HK40007609B - Transseptal insertion device - Google Patents

Description

Transseptal insertion device

Cross Reference to Related Applications

This application claims priority to US patent application US 15/784,792 entitled "TRANSSEPTAL INSERTION DEVICE (transseptal insertion device)" filed on 16.10.2017, and US patent application US 15/784,792 claims priority to US patent application US 62/409,448 entitled "TRANSSEPTAL INSERTION DEVICE (transseptal insertion device)" filed on 18.10.2016. All of the above applications are incorporated by reference herein in their entirety as if fully set forth herein.

Technical Field

The present invention relates generally to cardiac catheters and, more particularly, to transseptal insertion devices adapted to facilitate rapid and safe transseptal puncture and insertion of a needle or catheter through the septum of the heart to provide access to the left atrium when performing left atrial interventions.

Background

Cardiac catheterization is a medical procedure in which a long thin tube or catheter is inserted through an artery or vein into a specific region of the heart for diagnostic or therapeutic purposes. More specifically, the heart 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 coronary vessels and the finding of potential obstructions by taking X-ray images of a patient who has received an injection of dye (contrast agent) into a catheter previously injected into the artery. Left ventricular angiography enables the function of the left heart chamber and the left valve of the heart to be examined and may be combined with coronary angiography. Cardiac catheterization can also be used to measure the pressure of all four chambers of the heart and assess the pressure differential across the major heart valves. In a further application, cardiac catheterization may be used to estimate cardiac output or the amount of blood pumped by the heart per minute.

Some medical procedures may require catheterization into the left atrium of the heart. To this end, to avoid having to place a catheter in the aorta, access to the left atrium is typically achieved by accessing the right atrium, puncturing the interatrial septum between the left atrium and the right atrium of the heart, and passing the catheter through the interatrial septum into the left atrium. Transseptal punctures must be performed with extreme precision because accidental punctures of surrounding tissue can cause very serious damage to the heart. In addition, transseptal puncture may require complex instrumentation, which is not helpful in ensuring the accuracy of the puncture.

Accordingly, there is a definite need for a device adapted to facilitate rapid and safe transseptal puncture to provide access to the left atrium when performing left atrial interventions.

Disclosure of Invention

It is an object of the present invention to provide a device adapted to facilitate rapid and safe transseptal puncture to provide access to the left atrium when performing a left atrial intervention.

The present invention relates to transseptal insertion devices adapted to facilitate rapid and safe transseptal insertion of a needle or catheter through the interatrial septum, thereby providing access to the left atrium when performing a left atrial intervention. The transseptal insertion device is elongated but of a relatively reduced length and can be easily and safely rotated within the atrium of the heart to achieve proper orientation towards the heart septum.

The present invention, incorporating a first embodiment thereof, comprises a transseptal insertion device adapted to facilitate accurate and safe transseptal insertion of a needle or catheter through a heart septum, comprising a device housing and a slidable body slidably disposed in the device housing. The slidable body includes a pusher and a guide element extending from the pusher. The guide element may extend and retract from the distal end of the device housing.

In a second aspect, the guide element may be formed as a strip.

In another aspect, the device housing may include a housing interior and an annular housing gap surrounding the housing interior, and the guide element may be slidably disposed within the housing gap.

In another aspect, a device housing may include an outer housing wall, an inner housing wall, a housing interior formed by the inner housing wall, and an annular housing gap surrounding the housing interior.

In yet another aspect, the pusher can include a front pusher ring, a rear pusher ring spaced apart from the front pusher ring, and at least one pusher rod extending between the front pusher ring and the rear pusher ring.

In yet another aspect, one or more pusher rods may extend between the front pusher ring and the rear pusher ring.

In another aspect, the guide element may extend from a front pusher ring of the pusher,

in another aspect, the guide element may comprise a plurality of parallel spaced apart longitudinal strip elements, and the guide element may further comprise a plurality of endless transverse strip elements disposed in spaced relation to each other along the longitudinal strip elements.

In another aspect, the plurality of anchors may terminate respective longitudinal strip elements of the guide element for impacting the heart septum when a needle or catheter is inserted through the aperture in the heart septum.

In another aspect, at least one of the pusher and the guide element may be inflatable.

In another aspect, the device housing may comprise: an outer housing wall defining a housing interior; and a pusher channel extending through the outer housing wall, generally parallel and adjacent the housing interior. The guide element may further include a pusher having an inflatable pusher rod slidably disposed in the pusher channel, the pusher further having an inflatable pusher ring terminating the pusher rod and disposed in fluid communication with the pusher rod.

These and other objects, features and advantages of the present invention will become more apparent from the accompanying drawings and the detailed description of the preferred embodiments.

The objects of the invention and its particular features and advantages will become more apparent in view of the following drawings and accompanying detailed description. It should be understood that the detailed description and specific examples, while indicating the preferred embodiment of the invention, are intended for purposes of illustration only and are not intended to limit the scope of the invention.

Drawings

Preferred embodiments of the present invention will hereinafter be described in conjunction with the appended drawings provided to illustrate and not to limit the present invention, wherein like designations denote like elements, and in which:

FIG. 1 illustrates a front perspective view of a transseptal insertion device in accordance with a first embodiment of the present invention, the device shown exploded with a catheter;

FIG. 2 shows a front perspective view of the transseptal insertion device of FIG. 1 in a first, retracted position with a catheter partially extending through the device;

FIG. 3 shows a rear perspective view of the transseptal insertion device of FIG. 1 in a second, advanced position, wherein the catheter extends through and projects distally from the device;

FIG. 4 shows a cross-sectional view of the transseptal insertion device and catheter of FIG. 1 prior to puncturing the atrial septum, the transseptal insertion device and catheter shown in a first, retracted position in FIG. 2, with the cross-section taken along section 4-4 shown in FIG. 2;

FIG. 5 shows a similar cross-sectional view of the transseptal insertion device and catheter of FIG. 1, the atrial septum shown punctured, the transseptal insertion device shown in the second advanced position of FIG. 3, and the catheter shown extending through the heart septum;

FIG. 6 is a cross-sectional view taken along section 6-6 shown in FIG. 4;

FIG. 7 illustrates a front perspective view of a transseptal insertion device in accordance with a second embodiment of the present invention, the device shown exploded with a catheter;

FIG. 8 shows a front perspective view of the transseptal insertion device of FIG. 7 in a first, retracted position with the catheter partially extending through the device;

FIG. 9 shows a rear perspective view of the transseptal insertion device of FIG. 7 in a second, advanced position, wherein the catheter extends through and projects distally from the device;

FIG. 10 shows a cross-sectional view of the transseptal insertion device and catheter of FIG. 7 prior to puncturing the atrial septum, the transseptal insertion device and catheter shown in the first, retracted position of FIG. 8, with the cross-section taken along section 10-10 shown in FIG. 8;

FIG. 11 is a similar cross-sectional view of the transseptal insertion device and catheter of FIG. 7 with the atrial septum shown punctured, the transseptal insertion device shown in the second advanced position of FIG. 9 and the catheter shown extending through the heart septum;

FIG. 12 is a cross-sectional view taken along section 6-6 shown in FIG. 10;

FIG. 13 illustrates a front perspective view of a transseptal insertion device in accordance with a third embodiment of the present invention, the device shown exploded with a catheter;

FIG. 14 shows a cross-sectional view of the transseptal insertion device and catheter of FIG. 13 prior to puncturing the atrial septum, the transseptal insertion device and catheter being in a retracted position;

FIG. 15 shows an enlarged view of the distal end of the intermediate catheter of FIG. 14; and

fig. 16 illustrates a front perspective view of a transseptal insertion device in accordance with a fourth embodiment of the present invention, the device shown exploded with a catheter.

Like reference numerals refer to like parts throughout the several views of the drawings.

Detailed Description

In the following description, for purposes of example and explanation, numerous details are set forth; however, one of ordinary skill in the art will recognize that the invention can be practiced without these specific details.

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 embodiment described herein as "exemplary" or "illustrative" is not necessarily to be construed as preferred or advantageous over other embodiments. All of the embodiments described below are exemplary embodiments provided to enable persons skilled in the art to make or use the embodiments of the present disclosure and are not intended to limit the scope of the present disclosure, which is defined by the claims. For purposes of the description herein, the terms "upper," "lower," "left," "rear," "right," "front," "vertical," "horizontal," and derivatives thereof shall relate to the invention as oriented in fig. 1. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description. 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. Hence, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting, unless the claims expressly state otherwise.

As shown in all of the drawings, the present invention is directed to a transseptal insertion device adapted to facilitate rapid and safe transseptal puncture of the interatrial septum and insertion of a catheter therethrough to provide access to the left atrium when performing a left atrial intervention.

Referring initially to fig. 1-6, a transseptal insertion device 100 is illustrated in accordance with an exemplary embodiment of the present invention. As shown, transseptal insertion device 100 is generally elongate and disposed along a longitudinal axis 101. The transseptal insertion device 100 may include a device housing 102. The device housing 102 may be generally elongated and cylindrically arranged about the longitudinal axis 101, having an outer housing wall 104 and an inner housing wall 106 (fig. 4-6). The inner housing wall 106 may be substantially parallel to the outer housing wall 104 and concentric with the outer housing wall 104, and about the longitudinal axis 101. Annular shell gap 108 may be formed by outer shell wall 104 and inner shell wall 106, and between outer shell wall 104 and inner shell wall 106. Housing interior 110 may be formed by inner housing wall 106 and formed within inner housing wall 106. Device housing 102 may have a distal end 112 and a proximal end 114. In some embodiments, the distal end 112 of the device housing 102 may be tapered in longitudinal cross-section, as best shown in fig. 4 and 5. The front housing opening 116 may be disposed in communication with the housing gap 108 and the housing interior 110 at the distal end 112 of the device housing 102. The rear housing opening 118 may be provided in communication with the housing interior 110 at the proximal end 114 of the device housing 102.

In addition, the transseptal insertion device 100 includes a slidable body 120, the slidable body 120 disposed within the device housing 102 and slidably or longitudinally translatable relative to the device housing 102. The slidable body 120 of the present embodiment is composed of a pusher 122 and a tape guide member 132. In some embodiments, the slidable body 120, such as the pusher 122 and the tape guide element 132, may be formed as a one-piece unit, such as by injection molding, welding, or the like.

In some embodiments, the slidable body 120 is covered with a fabric such as PTFE/dacron, which makes it non-porous.

As best shown in fig. 1, pusher 122 is slidably disposed within housing gap 108 between outer housing wall 104 and inner housing wall 106 of device housing 102. In some embodiments, the pusher 122 may include a front pusher ring 124 and a rear pusher ring 126, the rear pusher ring 126 being spaced apart from the front pusher ring 124. At least one elongated pusher bar 128 may extend between the front pusher ring 124 and the rear pusher ring 126. In some embodiments, a plurality of pusher rods 128 may extend between the front pusher ring 124 and the rear pusher ring 126 in a generally parallel relationship to each other around the circumference of the front pusher ring 124 and the rear pusher ring 126.

With continued reference to fig. 1, the tape guide element 132 extends forward from the pusher 122, for example, forward from the front pusher ring 124 of the pusher 122. The tape guide element 132 laterally defines an interior space 133 so as to provide a guiding effect of a needle or catheter passing longitudinally through the interior space 133, as will be explained in more detail below. As shown, the tape guide element 132 may be generally elongate and cylindrical. In some embodiments, the tape guide element 132 may be laterally expandable and/or retractable, i.e. allowing for a change in its diameter; for example, the tape guide element 132 may expand into a conical shape according to which the distal end of the tape guide element 132 will have a larger diameter than the proximal end of the tape guide element 132. If the tape guide element 132 is expandable, the expansion is limited to a certain extent so that the tape guide element 132 still provides the above-mentioned guiding effect. In some embodiments, as shown in this figure, the tape guide element 132 may comprise a plurality of parallel longitudinal tape elements 134 disposed in spaced relation to one another about the circumference of the tape guide element 132; in turn, a plurality of parallel spaced apart transverse tape elements 136 may connect the longitudinal tape elements 134 to each other in the tape guide element 132. However, alternative embodiments are conceivable in which the structure of the tape guide element 132 may vary; for example, but not limiting of, the tape guide element may be made of oblique, disorganized elements that form a net. The ribbon guide element 132 may be made of a nickel titanium alloy, for example, but not limited thereto. In some embodiments, as shown in the present description, the widened portion or anchor 138 may terminate the distal end of the respective longitudinal strip element 134 of the strip guide element 132. The anchors 138 may be disposed about the perimeter of the tape guide element 132 and substantially coplanar with one another in a plane transverse to the longitudinal axis 101 of the transseptal insertion device 100. The anchor 138 may be made of tantalum, for example, but not limited thereto.

As shown in fig. 2 and 3, the slidable body 120 can slidably assume different longitudinal positions within the device housing 102. In the first or retracted position shown in fig. 2, slidable body 120 is retracted relative to device housing 102 such that strip guide element 132 is generally located within device housing 102 and pusher 122 protrudes rearwardly from proximal end 114 of device housing 102. In the second or advanced position, the slidable body 120 is moved forward relative to the device housing 102 such that the slidable body 120 is advanced through the front housing opening 116 and protrudes outwardly from the distal end 112 of the device housing 102, the strap guide element 132 extends outwardly and distally from the device housing 102, and the pusher 122 is generally housed within the device housing 102. More specifically, in the second advanced position, the pusher rod 128 may be received within the device housing 102, as shown, while the rear pusher ring 126 of the pusher 122 remains outside of the device housing 102 and rests on the proximal end 114 of the device housing 102 to prevent the slidable body 120 from further advancing through the device housing 102.

For purposes to be described hereinafter, during left atrial appendage surgery, the slidable body is used to anchor into the left atrial appendage when perforation may occur. Because it is non-porous, it will act as an occlusion balloon, preventing further extravasation of blood within the pericardial sac until more definitive surgery or hemostasis can be performed.

For purposes to be described below, a catheter 500 carrying a lance or needle may be inserted through transseptal insertion device 100 and guided by slidable body 120 to protrude outwardly from distal end 112 of device housing 102, as shown in fig. 3.

In some embodiments, the slidable body is used to remove an implanted mitral valve adjustmentProvided is a device. The slidable body is for securing to the anterior and posterior leaflets of the mitral valve. Once anchored, there is a mechanical, magnetic or electromagnetic lever that connects to the mitral valve adjusting device and stabilizes it. Energy is then delivered to the mitral valve through the slidable body 120 to ablate the anterior and posterior leaflets. Thereby, the mitral valve adjusting device is released and removed from the body. The slidable body 120 may also be used without a mitral valve adjustment device on the mitral valve, and may be usedFor use in ablating the anterior mitral leaflet prior to mitral valve implantation to prevent left ventricular outflow obstruction. In this case, the anterior mitral leaflet will be stabilized with a set of stabilizers that will be housed within the slidable body 120. The stabilizer will first be used to stabilize the mitral valve anterior leaflet and then the slidable body will be used to deliver energy to ablate the mitral valve anterior leaflet. The ablated tissue is then removed from the body using a stabilizing agent.

In certain embodiments, the slidable body is for anchoring into a pulmonary vein. Radiofrequency energy or other forms of energy can be delivered through the cable and slidable body to the pulmonary veins, causing electrical ablation.

An exemplary application of transseptal insertion device 100 to puncture an interatrial septum 520 will now be described with reference to fig. 4 and 5.

Initially, the transseptal insertion device 100 is disposed in a retracted or first position (described previously with reference to fig. 2) in which the slidable body 120 is retracted relative to the device housing 102, the distal end 112 of the device housing 102 providing a tapered leading or distal end of the transseptal insertion device 100. The transseptal insertion device 100 is then inserted into the right atrium 510 of the heart through a catheter extending through a vein (hereinafter referred to as an "outer catheter" for clarity); external catheters and veins are not shown in the drawings in order not to obscure the present invention.

Once the transseptal insertion device 100 reaches the right atrium 510, a separate second catheter 500 carrying a lance or needle (not shown) therein extends through the slidable body 120 and the housing interior 110 of the device housing 102. The catheter 500 may be of conventional design having an elongated, generally flexible catheter body 502 and a tapered catheter tip 504 terminating the catheter body 502. Before or after inserting the separate second catheter 500 into the transseptal insertion device 100, the surgeon slowly moves the transseptal insertion device 100 to place it proximate and facing the target point 522 or the area of the heart septum 520 to be punctured, as shown in fig. 4.

Once the transseptal insertion device 100 is disposed facing the target point 522 of the cardiac septum 520, the transseptal insertion device 100 is operated to switch from the retracted position of fig. 2 to the advanced position of fig. 3; in other words, the slidable body 120 is pushed forward relative to the device housing 102 such that the strap guide element 132 protrudes distally from the distal end 112 of the device housing 102. The transseptal insertion device 100 is disposed sufficiently close to the cardiac septum 520; thus, by pushing the slidable body 120 forward, the strap guide element 132 eventually contacts and rests on the heart septum 520. The anchors 138, if present, may engage the cardiac septum 520 to help stabilize the strap guiding element 132 to the cardiac septum 520 such that the strap guiding element 132 remains around the target point 522.

Once the strap guiding element 132 rests on the heart septum 520, the strap guiding element 132 and the heart septum 520 enclose the inner space 133 of the strap guiding element 132 and the target point 522 of the heart septum 520. A spear or needle may then be advanced through the catheter 500 and toward the heart septum 520, piercing the heart septum 520 and forming an orifice 530 in the heart septum 520. The arrangement of the slidable body 120 in the housing gap 108 between the outer housing wall 104 and the inner housing wall 106 of the device housing 102 helps stabilize the slidable body 120, thereby keeping the tape guide element 132 in the same position, providing safe and accurate targeting when puncturing the heart septum 520.

After forming the aperture 530 in the heart septum 520, the catheter 500 may then be inserted into the left atrium 512 of the patient's heart through the aperture 530 for left atrial access as is known in the art. The transseptal insertion device 100 may be maintained in the position of fig. 5 to stabilize the catheter 500 and maintain its proper orientation relative to the heart septum 520.

After cardiac catheterization procedure is completed, catheter 500 may be withdrawn from left atrium 512 through aperture 530 and retracted into strip guiding element 132. Next, as shown in fig. 4, the tape guide element 132 may be withdrawn from engagement with the heart septum 520 and into the shell gap 108. Finally, the transseptal insertion device 100 may be removed from the right atrium 510 through the outer catheter.

Those skilled in the art will appreciate that the transseptal insertion device 100 facilitates safer and faster insertion of the lance or needle and catheter 500 through the heart septum 520, thereby providing faster and safer access to the left atrium 512, minimizing the risk of trauma around tissue during insertion of the needle or catheter 500.

Referring next to fig. 7-12, a second illustrative embodiment of a transseptal insertion device is generally indicated by reference numeral 200. In the transseptal insertion device 200, elements similar to those of the device 100 previously described with reference to FIGS. 1-6 are identified by the same corresponding reference numerals in the 200-299 series of FIGS. 7-12. Unlike the previous device housing 102, the device housing 202 of the transseptal insertion device 200 of the present embodiment has a single housing wall 204. As shown in fig. 10 and 11, pusher channel 262 extends through and along housing wall 204 from proximal end 214 to distal end 212 of device housing 202. As shown in fig. 11, the distal end 212 of the device housing 202 may have a concave seating area 260 surrounding the front housing opening 216.

Similar to the previous embodiment, as shown in fig. 7-9, the slidable body 220 of the present embodiment includes a pusher 222 and a guide element 232 extending from the pusher 222. The pusher 222 depicted here consists of a single pusher rod 228. In turn, the guide element 232 is formed as a loop extending laterally from the pusher 222, the loop being shaped and sized to be received within the concave seating area 260 of the device housing 202. The slidable body 220 may be inflatable; for example, but not limiting of, pusher rod 228 and guide element 232 may be hollow, flexible, and in fluid communication with each other. The pusher bar 228 is configured to slide within a pusher channel 262 of the device housing 202. The pusher rod 228 may be disposed in fluid communication with an inflation fluid source (not shown) that supplies pressurized expandable fluid (not shown) through the pusher rod 228 into the guide element 232 to inflate the pusher rod 228 and the guide element 232 for a purpose that will be described below.

Similar to the previous embodiment, as shown in fig. 8 and 9, the slidable body 220 of the present embodiment may slidably assume different longitudinal positions within the device housing 202. In the first or retracted position shown in fig. 2, the slidable body 220 is retracted relative to the device housing 202 such that the annular guide element 232 rests on the concave seating area 260 of the device housing 202. In the second or advanced position, the slidable body 220 is moved forward relative to the device housing 202 such that the pusher rod 228 is advanced through the pusher channel 262 of the device housing 202 and the slidable body 220 protrudes outwardly from the distal end 212 of the device housing 202 such that the guide element 232 is spaced apart from the distal end 212 of the device housing 212. A catheter 500 carrying a lance or needle may be inserted through the transseptal insertion device 200 and guided by the annular guide element 232 of the slidable body 220 to project outwardly from the distal end 212 of the device housing 202, as shown in fig. 9.

An exemplary application of transseptal insertion device 200 to puncture an interatrial septum 520 will now be described with reference to fig. 10 and 11.

Initially, the transseptal insertion device 200 is disposed in a retracted or first position (described previously with reference to fig. 8), wherein the slidable body 220 is retracted relative to the device housing 202, and the distal end 212 of the device housing 202, together with the circular annular guide element 232, provides a circular leading or distal end of the transseptal insertion device 200. The transseptal insertion device 200 is then inserted into the right atrium 510 of the heart through a catheter extending through a vein (hereinafter referred to as an "outer catheter" for clarity); external catheters and veins are not shown in the drawings in order not to obscure the present invention.

Once the transseptal insertion device 200 reaches the right atrium 510, a separate second catheter 500 carrying a lance or needle (not shown) therein extends through the slidable body 220 and the housing interior 210 of the device housing 202. The catheter 500 may be of conventional design having an elongated, generally flexible catheter body 502 and a tapered catheter tip 504 terminating the catheter body 502. Before or after inserting the separate second catheter 500 into the transseptal insertion device 200, the surgeon slowly moves the transseptal insertion device 200 to place it proximate to and facing the target point 522 or the area of the heart septum 520 to be punctured, as shown in fig. 10.

Once the transseptal insertion device 200 is positioned facing the target point 522 of the cardiac septum 520, the transseptal insertion device 200 is operated to switch from the retracted position of fig. 8 to the advanced position of fig. 9; in other words, the slidable body 220 is pushed forward relative to the device housing 202 such that the annular guiding element 232 is distally separated from the distal end 212 of the device housing 202. The transseptal insertion device 200 is disposed sufficiently close to the cardiac septum 520; thus, by pushing the slidable body 220 forward, the annular guide element 232 eventually contacts and rests on the heart septum 520.

Once the annular guiding element 232 rests on the heart septum 520, the annular guiding element 232 and the heart septum 520 enclose the inner space 233 of the strip guiding element 232 and the target point 522 of the heart septum 520. The spear or needle may then be advanced through the catheter 500 and toward the heart septum 520, piercing the heart septum 520 and forming an aperture 530 in the heart septum 520.

After forming the aperture 530 in the heart septum 520, the catheter 500 may then be inserted into the left atrium 512 of the patient's heart through the aperture 530 for left atrial access as is known in the art. The transseptal insertion device 200 may be maintained in the position of fig. 11 to stabilize the catheter 500 and maintain its proper orientation relative to the heart septum 520.

After cardiac catheterization procedures are completed, catheter 500 may be withdrawn from left atrium 512 through aperture 530 and retracted into strip guiding element 232. Next, the annular guide element 232 may be withdrawn from engagement with the heart septum 520 and into the housing gap 208, as shown in fig. 4. Finally, the transseptal insertion device 200 may be removed from the right atrium 510 through the outer catheter.

Referring next to fig. 13-15, a third illustrative embodiment of a transseptal insertion device is generally indicated by reference numeral 300. In transseptal insertion device 300, elements similar to corresponding elements of device 100 previously described with respect to FIGS. 1-6 are identified by the same corresponding reference numerals in the 300-399 series in FIGS. 13-15. The transseptal insertion device 300 of this embodiment also includes an intermediate conduit 370 or tubule having an interior space 372. As best shown in fig. 14, the intermediate conduit 370 is disposed within the housing interior 310 of the device housing 302 between the inner housing wall 306 and the conduit 500. In other words, the intermediary catheter 370 is housed within the device housing 302 and, in turn, receives the catheter 500 intended to pierce and/or pass through the heart septum 520. As best shown in fig. 13 and 15, an outer, optionally annular, ultrasonic transducer 374 is carried by the intermediate catheter 370 at or near its distal end. The intermediate catheter 370 may extend outwardly and distally from the device housing 302 to allow the ultrasound transducer 374 to capture ultrasound images of the surroundings of the transseptal insertion device 300 and to facilitate accurate performance of the transseptal puncture procedure.

In certain embodiments, the device comprises a forward ultrasound transducer and/or a lateral ultrasound transducer. In certain embodiments, the forward and/or lateral ultrasound transducers comprise a chip or ultrasound chip designed to transmit and store electronic signals from the ultrasound transducer.

Referring next to FIG. 16, a fourth illustrative embodiment of a transseptal insertion device is generally indicated by reference numeral 400. In the transseptal insertion device 400, elements similar to those of the device 100 previously described with reference to FIGS. 1-6 are identified by the same corresponding reference numerals in the 400-499 series of FIG. 16. The transseptal insertion device 400 of this embodiment also includes an optional annular ultrasound transducer 474 carried by the slidable body 420, for example, by the front pusher ring 424 of the pusher 422. When the transseptal insertion device 400 is disposed in the advanced position, i.e., the slidable body 420 extends distally from the device housing 402, the ultrasound transducer 480 may capture ultrasound images of the environment surrounding the transseptal insertion device 400 to facilitate accurate performance of a transseptal puncture.

The transseptal insertion devices of the present invention may successfully assist a surgeon in performing at least one of the following techniques: transseptal visualization and stabilization; visualization and stabilization of the fossa ovalis; transseptal puncture and introduction across the septum into the left atrial safety zone (away from structures such as the aorta); leading into the left atrium (isolating pulmonary veins for AFib ablation); visualization of the left atrium; leading into the pulmonary vein; visualization and stability of the pulmonary veins, more particularly the pulmonary vein ostia; visualization and stabilization of the left atrial appendage; leading into the left atrial appendage; visualization and stabilization of the mitral valve; and into the mitral valve and left ventricle.

Since many modifications, variations and changes in detail can be made to the described preferred embodiment of the invention, it is intended that all matter contained in the foregoing description and shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense. Accordingly, the scope of the invention should be determined by the appended claims and their legal equivalents.

Claims (19)

1. A transseptal insertion device adapted to facilitate accurate and safe transseptal insertion of a needle or catheter through a heart septum, the transseptal insertion device comprising:

a device housing;

a slidable body slidably disposed in the device housing, the slidable body including a pusher and a guide element extending from the pusher, the guide element being extendable and retractable from a distal end of the device housing; wherein the guiding element defines an interior space that guides a needle or catheter for transseptal insertion through a heart septum; the guide element comprising a plurality of parallel spaced apart longitudinal elements, the guide element further comprising a plurality of annular transverse elements arranged spaced apart relative to each other along the longitudinal elements and connecting the longitudinal elements to each other in the guide element such that the longitudinal elements and the transverse elements define an opening, and wherein the guide element is configured such that the inner space of the guide element is open to an outer space of the device housing through the opening,

wherein the pusher comprises a front pusher ring, a rear pusher ring spaced from the front pusher ring, and at least one pusher rod extending between the front pusher ring and the rear pusher ring, the guide element extending from the front pusher ring of the pusher, and

wherein the slidable body is slidable between a first retracted position in which the slidable body is retracted relative to the device housing such that the guide element is located within the device housing, and a second advanced position in which the slidable body is moved forward relative to the device housing such that the guide element extends outwardly and distally from the device housing, and a rear pusher ring of the pusher remains outside of the device housing and rests on the proximal end of the device housing.

2. The transseptal insertion device of claim 1, wherein the transseptal insertion device provides access to the left atrium when performing a left atrial intervention.

3. The transseptal insertion device of claim 1, wherein the transseptal insertion device is configured to be elongated, and wherein the transseptal insertion device is configured to be rotated within an atrium of a heart to achieve a correct orientation toward a septum of the heart.

4. The transseptal insertion device of claim 1, wherein the guide element is made of nitinol.

5. The transseptal insertion device of claim 1, wherein the guide element is formed as a strip.

6. The transseptal insertion device of claim 1, wherein the device housing comprises a housing interior and an annular housing gap surrounding the housing interior, wherein the guide element is slidably disposed within the annular housing gap.

7. The transseptal insertion device of any of claims 1-6, wherein the device housing comprises:

the wall of the outer casing is provided with a plurality of grooves,

the wall of the inner shell is provided with a plurality of grooves,

a shell interior formed by the inner shell wall, an

An annular housing gap surrounding the housing interior.

8. The transseptal insertion device of claim 1, further comprising a plurality of anchors, wherein the plurality of anchors terminate respective longitudinal elements of the guide element for impacting a heart septum when a needle or catheter is inserted through an aperture in the heart septum.

9. The transseptal insertion device of any of claims 1-6 and 8, wherein at least one of the pusher and the guide element is inflatable.

10. The transseptal insertion device of any of claims 1-6 and 8, wherein the device housing comprises:

an outer housing wall defining a housing interior; and

a pusher channel extends through the outer housing wall, generally parallel and adjacent the housing interior.

11. The transseptal insertion device of any of claims 1-6 and 8, wherein the pusher has:

an inflatable pusher rod slidably disposed in the pusher channel; and

an inflatable pusher ring terminating the pusher rod and disposed in fluid communication with the pusher rod.

12. The transseptal insertion device of any of claims 1-6 and 8, wherein the guide element is expandable into a conical shape according to which a distal end of the guide element has a larger diameter than a proximal end of the guide element.

13. The transseptal insertion device of any of claims 1-6 and 8, wherein the slidable body is for removing the implanted mitral valve adjustment device from the body of the subject.

14. The transseptal insertion device of claim 13, wherein the slidable body is for anchoring to the anterior and posterior leaflets of the subject's mitral valve, and once anchored, uses mechanical or magnetic levers that attach to an implanted mitral valve adjustment device.

15. The transseptal insertion device of claim 13, wherein the slidable body is for anchoring to the anterior and posterior leaflets of the subject's mitral valve, and once anchored, uses an electromagnetic lever that is attached to an implanted mitral valve adjustment device.

16. The transseptal insertion device of claim 13, wherein the slidable body stabilizes the mitral valve while delivering energy to the mitral valve and ablating the anterior leaflet and the posterior leaflet, thereby releasing and removing the implanted mitral valve adjustment device from the body of the subject.

17. The transseptal insertion device of claim 13, wherein the slidable body ablates the anterior mitral leaflet prior to mitral valve implantation to prevent left ventricular outflow obstruction.

18. The transseptal insertion device of claim 13, wherein the slidable body stabilizes the anterior mitral leaflet with a set of stabilizers to be received within the slidable body.

19. The transseptal insertion device of claim 18 wherein, first, the stabilizer stabilizes the mitral valve anterior leaflet and then, the slidable body delivers energy to ablate the mitral valve anterior leaflet.