# Patent

## Title
Devices, systems, and methods for treating heart failure

## Abstract

The present teachings provide devices and methods for percutaneously removing internal tissue. Specifically, one aspect of the present teachings provides a tissue incising element with a sharp cutting edge and a longitudinal lumen and a tissue stabilizer slidably disposed within the longitudinal lumen of the tissue incising element. The tissue incising element has a deployed configuration during tissue cutting and a small collapsed configuration during the percutaneous delivery and removal. The tissue stabilizer includes a tissue supporting/gripping element configured to support tissue during incising and capture the removed tissue.

## Background
CROSS REFERENCE TO RELATED APPLICATION
This application claims the benefit of and priority to U.S. Provisional Patent Application No. 61/778,382, filed on Mar. 12, 2013. The entire content of the provisional application is incorporated herein by reference.


FIELD OF THE INVENTION
The present teachings relate to devices and methods of use thereof for treating heart failure. An example of the present teachings relates to a device that creates a shunt between two heart chambers thereby allowing blood flow from one to another heart chamber, changing (e.g. reducing) the blood pressure in a heart chamber. The present teachings further relate to devices and methods of use thereof to deliver such a device.
BACKGROUND
Congestive heart failure (CHF) is a condition affecting millions of people worldwide. CHF results from a weakening or stiffening of the heart muscle that commonly is caused by myocardial ischemia (due to, e.g., myocardial infarction) or cardiomyopathy (e.g., myocarditis, amyloidosis). CHF causes reduced cardiac output and inadequate blood to meet the needs of body tissue.
Treatments for CHF include: (1) pharmacological treatments, (2) assisting systems, and (3) surgical treatment. Pharmacological treatments, e.g., with diuretics, are used to reduce the workload of a heart by reducing blood volume and preload. While drug treatment improves quality of life, it has little effect on survival. Assisting devices, e.g., mechanical pumps, are used to reduce the load on the heart by performing all or part of the pumping function normally done by the heart. However, in a chronic ischemic heart, high-rate pacing may lead to increased diastolic pressure, calcium overload, and damage to the muscle fibers. There are at least three surgical procedures for treating a heart failure: (1) heart transplant, (2) dynamic cardiomyoplasty, and (3) the Batista partial left ventriculectomy. These surgical treatments are invasive and have many limitations.
CHF is generally classified into systolic heart failures (SHF) or diastolic heart failures (DHF). In a SHF, the pumping action of a heart is reduced or weakened. A normal ejection fraction (EF), which is a function of the volume of blood ejected out of the left ventricle (stroke volume) divided by the maximum volume remaining in the left ventricle at the end of the diastole or relaxation phase, is greater than 50%. In systolic heart failure, the EF is decreased to less than 50%. A patient with SHF may have an enlarged left ventricle because of cardiac remodeling developed to maintain an adequate stroke-volume. This pathophysiological phenomenon is often associated with an increased atrial pressure and a left ventricular filling pressure.
DHF is a heart failure without any major valve disease even while the systolic function of the left ventricle is preserved. Generally, DHF is failure of the ventricle to adequately relax and expand, resulting in a decrease in the stroke volume of the heart. Presently, there are very few treatment options for patients suffering from DHF. DHF afflicts between 30% and 70% of those patients with CHF.
There are several known techniques that can be used to treat the symptoms of DHF. Without attempting to characterize the following references, for example, U.S. Pat. No. 8,091,556 by Keren et al. discloses the use of an interatrial pressure relief shunt with a valve and a tissue affixation element at each end of the shunt; and United States Patent Application Publication No. 20050165344 by Dobak discloses a pressure relief system with an interatrial septal conduit with an emboli barrier or trap mechanism to prevent cryptogenic stroke due to thrombi or emboli crossing the conduit into the left sided circulation. Dobak also discloses a conduit with a one-way valve which directs blood flow from the left atrium to the right atrium.
The constantly evolving nature of heart failure represents a significant challenge for treatment. Therefore, there is a need for novel and adaptable methods and devices for treating DHF, for example, by creating a pressure relief shunt which can be retrieved, repositioned, adjusted, expanded, contracted, occluded, sealed and/or otherwise altered as required to treat the patient.
SUMMARY
One aspect of the present teachings provides devices for regulating blood pressure in a heart chamber. In various embodiments, the device for regulating blood pressure includes a transeptal tissue coring device for removing tissue from the heart, comprising a tissue incising element and a tissue stabilizer. In some embodiments, the tissue incising element comprises a proximal portion, a distal portion with a sharp edge at the distal end, and a longitudinal lumen extending from the proximal portion to the distal portion. In some embodiments, the tissue stabilizer comprises an elongated body, a distal portion, and a plurality of tissue supporting struts at the distal portion. In certain embodiments, the plurality of tissue supporting struts each comprises a fixed end attached to the elongated body and a free end configured to move radially away from the elongated body of the tissue stabilizer.
In various embodiments, the tissue stabilizer is slidably disposed within the longitudinal lumen of the tissue incising element. In some embodiments, the tissue supporting struts are stowed radially along the elongated body of the tissue stabilizer when the distal portion of the tissue stabilizer is constrained within the longitudinal lumen of the tissue incising element. In other embodiments, the tissue supporting struts expand radially to form a tissue supporting surface when the distal portion of the tissue stabilizer is exposed outside of the longitudinal lumen of the tissue incising element.
In various embodiments, a transseptal tissue coring device for removing tissue from the heart comprises a tissue incising element and a tissue stabilizer. In some embodiments, the tissue stabilizer comprises an elongated body, a distal portion, and a plurality of tissue supporting struts at the distal portion. In certain embodiments, the tissue supporting struts are formed by a plurality of slits along the elongated body of the tissue stabilizer.
In various embodiments, the tissue stabilizer is slidably disposed within the longitudinal lumen of the tissue incising element. In some embodiments, the tissue supporting struts are lengthened along the elongated body of the tissue stabilizer when the distal portion of the tissue stabilizer is constrained within the longitudinal lumen of the tissue incising element. In other embodiments, the tissue supporting struts are shortened and expand radially to form a tissue supporting surface when the distal portion of the tissue stabilizer is exposed outside of the longitudinal lumen of the tissue incising element.
Another aspect of the present teachings provides a method of percutaneously removing tissue from the heart. In various embodiments, the method comprises providing a transseptal tissue coring device comprising a tissue incising element with a sharp edge at a distal end and a tissue stabilizer having a plurality of tissue supporting struts at a distal portion of the tissue stabilizer where the tissue stabilizer is slidably disposed within an elongated lumen of the tissue incising element; advancing the transseptal tissue coring device to a proximity of the atrial septum; expanding the tissue supporting struts of the tissue stabilizer radially and positioning the tissue stabilizer against the atrial septum inside the left atrium; advancing the tissue incising element distally so that the sharp edge at the distal end of the tissue incising element is positioned against the atrial septum inside the right atrium; making an incision in the atrial septum by using the tissue incising element and/or the tissue stabilizer; and retracting the tissue stabilizer proximally, allowing the distal portion of the tissue stabilizer to slide back into the tissue incising element and the tissue supporting struts carrying the removed septal tissue to fold radially and distally, where the removed septal tissue is captured inside the elongated lumen of the tissue incising element.
Another aspect of the present teachings provides a method of percutaneously removing tissue from the heart. In various embodiments, the method comprises providing a delivery sheath and a transseptal tissue coring device, wherein the delivery sheath comprises a distal end and a longitudinal lumen, the transseptal tissue coring device is slidably disposed within the longitudinal lumen of the delivery sheath, wherein the transseptal tissue coring device comprises a tissue incising element with a sharp edge at a distal end and a tissue stabilizer having a plurality of tissue supporting struts at a distal portion, where the tissue stabilizer is slidably disposed within an elongated lumen of the tissue incising element; advancing the transseptal tissue coring device to a proximity of the atrial septum; expanding the tissue supporting struts of the tissue stabilizer radially and positioning the tissue stabilizer against the atrial septum inside the left atrium; advancing the tissue incising element distally so that the sharp edge at the distal end of the tissue incising element is positioned against the atrial septum inside the right atrium; incising the septal tissue using the tissue incising element and/or the tissue stabilizer; advancing the delivery sheath distally so that the distal end of the delivery sheath is at the proximity of the atrial septal tissue: retracting the tissue incising element proximally; and retracting the tissue stabilizer proximally to allow the distal portion of the tissue stabilizer to slide back into the delivery sheath and the tissue supporting struts carrying the removed septal tissue to fold radially and distally, wherein the removed septal tissue is captured inside the elongated lumen of the tissue incising element.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of an exemplary medical device in accordance with the present teachings.
FIG. 2 is a perspective view of the exemplary medical device of FIG. 1 in a constrained configuration.
FIGS. 3A-3C are perspective views of the exemplary medical device of FIG. 2 in accordance with the present teachings.
FIGS. 4A-4B are perspective views of an exemplary medical device in a constrained configuration.
FIGS. 4C-4D are perspective views of the exemplary medical device of FIGS. 4A-4B in accordance with the present teachings.
FIGS. 5A-5B are perspective views of the exemplary medical device in accordance with the present teachings.
FIGS. 6A-6B are perspective views of the exemplary medical device in accordance with the present teachings.
FIGS. 7A-7B are perspective views of the exemplary medical device in accordance with the present teachings.
FIG. 8 is a perspective view of an exemplary medical device in accordance with the present teachings.
FIGS. 9A-9C are perspective views of an exemplary medical device in accordance with the present teachings.
FIG. 10 is a perspective view of an exemplary medical device in accordance with the present teachings.
FIG. 11 is a perspective view of an exemplary medical device in accordance with the present teachings.
FIGS. 12A-12B are perspective views of an exemplary medical device in accordance with the present teachings.
FIGS. 13A-13E are perspective views of an exemplary embodiment of a tissue incising element in accordance with the present teachings.
FIGS. 14A-14D are perspective views demonstrating an exemplary process for deploying a medical device in accordance with the present teachings.
FIGS. 14E-14F are perspective views demonstrating an exemplary process for retrieving a piece of tissue and a medical device in accordance with the present teachings.



DETAILED DESCRIPTION
Certain specific details are set forth in the following description and drawings to provide an understanding of various embodiments of the present teachings. Those with ordinary skill in the relevant art will understand that they can practice other embodiments of the present teachings without one or more of the details described below. Finally, while various processes are described with reference to steps and sequences in the following disclosure, the steps and sequences of steps should not be taken as required to practice all embodiments of the present teachings.
As used herein, the terms “radially outward” and “radially away” means any direction which is not parallel with the central axis. For example, considering a cylinder, a radial outward member could be a piece of wire or a loop of wire that is attached or otherwise operatively coupled to the cylinder that is oriented at an angle greater than 0° relative to the central longitudinal axis of the cylinder.
As used herein, the term “lumen” means a canal, duct, generally tubular space or cavity in the body of a subject, including veins, arteries, blood vessels, capillaries, intestines, and the like. The term “lumen” can also refer to a tubular space in a catheter, a sheath, or the like in a device.
As used herein, the term “proximal” shall mean closest to the operator (less into the body) and “distal” shall mean furthest from the operator (further into the body). In positioning a medical device inside a patient, “distal” refers to the direction away from a catheter insertion location and “proximal” refers to the direction near the insertion location.
The exemplary devices described in various embodiments each is used to create an aperture or a shunt on the atrial septum, which allows fluid communication between the left and right atria and releases the left atrium pressure. It, however, should be appreciated that the present teachings are also applicable for use in other parts of the anatomy, or for other indications. For instance, a device, such as one described in the present teachings, could be used to create a shunt between the coronary sinus and the left atrium for the same indication. Additionally, a shunt such as one described in the present teachings could be placed between the azygous vein and the pulmonary vein.
The following description refers to FIGS. 1 to 14. A person with ordinary skill in the art would understand that the figures and description thereto refer to various embodiments of the present teachings and, unless indicated otherwise by their contexts, do not limit the scope of the attached claims.
The present teachings relate to a transseptal tissue coring device and methods of using such a device for percutaneously removing a certain size and/or amount of tissue from the atrial septum, producing an aperture in the atrial septum, and creating a left-to-right blood shunt in the atria. In some embodiments, the device includes an elongated tubular body with a tissue incising element at its distal end and a tissue stabilizer slidably disposed within the tubular lumen of the elongated body during delivery. The tissue stabilizer is configured to extend through an aperture on the septum, stabilize, and support the septum from the opposite side of an incision as described herein.
According to various embodiments, the tissue incising element is adapted at the distal end of the elongated tubular body. In some embodiments, the tissue incising element includes a proximal end, a distal end, and a body extending between the proximal end and the distal end. In some embodiments, the proximal end of the tissue incising element attaches to the distal end of the elongated tubular body and the distal end of the tissue incising element includes a sharp edge along the circumference configured for incising tissue. In some embodiments, the body of the tissue incising element has a tubular shape. In other embodiments, the body of the tissue incising element has a collapsible cone shape.
In various embodiments, a tissue stabilizer of the present teachings includes an elongated body with a distal portion and a proximal portion. In some embodiments, the distal portion of the tissue stabilizer has at least two radially expandable tissue supporting struts. In various embodiments, the tissue stabilizer has a pre-formed radially expanded configuration and a stowed configuration.
In various embodiments, a transseptal tissue coring device of the present teachings tracks over a guide wire, for example, positioned across a tissue beforehand. In some embodiments, the tissue stabilizer includes a tissue piercing element. For example, the tissue piercing element can be used to create an aperture on the septum.
In various embodiments, a transseptal tissue coring device of the present teachings includes an elongated delivery profile where the tissue supporting struts of the tissue stabilizer are stowed radially inward so that the entire tissue stabilizer is slidably disposed within the elongated lumen of the elongated member. In other embodiments, the transseptal tissue coring device includes an expanded deployed profile where the tissue stabilizer is exposed distally outside of the tissue incising element and the tissue supporting struts expand radially.
In various embodiments, a tissue coring device of the present teachings is configured to be percutaneously delivered into the right atrium, across the atrial septum, and inside the left atrium. In some embodiments, the tissue stabilizer supports a piece of septal tissue while the tissue incising element incises the tissue. In some embodiments, the tissue stabilizer captures and percutaneously removes the detached tissue from the body. In such embodiments, the aperture generated with the tissue coring device described herein allows blood flow from one side of the septum to the other. In some embodiments, the aperture has a minimum size of 3-4 mm in general diameter, so that the aperture will not heal itself, i.e. re-closure, over time, thereby allowing a continuous pressure relief to the left heart over time. In various other embodiments, the device is used with a delivery system.
FIG. 1 shows an exemplary embodiment of a transseptal tissue coring device (10) deployed inside a heart according to the present teachings. As illustrated in FIG. 1, the transseptal tissue coring device (10) includes an elongated tubular body (8) with a tissue incising element (12) connected at its distal end (6) and a tissue stabilizer (14). The elongated tubular body (8) has a proximal end (not shown), a distal end (6), and a central lumen (4) extending from the proximal end to the distal end (6). The tissue incising element (12) has a proximal end (11), a distal end (24), and an axial lumen (26). The proximal end (11) of the tissue incising element (12) is attached to the distal end (6) of the elongated tubular body (8) by a mechanical, chemical, thermal, or other mechanism known to those in the field. The distal end (24) of the tissue incising element (12) has a cutting edge. The axial lumen (26) of the tissue incising element (12) joins the central lumen (23) of the elongated tubular body (8) to form a continuous conduit. The tissue stabilizer (14) is slidably disposed within the axial lumen (26) of the tissue incising element (12). The tissue stabilizer (14) has an elongated body (34) with a proximal portion (not shown) and a distal portion (32). The distal portion (32) of the tissue stabilizer (14) has a tissue supporting/gripping element. In this particular embodiment, the tissue supporting/gripping element includes a plurality of struts (36) each with its fixed ends (40) connected to the elongated body (34) of the tissue stabilizer (14) and its free ends (38) extending radially outward from the elongated body (34) of the tissue stabilizer (14).
In some embodiments, the tissue coring device is percutaneously delivered via a delivery sheath (30). The delivery sheath (30) includes a proximal end (not shown), a distal end (31), and a longitudinal lumen (22). As described herein, the tissue coring device (10) includes an elongated delivery profile, a deployed profile, and a collapsed tissue retrieval profile. In its delivery profile, the entire tissue coring device (10) is slidably disposed within the lumen (22) of the delivery sheath (30). In its deployed profile, the tissue coring device (10) extends distally and the tissue incising element (12) and the tissue supporting/gripping element each exits outside of the lumen (22) of the delivery sheath (30) and resume its intended configuration. In its tissue retrieval profile, the tissue incising element (12) is pulled proximally back inside the lumen (22) of the delivery sheath (30) and the tissue supporting/gripping element collapses and is pulled proximally inside the lumen (26) of the tissue incising element (12) and/or the lumen (22) of the delivery sheath (30).
In some embodiments, the tissue incising element and the tissue stabilizer are incorporated with radiopaque markers so the devices may more easily be visualized using a radiographic imaging equipment such as with x-ray or fluoroscopic techniques. In some other embodiments, the entire transseptal tissue coring device is made of a radiopaque material. In some embodiments, the radiopaque marker/material is made of tantalum, tungsten, platinum irridium, gold, alloys of these materials or other materials that are known to those skilled in the art. In other embodiments, radiopaque markers comprising cobalt, fluorine or numerous other paramagnetic materials or other MR visible materials that are known to those skilled in the arts are incorporated in the tissue incising element and/or the tissue stabilizer. In certain embodiments, the paramagnetic material or MR visible material is incorporated with a radiopaque material. For example, two or more of a paramagnetic material, a MR visible material, an X-ray material, or a fluoroscopic material, each of which is described herein, can be arranged in alternating locations on the device to enable both x-ray and MR imaging of the device.
FIG. 1 illustrates one embodiment of the tissue stabilizer (14). According to this embodiment, the tissue supporting struts (36) of the tissue stabilizer (14) extend outside of the distal end (24) of the tissue incising element (12). For example, the elongated body (34) of the tissue stabilizer (14) extends distally so that the tissue supporting struts (36) extend outside of the axial lumen (26) of the tissue incising element (12). Although not shown in FIG. 1, the proximal end and the movement of the elongated body (34) is controlled by a clinician from outside of the body. FIG. 1 further illustrates an embodiment of the tissue stabilizer (14) deployed inside the left atrium (4) with the elongated body (34) of the tissue stabilizer (14) across the atrial septum (7) and the tissue supporting struts (36) of the tissue stabilizer (14) expanding radially outward. FIG. 1 further illustrates that the distal end (24) of the tissue incising element (12) is within the right atrium (2) and at a proximity to the atrial septum (7). FIG. 1 further illustrates one exemplary tissue incising element (12) having a tubular shaped body.
FIG. 2 shows an exemplary transseptal tissue coring device (10) having a distal portion in an elongated delivery profile. According to some embodiments, the tissue supporting/gripping element are held within the lumen (26) of the tissue incising element (12) or the lumen (4) of the elongated body (8) of the tissue coring device (10). According to this particular embodiment in FIG. 2, the tissue supporting struts (36) are stowed inward radially and the distal portion (32) of the tissue stabilizer (14) is disposed within the axial lumen (26) of the tissue incising element (12). In such an embodiment, the tissue supporting struts (36) of the tissue stabilizer (14) fold radially inward so that the free ends (38) of the struts (36) are tugged close to the longitudinal axis of the elongated body (34) of the tissue stabilizer (14). In one embodiment, the tissue supporting struts (36) are folded inward proximally so that the free ends (38) are tugged proximally to the fixed end (40), as seen in FIG. 2. In other embodiments, the tissue supporting struts (36) are folded inward distally so that the free ends (38) is tugged distally to the fixed end (40). In some embodiments, in its delivery profile, the tissue stabilizer (14) slides from the proximal end of the lumen (4) of the elongated tubular body (8) distally and to the axial lumen (26) of the tissue incising element (12). In another embodiment, the tissue stabilizer (14) is pre-loaded inside the axial lumen (26) of the tissue incising element (12) and both the elongated tubular body (8) and the tissue incising element (12) holding the tissue stabilizer (14) inside its axial lumen (26) are delivered via a delivery sheath into the heart. The tissue stabilizer (14) transitions from its stowed delivery profile to an expanded deployed profile, such as shown in FIGS. 3A-3C, when it extends distally outside of the lumen (26) of the tissue incising element (12).
According to another embodiment, the tissue stabilizer (14) can also be slidably disposed within a separate sheath which can slide through the conduit funned by the elongated body (8) and the tissue incising element (12). In such an embodiment, the tissue stabilizer (14) is deployed distally further away from the tissue incising element (12). One example of such a sheath (33) is shown in FIG. 3A.
FIGS. 3A-C illustrate an exemplary transseptal tissue coring device according to the present teachings. FIGS. 3A-C show the distal portion of the transseptal tissue coring device (10) in the deployed profile, where the distal portion (32) of the tissue stabilizer (14) is extended outside of the tissue incising element (12) and the tissue supporting struts (36) expand radially outward to form a tissue supporting surface. In some embodiments, the tissue supporting surface is substantially planar and is substantially parallel to the atrial septum, as illustrated in FIG. 3A. In other embodiments, the tissue supporting surface has a concave shape or a sloped shape as shown in FIG. 3B, where the free ends (38) of the struts (36) are proximal to the fixed ends (40) of the struts (36). In yet other embodiments, the tissue supporting surface has a convex shape or a sloped shape as shown in FIG. 3C, where the free ends (38) of the struts (36) are distal to the fixed ends (40) of the struts (36). One with ordinary skill in the art would also understand that the radially expanded struts (36) can form a tissue supporting surface with any shapes and forms and disclosure of various embodiments of the present teachings should not be viewed as limiting.
According to some embodiments, during a tissue retrieval as described herein, the tissue stabilizer (14) is pulled proximally back inside the axial lumen (26) of the tissue incising element (12) from the distal end (24) of the tissue incising element (12); and, constrained by the lumen of the tissue incising element (12), the tissue supporting struts (36) fold distally inward and the tissue stabilizer (14) resumes the elongated profile. Alternatively, the tissue stabilizer (14) is pulled proximally into the lumen of a sheath from its distal end and, constrained by the sheath, the tissue supporting struts (36) fold distally inward and the tissue stabilizer (14) resumes its elongated profile.
FIGS. 4A-D illustrate several other exemplary tissue supporting struts (76) in their delivery and deployed profiles. In FIG. 4A, the distal portion of the transseptal tissue coring device (50) is in an elongated delivery profile, where the tissue supporting struts (76) are constrained inward radially and the distal portion (72) of the tissue stabilizer (54) is disposed within the axial lumen (26) of the tissue incising element (12). In this embodiment, the tissue stabilizer (54) has a generally tubular body (70) with a proximal portion (not shown), a distal portion (72), and a central lumen (74) extending in between. The distal portion (72) of the tube forms tissue supporting struts (76). As seen in FIG. 4A, the distal portion (72) of the tube has a plurality of slits (78). Each slit (78) extends from a first location (80) to a second location (82) on the distal portion (72) of the tubular body (70). In one embodiment, the slits (78) have equal length, are parallel to one another, and are parallel to the longitudinal axis of the tubular body (70). In another embodiment, at least two slits (78) have different lengths from each other.
In an alternative embodiment, slits (78) may be cut at an angle such that they are helically disposed along the tubular body (70), as illustrated in FIG. 4B. In one embodiment, slits are straight. In another embodiment, slits (78) are not straight. For example, slits (78) may be zigzag, S-shaped, or C-shaped. One reasonably skilled in the art would be capable of selecting a shape and/or angle suitable for a given clinical application without any undue experimentation. In one embodiment, a strut (76) is formed between two slits (78) radially next to each other.
FIGS. 4C-D illustrate another embodiment of the transseptal tissue coring device (50) with its distal portion in a deployed profile. In this embodiment, the distal portion (72) of the tissue stabilizer (54) is extended outside of the axial lumen (26) of the tissue incising element (12) and the tissue supporting struts (76) expand radially outward and form a tissue supporting surface. As illustrated in FIG. 4C, in one embodiment, as the tissue supporting struts (76) become free from the constraint of the tissue incising element (52), the axial length of the distal portion (72) of the tubular body (70) is reduced, the struts (76) between the slits (78) are folded longitudinally to form tissue supporting struts (76), and the tissue supporting struts (76) form a tissue supporting surface. As illustrated in FIG. 41), in another embodiment, the struts (76) between slits (78) twist to form a tissue supporting surface. Similar to those illustrated in FIGS. 3A-C, the tissue supporting surface can be substantially planar, generally curved or sloped toward the septum, or generally curved or sloped away from the septum. Additionally, the tissue stabilizer (54) can also slidably be disposed within a separate sheath, which can slide through the conduit formed by the elongated body (8) and the tissue incising element (12).
According to some embodiments, during a tissue retrieval described herein, the tissue stabilizer (54) is pulled proximally back inside the axial lumen (26) of the tissue incising element (12) from its distal end (24) and, constrained by the tissue incising element, the tissue supporting struts (76) fold inward radially and the tissue stabilizer resumes its elongated profile. In an alternative embodiment, during tissue retrieval, the deployed tissue supporting struts (76) are forced by the distal end of the tissue incising element or a retrieval sheath to stretch longitudinally and reduce its profile as it is pulled proximally into the axial lumen of the tissue incising element or the sheath.
Although specific slitting patterns and shapes have been described here, one reasonably skilled in the art would understand that other designs can be incorporated without any undue experimentation to form a tissue stabilizer so long as each of such designs provides an elongated delivery profile and an expanded deployed profile. Thus, the specific embodiments described herein should not be viewed as limiting.
According to some embodiments, the tissue supporting struts (36, 76) transition from an elongated delivery profile to an expanded deployed profile by elastic recovery or thermal-shape transformation. In some embodiments, if a sufficiently elastic and resilient material is used, the struts (36, 76) can be pre-formed into the deployed shape and then elastically deformed and stowed during delivery. After the device is successfully delivered, it recovers to the preformed shape by the elastically recovery. In other embodiments, the tissue supporting struts (36, 76) may be manually expanded to the desired deployment shape and heat set in an oven while maintained in such a desired shape to memorize the shape. The struts (36, 76) are then distorted into a generally straightened profile during a delivery process and resume their intended deployed profile in vivo. In some embodiments the tissue supporting struts may be distorted from a generally straightened profile to their intended deployed profile in vivo by use of a wire attached to the most distal end. For example, the struts can be distorted into the deployed profile by moving the wire proximally to reduce the axial length of the distal portion and move the struts radially outward.
According to various embodiments, the tissue stabilizer includes at least two tissue supporting struts (36, 76). Devices according to the present teachings may include any number of tissue supporting struts (36, 76). In some embodiments, the tissue stabilizer includes eight tissue supporting struts (36, 76), as illustrated in FIGS. 3A-C and FIGS. 4A-D. Devices having between four and ten tissue supporting struts (36, 76) can be made without any significant changes in the processes described herein. A person with ordinary skill in the art can determine the appropriate number of tissue supporting struts (36, 76) based on a variety of anatomical and manufacturing factors.
According to some embodiments, during a tissue coring, the tissue stabilizer (14, 54) is deployed and positioned against one side of the tissue and the tissue incising element (12, 52) is deployed and positioned against the opposite side of the tissue. Thus, the tissue stabilizer (14, 54) provides support to the septal tissue during a tissue coring. In some embodiments, the deployed tissue stabilizer (14, 54) has a general size greater than the general size of the surface formed by the cutting edge of the tissue incising element (12, 52) so that a substantial area of the tissue to be cut is supported by the tissue supporting struts (36, 76). In some embodiments, the deployed tissue supporting struts form a surface 50-4000% greater than the surface formed by the cutting edge of the tissue incising element (12, 52). In some embodiments, the deployed tissue supporting struts (36, 76) form a surface with a general diameter of 5 mm to 25 mm. In other embodiments, the deployed tissue supporting struts (36, 76) form a tissue supporting surface with a general diameter 50-600% greater than the general diameter of the surface formed by the cutting edge of the tissue incising element (12, 52).
FIGS. 5A-5B further illustrate another embodiment of the tissue stabilizer (64) in a transseptal curing device of the present teachings. In some embodiments, the tissue stabilizer (64) has an elongated body (84) with a tissue gripping element (86) at its distal end. In these embodiments, the tissue gripping element has a helical screw like profile (88) with a short and sharp tip (87) for initial tissue engagement. In one embodiment, the tissue stabilizer (64) is advanced distally as indicated by arrow A to allow the tip (87) to engage and grip the tissue. A clinician then rotates the tissue stabilizer (64) as indicated by arrow B to allow the helical screw (88) to further dig into the tissue as shown in FIG. 5B. FIG. 5A shows a delivery profile of the tissue stabilizer (64), specifically, the helical screw like profile (88) held within the lumen of the tissue incising element (12) and the entire tissue coring device held within the lumen (22) of the sheath (30). FIG. 5B shows a deployed profile of the tissue stabilizer (64) where it is advanced distally outside of the lumen (22) of the sheath (30) and engages tissue. One skilled in the art can incorporate any suitable diameter, taper, pitch, lead, and/or thread design in designing and making the helical screw like profile (88) without any undue experimentation. According to some embodiments, during tissue retrieval, the deployed tissue gripping element simply carries the removed tissue, retract proximally, and enter the axial lumen of the tissue incising element or the sheath.
FIGS. 6A-6B further illustrate another embodiment of the tissue stabilizer (94). According to this embodiment, the tissue stabilizer (94) includes an elongated body (92) with a tissue gripping element (90) at its distal end. In addition, the tissue gripping element includes a sharp distal tip (97) for piercing tissue and multiple barb-like elements (96) with reversed hooks (98) at its distal end to engage and secure tissue. In one embodiment, to engage and grip tissue, the tissue stabilizer (94) is advanced distally as indicated by arrow C to allow the tip (97) to pierce the tissue and enter into the opposite side. The tissue stabilizer (94) is then withdrawn proximally, as indicated by arrow D, such that the reversed hooks (98) engage the tissue. FIG. 6A shows a delivery profile of the tissue stabilizer (94) where the helical screw like profile (88) is held within the lumen of the tissue incising element (12) and the tissue coring device is held within the lumen (22) of a sheath (30). FIG. 6B shows the deployed profile of the tissue stabilizer (94) where it is advanced distally outside of the lumen (22) of the sheath (30) and engages tissue. According to some embodiments, during tissue retrieval, the deployed tissue gripping element simply carries the removed tissue, collapse radially, retracts proximally, and enters the axial lumen of the tissue incising element or the sheath.
The tissue stabilizer (14, 54, 64, 94) can be made of a biocompatible metal or polymer. In some embodiments, the tissue stabilizer (14, 54, 64, 94) in whole or in part is made of an elastic material, a super-elastic material, or a shape-memory alloy which allows selected portions to distort into a generally straightened profile during the delivery process and resume and maintain its intended profile in vivo once deployed. In some embodiments, part or all of the tissue stabilizer (14, 54, 64, 94) is made of stainless steel, nitinol, Titanium, Elgiloy, Vitalium, Mobilium, Ticonium, Platinore, Stellite, Tantalum, Platium, Hastelloy, CoCrNi alloys (e.g., trade name Phynox). MP35N, or CoCrMo alloys or other metallic alloys. Alternatively, in such other embodiments, part or the entire device is made of a polymer such as PTFE, UHMPE, HDPE, polypropylene, polysulfone, polymethane, Pebax® or another biocompatible plastic.
FIGS. 1-12 illustrate various embodiments of a tissue incising element of the present teachings. According to some embodiments, the tissue incising element includes a distal end, a proximal end, an extended body between the distal end and the proximal end, an axial lumen through the entire length of the tissue incising element, and a luminal surface. In some embodiments, the proximal end of the tissue incising element joins the distal end of the elongated body (8). In some embodiments, the axial lumen of the tissue incising element joins the central lumen (23) of the elongated tubular body (8) and the axial lumen and the central lumen (23) form a continuous conduit. In some embodiments, the overall size of the tissue incising element remains the same during the percutaneous delivery and tissue removal processes. According to other embodiments, the tissue incising element has a compressed small diameter configuration during the percutaneous delivery, an expanded large diameter (at least at the distal end of the tissue incising element) deployed configuration during the tissue incision, and a collapsed small diameter configuration when the tissue incision element is removed from the body (“device retrieval”). In certain embodiments, the diameter at the distal end of the tissue incision element during the tissue incision process is up to 400% of that during the percutaneous delivery or device retrieval processes. According to other embodiments, the tissue incising element is configured to transition from the delivery configuration to the deployed configuration via an elastic transformation, a thermal transformation, a mechanical actuation, or other means known to those skilled in the art.
In various embodiments, the tissue incising element is configured to move distally or proximally by a clinician from outside of the body. In various embodiments, the tissue incising element is configured to rotate clock-wise or counter clock-wise by a clinician from outside of the body. The mechanism for percutaneously moving a medical device and/or the tissue stabilizer distally or proximally or rotating the medical device in a clock-wise or counter clock-wise fashion are known in the art. In some embodiments, the tissue incising element also includes a cutting edge for removing tissue. The cutting edge and use thereof is discussed herein, including as shown in FIGS. 13A-13E.
In various embodiments, the cross section of the tissue incising element (12) is circular or polygonal, such as square or hexagonal. In some embodiments, the cross section of the tissue incising element (12) is substantially uniform throughout its length. In other embodiments, the cross section of the tissue incising element (12) varies throughout the length.
In various embodiments, the tissue is removed by the a direct force “F1”, as shown in FIG. 1, applied by the tissue incising element against the deployed tissue stabilizer (14, 54). In various other embodiments, the septal tissue is removed by a torque “F2”, as shown in FIGS. 2 and 14D, by rotating the tissue incising element against the tissue stabilizer (14, 54). In yet other embodiments, the septal tissue is removed by a combination of a direct force “F1” and a torque “F2.”
FIGS. 1-6 illustrate several exemplary tissue incising elements (12) according to the present teachings. In various embodiments, the tissue incising element (12) includes a distal end (24), a proximal end, and a tubular body with an axial lumen (26) and a continuous luminal surface extending in between. In some embodiments, the tissue incising element (12) has an uniform diameter throughout its entire length. In various embodiments, the distal end of the tissue incising element (12) has a generally continuous sharp tissue cutting edge (106). In some embodiments, the proximal end (11) of the tissue incising element is capable of joining the proximal end of the elongated body (not shown) by a mechanical, a chemical, a thermal, or other mechanisms known to those in the field.
FIG. 7A illustrates another embodiment of the present teachings, where the tissue incising element (120) is at its deployed configuration. At its deployment configuration, the tissue incising element (120) is expanded in the shape of a cone, a bell, a funnel, a trumpet, or any other shapes that provide a greater diameter. FIG. 7A illustrates an embodiment of the present teachings where the tissue incising element (120) has a preformed cone shaped body (122). In some embodiments, the preformed cone shaped body includes a wide base at the distal end (124) and a narrow base at the proximal end (126). In some embodiments, the tissue incising element (120) includes a generally continuous tissue cutting edge (106) at its distal end (124). In some embodiments, the tissue incising element includes a preformed funnel-shaped body with a radially expanded distal portion, a tubular shaped segment at the distal end of the distal portion, a shorter but more steeply angled cone at the proximal end of the distal portion, and a tissue cutting edge at the distal end. In various embodiments, the tissue incising element has a collapsed configuration where the tissue incising element is constrained by a sheath, the cone shaped body collapses to form an elongated shape with the proximal and distal ends of the incising element being generally the same size.
In various embodiments, the tissue incising element (120) is preformed into its expanded profile and can transition from its expanded profile to its collapsed profile. In some embodiments, the cone shaped body includes one or more slits (128) and one or more flaps (130, 132). In some embodiments, some of these slits (128) are along a portion or the entire length of the cone shaped body (122) of the tissue incising element (120). In some embodiments, portions of the adjacent flaps (130, 132) of the tissue incising element (120) overlap when the tissue incising element (120) is in its collapsed profile. FIG. 7B illustrate the distal end view of the tissue incising element (120) in the collapsed profile where flaps (130, 132) defined by the slits collapse inward and sections of the flaps overlap one another.
FIG. 8 illustrates another exemplary tissue incising element (140) at its deployed configuration. In this particular example, the tissue incising element (140) includes a pre-formed generally cylindrical shaped distal portion (142) and the distal portion includes a continuous luminal surface, a generally continuous tissue cutting edge (106) at the distal end (144), and a proximal tab (146) adapted to connecting the distal portion (142) of the tissue incising element (140) to the distal end of the elongated body (8) (not shown). Similar to what is described in FIG. 8, the tissue incising element (140) transitions from its deployed profile to its collapsed profile through various means or designs. For example, the tissue incising element (140) can have at least one longitudinal slit and at least two flaps, of which portions overlap when the tissue incising element (140) collapses into a smaller delivery profile. In certain embodiments, the distal portion (142) and the proximal tab (146) of the tissue incising element (140) are portions of a unitary piece out of a same material. In certain embodiments, the distal portion (142) and the proximal tab (146) of the tissue incising element (140) are separate pieces that are joined together.
FIGS. 9A-9C illustrate another exemplary tissue incising element (150). Similar to what has been described in connection with FIG. 8, the tissue incising element (150) in its deployed configuration also includes an enlarged distal portion (152), a proximal tab (156), and a generally continuous tissue cutting edge (106) at the distal end (154). Unlike the embodiment illustrated in FIG. 8, the distal portion (152) of the tissue incising element (150) in this instance is preformed to a delivery profile adapted to be delivered through the sheath (30) as shown in FIG. 9A. Upon reaching the treatment site, the tissue incising element (150) extends outside of the sheath (30) and expanded manually, for example, by a balloon, as shown in FIGS. 9B and 9C. Similar to what has been described in connection with FIG. 8, the tissue incising element (150) has at least one longitudinal slit that facilitate a transition from the delivery profile to the deployed profile.
FIG. 10 illustrates another embodiment of a tissue incising element (160) at its deployed configuration according to the present teachings. In this particular example, the tissue incising element at its expanded profile (160) includes a general continuous cutting edge (106) at a distal end (162), a proximal end (164), an end elongated body (8) (not shown) joining the distal end and the proximal end, and a luminal surface (166). The distal end (162) of the tissue incising element (160) has a generally larger diameter than the proximal end (164). The luminal surface (166) connecting the proximal and distal ends (162, 164) are not continuous, but has a web like surface configuration. Examples of such a web like surface configuration include a coil, a helical spiral, a woven, individual rings, sequential rings with regular connection, periodic connections, a peak-peak connection, a peak-valley connection, and an open cell. Other examples of such a web like surface configuration can be found commonly in the stent design. One ordinarily skilled in the art would understand what has been shown in FIG. 10 is only an example and should not be viewed as limiting to the scope of the present teachings. According to some embodiments, such a web like surface configuration allows the tissue incising element (160) to have a compact delivery profile with a small diameter. Upon being released from a delivery system, the tissue incising element (160) expands either through an elastic recovery process or through a thermal shape memory transition process.
Choosing a method of making a tissue incising element depends mainly on the raw material. In some embodiments, wires are formed into a tissue incising element (160) in various ways by selecting from conventional wire forming techniques, including coiling, braiding, or knitting. In certain embodiments, subsequent welding at specific locations produces a closed-cell wire tissue incising element (160) with an increased longitudinal stability. In other embodiments, a tissue incising element (160) is produced by laser cutting or photochemical etching of a tubing. Similar to what has been described in connection with FIGS. 7-9, the tissue incising element (160) can have a preformed large or small diameter profile and/or can transition from a delivery configuration to a deployed configuration by an elastic recovery, a thermal transformation, or a mechanism enlargement.
FIG. 11 illustrates another exemplary tissue incising element (170) at its deployed configuration. Similar to what has been discussed in connection with FIG. 10, the tissue incising element (170) at its expanded profile has a distal end (172), a proximal end (174), and a luminal surface (176) with web-like surface extending between the distal and proximal end. In this particular example, the distal end has a larger dimension than the proximal end. Like the embodiment discussed in connection with FIG. 10, such a web like surface configuration allows the tissue incising element (170) to have a compact delivery profile and expand to a larger deployed profile by an elastic recovery process and a thermal shape memory transition process upon the tissue incising element being released from the delivery system.
In this particular example, the distal end (172) does not include a continuous distal edge. As shown in FIG. 11, the tissue incising element (170) includes a plurality of struts (178) extending from the proximal end (174) to the distal end (172). The struts each has a relative sharp distal tip for engaging the tissue and a sharp cutting edge (108) along one side that faces the adjacent strut. In various embodiments, the tissue incising element (170) is advanced distally outside of the sheath and expands to its deployed profile; the tissue incising element (170) at its deployed profile is further advanced distally so that the distal tips of the struts pierce the target tissue; and the tissue incising element (170) are rotated as indicated by the arrow B, allowing the cutting edge (108) further slicing the tissue. The cross-section of each of the distal portion of the struts can be of any shape as long as it is suitable for tissue incising. Similar to what has been described in connection with FIGS. 7-10, the tissue incising element (170) can have a preformed large or small diameter profile and/or transition from a delivery configuration to a deployed configuration by an elastic recovery, a thermal transformation, or a mechanism enlargement.
FIG. 12A illustrates another exemplary tissue incising element (180). In this particular example, the tissue incising element includes a plurality of cutting blades (182) arranged in a circle. In various embodiments, the cutting blades (182) are configured to pivot radially transitioning from a delivery profile to a deployed profile. In its delivery profile, constrained by a sheath, the cutting blades (182) of the tissue incising element (180) pivot inward radially with the distal ends (184) gathered closely and all blades (182) gathered next to one another to form a generally elongated profile. FIG. 12A illustrates a deployed profile of the tissue incising element (180). As shown in FIG. 12A, the tissue incising element extends outside of the distal end of the sheath and all the cutting blades (182) radially pivot outward with the distal ends (184) of the cutting blades (182) extending radially away from the central axis. Similar to what has been described in connection with FIG. 11, the cutting blade (182) can have a sharp distal tip for initially engaging the tissue and a cutting edge (108) along one side that faces an adjacent blade (182), as illustrated in FIG. 12B. Tissue is removed by first piecing the tissue with the distal tip of the cutting blades (182) and rotating the tissue incising element (180) to allow the cutting edges (108) of the blade (182) to incise the tissue. Similar to what has been described herein, the transition from a delivery profile to a deployed profile can be due to an elastic recovery or a thermal-shape transformation.
Now referring to FIGS. 13A-13E, certain exemplary cutting edges (106) of a tissue incising element of the present teachings are provided. According to some embodiments, the distal end of the tissue incising element includes a generally continuous cutting edge (106) along the circumference. In some embodiments, the tissue incising element has a luminal wall with an outer luminal surface (102) and an inner luminal surface (104). As illustrated in FIGS. 13A-13B, the cutting edge (106) includes a single edged bevel. FIG. 13A illustrates cutting edges (106) formed by a single edged bevel tapering from the outer luminal surface (102) to the inner luminal surface (104) and FIG. 13B illustrates a single edged bevel tapering from the inner (104) to the outer luminal surface (102). FIG. 13C shows a cutting edge (106) formed by a double edged bevel tapering from both the outer luminal surface and inner luminal surface (102, 104). Both the embodiments have a general “V” shaped cutting edge and can be used as cutting tools. The angle “θ” of the V shape at the cutting edge can range from 12 to 50 degrees.
In some embodiments, the bevel described herein is formed by removing a portion of the luminal wall by using a proper method, including grinding. According to some embodiments, the edge is formed by a straight bevel as illustrated in FIGS. 13A-13C. In other embodiments, the edge is formed by a conical, cannel, or rolled bevel curves or rolls as shown in FIG. 13D. In yet other embodiments, the edge is formed by a concave grind bevel as illustrated in FIG. 13E. One reasonably skilled in the art could use other designs create a cutting edge in of the tissue incising element without any undue experimentation. Thus what's described and illustrated herein should not be viewed as limiting.
In some embodiments, the mechanical cutting action of the tissue incising element may be coupled with a radio frequency energy source. For example, the radio frequency energy source can be used to thermally ablate tissue in contact with the tissue incising element. Without intending to limit the scope of the present teachings, the ablation action is used to reduce the force required to advance the tissue incisor through the septal wall.
According to some embodiments, the cutting edge (108) of a tissue incising element discussed in connection with FIGS. 11-12 include a single edged bevel, a double edged bevel with the angle “θ” of the cutting edge ranging from 12 to 50 degrees, a straight or curved bevel similar to those described in FIGS. 13A-13E.
In various embodiments, the elongated body (8) and the tissue incising element are parts of an uniform and monolithic body. In such embodiments, the entire elongated body (8) and the tissue incising element is made of one material strong enough for the tissue cutting and flexible enough to be delivered percutaneously into the body. In some embodiments, the tissue incising element is a separate component and is attached to the distal end of the elongated body (8). In such embodiments, the elongated body (8) is made of a flexible material such as polyether-block co-polyamide polymers, for example PebaxTM; polyethylene, polytetrafluoroethylene (EPTFE), Fluorinatedethylenepropylene (FEP), polyurethane etc. In addition, in such embodiments, the tissue incising element is made of a hard material such as stainless steel, titanium, ceramic, alloy metal etc. The attachment of the incising element and the elongated body can be achieved by a variety of means, including a mechanical means, for example an interference connection or a threaded connection between the distal portion and the tubular body: an energy means such as heat, laser, ultrasonic, or other types of welding etc; or a chemical means such as adhesive bonding, etc. Other methods of attachment known to those skilled in the art can also be incorporated.
Each of the exemplary tissue stabilizer described in FIGS. 1-6 and each of the tissue incising element described in FIGS. 1-12 can be combined to into a transseptal tissue coring device within the scope of the present teachings.
In some embodiments, the aperture created by a transseptal tissue coring device of the present teachings allows fluid communication between the left and right atria, thereby releasing the left heart pressure. In many embodiments, in order to provide a continuous relief to the left atrium, it is preferred that the aperture between the right and left atria does not re-close itself during a healing process. In certain embodiments, a tissue incising element of the present teachings has a cutting edge with a minimum diameter so that the aperture produced by the incising element also has a minimum size. For example, the cutting edge of the tissue incising element can have a general diameter of 4 mm to 12 mm.
Another aspect of the present teachings relate to methods of delivering and deploying a transseptal coring device. One ordinarily skilled in the art would understand that what is described below are only exemplary methods of percutaneously delivering a transseptal tissue coring device of the present teachings and that other methods can also be used without departing from the spirit of the present teachings. Accordingly, the disclosure should not be viewed as limiting. For example, a transseptal tissue coring device can be delivered without a delivery sheath or a tissue stabilizer can penetrate the septal tissue at its distal end, instead of tracking over a guide wire affixed in the septum beforehand.
Additionally, one ordinarily skilled in the art would also understand that although methods and processes of delivering and/or deploying a transseptal tissue coring device is described with reference to the exemplary devices described in FIGS. 2-3, these methods and/or processes can also be used with other embodiments, including those described in FIGS. 1-12. Thus what is disclosed here should not be viewed as limiting.
According to some embodiments, a transseptal tissue coring device of the present teachings is delivered through a standard right heart catheterization procedure. In such a procedure, the device is delivered through an insertion site on the femoral vein through the inferior vena cava to the right atrium. In some embodiments, a delivery sheath is used to transport a transseptal tissue coring device to a treatment location. In some embodiments, a guide wire is also used to locate a treatment site and assist the delivery of a transseptal tissue coring device to the treatment site.
Referring to FIG. 14A, according to various embodiments, a transseptal tissue coring device (10) is delivered via a delivery system. In some embodiments, a delivery system includes a delivery sheath (30) with a proximal end (not shown), a distal end (31), a longitudinal lumen (22) extending between the proximal and distal ends and a control mechanism attached to the proximal end of the delivery sheath (30) and configured to control the movement of both the delivery sheath and the transseptal tissue coring device (10). The transseptal tissue coring device (10) in its delivery profile, for example, as illustrated in FIG. 2, is slidably disposed within the central lumen (22) of the delivery sheath (30).
Still referring to FIG. 14A, the delivery system further includes a guide wire (130) to ensure that the transseptal tissue coring device (10) is placed at the desired treatment location. As shown in FIG. 14A, the guide wire (130) has a proximal end (not shown), a distal end (132), and an elongated body (134) extending between the proximal end and the distal end. The proximal end of the guide wire (130) is operably connected to the control mechanism outside of the body. In one embodiment, the guide wire (130) is slidably disposed within the tissue incising element (12) of the transseptal tissue coring device and side by side to the tissue stabilizer (14) of the transseptal tissue coring device (10). In another embodiment, the guide wire is disposed within a central lumen of the tissue stabilizer of the transseptal tissue coring device, for example, the central lumen (74) of the tissue stabilizer (54).
In yet another embodiment of the present teachings, as shown in FIG. 14A, the guide wire (130) is first delivered to the treatment site via a right heart catheterization and pierces through the atrial septum (7) so that the distal end (132) of the guide wire (130) is inside the left atrium (4), as illustrated in FIG. 14A. In some embodiments, a delivery sheath (30) holding a transseptal tissue coring device (12) in its delivery profile inside its central lumen (26) traces over the guide wire (130) and reaches the treatment site. In another embodiment, the transseptal tissue coring device (10) in its elongated delivery profile rides over the guide wire (130) without using a delivery sheath and reaches the treatment location.
Now referring to FIG. 14B, in some embodiments, the transseptal tissue coring device (10) is deployed by first advancing the coring device distally while holding the delivery sheath (30) held steady so that the tissue incising element (12) holding the tissue stabilizer (14) extends distally beyond the delivery sheath (30) and stops at a location approximate to the atrial septum (7). Alternatively, the delivery sheathing (30) holding the transseptal tissue coring device (10) in its delivery profile is advanced to a location approximate to the atrial septum (7) followed by withdrawing the delivery sheath (30) proximally while the transseptal tissue coring device (10) is held steady.
FIG. 14C illustrates an exemplary tissue stabilizer (14) with its distal portion and the tissue supporting struts (36) deployed inside the left atrium (4). In one embodiment, while holding the tissue incising element (12) steady, the tissue stabilizer (14) is advanced distally across the atrial septum (7). This step is achieved by the tissue stabilizer (14) tracing over the guide wire (130) or by the tissue stabilizer (14) piercing through the atrial septum (6) first at its distal end. As the distal portion of the tissue stabilizer (14) extends distally beyond the distal end of the tissue incising element (12), the tissue supporting struts (36) become free from the constraint of the tissue incising element (12) and extend radially outward to form a substantially planar tissue supporting surface. Thus, in certain instances, it is important to manage the distance between the distal end (24) of the tissue incising element (12) to the atrial septum (7), such that the tissue supporting struts (36) do not fully exit from the constraint of the tissue incising element (12) until they are fully inside the left atrium (4). In another embodiment, after the distal portion of the entire transseptal tissue coring device (10) in its delivery profile extends into the left atrium (4), while holding the tissue stabilizer (14), the tissue incising element (12) is retracted proximally to expose the tissue supporting struts (36). In this instance, the tissue supporting struts expand radially inside the left atrium (4) to form a substantially planar tissue supporting surface. In yet another embodiment, a separate sheath holding a tissue stabilizer (14) is used. In this instance, the separate sheath is extended from the right atrium across the atrial septum to the lift atrium, the tissue stabilizer is distally extended outside the separate sheath and the tissue supporting struts expanded radially.
In various embodiments, the deployment of a tissue incising element depends on the deployment of a tissue stabilizer. In various embodiments, the deployment of a tissue incising element is independent from the deployment of a tissue stabilizer. In some embodiments, a tissue incising element is deployed simultaneously as a tissue stabilizer. In some embodiments, a tissue incising element is deployed after the deployment of a tissue stabilizer.
In various embodiments, where a guide wire (130) is not used during a device delivery, a separate transseptal puncture needle can be used to create a small incision on the septum for a tissue stabilizer to cross over. In such embodiments, the tissue stabilizer can slide over the transseptal puncture needle. In other embodiments, the distal end of the tissue stabilizer can be used to perforate the atrial septum and allow the rest of the distal portion of the tissue stabilizer to cross the atrial septum. One reasonably skilled in the art would understand that other devices and/or methods can also be used deliver a tissue stabilizer across the atrial septum. For example, a radio frequency energy source can be coupled to a tissue stabilizer such that the distal end of the tissue stabilizer can create a small hole to allow the distal portion of the tissue stabilizer to cross over the atrial septum.
FIG. 14D illustrates an exemplary tissue coring process with a transseptal tissue coring device (10) according to the present teachings. First, the clinician withdraws the tissue stabilizer (14) proximally so that the radially expanded tissue supporting struts (36) are positioned against the atrial septum from the left atrium. Then the clinician incises tissue from the atrial septum by positioning the tissue incising element (12) against the atrial septum from the right atrium and advancing the tissue incising element (12) distally while holding the tissue stabilizer (14) steady. The tissue is cut by either a direct force “F1”, a torque “F2” as illustrated in FIG. 14D, or a combination of both.
FIG. 14E illustrates an exemplary process where a tissue stabilizer (14) captures and removes a piece of the septal tissue (150) from the body. In some embodiments, after septal tissue (150) is incised, the clinical retracts the tissue stabilizer (14) proximally inside the tissue incising element (12) and the tissue stabilizer carries the removed tissue (150). Specifically, as illustrated in FIG. 14E, as the tissue stabilizer (14) retracts proximally back into the tissue incising element (12), the distal end (24) of the tissue incising element (12) pushes the detached septal tissue (150) against the tissue supporting struts (36), and the tissue (150) and the tissue supporting struts (36) fold inward distally and enter the distal end (24) of the tissue incising element (12). The detached tissue (150) is captured between the folded tissue supporting struts (36) and the inner luminal wall of the tissue incising element (12).
In an alternative embodiment, as illustrated in FIG. 14F, after the tissue is incised, the tissue incising element (12) is retracted proximally and removed from the body while the delivery sheath (30) is advanced distally to a proximity of the atrial septum (7). Then, the tissue supporting struts (36) along with the detached septal tissue (150) are folded distally inward and enter the sheath from its distal end. The entire system including the sheath and the tissue stabilizer is then removed from the body as illustrated in FIG. 14F.
On reasonably skilled in the art would understand that a control mechanism can be used to manage the motion of the delivery sheath, the tissue incising element, the tissue stabilizer, and the guide wire, each of which is described herein. In some embodiments, each of the delivery sheath, the tissue incising element, the tissue stabilizer, and the guide wire moves independently. In other embodiments, motions of the delivery sheath, the incising element, the tissue stabilizer, and the guide wire can be linked to one another for convenience.
The present teachings are capable of other embodiments or of being practiced or carried out in various other ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.
Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which these present teachings belong. Methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present teachings. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.

## Claims

1. A transseptal tissue coring device comprising a cutting edge and a supporting surface, each of which comprises a delivery profile and a deployed profile;
wherein at least one dimension of the cutting edge in the deployed profile is up to 400% of that in the delivery profile; and
the cutting edge in the deployed profile is capable of applying a force against the supporting surface in the deployed profile to cut tissues; and
the supporting surface is derived from a tubular body having a proximal end, a distal end, and a plurality of slits extending substantially from the proximal end to the distal end;
wherein the deployed supporting surface is substantially parallel to a surface formed by the deployed cutting edge and is greater than the dimension of the deployed cutting edge.

2. The transseptal tissue coring device of claim 1, wherein the at least one dimension of the cutting edge in the deployed profile is about 4 mm.

3. The transseptal tissue coring device of claim 1, wherein at least one dimension of the cutting edge in the delivery profile is greater than that of the supporting surface in the delivery profile.

4. The transseptal tissue coring device of claim 1, wherein the cutting edge comprises a plurality of flaps.

5. The transseptal tissue coring device of claim 1, wherein the supporting surface comprises one or more supporting struts.

6. The transseptal tissue coring device of claim 1, wherein each of the slits is parallel to the longitudinal axis of the tubular body.

7. The transseptal tissue coring device of claim 1, wherein each the slits is spiral along the tubular body.

8. The transseptal tissue coring device of claim 1, wherein the device is configured to percutaneously remove internal tissue.

9. The transseptal tissue coring device of claim 8, wherein the internal tissue is from the atrial septum.

10. A transseptal tissue coring device comprising:
a tissue incising element comprising a proximal end, a distal end, a longitudinal lumen extending from the proximal end to the distal end, and a sharp edge at the distal end, and
a tissue stabilizer comprising an elongated body, a distal portion, and a plurality of tissue supporting struts formed by a plurality of slits along the elongated body of the distal portion of the tissue stabilizer, wherein the tissue supporting struts form a supporting surface, wherein the supporting surface is substantially parallel to a surface formed by the sharp edge of the tissue incising element; and
is greater than the dimension of the sharp edge of the tissue incising element.

11. The transseptal tissue coring device of claim 10, wherein each of the tissue supporting struts comprises a fixed end attaching to the elongated body and a free end extending radially away from the elongated body of the tissue stabilizer.

12. The transseptal tissue coring device of claim 10, wherein the tissue stabilizer comprises a delivery profile and a deployed profile and the tissue stabilizer is slidably disposed within the longitudinal lumen of the tissue incising element in its delivery profile.

13. The transseptal tissue coring device of claim 12, wherein the tissue supporting struts are stowed radially along the elongated body of the tissue stabilizer in the delivery profile.

14. The transseptal tissue coring device of claim 12, wherein the tissue supporting struts expand radially outward forming the supporting surface in the deployed profile.

15. A method of percutaneously removing tissue from the heart comprising:
providing a transseptal tissue coring device according to claim 10;
advancing the transseptal tissue coring device to a proximity of the atrial septum, expanding the tissue supporting struts of the tissue stabilizer radially and
positioning the tissue stabilizer against the atrial septum inside the left atrium,
positioning the tissue incising element against the atrial septum inside the right atrium,
advancing the tissue incising element distally,
incising tissue from the atrial septum, and
capturing the removed septal tissue inside the transseptal tissue coring device.