Cardiac therapy system

Abstract

Systems and methods for removing heart valve therapy are disclosed. The systems and methods can include a chord cutting device with a unique shape memory curvature, a capture basket catheter with a basket, and a leaflet cutting tool with a unique shape that can be pulled through leaflet tissue.

Description

Related applications

[0001] This application claims the benefit and priority of U.S. Provisional Application Serial No. 63 / 557,356, entitled “Leaflet Cutter With A Snare,” filed February 23, 2024, and U.S. Provisional Application Serial No. 63 / 671,685, entitled “Chord Cutter and Basket Improvements,” both of which are hereby incorporated herein by reference in their entirety. Background Technology

[0002] Heart valve conditions can occur when the leaflets of a heart valve cannot close completely, allowing blood to flow back or abnormally. Regurgitation is particularly common with the mitral valve, where the anterior leaflet fails to properly engage with the posterior leaflet. When the heart's ventricles contract, some blood moves from the left ventricle back into the left atrium instead of the aorta. A similar regurgitation can occur with the tricuspid valve, allowing blood to flow from the right ventricle back into the right atrium.

[0003] A common treatment for valvular regurgitation is the use of a device that juxtaposes or permanently connects the valve leaflets. This heart valve treatment hardware may have been placed surgically, transcatheterically, or minimally invasively. For example, the hardware or treatment for targeted removal could be a mitral clip (MitraClip, Abbott Structural, Santa Clara, CA), a PASCAL device (Edwards Lifesciences, Irvine, CA), surgically placed sutures (e.g., Alfieri sutures), or similar heart valve treatments. Other heart valve treatments may be the result of techniques that already involve the valve leaflet as part of the treatment target, and that portion or all of the involved leaflet needs to be removed. Other examples include chordal replacement technologies, placed transcatheterically or surgically, to compensate for inappropriate length, interruption, or misalignment of existing chordaes. For the purposes of this application, the phrase “heart valve treatment” should be defined as any device and / or method used for therapeutic heart valve treatment, such as leaflet clips, sutures, artificial chordae tendineae, or any other device or method associated with the treatment of heart valves and associated leaflets.

[0004] These heart valve treatments are typically performed via open cardiac surgery, which can be particularly invasive for patients and carries a relatively high risk of complications. Therefore, there is a continued need for less invasive methods of heart valve removal that present a lower risk of complications. Summary of the Invention

[0005] In some respects, the technology described herein relates to a tissue cutting catheter for use in the heart, the tissue cutting catheter comprising: an elongated control member; a filament connected to a distal portion of the elongated control member; wherein the filament has a memorized, unconstrained shape forming a first curve; and one or more electrodes positioned at the apex of the first curve.

[0006] In some respects, the technology described herein relates to a tissue cutting catheter, wherein a first curve includes a first filament segment, a second filament segment connected to and extending from the first filament segment, a third filament segment connected to and extending from the second filament segment, and a fourth filament segment connected to and extending from the third filament segment; and wherein the second filament segment and the fourth filament segment are formed at angles within a range of about 30 degrees and about 50 degrees.

[0007] In some respects, the technology described herein relates to a tissue cutting catheter, wherein a first curve includes a first filament segment, a second filament segment connected to and extending from the first filament segment, a third filament segment connected to and extending from the second filament segment, and a fourth filament segment connected to and extending from the third filament segment; and wherein the second filament segment and the fourth filament segment are formed at angles within a range of approximately 35 degrees and approximately 45 degrees.

[0008] In some aspects, the technology described herein relates to a tissue cutting catheter, wherein a first curve includes a first filament segment, a second filament segment connected to and extending from the first filament segment, a third filament segment connected to and extending from the second filament segment, and a fourth filament segment connected to and extending from the third filament segment; and wherein the circles tangentially contacting the second, third, and fourth filament segments have a diameter within a range of about 2.5 mm to about 13 mm.

[0009] In some aspects, the technology described herein relates to a tissue cutting catheter, wherein a first curve includes a first filament segment, a second filament segment connected to and extending from the first filament segment, a third filament segment connected to and extending from the second filament segment, and a fourth filament segment connected to and extending from the third filament segment; and wherein the circles tangentially contacting the second, third, and fourth filament segments have diameters within a range of about 3.7 mm, 3.9 mm, 4 mm, 4.1 mm, 4.2 mm, 4.3 mm, or 4.4 mm.

[0010] In some respects, the technology described herein relates to a tissue cutting catheter, wherein a first curve includes a first filament segment, a second filament segment connected to and extending from the first filament segment, a third filament segment connected to and extending from the second filament segment, and a fourth filament segment connected to and extending from the third filament segment; and wherein the first filament segment, the second filament segment, the third filament segment, and the fourth filament segment are positioned at different angles relative to each other.

[0011] In some respects, the techniques described herein involve tissue cutting catheters, wherein the first filament segment, the second filament segment, the third filament segment, and the fourth filament segment are generally located in the same plane.

[0012] In some respects, the techniques described herein relate to tissue cutting catheters, wherein a second, third, and fourth filament segment are generally positioned within a first plane, and wherein the first filament segment is generally positioned within a second plane different from the first plane.

[0013] In some respects, the technique described herein relates to a tissue cutting catheter, wherein a first curve is formed by a second filament segment, a third filament segment and a fourth filament segment, and wherein, when viewed toward the distal direction, the first curve bends in a generally clockwise direction.

[0014] In some respects, the technique described herein relates to a tissue cutting catheter, wherein a first curve is formed by a second filament segment, a third filament segment and a fourth filament segment, and wherein, when viewed toward the distal direction, the first curve bends in a generally clockwise direction.

[0015] In some respects, the technique described herein relates to a tissue cutting catheter, wherein a first curve is formed by a second filament segment, a third filament segment and a fourth filament segment, and wherein, when viewed toward the distal direction, the first curve bends in a generally counterclockwise direction.

[0016] In some respects, the techniques described herein relate to tissue cutting catheters, wherein the filament is formed into a loop, and wherein the loop forms a first filament segment, a second filament segment, a third filament segment, and a fourth filament segment.

[0017] In some respects, the technology described herein relates to a capture basket catheter for use in the heart, the capture basket catheter comprising: an elongated catheter body; a basket formed of one or more filaments woven together and connected to a distal portion of the elongated catheter body; and at least one flexible filament connected at multiple locations on the basket to limit the size of the basket's cellular structure.

[0018] In some respects, the techniques described herein relate to a capture basket conduit in which one or more filaments woven together form multiple cross filament sections; and in which at least one flexible filament forms a knot or loop around at least some of the cross filament sections.

[0019] In some respects, the techniques described herein involve capturing basket conduits, wherein at least one flexible filament forms a circumferential pattern around the basket.

[0020] In some respects, the techniques described herein involve capturing basket conduits, wherein at least one flexible filament extends longitudinally along the basket.

[0021] In some respects, the techniques described herein involve a capture basket conduit in which at least one flexible filament extends along the distal quarter, distal third, or distal half of the basket.

[0022] In some respects, the technology described herein relates to a capture basket conduit, wherein at least one flexible filament comprises a tensile-resistant or elastic material.

[0023] In some respects, the techniques described herein relate to a capture basket conduit, wherein at least one flexible filament comprises a solid PET filament, a solid metal filament, multiple polymer yarn fibers, or a solid silicone filament.

[0024] In some respects, the techniques described herein relate to a capture basket conduit, wherein the basket includes an opening in a cavity leading to the basket, the opening opening in a proximal direction when in an expanded configuration.

[0025] In some respects, the techniques described herein relate to a capture basket catheter, wherein the elongated catheter body further includes a distal tip member comprising a retaining portion at the intersection of two filament segments connected to one or more filaments.

[0026] In some respects, the technology described herein relates to a capture basket conduit, wherein the retaining portion comprises two upper wire openings and two lower wire openings; and wherein each of two wire segments passes through one of the two upper wire openings and one of the two lower wire openings.

[0027] In some respects, the techniques described herein relate to a capture basket conduit, wherein the distal tip member further includes two tightening filament openings, and wherein the tightening filaments are positioned to pass through the two tightening filament openings and through a loop in the basket.

[0028] In some respects, the technology described herein relates to a capture basket catheter for use in the heart, the capture basket catheter comprising: an elongated catheter body having; a basket formed of one or more wires woven together; and a distal tip member including a retaining portion connected to the intersection of two filament segments of the one or more filaments.

[0029] In some respects, the technology described herein relates to a capture basket conduit, wherein the retaining portion comprises two upper wire openings and two lower wire openings; and wherein each of two wire segments passes through one of the two upper wire openings and one of the two lower wire openings.

[0030] In some respects, the techniques described herein relate to a capture basket conduit, wherein the distal tip member further includes two tightening filament openings, and wherein the tightening filaments are positioned to pass through the two tightening filament openings and through a loop in the basket.

[0031] In some respects, the techniques described herein relate to a capture basket conduit, wherein two upper wire openings and two lower wire openings are located distal to two bundled wire openings.

[0032] In some respects, the technology described herein relates to a tissue cutting device for use in the heart, the tissue cutting device comprising: an elongated catheter body; a core wire connected to a distal end of the elongated catheter body; the core wire including a memory shape forming a first curve when unconstrained, a snare attachment structure located at or near the distal tip of the core wire, and one or more electrodes positioned along the first curve.

[0033] In some respects, the technology described herein relates to a tissue cutting device, wherein the first curve is within a range of about 160 degrees to about 200 degrees.

[0034] In some respects, the techniques described herein relate to tissue cutting devices, wherein the snare attachment structure is a second curve of the core wire, a sleeve, a coil, or a weld block.

[0035] In some respects, the technology described herein relates to a tissue cutting device that also includes a radiopaque marker positioned on the proximal segment of the core filament at a location laterally flush with the snare attachment structure.

[0036] In some respects, the technology described herein relates to a tissue cutting device that also includes a leaflet puncture tool positioned above the elongated catheter body and the core wire.

[0037] In some respects, the technology described herein relates to a method for removing a heart valve treatment device, the method comprising: positioning a core wire of a tissue cutting catheter to pass from a first side of the valve to a second side of the valve; forming a first curve of the core wire around the heart valve treatment device on the second side of the valve; positioning a snare attachment structure located on a distal region of the core wire to pass back to the first side of the valve; engaging a snare catheter with the snare attachment structure; and activating one or more electrodes along the first curve of the core wire to separate the heart valve treatment device from the valve leaflets.

[0038] In some respects, the technology described herein relates to a method for trimming heart valve leaflets, the method comprising: puncturing a heart valve leaflet with a leaflet puncture tool to form a first opening; positioning the core wire of a leaflet cutting catheter to pass from a first side of the valve to a second side of the heart valve; positioning the snare ring of a snare catheter through the second opening of the heart valve to the second side of the heart valve; engaging the snare ring with a snare attachment structure in a distal region of the core wire; and activating one or more electrodes along the core wire while simultaneously pulling the leaflet cutting catheter and the snare catheter to cut the heart valve leaflet. Attached Figure Description

[0039] The following figures illustrate certain exemplary aspects of this disclosure and should not be considered exclusive or limiting. As will be apparent to those skilled in the art and for which the benefits of this disclosure are available, the disclosed subject matter is capable of considerable modifications, alterations, combinations, and equivalents in form and function. Reference is made to the following figures:

[0040] Figure 1 The figure illustrates the distal end of a tissue cutting catheter with a curved (e.g., hook or "J" shape) filament in its unconstrained configuration.

[0041] Figure 2 The figure shows the distal end of a looped conduit with a wire loop that forms a general saddle shape when unrestrained.

[0042] Figure 3 The figure shows the distal end of a cutting element conduit with a wire having multiple electrodes.

[0043] Figure 4The figure shows the distal end of a capture basket conduit, which has a basket with an opening facing the proximal side.

[0044] Figure 5 , Figure 6 , Figure 7 and Figure 8 The diagram illustrates the use of Figure 1-4 The exemplary procedure shown is the removal of a mitral valve leaflet attached to the mitral valve or, alternatively, a leaflet clip attached to the tricuspid valve using a catheter.

[0045] Figure 9 The figure shows a three-dimensional view of the distal end of the tissue cutting catheter.

[0046] Figure 10 The figure shows a side view of a tissue cutting catheter.

[0047] Figure 11 The figure shows a side view of a tissue cutting catheter.

[0048] Figure 12 The figure shows a side view of a tissue cutting catheter.

[0049] Figure 13 The figure shows an end view of the tissue cutting catheter viewed from the distal side.

[0050] Figure 14 The figure shows an end view of the tissue cutting catheter viewed proximally.

[0051] Figure 15 The figure shows a three-dimensional view of the distal end of the tissue cutting catheter.

[0052] Figure 16 The figure shows another perspective view of the tissue cutting catheter.

[0053] Figure 17 The figure shows a side view of a tissue cutting catheter.

[0054] Figure 18 The figure shows another side view of the tissue cutting catheter.

[0055] Figure 19 The figure shows an end view of the tissue cutting catheter viewed from the distal direction.

[0056] Figure 20 The figure shows an end view of the tissue cutting catheter viewed from the proximal direction.

[0057] Figure 21 The figure shows a three-dimensional view of the distal end of the tissue cutting catheter.

[0058] Figure 22 The figure shows another perspective view of the tissue cutting catheter.

[0059] Figure 23 The figure shows a side view of a tissue cutting catheter.

[0060] Figure 24 The figure shows another side view of the tissue cutting catheter.

[0061] Figure 25 The figure shows an end view of the tissue cutting catheter viewed from the distal direction.

[0062] Figure 26 The figure shows an end view of the tissue cutting catheter viewed from the proximal direction.

[0063] Figure 27 The figure shows a side view of a capture basket conduit 130, which includes flexible filaments 136 along the distal portion of a basket 131.

[0064] Figure 28 The figure shows Figure 27 A magnified view of the net basket.

[0065] Figure 29 The figure shows a side view of a capture basket catheter used with a snare catheter and a capture valve leaflet clip.

[0066] Figure 30 The figure shows a leaflet clip positioned inside the basket of the capture basket duct.

[0067] Figure 31 The diagram shows the proximal opening of a basket that is closed by a binding wire surrounding a loop guide tube.

[0068] Figure 32 The figure shows a side view of the distal tip member.

[0069] Figure 33 The diagram illustrates the relationship between... Figure 32 The view is taken at approximately 90 degrees from the other side of the distal tip member.

[0070] Figure 34 The figure shows a side view of a tissue cutting device that can be used to cut tissue bridges (e.g., valve leaflet clips) connected to heart valve treatment devices.

[0071] Figure 35 The diagram illustrates the relationship between... Figure 34 The view is a side view of the tissue cutting device viewed at approximately 90 degrees from different sides.

[0072] Figure 36 The figure shows a three-dimensional view of the tissue cutting device.

[0073] Figure 37 The figure shows a view of the mitral valve leaflets in the left ventricle.

[0074] Figure 38 The figure shows a view of the mitral valve leaflets in the left ventricle.

[0075] Figure 39 The figure shows a view of the mitral valve leaflets in the left ventricle.

[0076] Figure 40 and Figure 41 The figure shows a view of the leaflet clip on the mitral valve leaflet.

[0077] Figure 42 The figure shows a view of the mitral valve leaflets from the left atrium.

[0078] Figure 43 The figure shows a view of the mitral valve leaflets from the left atrium.

[0079] Figure 44 The figure shows a view of the mitral valve leaflets from the left atrium.

[0080] Figure 45 The figure shows a view of the mitral valve leaflet 14 from the left atrium 10 side.

[0081] Figure 46 The figure shows a side view of a leaflet cutting system, which may include a leaflet cutting catheter, a leaflet puncture tool, and a snare catheter.

[0082] Figure 47 The diagram shows the left ventricular side of the mitral valve leaflet.

[0083] Figure 48 The figure shows another view of the mitral valve leaflet on the left ventricular side.

[0084] Figure 49 The figure shows another view of the mitral valve leaflet on the left ventricular side.

[0085] Figure 50 The figure shows another view of the mitral valve leaflet on the left ventricular side. Detailed Implementation

[0086] Those skilled in the art will understand that this disclosure is not limited to what is specifically shown and described herein. In view of the teachings herein, various modifications and variations are possible without departing from its scope, spirit, or intent.

[0087] While different examples may be described in this specification, it is particularly contemplated that any features from different examples may be used and put together in any combination. In other words, features from different examples can be mixed and matched with each other. Therefore, while every permutation of features from different examples may not be explicitly shown or described, the intent of this disclosure is to cover any such combination, especially as will be understood by those skilled in the art.

[0088] The terminology used in this disclosure should be interpreted in a permissible manner and is not intended to be limiting. In the drawings, the same reference numerals refer to the same elements. Unless otherwise indicated, all drawings are not drawn to scale. Unless otherwise indicated, the term "about" is defined as ±5% of the stated value.

[0089] The term “distal” or “distal” generally refers to the direction or area toward the end of the device inside the patient’s body (e.g., away from the physician / clinician), while the term “proximal” or “proximal” refers to the direction or area toward the end of the device that is outside the patient (e.g., toward or closer to the physician / clinician or the handle / center of the device).

[0090] The range of numbers discussed in this specification should be interpreted as an inclusive range and as covering / disclosing multiple numbers within those ranges. Specifically, for the purposes supported by the claims, the range should be considered to enumerate numbers in increments of two decimal places (hundredths) (e.g., 0.01, 0.02, 0.03, etc.). In the context of this specification, any of these incremental numbers taken from the range should be understood to be significant and important.

[0091] Although the examples in this manual may specifically describe the mitral valve, they may also be used in combination with other valves, such as the tricuspid valve.

[0092] Figures 1-3 The diagram illustrates the distal ends of various catheter tools that can be used to treat heart valves, including the removal of certain heart valve treatment devices (e.g., heart valve leaflet clips). Figures 4-8 These catheter tools and examples of their use with the steerable sheath 116 are described in the document.

[0093] Figure 1 The figure illustrates the distal end of a tissue cutting catheter 184 having a filament 184A in its unconstrained configuration, forming a curve 184D (e.g., a hook, a "J" shape, or a "V" shape). Optionally, the filament 184A may also be formed in a ring shape, such as... Figure 1 As shown, but alternatively, non-circular bent wire can be used.

[0094] Multiple (e.g., two) electrodes 184B may be located on the filament 184A. In some examples, the electrodes 184B are located at least at the base / apex of the curve 184D (or “V” shape), and optionally at other locations. In some examples, the curve or “V” shape may facilitate the delivery of tendons or tissue to the location of the electrodes 184B. In some examples, the filament 184A may be conductive and have shape memory properties (e.g., nitinol), the filament 184A may have an insulating layer along its majority length, and the electrodes 184B may comprise a more heat-resistant material (e.g., stainless steel) attached to and directly connected to the shape memory material. Thus, the curve 184D may be shaped along with the shape memory material, and the electrodes 184B may be expected to conduct current with minimal or no damage.

[0095] The wire 184A can be connected to an elongated catheter body 184C, which includes a conductive path communicating with the proximal ends of both the wire 184A and the elongated catheter body 184C, thereby allowing it to be connected to a current source (e.g., a monopolar radiofrequency current). Therefore, the length of the elongated catheter body 184C is sufficient to reach a desired target location within the heart from outside the patient's body. Electrodes 184B of the wire 184A can further conduct current that can cut tissue near or upon contact with it. This tool can be particularly useful for cutting chordae tendineae and tissues within the heart, such as valve leaflet tissue.

[0096] Figure 2 The figure illustrates the distal end of a snare catheter 186 with a wire loop 186A that forms a generally saddle shape when unrestrained. The wire loop 186A can be attached to an elongated control wire within the catheter body 186C of the snare catheter 186, extending downwards to the proximal end of the catheter body 186C, allowing the user to pull the control wire and thus pull the wire loop 186A into one or more openings 186B located at the distal portion of the catheter body 186C of the snare catheter 186. The control wire and catheter body 186C may have a length that allows the wire loop 186A to travel within the patient's heart when accessed by a physician. Therefore, the wire loop 186A can be closed around an object during procedures, particularly within the heart. This tool is particularly useful for snareing heart valve treatment devices such as leaflet clips during heart valve removal procedures.

[0097] Figure 3The figure illustrates the distal end of a cutting element catheter 188 having a filament 188A with multiple electrodes 188B. The filament 188A may be in the form of a loop (e.g., a curved or saddle-shaped loop) attached to an elongated catheter body 188C, which conducts current (e.g., monopolar radiofrequency current) from its proximal end to the filament 188A and the multiple electrodes 188B when in proximity to or in contact with tissue. In some examples, the filament 188A may be constructed of a shape memory filament having an electrically insulating layer surrounding its outer side. Each of the multiple electrodes 188B may optionally be constructed of a non-shape memory material (e.g., stainless steel) that is more resilient to thermal damage. When unconstrained, the filament 188A may form a generally saddle shape such that when pulled into a larger sheath or catheter, the distal end of the filament 188A closes around the desired target device. This tool can be used in particular to move around heart valve treatment devices (such as leaflet clips) and then cut the leaflet tissue adjacent to the heart valve treatment device, thereby releasing the heart valve treatment device.

[0098] Figure 4 The illustration shows the distal end of a capture basket catheter 190 having a basket 190A with a proximal opening. The basket 190A may be constructed of a mesh or similar material attached to a tightening ring 190B. In some examples, the mesh may consist of a single or multiple braided nitinol wires woven within itself. The tightening ring 190B may be attached to an elongated control wire within the catheter body 190C, extending downwards to the proximal end of the catheter body 190C, allowing the user to pull the control wire at a proximal position and thereby also pull the tightening ring 190B, tightening or closing the opening of the basket 190A. In some examples, the basket 190A and / or the tightening ring 190B may include an electrical insulating layer to prevent unwanted electrical conduction when used with a cutting element catheter 188. This tool may be particularly useful for capturing cardiac valve treatment devices (such as leaflet clips) that have been removed from the valve leaflets.

[0099] Figures 5-8 The diagram illustrates the use of Figures 1-4 The illustrated procedure involves using a catheter to remove the leaflet clip 50 of the mitral valve leaflet 14 attached to the mitral valve.

[0100] Go to Figure 5The catheter initially enters the left atrium 10 of the heart via a transeptal procedure. The distal end of a steerable sheath 116 then travels through the diaphragm and into the left atrium above the mitral valve leaflet 14. In some examples, another catheter or sheath 109 may travel beyond the steerable sheath 116 and into the left ventricle 12, passing through the mitral valve leaflet 14. A tissue-cutting catheter 184 may travel through the sheath 109 such that its wire 184A is also positioned within the left ventricle 12 of the heart, below the mitral valve leaflet 14. The tissue-cutting catheter 184 can be activated (e.g., by applying an RF current) to aid in cutting the chordae tendineae 15 and other tissue that may surround or be attached to the leaflet clip 50, thereby allowing better access to the leaflet clip 50. Additionally, other tissue, such as the mitral valve leaflet 14, may be cut as needed.

[0101] Turning Figure 6 The tissue cutting catheter 184 can be retracted into the sheath 109 and / or the steerable sheath 116 (and / or completely removed from the system), and the snare catheter 186 and the cutting element catheter 188 can travel through the steerable sheath 116. The wire loop 186A of the snare catheter 186 can first travel between the mitral valve leaflets 14 and into the left ventricle 12, such that the wire loop 186A is positioned around the leaflet clamp 50, and then tightened around the leaflet clamp 50.

[0102] Turning Figure 7 The snare catheter 186 can be moved distally away from the mitral valve leaflet 14 to aid in distal movement of the leaflet clip 50 and expose the tissue of the mitral valve leaflet 14 closest to the leaflet clip 50. The wire 188A (e.g., wire loop) of the cutting element catheter 188 can be moved proximally and directly above the leaflet clip 50, and then the plurality of electrodes 188B of the wire 188A (e.g., using RF current) can be activated to cut the tissue of the mitral valve leaflet 14 and thereby release the leaflet clip 50.

[0103] Turning Figure 8 The cutting element catheter 188 can be removed from the steerable sheath 116 and / or sheath 109 and replaced by the capture basket catheter 190. The wire loop 186A of the snare catheter 186 can retract the leaflet clip 50 proximally into the left atrium 10, and then the mesh basket 190A can be placed on the leaflet clip 50 and at least partially tightened to close it. The leaflet clip 50, the snare catheter 186, and the capture basket catheter 190 can be removed from the heart.

[0104] In some examples, a patient may have two leaflet clips 50, and thus the main channel of the steerable sheath 116 may be large enough in diameter to completely remove the first leaflet clip 50 and remain in place to allow the introduction of a new removal device to remove the second leaflet clip 50. The steerable sheath 116 may also be removed or left in place to allow any further procedures to be performed, such as replacing the mitral valve leaflet 14 with an artificial valve and closing the opening created through the diaphragm of the heart. While the mitral valve has been described, similar procedures can be performed on any valve in the heart, such as the tricuspid valve.

[0105] As mentioned above, Figure 1 The tissue cutting catheter 184 can be used for a variety of different cutting procedures within the heart, such as cutting the chordae tendineae of the mitral valve. Depending on the procedure and requirements, different shapes and configurations can be helpful.

[0106] An example of this can be found in Figure 9 As seen in the figure, this diagram shows a three-dimensional view of the distal end of the tissue cutting catheter 100. Figure 10 The figure shows a side view of the tissue cutting catheter 100. Figure 11 The figure shows a side view of the tissue cutting catheter 100. Figure 12 The figure shows a side view of the tissue cutting catheter 100. Figure 13 The figure shows an end view of the tissue cutting catheter 100 viewed from the distal side. Figure 14 The figure shows an end view of the tissue cutting catheter 100 viewed proximally. These figures will be discussed below.

[0107] The tissue cutting catheter 100 is generally similar to the previously described tissue cutting catheter 184, but has a filament 104 at its distal end that forms a unique memory bend shape 102 when unconstrained. In some examples, the filament 104 may be formed into an annular shape with a distal annular opening 104A, and alternatively, the filament 104 may be formed into a non-annular shape, such as a single segment of filament. The filament 104 may include conventional filaments, metal struts, and similar structural members. In some examples, the memory bend shape 102 positions the distal tip of the filament 104 proximal to the apex of the memory bend shape 102 and proximal to one or more electrodes 106 of the filament 104.

[0108] In some examples, filament 104 may be made of a shape memory filament material (such as nitinol), which allows for the imprinting of a memorized curved shape 102. Fiber 104 may be connected to the distal portion of an elongated control filament 105. Figure 13 , Figure 14The length of the elongated control wire 105 allows the distal end of 100 to reach the patient's heart, while the physician manipulates the proximal portion of the tissue-cutting catheter 100.

[0109] The filament 104 may include one or more electrodes 106 (e.g., one, two, three, four, five, six, or more electrodes). Electrodes 106 may be directly connected to the filament 104 and may be made of a material resilient to electrical or thermal damage. For example, one or more electrodes 106 may be made of stainless steel. One or more electrodes 106 may extend entirely around the diameter of the filament 104, or may be positioned only along a portion of the diameter of the filament 104, such as only on the inner surface of the memory-defined curved shape 102. An insulating coating may be provided on exposed areas of the filament 104 other than the one or more electrodes 106. Current (such as a monopolar RF current) may be supplied to the proximal portion of the elongated control filament 105 to the filament 104, and further to the one or more electrodes 106, as needed by a physician, to selectively cut cardiac tissue. In some examples, at least some of the electrodes 106 are located at the apex of the memory-defined curved shape 102, in this example the apex may be a third filament segment 102C.

[0110] In this example, the memory's curved shape 102 is bent in such a way that the filament 104 is generally kept in a single plane. In other words, the longitudinal axis 100A of the reference tissue cutting catheter 100 ( Figure 10 The curved shape 102 of the memory bends only along a single radial direction away from the longitudinal axis 100A. Therefore, the curved shape 102 of the memory is approximately flat, as... Figures 11-14 As shown.

[0111] In this example, the curved shape 102 of the memory can be composed of multiple straight segments angled relative to each other. Alternatively, the curved shape 102 of the memory can be a completely continuous curved shape. The first filament segment 102A can be generally aligned with or parallel to the longitudinal axis 100A. The second filament segment 102B is connected at an angle in the plane to the distal end of the first filament segment 102A and extends from the distal end of the first filament segment; the third filament segment 102C is connected at an angle in the same plane to the distal end of the second filament segment 102B and extends from the distal end of the second filament segment; and the fourth filament segment 102D is connected to the distal end of the third filament segment 102C and extends from the distal end of the third filament segment. Each of these segments can be positioned at a different angle relative to adjacent segments, while also remaining generally in the same plane.

[0112] In some examples, the third filament segment 102C is generally perpendicular to 100A and may include one or more electrodes 106. In some examples, the distal end of the fourth filament segment 102D is positioned more proximally than the third filament segment 102C. In some examples, the longitudinal axes of each of the second filament segment 102B and the fourth filament segment 102D form an angle 102E relative to each other within a range of approximately 0 degrees to approximately 90 degrees. Figure 10 In some examples, the longitudinal axes of each of the second filament segment 102B and the fourth filament segment 102D are formed relative to each other at an angle 102E within a range of approximately 35 degrees to approximately 45 degrees. Figure 10 ).exist Figure 10 In one example, the longitudinal axes of each of the second filament segment 102B and the fourth filament segment 102D form an angle 102E, which is approximately 40 degrees. In some examples, the longitudinal axes of each of the second filament segment 102B and the fourth filament segment 102D form an angle 102E of approximately 39 degrees, 40 degrees, 41 degrees, 42 degrees, 43 degrees, or 44 degrees. Figure 10 In some examples, the circles tangentially contacting the second filament segment 102B, the third filament segment 102C, and the fourth filament segment 102D have diameters ranging from about 2.5 mm to about 13 mm. In some examples, the circles tangentially contacting the second filament segment 102B, the third filament segment 102C, and the fourth filament segment 102D have diameters of about 3.7 mm, 3.9 mm, 4 mm, 4.1 mm, 4.2 mm, 4.3 mm, or 4.4 mm.

[0113] Due to limited space, the valve's orientation relative to other anatomical features (such as the location of chordae tendineae attachments), and the presence of cardiac valve treatment devices (e.g., valve leaflet clips 50), the angles and radii of curvature mentioned above can be particularly advantageous for the ability to cut chordae tendineae and similar tissues within the cardiac chamber. In other words, the example angles and radii of curvature in this example, as well as in other examples in this specification, allow users to navigate within the heart more easily and efficiently, which can reduce surgical time and potential complications (e.g., unintended cut locations).

[0114] In some examples, the second filament segment 102B may have a length within a range of about 1.5 mm to about 16 mm (or about 5.3 mm as shown in the figure), the third filament segment 102C may have a length within a range of about 1.5 mm to 9.5 mm (or about 3 mm as shown in the figure), and the fourth filament segment 102D may have a length within a range of about 1.5 mm to 16 mm (or about 5 mm as shown in the figure).

[0115] The filament 104 of the tissue cutting catheter 100 may also include a radiopaque coil positioned along some or all of the length of an underlying shape memory filament (e.g., nitinol filament) to help improve the visibility of the filament 104 under fluorescence microscopy. In some examples, the radiopaque coil is made of tungsten. Any other examples disclosed in this specification may use similar techniques to improve visibility.

[0116] Since the tissue cutting catheter can pass through the valve substantially vertically, it can be helpful for the memory's curvature to have a more complex shape that bends in multiple planes. For example, the memory's curvature can be formed into a generally spiral or vortex shape, as a continuous curvature or with discrete straight segments.

[0117] An example of this more complex shape can be seen, which has the memory of the clockwise curved shape 112 of the tissue cutting catheter 110. Figure 15 The figure shows a three-dimensional view of the distal end of the tissue cutting catheter 110. Figure 16 The figure shows another perspective view of the tissue cutting catheter 110. Figure 17 The figure shows a side view of the tissue cutting catheter 110. Figure 18 The figure shows another side view of the tissue cutting catheter 110. Figure 19 The figure shows an end view of the tissue cutting catheter 110 viewed from the distal direction. Figure 20 The figure shows an end view of the tissue cutting catheter 110 viewed proximally. These figures will be discussed below.

[0118] The tissue cutting conduit 110 is generally similar to the previously described tissue cutting conduit 100, but has a memory clockwise curved shape 112 that differs from the memory curved shape 102. In other words, the tissue cutting conduit 110 may be similar to the tissue cutting conduit 100, but at the same viewing angle, compared to the 0-degree flat shape of the tissue cutting conduit 100, the angle 112F ( Figure 18 () greater than 0 degrees.

[0119] In this example, the clockwise curved shape 112 of the memory can be composed of multiple straight segments angled relative to each other. The first filament segment 112A can be generally aligned with or parallel to the longitudinal axis 110A. The second filament segment 112B extends from the distal end of the first filament segment 112A, the third filament segment 112C extends at an angle from the distal end of the second filament segment 112B in the same plane, and the fourth filament segment 112D extends at an angle from the distal end of the third filament segment 112C in the same plane.

[0120] In some examples, the longitudinal axis of the first filament segment 112A (e.g., the longitudinal axis 110A of the tissue cutting catheter 110) and the longitudinal axis of the second filament segment 112B are formed in the first direction at an angle 112F within a range of about 1 degree to about 90 degrees (see [reference]). Figure 18 In some examples, the longitudinal axis of the first filament segment 112A (e.g., the longitudinal axis 110A of the tissue cutting catheter 110) and the longitudinal axis of the second filament segment 112B are formed in the first direction at an angle 112F within a range of about 60 degrees to about 80 degrees (see Figure 18 In some examples, the longitudinal axis of the first filament segment 112A and the longitudinal axis of the second filament segment 112B are formed in the first direction at an angle 112F within a range of approximately 65 degrees to approximately 75 degrees (see [reference]). Figure 18 In some examples, the longitudinal axis of the first filament segment 112A and the longitudinal axis of the second filament segment 112B may be further formed at an angle within a range of about 15 degrees to about 25 degrees in the second direction, which may be at about 90 degrees with the first direction (i.e., forming an angle with respect to the longitudinal axis 110A along two different directions).

[0121] In some examples, the longitudinal axis of the third filament segment 112C is approximately perpendicular to the longitudinal axis 110A of the tissue cutting catheter 110. In some examples, the distal end of the fourth filament segment 112D is positioned more proximally than the third filament segment 112C. In some examples, the second filament segment 112B, the third filament segment 112C, and the fourth filament segment 112D are all substantially in the same plane, such as... Figure 18 The best view is in the middle. In this respect, the shape of the clockwise curved shape 112 of the memory is similar to the shape of the curved shape 102 of the memory, except that the angle between the longitudinal axis of the first filament segment 112A and the longitudinal axis of the second filament segment 112B bends to the plane of the remaining segment.

[0122] In some examples, the longitudinal axes of each of the second filament segment 112B and the fourth filament segment 112D form an angle 112E between each other within a range of approximately 0 degrees and approximately 90 degrees. Figure 19 In some examples, the longitudinal axes of each of the second filament segment 112B and the fourth filament segment 112D are formed relative to each other at an angle 112E within a range of approximately 35 degrees to approximately 45 degrees. Figure 19 ).exist Figure 19In one example, the longitudinal axes of each of the second filament segment 112B and the fourth filament segment 112D form an angle 112E of approximately 40 degrees. In some examples, the longitudinal axes of each of the second filament segment 112B and the fourth filament segment 112D form an angle 112E of approximately 39 degrees, 40 degrees, 41 degrees, 42 degrees, 43 degrees, or 44 degrees. Figure 19 In some examples, the circles tangentially contacting the second filament segment 112B, the third filament segment 112C, and the fourth filament segment 112D have diameters ranging from about 2.5 mm to about 13 mm. In some examples, the circles tangentially contacting the second filament segment 112B, the third filament segment 112C, and the fourth filament segment 112D have diameters of about 3.7 mm, 3.9 mm, 4 mm, 4.1 mm, 4.2 mm, 4.3 mm, or 4.4 mm.

[0123] In some examples, the second filament segment 112B may have a length of about 1.5 mm to about 16 mm (or about 5.3 mm as shown in the figure), the third filament segment 112C may have a length of about 1.5 mm to 9.5 mm (or about 3 mm as shown in the figure), and the fourth filament segment 112D may have a length of about 1.5 mm to 16 mm (or about 5 mm as shown in the figure).

[0124] At least some of the one or more electrodes 106 may be positioned at the apex of the clockwise curved shape 112 of the memory (such as the third filament segment 112C in this example).

[0125] Another example of a more complex shape of the tissue cutting catheter can be seen, which has the memory of the counterclockwise curved shape 122 of the tissue cutting catheter 120. Figure 21 The figure shows a three-dimensional view of the distal end of the tissue cutting catheter 120. Figure 22 Another perspective view of the tissue cutting catheter 120 is shown. Figure 23 The figure shows a side view of the tissue cutting catheter 120. Figure 24 The figure shows another side view of the tissue cutting catheter 120. Figure 25 The figure shows an end view of the tissue cutting catheter 120 viewed from the distal direction. Figure 26 The figure shows an end view of the tissue cutting catheter 120 viewed proximally. These figures will be discussed below.

[0126] The tissue cutting conduit 120 is generally similar to the previously described tissue cutting conduit 100, but has a memory counterclockwise curved shape 122 that differs from the memory curved shape 102. In other words, the tissue cutting conduit 120 may be similar to the tissue cutting conduit 100, but at the same viewing angle, relative to the 0-degree flat shape of the tissue cutting conduit 100, where the angle 122F is greater than 0 degrees ( Figure 23 ).

[0127] In this example, the counterclockwise curved shape 122 of the memory can be composed of multiple straight segments angled relative to each other. The first filament segment 122A may be generally aligned with or parallel to the longitudinal axis 120A. The second filament segment 122B extends from the distal end of the first filament segment 122A, the third filament segment 122C extends at an angle from the distal end of the second filament segment 122B in the same plane, and the fourth filament segment 122D extends at an angle from the distal end of the third filament segment 122C in the same plane.

[0128] In some examples, the longitudinal axis of the first filament segment 122A (e.g., the longitudinal axis 120A of the tissue cutting catheter 120) and the longitudinal axis of the second filament segment 122B are formed in the first direction at an angle 122F within a range of about 1 degree to about 90 degrees (see [reference]). Figure 23 In some examples, the longitudinal axis of the first filament segment 122A (e.g., the longitudinal axis 120A of the tissue cutting catheter 120) and the longitudinal axis of the second filament segment 122B are formed in the first direction at an angle 122F within a range of about 60 degrees to about 80 degrees (see [reference]). Figure 23 In some examples, the longitudinal axis of the first filament segment 122A and the longitudinal axis of the second filament segment 122B are formed in the first direction at an angle 122F within a range of approximately 65 degrees to approximately 75 degrees (see [reference]). Figure 23 In some examples, the longitudinal axis of the first filament segment 122A and the longitudinal axis of the second filament segment 122B may further form an angle in a second direction that can be about 90 degrees from the first direction, within a range of about 15 degrees to about 25 degrees (i.e., forming an angle relative to the longitudinal axis 120A along two different directions).

[0129] In some examples, the longitudinal axis of the third filament segment 122C is approximately perpendicular to the longitudinal axis 120A of the tissue cutting catheter 120. In some examples, the distal end of the fourth filament segment 122D is positioned more proximally than the third filament segment 122C. In some examples, the second filament segment 122B, the third filament segment 122C, and the fourth filament segment 122D are all substantially in the same plane, such as... Figure 23The best view is as follows. In this respect, the shape of the counterclockwise curved shape 122 of the memory is similar to the shape of the curved shape 102 of the memory, except that the angle between the longitudinal axis of the first filament segment 122A and the longitudinal axis of the second filament segment 122B bends to the plane of the remaining segment. By comparison Figure 19 and Figure 25 The views best illustrate the difference between the clockwise curved shape 112 of the tissue cutting catheter 110 and the counterclockwise curved shape 122 of the tissue cutting catheter 120, providing distal-facing views of the shapes of the memories. In these views, the clockwise curved shape 112 of the memory appears to be curved in a clockwise direction, while the counterclockwise curved shape 122 of the memory appears to be curved in a counterclockwise direction.

[0130] In some examples, the longitudinal axes of each of the second filament segment 122B and the fourth filament segment 122D form an angle 122E between each other within a range of approximately 0 degrees and approximately 90 degrees. Figure 25 In some examples, the longitudinal axes of each of the second filament segment 122B and the fourth filament segment 112D are formed relative to each other within an inclusive range of approximately 35 degrees and approximately 45 degrees at angle 122E. Figure 25 ).exist Figure 25 In one example, the longitudinal axes of each of the second filament segment 112B and the fourth filament segment 112D form an angle 112E of approximately 40 degrees. In some examples, the longitudinal axes of each of the second filament segment 122B and the fourth filament segment 122D form an angle 112E of approximately 39 degrees, 40 degrees, 41 degrees, 42 degrees, 43 degrees, or 44 degrees. Figure 25 In some examples, the circles tangentially contacting the second filament segment 122B, the third filament segment 122C, and the fourth filament segment 122D have diameters ranging from about 2.5 mm to about 13 mm. In some examples, the circles tangentially contacting the second filament segment 122B, the third filament segment 122C, and the fourth filament segment 122D have diameters of about 3.7 mm, 3.9 mm, 4 mm, 4.1 mm, 4.2 mm, 4.3 mm, or 4.4 mm.

[0131] In some examples, the second filament segment 122B may have a length of about 1.5 mm to about 16 mm (or about 5.3 mm as shown in the figure), the third filament segment 122C may have a length of about 1.5 mm to 9.5 mm (or about 3 mm as shown in the figure), and the fourth filament segment 122D may have a length of about 1.5 mm to 16 mm (or about 5 mm as shown in the figure).

[0132] At least some of the electrodes in one or more electrodes 106 may be located at the apex of the counterclockwise curved shape 122 of the memory (such as the third filament segment 122C).

[0133] In the previously described examples or other examples of tissue cutting catheters 100, 110, and 120, the filament 104 may, in some examples, be a nitinol filament having a diameter of about 0.014 inches (0.36 mm). Each of the one or more electrodes 106 may have an outer diameter of about 0.027 inches (0.69 mm) and a length of about 0.055 inches (1.40 mm).

[0134] As previously described, the capture basket catheter 190 can be used to remove cardiac treatment devices (e.g., valve leaflet clips 50) from a patient's heart. Such a capture basket catheter 190 may include one or more additional unique features, as further described below.

[0135] A unique aspect is that flexible filaments, such as sutures, ropes, yarns, silk, or similar components, are included along the distal end of the basket to help prevent the opening size of the basket from increasing and causing cardiac treatment devices (e.g., valve clips 50) captured within it to escape.

[0136] For example, Figure 27 The figure shows a side view of a capture basket conduit 130, which includes flexible filaments 136 along the distal portion of a basket 131. Figure 28 The figure shows Figure 27 A magnified image of the Nets' 131-point basket.

[0137] In general, the capture basket conduit 130 is similar to the capture basket conduit 190 previously described. The basket 131 may consist of one or more wires 135 woven together to form a basket shape with an opening facing the proximal side. In some examples, a mesh tube may be woven first, and then one end of the tube may be joined, fused, welded, or glued together to form a basket tip 137 at the distal end of the basket 131.

[0138] The basket 131 may form multiple loops along or near its proximal edge and around its proximal opening, through which the tightening wire 134 passes. The tightening wire 134 may enter the channel of the elongated catheter body 132 and connect to the elongated control wire (or optionally extend only from the proximal end of the elongated catheter body 132), allowing the physician to pull proximally and reduce the diameter of the distal loop of the tightening wire 134 and the diameter of the proximal opening of the basket 131.

[0139] Due to the woven nature of the basket 131, individual filaments 135 (or segments thereof) can move relative to each other to allow the basket 131 to expand and contract radially. However, in some cases, when the basket 131 is in its radially expanded configuration, it is possible for some individual filaments 135 (or segments thereof) to move, resulting in an increase in the size of one of the openings / cells of the basket 131. If the increase in size is large enough, any contents of the basket 131 (such as the valve leaflet clip 50) may escape.

[0140] The size of the opening / cell can be limited or constrained by including one or more flexible filaments 136. In some examples, the flexible filaments 136 can be connected at multiple locations where one or more filaments 135 overlap each other as part of a weaving pattern. In some examples, the flexible filaments 136 can form knots 136A or one or more loops around the intersection of two segments of one or more filaments 135. The flexible filaments 136 can form multiple knots 136A or loops at multiple intersection locations of different filament segments. Knots 136A can help constrain the movement of filament segments across locations, and the length of the flexible filament 136 between two knots 136A can further constrain movement. In this respect, adding flexible filaments 136 to the basket 131 may be helpful when the basket 131 is in its expanded configuration.

[0141] The flexible filament 136 can extend laterally between the intersections of the filament sections around the circumference of the basket 131, such as... Figure 28 As seen in the diagram, this creates a transverse band pattern. Flexible filaments 136 may additionally or alternatively extend longitudinally between the intersections of the filament sections.

[0142] In some examples, all or most of the intersections of the wire sections along the distal quarter, distal third, or distal half of the basket 131 are constrained by knots 136A of the flexible filaments 136. In some examples, all or most of the intersections of the wire sections along the entire basket 131 are constrained by knots 136A of the flexible filaments 136.

[0143] The flexible filament 136 can be a single filament or multiple discrete filaments. The flexible filament 136 can be made of a relatively tensile-resistant material or a relatively elastic material. In some examples, the flexible filament 136 can be made of solid PET filaments, solid metal filaments (e.g., nitinol or radiopaque materials such as tantalum), multiple polymer yarn fibers (e.g., PET yarn / fiber), surgical sutures, solid silicone filaments, or other similar materials.

[0144] Figure 29The figure shows a side view of a capture basket catheter 130 used in conjunction with a snare catheter 186 and a captured leaflet clip 50. The basket 131 is in its radially expanded configuration as the snare catheter 186 moves the leaflet clip 50 toward the proximal opening of the basket 131.

[0145] Figure 30 The figure shows a leaflet clip 50 positioned within a basket 131 of a capture basket catheter 130. Flexible filaments 136 help constrain the size of the opening or cell of the basket 131 so that the leaflet clip 50 is not accidentally pushed through the basket 131.

[0146] Figure 31 The diagram shows the proximal opening of the basket 131, which is secured and closed by a binding wire 134 surrounding the loop conduit 186.

[0147] The capture basket catheter 130 may also, or alternatively, include a unique mounting arrangement to the elongated catheter body 132. Depending on how the elongated catheter body 132 can be connected to the basket 131, the capture basket catheter 130 may have a tendency to rotate such that the distal end of the capture basket catheter 130 is substantially misaligned with the axis of the elongated catheter body 132. For example, if the capture basket catheter 130 rotates such that its opening opens perpendicular to the axis of the elongated catheter body 132 or even in a distal direction, this may be undesirable and may increase the difficulty for physicians attempting to align and / or capture the heart valve treatment device. Therefore, in some cases, it may be helpful to connect the basket 131 and the elongated catheter body 132 in a manner that prevents or limits this type of rotation.

[0148] In one example, the distal tip member 133 of the elongated conduit body 132 may provide multiple connection points to the basket 131 to help constrain movement between components. Figure 32 The figure shows a side view of the distal tip member 133, and Figure 33 The diagram illustrates the relationship between... Figure 32 The view is a view of the distal tip member 133 at approximately 90 degrees from the other side.

[0149] The distal tip member 133 may include a retaining portion comprising a plurality of separate openings through its wall that allow both sections of the bundled filaments 134 and 135 to be captured.

[0150] In some examples, the distal tip member 133 may have a generally cylindrical tubular shape 133A that is at least partially hollow. The distal end of the distal tip member 133 may include a rounded or damage-preventable end portion 133E.

[0151] The distal tip member 133 may include two binding wire openings 133D, which are sized large enough to accommodate binding wire 134 positioned therethrough. In some examples, the two binding wire openings 133D open into an internal channel of the elongated catheter body 132 that extends to the proximal end of the elongated catheter body 132, allowing a physician to pull and reduce the size of the loop formed by the binding wire 134.

[0152] The distal tip member 133 may also include two upper wire openings 133B and two lower wire openings 133C, which are sized to allow one or more segments of wire 135 to pass through and are positioned on the side of the distal tip member 133 to create two intersecting channels therethrough.

[0153] In some examples, the two net wire openings 133B and the two bottom wire openings 133C are sized and positioned to capture two segments of one or more filaments 135 as part of their weaving pattern at their intersection. In this respect, one segment of the one or more filaments 135 may pass through one of the two net wire openings 133B and one of the two bottom wire openings 133C on the side opposite to the net wire opening 133B. A second segment of the one or more filaments 135 may similarly pass through the remaining openings of the two net wire openings 133B and the two bottom wire openings 133C, such that the two segments of the one or more filaments 135 cross inside the distal tip member 133. Figure 32 As shown, the distance between the two sections of one or more wires 135 on either side of the distal tip member 133 increases, thus restricting the lateral and longitudinal movement of the distal tip member 133 relative to the basket 131.

[0154] Therefore, the elongated catheter body 132 can maintain a constant rotational orientation relative to the basket 131 during surgery (i.e., the basket 131 will not rotate substantially out of alignment with the axis of 132 and will maintain an opening in the lumen leading to the basket 131 in the proximal direction). Additionally, this arrangement allows the distal tip member 133 to connect at both a more proximal position (i.e., the two bundle wire openings 133D) and a more distal position (i.e., the two upper wire openings 133B and the two lower wire openings 133C), which helps prevent the basket 131 from rotating proximally toward the elongated catheter body 132 (i.e., flipping backward). This arrangement also helps the basket 131 spring back to its original intended position relative to the elongated catheter body 132 when flipped during surgery. Since it is difficult to guide and use the basket 131 during surgery when the basket 131 and its proximal opening are not relatively perpendicular to the elongated catheter body 132 (e.g., at 45 degrees and 135 degrees relative to the longitudinal axis of the elongated catheter body 132), maintaining this "vertical" orientation can significantly improve the navigation and capture time of the heart valve treatment device (e.g., the leaflet clip 50).

[0155] Variations in the structure of 133 are also possible. For example, instead of an opening in the distal tip member 133, a ring or tube may be instead attached to the outside of the distal tip member 133 to create a channel corresponding to the opening described previously. In another example, filaments or sutures may be wound around a portion of 133 and around the intersection of two segments of one or more filaments 135. In another example, the intersection of the two segments of one or more filaments 135 may be glued with adhesive or directly welded to the distal tip member 133.

[0156] In some examples, the capture basket conduit 130 may include a flexible filament 136, a distal tip member 133, or both of the foregoing features.

[0157] exist Figures 1-4 The device shown and described herein can be used to cut tissue immediately adjacent to the heart valve treatment device. In some cases, this tissue immediately adjacent to the device (e.g., leaflet clip 50) and the remainder of the mitral valve leaflet 14 is referred to as a tissue bridge. Other devices and techniques for cutting this tissue bridge are also possible.

[0158] Figure 34 The figure shows a side view of a tissue cutting device 140, which can be used to cut tissue bridges connected to heart valve treatment devices (e.g., valve leaflet clips 50). Figure 35 The diagram illustrates the relationship between... Figure 34 The side view of the tissue cutting device 140 is viewed from different sides at approximately 90 degrees. Figure 36 The figure shows a perspective view of the tissue cutting device 140. These figures will be discussed below.

[0159] Overall, the tissue cutting device 140 has a shape that allows it to be positioned simultaneously in two locations between the leaflets, each on an opposite side of the leaflet clamp 50. Therefore, a portion of the tissue cutting device 140 can contact the leaflet tissue adjacent to the connection point of the leaflet clamp 50.

[0160] In some examples, the tissue cutting device 140 may include a core filament 142. The distal region of the core filament 142 is shown in the figure and may be connected to a larger elongated catheter body or may extend to a proximal position. The core filament 142 may be made of a shape memory material such as nitinol and may have a memory shape that forms a first curve 142A and a second curve 142B when the core filament 142 is unconstrained.

[0161] The first curve 142A can generally orient the distal region of the core filament 142 at a location adjacent to the first curve 142A. In some examples, the first curve 142A can be bent within a range of about 160 degrees to about 200 degrees. In some examples, the first curve 142A can be bent within a range of about 170 degrees to about 190 degrees. In some examples, the first curve 142A can be bent at about 180 degrees. In some examples, the first curve 142A can orient the immediately adjacent and immediately distal portions of the core filament 142 in a generally parallel arrangement. In some examples, the first curve 142A has a diameter within a range of about 66 mm to about 18 mm.

[0162] The core wire 142 may include a snare attachment structure at or near the distal tip of the core wire 142, to which a separate snare catheter may be attached intracardiacly, as discussed later. In this example, the snare attachment structure may take the form of a second curve 142B, which may be located at or very close to the distal tip of 142B, and the distal tip of the core wire 142 may be generally oriented near the location of the second curve 142B. Alternatively, the snare attachment structure may be an enlargement (e.g., a cannula, coil, or weld block) on the distal end of the core wire 142.

[0163] In some examples, the second curve 142B may bend within a range of about 160 degrees to about 200 degrees. In some examples, the second curve 142B may bend within a range of about 170 degrees to about 190 degrees. In some examples, the second curve 142B has a diameter within a range of about 2 mm to about 8 mm.

[0164] In some examples, the length of the core wire 142 between the first curve 142A and the second curve 142B can be within the range of about 5 mm to about 15 mm.

[0165] In some examples, the core filament 142 may have a third curve 142C that is substantially perpendicular to the first curve 142A. Figure 35 The third curve 142C may optionally partially or completely overlap with the first curve 142A. In some examples, the third curve 142C bends within a range of about 5 mm to about 12 mm and may have a radius of curvature within a range of about 2 mm to about 10 mm. When the core wire 142 is positioned through the valve, the first curve 142A and the third curve 142C can help achieve a position adjacent to the valve leaflet clip 50 against the valve leaflet, as further described below.

[0166] The length of the first curve 142A may include one or more electrodes 146. This example provides three or more electrodes 146, but more or fewer electrodes are possible. The core filament 142 may be electrically connected to a power source at the proximal end of the tissue cutting device 140. The distal region of the core filament 142 may be completely covered with an electrically insulating layer, except at the electrodes 146. The electrodes 146 may be exposed areas of the core filament 142 without an electrically insulating layer, or they may be separate tubes, sleeves, or areas in contact with the core filament 142. The electrodes 146 may also be made of materials more resistant to electrical or thermal damage than nitinol, such as stainless steel.

[0167] The tissue cutting device 140 may also include one or more radiopaque markers 144 attached to the mandrel 142. In one example, the one or more radiopaque markers 144 may be positioned such that, when in their unconstrained position, the second curve 142B is positioned parallel to or laterally adjacent to the second curve 142B or laterally flush with the second curve 142B (e.g., the one or more radiopaque markers 144 are positioned on a proximal segment of the mandrel 142 that is substantially parallel to the distal segment of the mandrel 142B of the second curve 142B). This allows the physician to better understand how far the mandrel 142 is positioned across the valve and where the second curve 142B is located. The one or more radiopaque markers 144 may also be located at other locations, such as near the distal tip of the mandrel 142.

[0168] In an alternative example, the second curve 142B can be replaced by an enlargement near the distal end of the core filament 142, which prevents the loop guide 186 from slipping off when engaged with the core filament 142.

[0169] An exemplary method using the tissue cutting device 140 will now be described. Figure 37The figure shows a view of the mitral valve leaflet 14 within the left ventricle 12. A leaflet clip 50 is clamped onto both mitral valve leaflets 14. A sheath 109 can be positioned through one side of the opening of the mitral valve leaflet 14.

[0170] Figure 38 The figure shows a view of the mitral valve leaflet 14 within the left ventricle 12. The core wire 142 extends beyond the sheath 109 to expose the first curve 142A. In some examples, the core wire 142 may be wrapped within the sheath 109 such that the first curve 142A remains within the passageway of the sheath 109. This allows a small portion of the first curve 142A to initially advance distally beyond the sheath 109. In other examples, the core wire 142 may be positioned vertically within the sheath 109 such that the second curve 142B is the first portion of the core wire 142 exiting the sheath 109.

[0171] Figure 39 The figure shows a view of the mitral valve leaflet 14 within the left ventricle 12. The first curve 142A of the core wire 142 can be positioned around the leaflet clip 50.

[0172] Figure 40 and Figure 41 The figure shows a view of the leaflet clip 50 on the mitral valve leaflet 14. The first curve 142A of the core wire 142 can be further moved to a region adjacent to the leaflet clip 50, forming a "tissue bridge" or leaflet tissue. Therefore, the electrode 146 can also be located at this tissue bridge region. The third curve 142C further facilitates this location.

[0173] Figure 42 The figure shows a view of the mitral valve leaflet 14 from the left atrium 10 side. The second curve 142B of the core wire 142 can travel through the opposite side of the valve leaflet clamp 50 to the sheath 109. In other words, the valve leaflet clamp 50 can create at least two openings through the valve on either side of the valve leaflet clamp 50. The portion of the core wire 142 near the first curve 142A can be positioned on one side, while the portion of the core wire 142 away from the first curve 142A can be positioned on the other side. Therefore, the second curve 142B is exposed within the valve on the left atrium 10 side.

[0174] Figure 43 The figure shows a view of the mitral valve leaflet 14 from the left atrium 10 side. The aforementioned snare catheter 186 can then travel beyond the sheath 109 (or alternatively, a separate sheath), and the wire loop 186A can be positioned above the second curve 142B. As shown, one or more radiopaque markers 144 on the core wire 142 can provide a reference point at which the wire of the snare catheter 186 loop 186 is "hooked" onto the second curve 142B.

[0175] Figure 44 The figure shows a view of the mitral valve leaflet 14 from the left atrium 10 side. Next, the wire ring 186A of the loop catheter 186 can be pulled proximally back, thereby reducing the size of the wire ring 186A outside one or more openings 186B. This allows for better engagement of the second curve 142B with the wire ring 186A.

[0176] Figure 45 The figure shows a view of the mitral valve leaflet 14 from the left atrium 10 side. Next, as current (e.g., RF current) is supplied to the tissue cutting device 140, the snare catheter 186 (and / or sheath 109) can be pulled proximally back. Current can pass through the core wire 142 and exit the electrode 146, cutting the tissue bridge adjacent to the leaflet clip 50 and releasing the leaflet clip 50 from the mitral valve leaflet 14. Typically, in the case of the mitral valve, the tissue cutting device 140 will separate the leaflet clip 50 from only one leaflet (e.g., the anterior leaflet). The leaflet clip 50 will typically remain attached to the other leaflet (e.g., the posterior leaflet), but this will facilitate the placement of the artificial valve replacement. The leaflet clip 50 will typically be captured between the artificial valve frame and the posterior wall. If the leaflet clip 50 remains on the anterior leaflet, it can swing into the LVOT (left ventricular outflow tract) during cardiac circulation and is therefore generally undesirable. Alternatively, it can be executed if desired. Figures 5-8 The steps shown are for completely removing the clip. Therefore, if in Figures 5-8 If any challenges arise during the steps shown, the physician can immediately switch the surgery to valve implantation.

[0177] Depending on the type of surgery, it may be helpful to create a relatively larger, narrower incision or opening through the leaflet (e.g., mitral valve leaflet 14). For example, leaflet cutting may help remove the leaflet clip 50 and / or reshape the leaflet before implanting an artificial valve.

[0178] Figure 46 The figure shows a side view of a leaflet cutting system 150, which may include a leaflet cutting catheter 151, a leaflet puncture tool 156, and a snare catheter 186. The leaflet cutting system 150 can be used in a similar manner to the tissue cutting device 140, wherein the snare catheter 186 is used to pull a portion of the leaflet cutting catheter 151 through a portion of the leaflet tissue.

[0179] The leaflet cutting catheter 151 can be similar to the tissue cutting device 140 previously described. For example, the leaflet cutting catheter 151 includes a core filament 152 similar to a core filament 142 having a memory-given shape, which includes a first curve 152A similar to a first curve 142A. In this example, the core filament 152 includes an enlargement 152C (e.g., a tube or welded portion) near the distal end of the core filament 152 in place of a second curve 142B of the core filament 142; however, either can be used with the core filament 152. The core filament 152 may also similarly include one or more electrodes 152B similar to electrodes 146, which are positioned along the first curve 152A. Only one electrode 152B is illustrated, but multiple (e.g., similar to electrodes 146) are also possible. The core filament 152 can be connected to a power source directly or indirectly via the catheter body to which it is attached, such that one or more electrodes 152B can be selectively energized.

[0180] The leaflet cutting system 150's leaflet puncture tool 156 can be positioned over the leaflet cutting catheter 151, allowing the leaflet puncture tool to initially create a puncture through the leaflet. The leaflet puncture tool 156 can be a tubular catheter body having a sharp distal edge that can physically puncture the leaflet when it is pressed against it. Alternatively, the distal edge of the leaflet puncture tool 156 may include one or more electrodes that can be activated to puncture the leaflet.

[0181] The leaflet cutting system 150 can be used as follows. Figure 47 The diagram shows the left ventricular side 12 of the mitral valve leaflet 14. On the opposite left atrium side 10 of the mitral valve leaflet 14, a sheath 109 can be positioned, and the leaflet puncture tool 156 can be moved distally out of the sheath 109. The distal edge of the leaflet puncture tool 156 can be pushed against the left atrium side 10 of one of the mitral valve leaflets 14 at the desired location, allowing the distal edge to puncture into the left ventricular side 12, as shown. Figure 47 As shown. Aspiration using a syringe through the channel of the leaflet puncture tool 156 can be used to keep the mitral valve leaflet 14 against the distal opening of the leaflet puncture tool 156 for easy cutting.

[0182] Figure 48 The figure shows another view of the mitral valve leaflet 14 on the left ventricle 12 side. Next, 152 can advance away from the leaflet puncture tool 156 and into the left ventricle 12, exposing at least the enlargement 152C and one or more electrodes 152B. Additionally, the wire loop 186A of the snare catheter 186 can advance through separate existing openings within the valve, such as the natural valvular opening between the mitral valve leaflets 14 or another previously cut narrow incision / orifice.

[0183] Figure 49 The figure shows another view of the mitral valve leaflet 14 on the left ventricular 12 side. As seen in the figure, the wire loop 186A can be positioned around the core wire 152 of the leaflet cutting system 150 and tightened sufficiently such that the enlargement 152C prevents the tightened wire loop 186A from slipping off the core wire 152. Next, both the core wire 152 and the loop catheter 186 (and optionally the leaflet puncture tool 156 and sheath 109) can be pulled proximally, which also pulls one or more electrodes 152B against the left ventricular 12 side of the mitral valve leaflet 14. Current (e.g., RF current) can be supplied to the core wire 152, passed down along the core wire 152, and flows out from the one or more electrodes 152B that cut the mitral valve leaflet 14.

[0184] Figure 50 The figure shows another view of the mitral valve leaflet 14 on the left ventricular side 12. A narrow incision 14A can be seen in the figure after the core wire 152 has passed through the mitral valve leaflet 14. Depending on the nature of the procedure, this cutting operation can be performed once or several times to achieve the desired opening or cutting pattern.

Claims

1. A tissue cutting catheter for use in the heart, comprising: Long control components; A filament, the filament being connected to the distal portion of the elongated control member; The filament has a memory-based, unconstrained shape that forms the first curve; as well as, One or more electrodes, wherein the one or more electrodes are positioned at the apex of the first curve.

2. The tissue cutting catheter according to claim 1, wherein, The first curve includes a first filament segment, a second filament segment connected to and extending from the first filament segment, a third filament segment connected to and extending from the second filament segment, and a fourth filament segment connected to and extending from the third filament segment; wherein the second filament segment and the fourth filament segment form an angle within a range of approximately 30 degrees and approximately 50 degrees.

3. The tissue cutting catheter according to claim 1, wherein, The first curve includes a first filament segment, a second filament segment connected to and extending from the first filament segment, a third filament segment connected to and extending from the second filament segment, and a fourth filament segment connected to and extending from the third filament segment; wherein the second filament segment and the fourth filament segment form an angle within a range of approximately 35 degrees and approximately 45 degrees.

4. The tissue cutting catheter according to claim 1, wherein, The first curve includes a first filament segment, a second filament segment connected to and extending from the first filament segment, a third filament segment connected to and extending from the second filament segment, and a fourth filament segment connected to and extending from the third filament segment; and wherein the circles tangentially contacting the second filament segment, the third filament segment, and the fourth filament segment have a diameter within a range of about 2.5 mm to about 13 mm.

5. The tissue cutting catheter according to claim 1, wherein, The first curve includes a first filament segment, a second filament segment connected to and extending from the first filament segment, a third filament segment connected to and extending from the second filament segment, and a fourth filament segment connected to and extending from the third filament segment; and wherein the circles tangentially contacting the second filament segment, the third filament segment, and the fourth filament segment have diameters within the range of approximately 3.7 mm, 3.9 mm, 4 mm, 4.1 mm, 4.2 mm, 4.3 mm, or 4.4 mm.

6. The tissue cutting catheter according to claim 1, wherein, The first curve includes a first filament segment, a second filament segment connected to and extending from the first filament segment, a third filament segment connected to and extending from the second filament segment, and a fourth filament segment connected to and extending from the third filament segment; wherein the first filament segment, the second filament segment, the third filament segment, and the fourth filament segment are positioned at different angles relative to each other.

7. The tissue cutting catheter according to claim 6, wherein, The first filament section, the second filament section, the third filament section, and the fourth filament section are approximately located in the same plane.

8. The tissue cutting catheter according to claim 6, wherein, The second filament segment, the third filament segment, and the fourth filament segment are generally located within a first plane, and the first filament segment is generally located within a second plane different from the first plane.

9. The tissue cutting catheter according to claim 8, wherein, The first curve is formed by the second filament segment, the third filament segment and the fourth filament segment, and wherein, when viewed toward the distance, the first curve bends in a generally clockwise direction.

10. The tissue cutting catheter according to claim 8, wherein, The first curve is formed by the second filament segment, the third filament segment and the fourth filament segment, and wherein, when viewed toward the distance, the first curve bends in a generally clockwise direction.

11. The tissue cutting catheter according to claim 8, wherein, The first curve is formed by the second filament segment, the third filament segment and the fourth filament segment, and wherein, when viewed toward the distance, the first curve bends in a generally counterclockwise direction.

12. The tissue cutting catheter according to claim 6, wherein, The filament is formed into a ring, wherein the ring forms a first filament segment, a second filament segment, a third filament segment, and a fourth filament segment.

13. A capture basket catheter for intracardiac use, comprising: Long catheter body; A mesh basket, which is formed of one or more filaments woven together and connected to the distal portion of the elongated conduit body; as well as, At least one flexible filament is connected at multiple locations on the basket to limit the size of the basket's cells.

14. The capture basket conduit according to claim 13, wherein, The one or more filaments woven together form multiple cross filament sections; and wherein the at least one flexible filament forms a knot or loop around at least some of the cross filament sections.

15. The capture basket conduit according to claim 14, wherein, The at least one flexible filament forms a circumferential pattern around the basket.

16. The capture basket conduit according to claim 15, wherein, The at least one flexible filament also extends longitudinally along the basket.

17. The capture basket conduit according to claim 14, wherein, The at least one flexible filament extends along the distal quarter, distal third, or distal half of the basket.

18. The capture basket conduit according to claim 17, wherein, The at least one flexible filament comprises a tensile-resistant material or an elastic material.

19. The capture basket conduit according to claim 18, wherein, The at least one flexible filament includes a solid PET filament, a solid metal filament, multiple polymer yarn fibers, or a solid silicone filament.

20. The capture basket conduit according to claim 19, wherein, The basket includes an opening in a cavity leading to the basket, which opens in the proximal direction when in an expanded configuration.

21. The capture basket conduit according to claim 13, wherein, The elongated catheter body also includes a distal tip member, the distal tip member including a retaining portion connected to the intersection of two filament sections of the one or more filaments.

22. The capture basket conduit according to claim 21, wherein, The retaining portion includes two upper wire openings and two lower wire openings; and wherein each of the two wire sections passes through one of the two upper wire openings and one of the two lower wire openings.

23. The capture basket conduit according to claim 22, wherein, The distal tip member also includes two filament openings, wherein the filaments are positioned to pass through the two filament openings and through a loop in the basket.

24. A capture basket catheter for intracardiac use, comprising: An elongated catheter body, the elongated catheter body having; A wire basket, said wire basket being formed from one or more filaments woven together; as well as, The distal tip member includes a retaining portion connected to the intersection of two filament sections of the one or more filaments.

25. The capture basket conduit according to claim 24, wherein, The retaining portion includes two upper wire openings and two lower wire openings; and wherein each of the two wire sections passes through one of the two upper wire openings and one of the two lower wire openings.

26. The capture basket conduit according to claim 25, wherein, The distal tip member also includes two filament openings, wherein the filaments are positioned to pass through the two filament openings and through a loop in the basket.

27. The capture basket conduit according to claim 26, wherein, The two upper wire openings and the two lower wire openings are located on the far side of the two bundled wire openings.

28. A tissue cutting device for use within the heart, comprising: Long catheter body; A core filament connected to the distal end of the elongated catheter body; the core filament includes a memory shape that forms a first curve when unconstrained, a snare attachment structure located at or near the distal tip of the core filament, and one or more electrodes positioned along the first curve.

29. The tissue cutting apparatus according to claim 28, wherein, The first curve is within a range of approximately 160 degrees to approximately 200 degrees.

30. The tissue cutting apparatus according to claim 29, wherein, The snare attachment structure is a second curve of the core wire, a sleeve, a coil, or a welding block.

31. The tissue cutting apparatus of claim 30, further comprising a radiopaque marker positioned on the proximal section of the core filament at a position laterally flush with the snare attachment structure.

32. The tissue cutting apparatus of claim 28 further includes a leaflet puncture tool positioned above the elongated catheter body and the core wire.

33. A method for removing a heart valve treatment device, comprising: Position the core wire of the tissue cutting catheter to pass from the first side of the valve to the second side of the valve; The first curve of the core wire is arranged in a loop around the heart valve treatment device on the second side of the valve; Position the snare attachment structure located on the distal region of the core filament to extend back to the first side of the valve; Engage the snare conduit with the snare attachment structure; as well as, One or more electrodes are activated along the first curve of the core wire to separate the heart valve treatment device from the valve leaflets.

34. A method for repairing heart valve leaflets, comprising: The heart valve leaflets are punctured using a leaflet puncture tool to create the first opening; Position the core wire of the leaflet cutting catheter to pass from the first side of the valve to the second side of the heart valve; Position the snare ring of the snare catheter to the second side of the heart valve through the second opening of the heart valve; Engage the snare ring with the snare attachment structure in the distal region of the core wire, and One or more electrodes are activated along the core wire while simultaneously pulling the leaflet cutting catheter and the snare catheter to cut the heart valve leaflets.

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