

With reference now to <FIG>, shown is an embodiment of transseptal insertion device <NUM> with radiofrequency (RF) energy capability. Transseptal insertion device <NUM> shown includes sheath <NUM>, overhanging one or more balloons <NUM>, and dilator <NUM>. Dilator <NUM> may include cap or crown <NUM>, on distal end as shown, with RF energy capability or capable of delivering RF energy. Alternatively, cap or crown may include or be an RF electrode. Dilator <NUM> may be connected, e.g., on proximate end (not shown) to a radiofrequency energy source (not shown) at, e.g., external hub, that provides RF energy to cap or crown <NUM>. The RF energy may be delivered through dilator <NUM>. So equipped with cap or crown <NUM>, dilator <NUM> may tent interaxial septum and create puncture of interaxial septum through delivery of RF energy. In this embodiment, the use of a sharp needle may be avoided. The dilator with cap or crown on distal end with RF energy capability or capable of delivering RF energy may be used for transseptal insertion devices <NUM> and <NUM> shown in <FIG> and 3A-3B.

With reference to <FIG>, shown is transseptal insertion device <NUM> including drive assembly <NUM>, which is coupled to dilator <NUM>, and knob <NUM> coupled to drive assembly <NUM> to cause dilator <NUM> to traverse along an axial direction of sheath or catheter shaft <NUM>. Dilator <NUM> may move backwards or forwards along the axial direction of sheath <NUM> while knob <NUM> is rotated. The drive assembly <NUM> may include nut assembly to drive the dilator <NUM>. Dilator <NUM> may be with or without RF energy capability.

With reference now to <FIG>, shown is distal end of an embodiment of transseptal insertion device <NUM> in which overhanging balloons <NUM> is inflated by supplying gas or fluid into balloon <NUM> through hypotube (not shown). Dilator <NUM> is shown positioned within center lumen <NUM> of sheath <NUM> with tip of dilator <NUM> positioned at distal tip <NUM> of transseptal insertion device <NUM> and sub-planar to overhanging balloon <NUM>. The plane that is referred to here is the plane perpendicular to the axis of transseptal insertion device <NUM> and dilator <NUM>, formed by the end of overhanging balloon <NUM>. Hence, dilator <NUM> remains sub-planar to overhanging balloon <NUM> until operator intends balloon <NUM> to be deflated and dilator <NUM> to tent and puncture interatrial septum <NUM>. As noted above, balloon <NUM> preferably extends completely around circumference of tip <NUM> of transseptal insertion device <NUM>. Accordingly, <FIG> only illustrates cross-section of inflated balloon <NUM>.

With reference now to <FIG>, shown is a front, cross-sectional view of distal end an embodiment of transseptal insertion device <NUM> in which overhanging balloon <NUM> is inflated. As shown, inflated overhanging balloon <NUM> preferably extends around entire circumference of sheath <NUM> (and, therefore, device <NUM>). Shown situated within lumen <NUM> of sheath <NUM> is tip of dilator <NUM>. Tip of dilator <NUM> is positioned within tip <NUM> of transseptal insertion device <NUM>, as it would be prior to being extended past tip <NUM> and puncturing an interatrial cardiac septum.

With reference now to <FIG>, shown is distal end of an embodiment of transseptal insertion device <NUM> with dilator <NUM> advanced forward in order to tent the interatrial septum <NUM>. Dilator <NUM> is shown extending through center lumen <NUM> of sheath <NUM> and past overhanging balloon <NUM>. At this stage, balloon <NUM> may be deflated by removing gas or fluid in balloon <NUM> through hypotube. Extended as such, and pressed against interatrial septum <NUM>, dilator <NUM> tents the interatrial septum <NUM> away from transseptal insertion device <NUM>.

With reference now to <FIG>, shown is shown is distal end of an embodiment of transseptal insertion device <NUM> with dilator <NUM> advanced forward through interatrial septum <NUM>, after puncturing septal wall (e.g., through application of energy through dilator <NUM> as described herein) and transseptal wire or wire rail <NUM> extending through dilator <NUM> and into left atrium chamber <NUM>. Wire rail <NUM> may sit in a lumen <NUM> of dilator <NUM>. Dilator <NUM> may be used as a conduit to advance the wire rail <NUM> into the left atrium.

Wire rail <NUM> may act as a guide for devices to enter the left atrium through the puncture in the septal wall made by transseptal insertion device <NUM>. For example, wire rail <NUM> may guide transseptal insertion device <NUM> or other catheters in the left atrium. In this manner, catheters may be advanced safely into the left atrium over or guided by wire rail <NUM>. In an embodiment, wire rail <NUM> may be energized (e.g., to ablate or puncture the septum with energy delivered from source at proximal end of transseptal insertion device <NUM>).

With continued reference to <FIG>, dilator <NUM> preferably defines and includes an opening or lumen <NUM> extending through its tip and through which transseptal wire <NUM> extends. With dilator <NUM> extended as shown and tenting interatrial septum, septum may be punctured by energy delivered through cap or electrode at tip of dilator <NUM> and transseptal wire rail <NUM> extended through opening in tip of dilator <NUM> and through puncture made in interatrial septum by dilator <NUM> cap.

With reference to <FIG>, shown are different views of an embodiment of transseptal insertion device <NUM> with a flexible sheath <NUM> flexed or angulated at different angles. Transseptal insertion device <NUM> may be flexed or angulated depending on the anatomy of the atria using fixed angled dilators <NUM> that are inserted into lumen shaft of sheath <NUM>, causing sheath <NUM> to flex. Such fixed angled dilators <NUM> may be, e.g., any angle from <NUM>-<NUM>°. Alternatively, sheath <NUM>, lumen shaft and dilator <NUM> may be all flexible (preferably, hypotubes, needle and catheter inserted through such flexible sheath <NUM> are flexible or malleable, at least in part) and transseptal insertion device <NUM> may be flexed or angulated, thereby flexing or angulating sheath <NUM> and dilator <NUM>, using, e.g., a handle or wire (not shown) connected to tip <NUM> of device <NUM>. Handle and/or wire may also be used to turn or flex or move tip <NUM> of transseptal insertion device <NUM>, e.g., moving tip <NUM> of sheath "up" or "down" or "left" or "right" or angulating tip <NUM> relative to axis of sheath <NUM> as shown.

With reference now to <FIG>, shown is distal end of an embodiment of transseptal insertion device <NUM> with inflated overhanging balloon <NUM>. Balloon <NUM> shown is an embodiment with one or more markers <NUM>. Marker <NUM> may be, e.g., a radiopaque and/or echogenic marker <NUM>. As a radiopaque or echogenic marker, marker <NUM> will be visible on scanners used by those performing cardiac catheterizations. The markers <NUM> may be in the form of letters, such as an E or a C. Marker <NUM> enables the appropriate positioning of balloon <NUM> and sheath <NUM> in the <NUM>-dimensional space (e.g., of the atrium) using imaging to view the marker <NUM> and, therefore, the position of balloon <NUM>.

Specifically, in operation, the less posterior distal tip <NUM> is positioned, the more of the E (or C) will be shown. As operator of transseptal insertion device <NUM> turns or rotates distal tip <NUM> toward posterior of patient, less of the arms of the E will be seen. In a preferred embodiment, when only the vertical portion of the E is visible (i.e., appearing as an I) distal tip <NUM> will be rotated to its maximum posterior position.

With continuing reference to <FIG>, balloon <NUM> is shown as inflated. However, distal end of dilator <NUM> is shown extruding or extending distally from balloon <NUM>, past plane formed by distal end of inflated balloon <NUM>. According, dilator <NUM> has been moved into the tenting and puncturing position, adjacent to interaxial septum. At this stage, balloon <NUM> may be deflated or will soon be deflated, and puncture of the interaxial septum is imminent.

With reference now to <FIG>, shown is another embodiment of overhanging balloon <NUM> which may be deployed in embodiments of transseptal insertion device <NUM>. Overhanging balloon <NUM> may include ring or band <NUM> around a portion of balloon <NUM>. Ring or band <NUM> may serve as a marker, similar to markers <NUM> shown in <FIG>. Hence, ring <NUM> may be radiopaque or echogenic and may be view by scanning devices used for visualization in cardiac catheterizations (e.g., fluoroscopic imaging devices). Similar to the letter E or C, the view of the ring <NUM> changes as the distal tip <NUM> of transseptal insertion device <NUM> moves more posterior. When in a least posterior position, ring <NUM> may appear as just a line or band positioned across axis of transseptal insertion device <NUM>. When device <NUM> is rotated so that distal tip <NUM> is significantly closer to the posterior, ring <NUM> may appear as a full "flat" circle or ring. In <FIG>, distal tip <NUM> is partially rotated so that ring <NUM> is partially visible.

With reference to both <FIG>, the marker <NUM> and ring <NUM> are described and shown as located on balloon <NUM>. In embodiments, marker <NUM> and/or ring <NUM> may also be located on sheath <NUM> and/or dilator <NUM>. So located, marker <NUM> and/or ring <NUM> would operate in effectively the same manner as described above (i.e., the arms of the E would disappear as the distal end was moved more to the posterior and the ring would become more visible). Markers <NUM> and/or rings <NUM> may be placed on all of balloon <NUM>, sheath <NUM>, and dilator <NUM>, or a combination thereof.

With reference now to <FIG>, shown is distal end of an embodiment of transseptal insertion device <NUM> that includes dilator <NUM> with electrode tip. Shaft of dilator <NUM> defines and contains a center lumen <NUM>. Lumen <NUM> may be defined in the range of, but not limited to, <NUM> to <NUM> inches. <NUM> inch = <NUM>.

Dilator <NUM> may be made from a polymer material (e.g., HDPE, LDPE, PTFE, or combination thereof). Dilator shaft <NUM> shown includes a distal electrode tip <NUM>. Electrode tip <NUM> may be comprise a metallic alloy (e.g., PtIr, Au, or combination thereof). In preferred embodiments, the size and shape of electrode tip <NUM> is selected to be sufficient to generate a plasma for in vivo ablation of tissue in an applied power range of, but not limited to, <NUM>-30W. Electrical conductor <NUM> extends from electrode tip <NUM> to the proximal end (not shown) of the dilator <NUM>. Electrical conductor <NUM> may run axially through an additional lumen <NUM> defined by and contained in dilator shaft <NUM>. Electrical conductor <NUM> may contain a coil feature <NUM> to accommodate lengthening during bending or flexing of dilator <NUM>.

Attached to distal end of sheath <NUM> is contains overhanging balloon <NUM> that is connected to hypotube <NUM>. Overhanging balloon <NUM> may be made from a polymer material (e.g., PET, Nylon, Polyurethane, Polyamide, or combination thereof). Overhanging balloon <NUM> may be in the range of, but not limited to, <NUM>-<NUM> in diameter and <NUM>-<NUM> in length. Overhanging balloon <NUM> may be inflated via injection of gas or fluid through hypotube <NUM> connected to balloon <NUM>. Overhanging balloon <NUM> may be deflated by removing gas or fluid in balloon <NUM> through hypotube <NUM> connected to balloon <NUM>. During the proper functioning or operation of transseptal insertion device <NUM> for puncturing the interatrial septum, balloon <NUM> may be deflated when dilator <NUM> moves out of lumen <NUM> by removing gas or fluid from balloon <NUM>. Overhanging balloon <NUM> is of form such balloon <NUM> overhangs or extends from distal end <NUM> of sheath <NUM>. Overhang or extension <NUM> may be in the range of, but not limited to, <NUM>-<NUM>. The end of the overhang or extension <NUM> is the plane to which dilator <NUM> remains sub-planar until moving to tent and puncture the interatrial septum.

With reference now to <FIG>, shown is an embodiment of transseptal insertion device <NUM> that includes a mechanical deflection mechanism. Mechanical deflection mechanism may enable distal end of sheath <NUM> to be deflected or angulated to various angles with respect to axis of transseptal insertion device <NUM>. Mechanical deflection mechanism may include a pull wire anchor <NUM> affixed to distal end of sheath <NUM> and pull wire actuator <NUM> connected to pull wire anchor <NUM> with pull wire (not shown). Rotation of pull wire actuator <NUM>, as shown, may exert force on pull wire anchor <NUM> that deflects or angulates distal end of sheath <NUM>. Pull wire actuator <NUM> may be rotated by handle connected thereto (not shown). Deflection or angulation of distal end of sheath <NUM> may enable better intersection (e.g., more perpendicular, flush) with interaxial septum and, therefore, better puncture and insertion by transseptal insertion device <NUM>.

With reference now to <FIG>, shown are three (<NUM>) embodiments of curved dilators <NUM>, each with a different curve profile (i.e., different angle of deflection or curve). Curved dilators <NUM> may be used in embodiments of transseptal insertion device <NUM> with flexible or malleable sheath <NUM>. Such a flexible or malleable sheath <NUM> may be referred to as a steerable sheath <NUM> as it is "steered" by curved dilator <NUM> inserted in sheath <NUM>.

With reference now to <FIG>, shown is an embodiment of transseptal insertion device <NUM> with an external stabilizer <NUM>. Stabilizer <NUM> keeps proximal end of transseptal insertion device <NUM> stable while allowing movement of transseptal insertion device <NUM> towards the distal and proximal ends of device <NUM>, rotational/torqueing movement of proximal end of device <NUM>, and manipulation of dials or other controls of device <NUM>. In effect, stabilizer <NUM> substantially prevents unwanted movement of the transseptal insertion device <NUM> and, importantly, distal end of sheath <NUM>, balloon <NUM>, and dilator <NUM>.

Stabilizer <NUM> includes connecting rods or arms <NUM> that connect stabilizer <NUM> to handle <NUM> at proximal end of transseptal insertion device <NUM>. Connecting arms <NUM> are attached to stabilizer platform <NUM>. Connecting arms <NUM> preferably hold the handle <NUM> securely and tightly, while permitting desired rotational movements and control manipulation. Stabilizer platform <NUM> is moveably attached to stabilizer base <NUM> so that stabilizer platform <NUM>, and hence handle <NUM> and transseptal insertion device <NUM>, may be slid forwards and backwards along axis of transseptal insertion device <NUM> towards and away from insertion point in patient (typically femoral vein at the groin of patient). Stabilizer base <NUM> is typically secured to a flat, stable surface, such as a table, or the leg of the patient. Configured as such, stabilizer <NUM> prevents unwanted vertical, rotational, or other movement of transseptal insertion device <NUM> and its handle <NUM>, keeping transseptal insertion device <NUM> and its handle <NUM> stable while permitting precise manipulation of handle <NUM> and its controls.

With continuing reference to <FIG>, as shown, proximal end of transseptal insertion device <NUM> may include a handle <NUM> for control and manipulation of transseptal insertion device <NUM> and, particularly, dilator <NUM> and distal end of dilator <NUM>. Handle <NUM> may include a dial <NUM> that may be used to turn or deflect distal end of dilator <NUM>, effectively moving the distal end of dilator <NUM> up or down in relation to axis of transseptal insertion device <NUM> (as indicated by arrows in <FIG>). Handle <NUM> may also include dial <NUM> for extruding/extending distal end of dilator <NUM> out of sheath <NUM> and retracting dilator <NUM> back into sheath <NUM>, effectively moving dilator <NUM> along axis of transseptal insertion device <NUM> (as indicated by arrows in <FIG>). Handle <NUM> may also be rotated, as indicated by rotational arrow in <FIG>, in order to deflect or turn distal end of transseptal insertion device to left or right in relation to axis of transseptal insertion device <NUM>, increasing or decreasing dilator <NUM> angle of deflection in that direction. If dial <NUM> moves distal end of dilator <NUM> along Y axis, and transseptal insertion device <NUM> axis is considered the Z axis, so that dial <NUM> moves dilator <NUM> along Z axis rotating handle <NUM> moves distal end of transseptal insertion device <NUM> (and hence distal end of dilator <NUM>) along X axis. Handle <NUM> includes a port through which dilator <NUM> and other devices inserted into transseptal insertion device <NUM> may be inserted. Handle <NUM> may also include one or more tubes or other ports permitting connection to external hubs and external energy sources, inflation liquids or gas.

In embodiments shown herein, balloon <NUM> and dilator <NUM> may be used as energy sources in the left atrium and may be used to deliver energy to the pulmonary veins, left atrial appendage, mitral valve and the left ventricle present in the left atrium. Such embodiments may include external energy sources connected to balloon <NUM> and/or dilator <NUM> through wires or other conductors extending lumen in sheath <NUM>. Delivery of energy via balloon <NUM> or dilator <NUM> may be thermal/Cryo or radiofrequency, laser or electrical. The delivery of such energy could be through a metallic platform such as a Nitinol cage inside or outside balloon <NUM>. Transseptal insertion device <NUM> may also include an energy source external to the proximal end of the sheath and operatively connected to balloon <NUM> to deliver energy to balloon <NUM>.

With reference now to <FIG> shown is an embodiment of transseptal insertion device <NUM> enabling differential expansion of balloon <NUM>. Differential expansion of balloon <NUM> enables balloon <NUM> inflation to be adjusted based on the needs of the device operator and the conditions present in the patient's heart. For example, the size of the fossa ovalis portion of the interatrial septum may dictate the desired size of the inflated balloon <NUM> needed at the puncture site (interatrial septum if often punctured through the fossa ovalis). Fossae can vary greatly in size. The larger the fossa, the harder it will be to tent the interatrial septum with balloon <NUM>. Large fossa tend to be saggy and more difficult to manipulate. Hence, with a large fossa, a larger distal end of balloon <NUM> will make proper tenting of the interatrial septum easier. Indeed, it may be ideal to have balloon <NUM> inflated uniformly until intersecting or passing through fossa and then differentially expanding distal end <NUM> of balloon <NUM> to move fossa out of the way. In <FIG>, distal end or portion <NUM> of balloon <NUM> is smaller (less expanded) than proximal end <NUM> of balloon <NUM>.

Oppositely, the smaller the fossa, the easier it will be to tent the interatrial septum but, there will be less room to maneuver balloon <NUM> near interatrial septum. Consequently, a smaller distal end of balloon <NUM> is desired. It also may be beneficial to expand the proximal portion <NUM> more in order to help fix or secure balloon <NUM> in place. In <FIG>, distal end or portion of balloon <NUM> is larger (more expanded) than proximal end or portion of balloon <NUM>. In both <FIG>, dilator <NUM> has extruded from sheath <NUM> and past distal end of balloon <NUM>, tenting interatrial septum <NUM>, and puncture is imminent.

This differential expansion of balloon <NUM> may be achieved, e.g., by using different materials for different portions of balloon <NUM> (e.g., a more expandable material for distal end <NUM> than proximal end or portion <NUM>, or vice versa). In general, balloon <NUM> may be made of either compliant or non-compliant material, or a combination thereof. Compliant material will continue expanding as more inflating liquid or gas is added to balloon <NUM> (at least until failure). Non-compliant material will only inflate up to a set expansion or designated inflation level. Combinations of compliant and non-compliant material may be used to provide a differentially expanding balloon <NUM>. For example, distal end <NUM> may be formed from compliant material and proximal end <NUM> from non-compliant material to enable a larger distal end <NUM>. Oppositely, proximal end <NUM> may be formed from compliant material and distal end <NUM> from non-compliant material to enable a larger proximal end <NUM>. Other means for providing differential expansion of balloon <NUM> may be used, such as applying energy to different portions of balloon <NUM> to increase or decrease the compliance, and expandability, of that portion.

Balloon <NUM> may also be used to direct other equipment into these anatomical locations or be used as an angiographic or hemodynamic monitoring balloon. Differential expansion of balloon <NUM> may be utilized for proper orientation or direction of such equipment.

With reference now to <FIG>, shown is an embodiment of a malleable transseptal needle <NUM> that may be used with transseptal insertion device <NUM> with a flexible sheath or otherwise capable of multiple angulations. In embodiments, malleable transseptal needle <NUM> may be of a variety of diameters and lengths. For example, embodiments include an <NUM> gauge transseptal needle and that is available in <NUM>, <NUM>, and <NUM> lengths. In embodiments, the malleable transseptal needle <NUM> has different stiffness in a proximal segment <NUM>, distal segment <NUM>, and in a middle segment <NUM> between. For example, malleable transseptal needle <NUM> may be stiffer in the proximal segment <NUM> and distal segment <NUM> and more flexible (less stiff) in a middle segment or mid-section <NUM>. The mid-section may be the section where transseptal insertion device <NUM> and dilator <NUM> angulate. In an embodiment, malleable transseptal needle <NUM> is used and a control handle provided that enables three-dimensional movements. Malleable transseptal needle <NUM> shown is, preferably, malleable or flexible at least in part. Proximal end <NUM> of malleable transseptal needle <NUM> may be stiff (e.g., made from a stiff material, such as a metal). Mid-section or middle <NUM> of malleable transseptal needle <NUM> may be malleable or flexible (e.g., made from a flexible, malleable material, such as rubber). Accordingly, mid-section may flex or bend, enabling malleable transseptal needle <NUM> to pass through angulated or flexed sheath <NUM>.

Distal end <NUM> of malleable transseptal needle <NUM> (i.e., end that punctures interatrial cardiac septum) may be stiff with a cap or electrode at its tip for delivering energy to interatrial septum to puncture interatrial septum. In embodiments, transseptal needle is able to transmit radiofrequency energy to create a controlled septal puncture. Such a transseptal needle may or may not be malleable, but is able deliver RF energy through a cap or crown (e.g., an electrode) at its distal end tip. The needle <NUM> may be connected, e.g., on proximate end (not shown) to a radiofrequency (RF) energy source (not shown) at, e.g., external hub, that provides RF energy through needle to its distal end tip. In such an embodiment, dilator <NUM> may tent interaxial septum and RF energy capable transseptal needle may create puncture of interaxial septum through delivery of RF energy.

Embodiments may include an additional dilator which would be able to dilate the distal end of sheath <NUM>, or the entire sheath length, thereby significantly increasing the French size of the sheath <NUM>. For example, balloons deployed within sheath <NUM> may be inflated to expand sheath <NUM>. In such embodiments, transseptal insertion device <NUM> may, therefore, be used to accommodate and deliver larger devices or be able to retrieve devices once they have been extruded from sheath <NUM> and have embolized. Such balloons may be inflated through one or more hypotubes.

In embodiments, energy, typically electrical energy, may directed through transseptal insertion device <NUM> may be used to increase or decrease the French size of sheath <NUM>. In such embodiments, sheath <NUM> is fabricated from materials that are known to increase in malleability and or expand when certain energies are applied. In this manner, the French size of sheath <NUM> may be adjusted to a size deemed necessary during a given procedure. Such energy may be applied through wires or conductive material, connected to energy source external to proximal end of transseptal insertion device <NUM>, attached to or fabricated within sheath <NUM> or other components of transseptal insertion device <NUM>. Likewise, parts or portions of transseptal insertion device <NUM> may be selectively made more rigid or more malleable/soft with the application of energy. Therefore, with the application of differential energy to different parts of transseptal insertion device <NUM> at different times, transseptal insertion device <NUM> size may be adjusted to enable various devices that are ordinarily larger and bulkier than the catheter to traverse through the catheter. In embodiments, transseptal insertion device <NUM> may accommodate devices up to <NUM> Fr.

In an embodiment of transseptal insertion device <NUM>, visualization of an intrathoracic region of interest using MRI techniques may be provided. Embodiments may, for example, provide a needle system comprising a hollow needle having a distal portion and a proximal portion, said distal portion having a distal-most end sharpened for penetrating a myocardial wall. The needle may include a first conductor, an insulator/dielectric applied to cover the first conductor over the proximal portion of said needle and a second conductor applied to cover the insulator/dielectric. The method may further direct the needle system into proximity to a myocardial wall, track progress of the needle system using active MRI tracking, penetrate the myocardial wall to approach the intrathoracic region of interest, and, use the needle system as an MRI antenna to receive magnetic resonance signals from the intrathoracic region of interest.

In related embodiments, MRI antenna may be installed on distal tip <NUM> of sheath <NUM>, dilator <NUM> or on balloon <NUM>, similar to ultrasound chips or transducers <NUM> or <NUM> described above. Wires connecting such MRI antenna or other MRI components may pass through lumen in dilator <NUM> or sheath <NUM> and connect with appropriate magnetic resonance energy source on exterior of distal end of transseptal insertion device <NUM>.

With reference now to <FIG>, shown are an embodiment of transseptal insertion device <NUM> with puncture member balloon seal. With reference to <FIG>, shown are a side view, a close-in side view of the section C, and a cross-sectional view of the section D-D of the transseptal insertion device <NUM>, respectively, when the puncture member balloon <NUM> is deflated. With reference now to <FIG>, shown are a side view, a close-in side view of the section E, and a cross-sectional view of the section F-F of the transseptal insertion device <NUM>, respectively, when the puncture member balloon <NUM> is inflated.

Referring to <FIG>, the transseptal insertion device <NUM> includes a radiofrequency (RF) generator plug <NUM>, Y-connector <NUM>, and puncture member multi-lumen extension <NUM> that includes sheath <NUM> and puncture member <NUM> (see <FIG>). The RF generator plug <NUM> is connected to the puncture member multi-lumen extension <NUM> through a Y-connector <NUM>, and provides power for a RF generator (not shown) that may be positioned in the puncture member <NUM> located in the multi-lumen extension <NUM>. The puncture member <NUM> is located inside the sheath <NUM>, and has a distal end (puncture tip) <NUM> that is positioned toward the cardiac interatrial septum of the patient when the device <NUM> is in use. The puncture member balloon <NUM> is mounted on the puncture member <NUM> and is located near the distal end <NUM> of the puncture member <NUM>. The close-in side view <FIG> and the cross-sectional view <FIG> show deflated puncture member balloon <NUM>, while the close-in side view <FIG> and the cross-sectional view <FIG> show inflated puncture member balloon <NUM>.

The puncture member <NUM> includes an puncture member port <NUM> for inflating or deflating the puncture member balloon <NUM>, and a lumen <NUM> which is connected to the puncture member port <NUM> that supplies gas or fluid to the puncture member port <NUM> to inflate the puncture member balloon <NUM>. The puncture member <NUM> may include at least one RF tip <NUM> at the distal end <NUM> of the puncture member <NUM>. The RF tip <NUM> is capable of delivering RF energy. The RF generator (not shown) produces RF energy, and the RF energy is supplied to the RF tip <NUM>. The puncture member <NUM> includes a lumen <NUM> for wires that delivers RF energy to the RF tip <NUM>.

With reference to <FIG>, shown are a side view and a close-in side view of the section D of the transseptal insertion device <NUM>, respectively, when the positioning balloon <NUM> is inflated. The sheath <NUM> may have the sheath marker band <NUM>, and the puncture member balloon <NUM> may be aligned with the sheath marker band <NUM>. The sheath <NUM> includes one or more inflation ports <NUM> connected to the positioning balloons <NUM>, and at least one tube <NUM> that delivers gas or fluid to the inflation port <NUM> to inflate the positioning balloons <NUM>. The tube <NUM> may be the hypotube <NUM> (see <FIG>). The sheath <NUM> also includes one or more deflation ports <NUM> that is connected to the positioning balloons <NUM>. When the puncture member balloon <NUM> is inflated, the inflated puncture member balloon <NUM> seals the one or more deflation ports <NUM> in the sheath <NUM>, preventing leak from the positioning balloons <NUM> and permitting inflation of the positioning balloons <NUM>. The position balloons <NUM> are then inflated through the inflation port <NUM> of the sheath <NUM>. The non-compliant or semi-compliant puncture member balloon <NUM> seals off the deflation ports <NUM> of the sheath <NUM>, allowing the positioning balloons <NUM> to inflate and position the distal end <NUM> of the puncture member <NUM> to the fossa ovalis (see <FIG> for example).

With reference to <FIG>, shown are a side view and a close-in side view of the section B of transseptal insertion device <NUM>, respectively, when the puncture member <NUM> advances toward fossa ovalis. Once precisely positioned, the puncture member <NUM> is then pushed distally towards the fossa ovalis. The inflated puncture member balloon <NUM> moves away from the deflation ports <NUM>, exposing the deflation ports <NUM>. The positioning balloons <NUM> deflate through the deflation ports <NUM>. However, the positioning balloons <NUM> may be deflated through both inflation ports <NUM> and the deflation ports <NUM>.

With reference to <FIG>, shown are a close-in side view of the section E with inflated balloon, a close-in side view of section C with deflated balloon, and a cross-sectional view of the section D-D of an embodiment of transseptal insertion device <NUM>, respectively. With reference to <FIG>, shown are side views of the distal end portion of the puncture member multi-lumen extension <NUM> and a cross-sectional view of the section A-A of the distal end portion of the puncture member multi-lumen extension <NUM> of the transseptal insertion device <NUM> of the additional embodiment, respectively.

In these embodiments, the improved transseptal insertion device may utilize the puncture member balloon <NUM> for visibility, anchoring against the septum and preventing inadvertent advancement into the left atrium. In such an embodiment, the transseptal puncture member balloon <NUM> is inflated (see <FIG>) through the puncture member port <NUM>, once the puncture member is outside the shaft and is tenting the septum (i.e., the puncture member balloon is pressing against the septum, tenting the septum away from shaft end). The puncture member balloon <NUM> is <NUM> to <NUM> (distance L in <FIG>) proximal to the tip of the puncture member and prevents the puncture member from being pushed beyond the <NUM> to <NUM> into the left atrium. After successful puncture of the interatrial septum, a <NUM> (<NUM>") guidewire in the guide wire access lumen (or center lumen) <NUM> (See <FIG>) is advanced into the left atrium and the puncture member balloon <NUM> is deflated (see <FIG>) and the puncture member withdrawn back into the shaft. <NUM> inch = <NUM>.

In the embodiments, the positioning balloon <NUM> on the sheath or shaft <NUM> may have separate hypotubes for inflation and deflation. For example, the sheath <NUM> may have inflation hypotube 516a and a deflation hypotube 516b to inflate and deflate the positioning balloon <NUM>, respectively. However, the embodiment is not limited to this configuration. The positioning balloons <NUM> may be inflated and deflated through the same hypotube (for example, see <FIG>). The puncture member <NUM> has a puncture member port <NUM> to inflate and deflate the puncture member balloon <NUM>. The puncture member may have a radiofrequency tip <NUM> at a distal end of the puncture member <NUM>. For the small, medium and large curl shafts, the puncture member length is small, medium and large. The curl shaft chosen depends on the size of the atrium. For example, a small curl shaft is used for small atrium. When advanced beyond the shaft <NUM>, the puncture member <NUM> can only be advanced to a max of <NUM> to <NUM> coming to a hard stop.

In the embodiment, the positioning balloon <NUM> may be inflated through a separate hypotube, overhangs the shaft by <NUM>, and has variable dimension based on the amount of fluid or air infused or insufflated into the balloon. For small, medium and large curl shafts, the puncture member <NUM> has a conical tip with no radiofrequency or another energy source. The puncture member may have an <NUM> lumen (<NUM>") to <NUM> (<NUM>") lumen <NUM>. <NUM> inch = <NUM>.

Through this lumen, a wire which may or may not have radiofrequency energy capability may be advanced across the septum. Through this lumen a Brockenbrough needle or a radiofrequency tip needle could be advanced and used to cross the septum. In <FIG>, the wiring member <NUM> may be the wire, Brockenbrough needle, or a radiofrequency tip needle. The transseptal insertion device <NUM> includes a sheath <NUM> that defines at least one lumen <NUM> therein, one or more positioning balloons <NUM> that are connected to the distal end <NUM> of the sheath <NUM>, a puncture member <NUM> movably positioned within the at least one lumen <NUM>, and a puncture member balloon <NUM> mounted on the puncture member <NUM>. The puncture member <NUM> defines a center lumen <NUM> therein, and a wire member <NUM>, for example, is positioned inside the center lumen <NUM>.

With reference to <FIG>, shown are a side view of the distal tip <NUM> portion and a cross-sectional view of the section B-B of the distal tip <NUM> portion of the transseptal insertion device <NUM> of the disclosed invention, respectively. In the embodiments, the balloon <NUM> on the sheath <NUM> may have separate hypotubes for inflation and deflation. For example, the sheath <NUM> may have inflation hypotube 516a and a deflation hypotube 516b to inflate and deflate the balloon <NUM>, respectively. However, the embodiment is not limited to this configuration. The balloon <NUM> may be inflated and deflated through the same hypotube (for example, see <FIG> and <FIG>). The balloon <NUM> of pulmonary artery and venous balloon tipped transseptal insertion device <NUM> may be used to completely occlude the respective vessels they are introduced into. The transseptal insertion device <NUM> has a center lumen <NUM> in which a wire member or dilator <NUM> is movably disposed. The dilator <NUM> may be a wire, Brockenbrough needle, radiofrequency tip needle, pigtail catheter, or transseptal wire.

In an embodiment, the transseptal insertion device <NUM> may have additional lumens 15a, 15b for flushing and aspirating with presence of proximal and distal ports forming a loop of fluid circulation for aspiration either mechanically or using the venturi effect. However, the disclosed invention is not limited to this configuration. The catheter insertion device <NUM> may be configured to perform flushing and/or aspirating through the lumen <NUM>, or may have more than one lumen for dilator, flushing and aspirating. When the catheter insertion device <NUM> has a multiple lumens, one lumen 15a, for example, may be used for an aspiration port which may be attached to a mechanical aspiration system or an automated closed loop system capable of applying varying degrees of aspiration force, and the other lumen 15b may be used for an infusion port for infusing fluids and pharmaceutical agents either mechanically or using an infusion system with varying levels of infusion pressures. The pulmonary artery balloon tipped transseptal insertion device <NUM> may be used to infuse fluids and pharmaceutical agents through the one or more lumens. The pulmonary artery and venous transseptal insertion device <NUM> may be connected in a closed loop system whereby the optimal pressure for retrograde perfusion/flushing of the pulmonary vasculature may be performed.

In an embodiment, various types of wire members or dilators <NUM> may be separately disposed on one or more lumens. For example, one of the wire members <NUM> may be a pigtail catheter, and the pigtail catheter may be present as well either via a separate lumen 15a or 15b or in the main lumen <NUM>. The pigtail catheter may be a straight catheter with multiple pores for pharmaceutical infusion.

With reference now to <FIG>, shown is an embodiment of transseptal puncture system <NUM>, in accordance with the present claimed invention, including an improved handle <NUM> assembled with and connect to transseptal insertion device <NUM>. The transseptal insertion device <NUM> may be any transseptal insertion devices disclosed in this specification. The transseptal insertion device <NUM> may be referred to as transseptal puncture system shaft or transseptal insertion shaft. As is shown in <FIG>, distal end <NUM> of the transseptal insertion shaft <NUM> is at opposite end of improved transseptal puncture system <NUM> from handle <NUM>. Distal end <NUM> bends or flexes as handle overmold of the handle <NUM> is rotated. Handle <NUM> may also be moved towards or away from distal end <NUM> of the transseptal puncture system shaft <NUM> in order to insert or retract improved transseptal puncture system <NUM>.

With reference to <FIG>, shown are side and cross-sectional views of an embodiment of an improved handle <NUM> for an improved transseptal puncture system <NUM>, in accordance with the present claimed invention. The handle <NUM> may be used to control movements of the transseptal insertion shaft <NUM>, for example by extending the transseptal insertion shaft <NUM> shown in <FIG>, turning/flexing the distal end <NUM> of the transseptal insertion shaft <NUM> of the transseptal puncture system <NUM>, inflating puncture member balloon and positioning balloons, etc. The handle <NUM> includes two twister thread half shells <NUM>, a grip overmold <NUM>, a handle outer sleeve <NUM>, a stop cock <NUM> for controlling flow of inflation gas for inflating puncture member and positioning balloons, tubing <NUM> through which inflation gas flows, and introducer assembly <NUM>. Transseptal insertion shaft <NUM> extends out of the distal end of the handle <NUM> on which the grip overmold <NUM> is located (left side of the handle in <FIG>). Introducer assembly <NUM> includes silicon seal to tubing <NUM> which seals a connection between the transseptal insertion shaft <NUM>, and the tubing <NUM>. Grip overmold <NUM> provides grip for handle <NUM> and is used to turn or rotate twister half shells <NUM> and otherwise operate handle <NUM>. Handle outer sleeve <NUM> encases proximal end (right side of the handle in <FIG>). The tubing <NUM> may include one or more supply tubes that may supply gas to inflate one or more positioning balloons and to inflate the puncture member balloon. The tubing <NUM> may have additional tube to remove gas from the positioning balloon, deflating the one or more positioning balloons.

With reference to <FIG>, shown is a cross-section (on line A-A shown in <FIG>) of the embodiment of the handle <NUM> for the transseptal puncture system <NUM>. <FIG> shows cross-section of two twister thread half shells <NUM>. Also shown is grip overmold <NUM> and cross-section of introducer assembly <NUM> through which tubing <NUM> introduces inflation gas. As shown, handle <NUM> also includes twister bolt inner <NUM>, a nut inner <NUM>, a nut outer <NUM>, a handle inner <NUM>, a coupler <NUM>, a wire clamp assembly <NUM>, and a handle inner cover <NUM>. Nut inner <NUM> and nut outer <NUM> are each connected to one of two pull wires <NUM> and <NUM> (see <FIG>) that extend through shaft <NUM> of the transseptal puncture system <NUM> and attached to different sides of distal end of the shaft <NUM>. Nut inner <NUM> and nut outer <NUM> are rotated in different, opposite directions by turning of twister thread half shells <NUM>. Twister thread half shells <NUM> have internal threads that engage with nut outer <NUM>. Nut outer <NUM> has an alignment key that engages the nut inner <NUM> and allows nut inner <NUM> to move linearly, sliding against the nut outer <NUM>. The internal thread of the nut inner <NUM> engages with the twister bolt inner <NUM>. The twister bolt inner <NUM> is locked into the twister half shell <NUM>. Both twister half shells <NUM> and the twister bolt inner <NUM> turn together then simultaneously engaging the outer nut <NUM> and inner nut <NUM> moving in opposite directions. When twister thread half shells <NUM> are rotated in a first direction, nut inner <NUM> rotates and pulls the pull wire, to which the nut inner <NUM> is coupled by wire clamp assembly <NUM>, towards the proximal end of handle <NUM> (right side of handle <NUM> in <FIG>). This movement causes the side of the distal end of shaft <NUM>, to which nut inner <NUM> pull wire is attached, to bend or flex towards proximal end of the transseptal puncture system <NUM>. Rotating twister thread half shells <NUM> in a second direction causes the nut outer <NUM> to rotate and pull the pull wire, to which the nut outer <NUM> is coupled by wire clamp assembly <NUM>, towards the proximal end of handle <NUM> (right side of handle <NUM> in <FIG>). This movement causes the side of the distal end of shaft <NUM>, to which nut outer <NUM> pull wire is attached, to bend or flex towards proximal end of the transseptal puncture system <NUM>. Embodiments provide up to <NUM> degrees of flex or turn for distal end of shaft. When nut inner <NUM> and nut outer <NUM> so rotate, the nut inner <NUM> and the nut outer <NUM> each slides in the opposite direct along their smooth adjoining surfaces.

The puncture system shaft <NUM> of the transseptal puncture system <NUM> extends through cavity defined by and at center of twister bolt inner <NUM> and handle inner <NUM> through to proximal end (right side of <FIG>) of handle and introducer assembly <NUM>. The proximal end of the transseptal insertion shaft <NUM> is coupled to the introducer assembly <NUM>. Twister bolt inner <NUM> has external thread that engages with the nut inner <NUM>. The twister thread half shells <NUM>, nut inner <NUM>, and nut outer <NUM> rotate about the twister bolt inner <NUM>. Twister bolt inner <NUM> is also clamped between twister thread half shells <NUM>. Twister bolt inner <NUM> turns or rotates together with grip overmold <NUM>, engaging nut inner <NUM>. Coupler <NUM> couples nut inner <NUM> and nut outer <NUM> to wire clamp assembly <NUM>. Grip overmold <NUM> is over-molded onto twister half shells <NUM>.

With reference now to <FIG>, shown is a partial cross-sectional perspective side view of an embodiment of the handle <NUM> for the transseptal puncture system <NUM>. Shown are twister thread half shells <NUM>, grip overmold <NUM>, handle outer sleeve <NUM>, twister bolt inner <NUM>, nut inner <NUM>, nut outer <NUM>, and handle inner <NUM>. <FIG> more clearly shows threads of twister thread half shells <NUM> and twister bolt inner <NUM>, and their interaction with nut inner <NUM> and nut outer <NUM>.

With reference now to <FIG>, shown is perspective view of an embodiment of the handle <NUM> for the transseptal puncture system <NUM>. Shown are grip overmold <NUM>, handle outer sleeve <NUM>, stop cock <NUM>, tubing <NUM>, and introducer assembly <NUM>. Also shown is transseptal insertion shaft <NUM> of the transseptal puncture system <NUM> attached to handle <NUM> and extending out of distal end of handle <NUM>.

With reference now to <FIG>, shown is a cross-section perspective view of proximal end of an embodiment of the handle <NUM> for the transseptal puncture system <NUM>. Shown is introducer assembly <NUM> in greater detail. Tubing <NUM> is coupled to introducer assembly <NUM> with silicon seal. Proximal end of the transseptal insertion shaft <NUM> of the transseptal puncture system <NUM> extends through proximal end of the handle <NUM> to introducer assembly <NUM>. As shown, introducer assembly <NUM> defines an opening or port <NUM> allowing communication to the interior of shaft <NUM> (e.g., through which drugs, etc. can be introduced into improved transseptal puncture system). For example, drugs may be delivered through the center lumen <NUM> or additional lumen 15a or 15b (see <FIG>) from the opening defined in the introducer assembly <NUM>. Introducer assembly <NUM> includes introducer assembly connector <NUM>, shaft connector <NUM>, and assembly cover <NUM>. The shaft connector <NUM> hold the proximal end of the shaft <NUM>. Also shown are handle outer sleeve <NUM>, handle inner <NUM> and a handle inner cover <NUM>. The introducer assembly <NUM> may have a gas supply port <NUM> that connects the tubing <NUM> to an interior of the shaft <NUM> such that gas supplied from the tubing <NUM> is supplied to one of the hypotubes 516a and 516b of the sheath <NUM> of the shaft <NUM>. The tubing <NUM> may include additional tube that is configured to remove gas from the positioning balloon <NUM> through one of the hypotubes 516a and 516b of the sheath <NUM> of the shaft <NUM>.

One of the many advantages of embodiments of the improved handle <NUM> for the transseptal puncture system <NUM> is the minimal amount of adhesive that is used to assembly handle <NUM>. In embodiments, introducer assembly connector <NUM> adheres to handle inner <NUM>, shaft <NUM>, and shaft connector <NUM>. Shaft connector <NUM> adheres to shaft and assembly cover <NUM>, and assembly cover <NUM> adheres to tubing <NUM>. Substantially all of the remaining parts of embodiments of the improved handle <NUM> are connected without adhesive.

With reference now to <FIG>, shown is a cross-sectional view of various components of an embodiment of the handle <NUM> for the transseptal puncture system <NUM>. Shown are a twister thread half shell <NUM>, twister bolt inner <NUM>, nut inner <NUM>, nut outer <NUM>, and handle inner <NUM>. These components snap in place when assembled. For example, twister bolt inner <NUM> snaps into twister thread half shells <NUM>, and nut inner <NUM> and nut outer <NUM> are assembled onto twister bolt inner <NUM>. Handle inner <NUM> is slid onto proximal ends of nut inner <NUM> and nut outer <NUM>.

With reference now to <FIG>, shown is a cross-sectional view of various components of an embodiment of the handle <NUM> for the transseptal puncture system <NUM>. Shown are twister thread half shells <NUM>, handle overmold <NUM>, twister bolt inner <NUM>, nut inner <NUM>, nut outer <NUM>, handle inner <NUM>, coupler <NUM>, clamp assembly <NUM>, and shaft <NUM>. Also shown are pull wires <NUM> and <NUM>, which are clamped and coupled to nut inner <NUM> and nut outer <NUM> with clamp assembly <NUM> and coupler <NUM>. As shown, guide wires <NUM> and <NUM> extend into shaft <NUM> through lumen (not shown) in outer sheath of shaft <NUM>.

With reference now to <FIG>, shown is an embodiment of improved handle <NUM>, with at least one flush port <NUM> formed in the introducer assembly <NUM>, for an improved transseptal puncture system <NUM>. As shown, handle <NUM> further includes at least one flush port <NUM> which may be used to flush fluid and material retrieved by the improved transseptal puncture system <NUM>. Such fluid or material may be taken from the distal end of the system (e.g., by the distal tip of the shaft) from inside the atrium. The flush port <NUM> may be in communication with at least one flush tube <NUM> to which a gentle suction may be applied to flush the fluid or material out of the atrium (i.e., by sucking such fluid or material through the shaft of the improved transseptal puncture system) to the flush port <NUM> and out the flush tube <NUM>. The flush port <NUM> is in communication with interior of the puncture system shaft <NUM>, and may be connected to a center lumen <NUM> or additional lumen 15a or 15b (see <FIG>). The flush port <NUM> may be used as an opening through which drugs, etc. can be introduced into the transseptal puncture system shaft <NUM>. For example, drugs may be delivered through the center lumen <NUM> or additional lumen 15a or 15b (see <FIG>) from the flush port <NUM>. In another embodiment, the introducer assembly <NUM> may include multiple ports <NUM>, to which multiple tubes <NUM> are connected, for infusing fluids and pharmaceutical agents and for flushing and aspirating of materials. <FIG> also show tubing <NUM> through which inflation gas flows.

Claim 1:
A transseptal puncture system (<NUM>) which is suitable for facilitating precise and safe transseptal puncture of a cardiac interatrial septum of a patient, comprising:
a handle (<NUM>) comprising:
two twister thread half shells (<NUM>) having internal threads;
a twister bolt inner (<NUM>) placed inside and locked into the two twister thread half shells (<NUM>);
a nut inner (<NUM>) placed inside the two twister thread half shells, wherein the nut inner (<NUM>) engages with the twister bolt inner (<NUM>);
a nut outer (<NUM>) placed inside the two twister thread half shells, wherein the internal threads of the twister thread half shells (<NUM>) engage with the nut outer (<NUM>), and wherein the nut inner and nut outer rotate in opposite directions to each other when the two twister thread half shells are turned in a direction;
a first pull wire (<NUM>) coupled to the nut inner (<NUM>) and a second pull wire (<NUM>) coupled to the nut outer (<NUM>); and
a grip overmold (<NUM>) over-molded onto the two twister thread half shells (<NUM>);
and a transseptal insertion shaft (<NUM>) comprising:
a sheath (<NUM>, <NUM>) that defines one or more lumens therein and has a distal end that is positioned toward the patient when the transseptal insertion shaft (<NUM>) is in use;
and at least one positioning balloon (<NUM>, <NUM>) connected to the distal end of the sheath, wherein the at least one positioning balloon, when inflated and the transseptal insertion shaft (<NUM>) is in use, overhangs and extends past the distal end of the sheath (<NUM>, <NUM>), and wherein the sheath includes one or more hypotubes (516a,b) connected to the at least one positioning balloon to inflate the positioning balloon,
wherein a proximal end of the transseptal insertion shaft (<NUM>) is coupled to the handle (<NUM>), and a distal end of the first pull wire (<NUM>) is attached to a first side of the transseptal insertion shaft and a distal end of the second pull wire (<NUM>) is attached to a second side of the transseptal insertion shaft.