Non-invasive muscle resection devices and methods

Abstract

This disclosure relates to a catheter-guided myorectomy device. The device comprises a catheter having a distal end and a body having a first lumen and a second lumen. A blade assembly is located in the second lumen of the catheter and is movable between a retracted position and an extended position relative to the distal end. A suction assembly is configured to direct suction force through the first lumen.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the benefit of priority based on U.S. Provisional Application No. 63 / 457,605, filed on April 6, 2023. The disclosure of the prior application constitutes part of the disclosure of this application and is hereby incorporated by reference in its entirety.

[0002] This disclosure relates to catheters, and more particularly to catheter devices for performing septal myectomy.

Background Art

[0003] Hypertrophic cardiomyopathy (HCM) is a disease in which the myocardium thickens (hypertrophies). The thickening of the myocardium can make it difficult for the heart to pump blood. Septal myectomy is an open - heart surgery for treating hypertrophic cardiomyopathy (HCM) and involves removing a portion of the overly thickened septum located between the right and left ventricles.

[0004] In septal myectomy, a surgeon typically makes a long incision along the patient's chest midline along the sternum, detaches a portion of the sternum, and / or expands the thoracic cage to reach the heart. The surgical team connects the patient's heart to a cardiopulmonary bypass device that supplies oxygen to the patient's blood and pumps the blood throughout the patient's body during the surgery. The surgeon uses a blade to remove a portion of the thickened septum near the base of the heart. After removing the hypertrophied myocardium, the surgical team disconnects the cardiopulmonary bypass device from the patient, detaches the device from the patient, re - fixes the sternum with wires, and closes the patient's skin incision with sutures or staples. At present, there is no approach for performing septal myectomy minimally invasively.

Summary of the Invention

[0005] This disclosure relates to devices and methods for performing minimally invasive septal myectomy.

[0006] In a first exemplary embodiment, the catheter-guided myorectomy device may comprise a catheter body having a distal end, a first lumen, and a second lumen. A blade assembly may be located within the second lumen of the catheter and be movable between a retracted position and an extended position relative to the distal end. A suction assembly may be configured to direct suction force through the first lumen.

[0007] In a second exemplary embodiment, a method for removing tissue from a subject's heart may include inserting a catheter device through the subject's aortic valve. The catheter device comprises a body having a distal end, an outer sheath, a blade assembly, and a suction assembly, wherein the blade assembly and the suction assembly may be positioned within the outer sheath during insertion. The method may include securing the distal end of the catheter device to the tissue of a target site in the heart and exposing the blade assembly to the tissue. The method may also include applying suction force to the distal end via the suction assembly.

[0008] In a third exemplary embodiment, the catheter-guided myorectomy device may comprise a catheter body having a distal end defining an opening and a proximal end opposite to the distal end. A handle may be coupled to the proximal end of the catheter body. A suction assembly may be configured to direct suction force towards the opening of the catheter body. A blade assembly may have a blade configured to extend through the opening.

[0009] A catheter-guided myorectomy device and a method for removing tissue from a subject's heart according to any of the first, second, or third exemplary embodiments may include one or more of the following forms:

[0010] In one embodiment, the third lumen may be located within the second lumen of the catheter body.

[0011] In some configurations, the fixing assembly may be located within the third lumen of the catheter body.

[0012] In other embodiments, the fixed assembly may have a helical anchor that is movable between an extended position and a retracted position.

[0013] In other embodiments, the third lumen may be configured to deliver saline irrigation through the distal end of the catheter body.

[0014] In yet another embodiment, the third lumen may be configured to deliver suction force through the distal end of the catheter body.

[0015] In one example, the blade assembly may have a shaft and a blade coupled to the shaft.

[0016] In some examples, the shaft may define the third lumen.

[0017] In other examples, the catheter body may have a sheath surrounding the blade assembly.

[0018] In some examples, the sheath may be movable to expose the blade assembly.

[0019] In other examples, the porous filter may be attached to the catheter body and positioned at an interval from the distal end.

[0020] In some examples, when the filter is in an extended configuration, the filter may be configured to engage with the arterial wall.

[0021] In yet another example, the distal end of the catheter body may be operable.

[0022] In one aspect, a marker visible under fluoroscopy may be coupled to the catheter body.

[0023] In some aspects, the marker may be longitudinally aligned with a port formed in the catheter body.

[0024] In other aspects, the aspiration assembly may have a port that is in fluid communication with the first lumen and is coupled to the catheter body.

[0025] In other embodiments, fixing the distal end may include inserting the anchor coupled to the blade assembly into the tissue.

[0026] In still other embodiments, fixing the distal end may include applying a suction force to the target site to attach the distal end to the target site.

[0027] In some forms, the method may include inserting the catheter device through the femoral vein before inserting the catheter device through the aortic valve.

[0028] In other forms, the method may include monitoring the position of the distal end of the catheter device under fluoroscopy.

[0029] In some forms, the catheter device may have a marker disposed at the distal end and visible under fluoroscopy.

[0030] In other forms, the method may include delivering saline through the distal end of the body.

[0031] In some forms, the saline may be configured to move through an internal lumen of the catheter device.

[0032] In one embodiment, this method may include deploying a filter within the aorta of the subject.

[0033] In some embodiments, the filter may be coupled to the outer sheath of the catheter device and configured to engage with the inner wall of the aorta.

[0034] In one example, the helical anchor may be movable between an extended position and a retracted position, in the extended position the helical anchor extends through a second opening at the distal end of the catheter body, and in the retracted position the helical anchor is positioned entirely within the catheter body.

[0035] In other examples, the catheter cap may define the tip of the catheter body.

[0036] In some examples, the tip may define the second opening.

[0037] In other examples, the distal end of the catheter body may have a blade housing that defines the internal volume and the opening at the distal end.

[0038] In other examples, the blade may be located within the internal volume.

[0039] In one embodiment, the suction assembly may have a first lumen that is in fluid communication with the internal volume of the blade housing.

[0040] In other embodiments, the second lumen may be configured to deliver saline solution irrigation through the opening of the catheter body.

[0041] In some embodiments, the second lumen may be in fluid communication with the internal volume of the blade housing.

[0042] In other embodiments, the pull wire may extend through the catheter body and be coupled to the distal end.

[0043] In one embodiment, the pull wire may be fixed to the catheter cap.

[0044] In other embodiments, the guidewire may extend through the catheter body and be positioned within the ventricle or atrium to position its distal end toward a target tissue site.

[0045] In one embodiment, the embolic protection device may be configured to move between a retracted position and an unfolded position, wherein in the retracted position, the embolic protection device is in a folded configuration, and in the unfolded position, the embolic protection device is in a configuration that is radially extended relative to the catheter body.

[0046] In other configurations, the motor may be located within the handle and operably coupled to the blade assembly.

[0047] In some cases, the methods and devices described herein provide an alternative to open-heart surgery, thereby reducing the health risks and recovery time associated with open-heart surgery.

[0048] In some examples, the devices described herein provide built-in safety devices for preventing stroke during treatment.

[0049] Other features and advantages of this disclosure will become apparent from the following detailed description, drawings, and claims. [Brief explanation of the drawing]

[0050] [Figure 1] Figure 1 is a perspective view of a catheter-guided myorectomy device assembled according to the teachings of this disclosure. [Figure 2A] Figure 2A is a partial cross-sectional view of the muscle resection device shown in Figure 1, with the fixation assembly in the retinal position. [Figure 2B] Figure 2B is a partial cross-sectional view showing the fixation assembly in the muscle resection device of Figure 1 in the extended position. [Figure 3] Figure 3 is a partial fluoroscopic front view of the muscle resection device shown in Figure 1. [Figure 4] Figure 4 shows an anatomical representation of a human subject's heart and the muscle resection device shown in Figure 1 attached to the septum of the left ventricle of that heart. [Figure 5] Figure 5 is a magnified view of the muscle resection device positioned adjacent to the septum shown in Figure 4. [Figure 6] Figure 6 is a magnified view of the muscle resection device attached to the septum shown in Figure 4. [Figure 7] Figure 7 is a flowchart illustrating a method for performing minimally invasive septal muscle resection according to the teachings of this disclosure. [Figure 8] Figure 8 shows another example of a catheter-guided myorectomy device assembled in accordance with the teachings of this disclosure and placed inside the heart of a human subject. [Figure 9] Figure 9 is a front view of the muscle resection device shown in Figure 8. [Figure 10] Figure 10 is a perspective view of another catheter-guided myorectomy device assembled according to the teachings of this disclosure. [Figure 11] Figure 11 is a magnified view of the device shown in Figure 10, and shows the embolic protection device in its storage position. [Figure 12] Figure 12 is a magnified view of the device shown in Figure 10, and shows the embolic protection device in the deployed position. [Figure 13] Figure 13 is a partial perspective view of the distal end of the device shown in Figure 10, showing the blade assembly in the retracted position. [Figure 14] Figure 14 is a bottom view of the distal end of the device shown in Figure 10, showing the blade assembly in the stowed position. [Figure 15] Figure 15 is a side view of the distal end of the device shown in Figure 10, showing the blade assembly in the position of use. [Figure 16]Figure 16 is a magnified cross-sectional view of the distal end of the device shown in Figure 10. [Modes for carrying out the invention]

[0051] This disclosure relates to a catheter device and method for performing minimally invasive septal muscle resection. In one example, the device includes a rotatable and maneuverable microblade, a suction cup-type vacuum tip, and continuous saline irrigation. The device is configured to excise tissue, irrigate with saline, and recover the tissue and irrigation fluid from the site.

[0052] In Figures 1 to 3, an exemplary catheter-guided myorectomy device 10 (also referred to herein as the "catheter device" or "myorectomy device") comprises a proximal handle 12, a catheter body 14, and a distal blade assembly 18. The device 10 includes a blade assembly 18 coupled to the body 14, a suction assembly 22 configured to direct suction force towards the distal end 26 of the body 14, and a fixing assembly 30 configured to attach the distal end 26 to a target tissue site. The distal end 26 of the catheter 14 has a first opening 34 at the tip of the catheter 14 and a second opening 38 positioned perpendicular to the first opening 34. The distal end 26 of the catheter 14 is steerable in at least two directions with respect to the X-axis.

[0053] The handle 12 has several operating elements 15 (e.g., buttons, knobs, dials, or slides) configured to operate various functions of the device 10 (e.g., suction force, saline delivery, blade operation, catheter delivery configuration, and configuration during use). For example, one or more of the operating elements 15 are configured to operate the distal end 26 of the catheter 14, to operate the blade assembly 18, to operate suction, and / or to control saline delivery. The handle 12 may also house a battery, motor, or other operating components for operating the device 10. As schematically shown in Figure 1, the vacuum source 23 and saline source 73 are connected to a lumen of the device 10 extending from the proximal end of the handle 12. However, in other examples, the lumen may extend outward from the side wall of the handle 12.

[0054] The catheter body 14 has a first lumen 42 and a second lumen 46 positioned adjacent to the first lumen 42. The blade assembly 18 is housed within the second lumen 46 and is movable between a retracted position and an extended position relative to the distal end 26. The suction assembly 22 has a plurality of ports 50 formed in the outer sheath 52 of the catheter body 14 and is configured to direct suction force through the first lumen 42. The outer sheath 52 defines the first lumen 42 and at least partially defines the second lumen 46. As shown in Figures 2A and 2B, the outer sheath 52 forms a bulging distal end that is slightly wider than the width of the catheter body 14. The size of the catheter may range from 14 French to 24 French.

[0055] The blade assembly 18 has a shaft 54 ​​and a blade 58 rotatably coupled to the shaft 54. During a procedure, the physician may manually operate the blade assembly 18 (for example, by rotating the shaft by hand) or the blade assembly 18 may be driven by a motor device. The blade 58 includes two or more elements that rotate with respect to the X axis. Furthermore, the blade assembly 18 is axially movable along the X axis between a retracted position and an extended position relative to the catheter body 14. To move the blade assembly 18, the physician may move the outer sheath 52 in the P direction to expose the blade assembly 18 without moving the blade assembly 18, or move the blade assembly 18 in the F direction without moving the outer sheath 52. In Figures 2A, 2B, and 3, when the blade assembly 18 is in the extended position, the tip 60 of the blade 58 extends a distance E through the second opening 38 of the distal end 26 of the catheter. Distance E ranges from approximately 0.8 mm or more (for example, approximately 0.81 mm or more, approximately 0.82 mm or more, approximately 0.83 mm or more, approximately 0.84 mm or more, approximately 0.85 mm or more, approximately 0.86 mm or more, approximately 0.87 mm or more, approximately 0.88 mm or more, approximately 0.89 mm or more, approximately 0.9 mm or more, approximately 0.91 mm or more, approximately 0.92 mm or more, approximately 0.93 mm or more, approximately 0.94 mm or more, approximately 0.95 mm or more, approximately 0.96 mm or more, approximately 0.97 mm or more, approximately 0.98 mm or more, approximately 0.99 mm or more, approximately 1 mm) to approximately 1. The dimensions may be within the range of 2 mm or less (for example, approximately 1.19 mm or less, approximately 1.18 mm or less, approximately 1.17 mm or less, approximately 1.16 mm or less, approximately 1.15 mm or less, approximately 1.14 mm or less, approximately 1.13 mm or less, approximately 1.12 mm or less, approximately 1.11 mm or less, approximately 1.1 mm or less, approximately 1.09 mm or less, approximately 1.08 mm or less, approximately 1.07 mm or less, approximately 1.06 mm or less, approximately 1.05 mm or less, approximately 1.04 mm or less, approximately 1.03 mm or less, approximately 1.02 mm or less, approximately 1.01 mm or less, approximately 1 mm). In the retracted position, the tip 60 of the blade 58 does not extend through the opening 38.

[0056] The suction assembly 22 includes a vacuum source 23 (Figure 1) that fluidly communicates with the first lumen 42 of the catheter body 14. Multiple ports 50 fluidly communicate the first lumen 42 and the second lumen 46, providing suction force to the openings 34, 38 at the distal end 26 of the catheter 14. Multiple fluoroscopically visible markers 64 are positioned to align with the ports 50. When the outer sheath 52 is retracted to expose the blade 58, the markers 64 indicate the depth to which the blade assembly 18 has penetrated the muscle tissue. With this configuration, as the blade assembly 18 pulverizes the target tissue, the suction assembly 22 collects and removes the pulverized tissue from the target site. The markers 64 can be used to locate the catheter 14 fluoroscopically and in conjunction with transesophageal echocardiography (TEE). The markers 64 also serve as a guide for how far the catheter body 14 needs to be advanced along the length of the septum.

[0057] The fixed assembly 30 is coupled to the blade assembly 18 and is movable between the retracted position shown in Figure 2A and the extended position shown in Figure 2B. The fixed assembly 30 is located within a third lumen 68 defined by the shaft 54 ​​of the blade assembly 18 and includes a helical anchor 72 and a rotatable bit 76. The helical anchor 72 moves independently of the blade assembly 18. When the fixed assembly 30 is activated, the rotatable bit 76 rotates, which in turn rotates the helical anchor 72. With this configuration, when the fixed assembly 30 extends beyond the tip of the catheter 14 through either the first opening 34 or the second opening 38, the bit 76 rotates to penetrate the anchor 72 into the target tissue site. Simultaneously, the physician can move the fixed assembly 30 to the extended position. Once the fixed assembly 30 is sufficiently anchored to the target tissue, the blade assembly 18 can be extended over the fixed assembly 30 to begin excision of the target tissue. In some embodiments, the third lumen 68 is configured to deliver saline solution from a fluid source 73 and / or suction force from a vacuum source 23 through the distal end 26 of the catheter 14 during the procedure.

[0058] Referring to Figure 4, the muscle resection device 10 is placed inside the subject's body to perform a septal muscle resection. The catheter body 14 extends into the aorta 80 through the femoral vein 78 and passes through the subject's aortic valve 82. The distal end 26 of the catheter 14 is positioned in the left ventricle of the subject's heart 86 and is coupled to a tissue site 88 within the heart 86. The fixation assembly 30 is fixed to the hypertrophied tissue site 88, and the distal end 26 of the catheter 14 is positioned around the fixation assembly 30, providing a vacuum for aspirating the shredded tissue as the blade assembly 18 advances into the tissue site 88. Although the illustrated device 10 is shown via the femoral vein and aortic valve, the device 10 may be inserted into the patient via other routes to reach the target site, such as from a peripheral vein or the apex of the heart.

[0059] In Figure 5, prior to the advancement and activation of the blade assembly 18, the distal end 26 of the catheter 14 is positioned adjacent to the target tissue site 88 with echocardiographic and fluoroscopic guidance. The fixing assembly 30 extends from the distal end 26, rotates and advances axially, and is fixed within the tissue site 88 by an anchor. Once anchored, as shown in Figure 6, the distal end 26 of the catheter advances beyond the fixing assembly 30, and the embolic protection device 90 deploys within the aorta 80. In Figure 6, the blade assembly 18 is positioned in contact with the tissue target site.

[0060] In the aorta 80 shown in Figures 4 to 6, the embolic protection device 90 is connected to the catheter body 14 and engages with the wall of the aorta 80. The device 90 is a sieve-shaped filter 90, positioned away from the distal end 26, and configured to capture fragmented muscle tissue to prevent it from flowing into the aorta 80. The filter 90 is movable between a folded state when the catheter 14 is delivered to the target site and an expanded state shown in Figure 4 when the blade assembly 18 is activated. By capturing fragmented muscle tissue in the ascending aorta 80, the filter 90 functions as a stroke prevention device while allowing blood to pass through the filter holes.

[0061] For example, Figure 7 shows a method 92 for performing a minimally invasive septal myectomy using a myectomy device 10 shown in Figures 1 to 6. For ease of explanation, method 92 will be described with reference to the myectomy device inserted into the subject shown in Figures 1 to 6. However, method 92 may be performed using other exemplary myectomy devices. For a human patient, method 92 may include inserting the device 10 through the femoral vein 78 in the patient's groin and guiding the distal end 26 of the device 10 to the patient's heart 86. Method 92 includes a step 94 of inserting the catheter device 10 through the subject's aortic valve 82, as shown in Figure 4. The catheter device 10 has a body 14 with a distal end 26, an outer sheath 52, a blade assembly 18, and a suction assembly 22. The blade assembly 18 and the suction assembly 22 are located within the outer sheath 52 during insertion. The device 10 passes through the aortic valve 82 and enters the left ventricle of the subject's heart 86. Method 92 may include using echocardiographic and fluoroscopic guidance to guide the distal end 26 of the catheter to the desired hypertrophied segment 88 that needs to be resected.

[0062] Method 92 includes step 96 of fixing the distal end 26 of the catheter device 10 to tissue 88 at a target site in the heart 86, as shown in Figures 4 and 5. In this embodiment, the helical anchor 72 of the fixing assembly 30 advances beyond the tip of the catheter body 14 into the thickened tissue 88. Step 98 of Method 92 then includes exposing the blade assembly 18 to the tissue 88 by moving the blade assembly 18 against the outer sheath 52 of the body 14. Method 92 includes step 100 of applying suction force to the target site in the heart 86, specifically around the blade assembly 18, to collect and remove the shredded tissue from the heart 86.

[0063] Method 92 may include the step of monitoring the position of the distal end 26 of the catheter device 10 under fluoroscopy. For example, multiple markers 64 placed on the distal end 26 of the catheter device 10 can help the physician locate the position of the distal end 26 within the heart and to determine how far the blade assembly 18 has penetrated the target tissue 88.

[0064] Method 92 may also include the step of delivering saline solution from a saline source 73 through the distal end 26 of the catheter 14. The saline solution is configured to move through an internal lumen 68 of the catheter device 10. In this example, the internal lumen 68 is defined by the shaft 54 ​​of the blade assembly 18. The saline solution may be supplied continuously throughout the procedure to aspirate and collect the shredded muscle. Furthermore, the internal lumen 68 may be fluidly coupled to a vacuum source to generate an aspiratory force at the distal end 26 of the device 10.

[0065] Method 92 may include deploying an embolic protection device 90 positioned within the subject's aorta 80 when the distal end 26 of the catheter 14 is positioned within the left ventricle. The filter 90 is coupled to the outer sheath 52 of the catheter device 10 and is configured to engage with the inner wall of the aorta 80 after deployment.

[0066] The blade assembly 18 of the muscle resection device 10 in Figures 1 to 16 has three blades, but in other embodiments, the blade assembly 18 may have two blades, such as the blade assembly 118 of the device shown in Figures 8 and 9.

[0067] Referring here to Figures 8 and 9, the second exemplary catheter-guided myoresection device 110 can also perform the method 92 shown in Figure 7. The second exemplary myoresection device 110 is similar to the myoresection device 10 shown in Figures 1 to 6, except that the second exemplary myoresection device 110 has a different blade assembly 118 and a fixing assembly 130. Elements of the second exemplary myoresection device 110 that are similar to elements of the myoresection device 10 shown in Figures 1 to 6 are denoted by the same reference numeral plus 100. Descriptions of many of these elements have been simplified or even omitted for the sake of brevity.

[0068] In this example, the distal end 126 of the catheter includes a distal opening 134 through which the blade assembly 118 extends. As shown in Figure 9, the catheter 114 has an outer sheath 152 defining a first lumen 142 and a first inner sheath 156 defining a second lumen 146. The first and second lumens 142 and 146 are axially aligned with respect to the Y-axis of the catheter device 110 and are radially spaced apart from each other with a gap G. The dimensions of the gap G may be in the range of approximately 2 mm or more (for example, approximately 2.1 mm or more, approximately 2.2 mm or more, approximately 2.3 mm or more, approximately 2.4 mm or more, approximately 2.5 mm or more, approximately 2.6 mm or more, approximately 2.7 mm or more, approximately 2.7 mm or more, approximately 2.8 mm or more, approximately 2.9 mm or more, approximately 3.0 mm or more, approximately 3.1 mm or more, approximately 3.2 mm or more, approximately 3.3 mm or more, approximately 3.4 mm or more, approximately 3.5 mm) to approximately 5 mm or less (for example, approximately 4.9 mm or less, approximately 4.8 mm or less, approximately 4.7 mm or less, approximately 4.6 mm or less, approximately 4.4 mm or less, approximately 4.3 mm or less, approximately 4.2 mm or less, approximately 4.1 mm or less, approximately 4.0 mm or less, approximately 3.9 mm or less, approximately 3.8 mm or less, approximately 3.7 mm or less, approximately 3.6 mm or less, approximately 3.5 mm).

[0069] To fix the distal end 126 to the target site 88 and to collect the shredded tissue during the muscle resection, suction force is applied at the distal end 126 through the first lumen 142 between the outer sheath 152 and the inner sheath 156 of the catheter body 114. The outer sheath diameter D is approximately 1 cm or more (for example, approximately 1.01 cm or more, approximately 1.02 cm or more, approximately 1.03 cm or more, approximately 1.04 cm or more, approximately 1.05 cm or more, approximately 1.06 cm or more, approximately 1.07 cm or more, approximately 1.08 cm or more, approximately 1.09 cm or more, approximately 1.1 cm or more, approximately 1.11 cm or more, approximately 1.12 cm or more, approximately 1.13 cm or more, approximately 1.14 cm or more, approximately 1.15 cm or more, approximately 1.16 cm or more, approximately 1.17 cm or more, approximately 1.18 cm or more, approximately 1.19 cm or more, approximately 1.2 cm or more, approximately 1.21 cm or more, approximately 1.22 cm or more, approximately 1.23 cm or more, approximately 1.24 cm or more, approximately 1.25 cm) to approximately 1 It may have dimensions within the range of 0.5 cm or less (for example, approximately 1.49 cm or less, approximately 1.48 cm or less, approximately 1.47 cm or less, approximately 1.46 cm or less, approximately 1.45 cm or less, approximately 1.44 cm or less, approximately 1.43 cm or less, approximately 1.42 cm or less, approximately 1.41 cm or less, approximately 1.4 cm or less, approximately 1.39 cm or less, approximately 1.38 cm or less, approximately 1.37 cm or less, approximately 1.36 cm or less, approximately 1.35 cm or less, approximately 1.34 cm or less, approximately 1.33 cm or less, approximately 1.32 cm or less, approximately 1.31 cm or less, approximately 1.3 cm or less, approximately 1.29 cm or less, approximately 1.28 cm or less, approximately 1.27 cm or less, approximately 1.26 cm or less, approximately 1.25 cm).

[0070] The blade assembly 118 is located within the second lumen 146 and is exposed by retracting the outer sheath 152 and / or inner sheath 156 relative to the blade assembly 118. The blade 158 of the blade assembly 118 includes two opposing elements that rotate with respect to the Y axis. Similar to the first exemplary blade assembly 18, the second exemplary blade assembly 118 includes a shaft 154 that defines a third lumen 168. The third lumen 168 can provide suction force and / or deliver saline solution to a target tissue site 88.

[0071] Unlike the fixation assembly 30 of the first exemplary myorectomy device 10, the fixation assembly 130 in the second exemplary device 110 is achieved by a suction assembly 122 and / or additional suction force. Thus, step 96 of fixing the distal end 126 of the catheter device 110 in method 92 includes applying suction force to the target site 88 through the first lumen 142 to bind the distal end 126 to the target site 88.

[0072] Referring here to Figures 10 to 16, the third exemplary catheter-guided myoresection device 210 can also be subjected to the method 92 shown in Figure 6. The third exemplary myoresection device 210 is similar to the myoresection device 10 shown in Figures 1 to 6. Therefore, components of the third exemplary myoresection device 210 that are similar to the components of the myoresection device 10 shown in Figures 1 to 6 are given the same reference numerals plus 200. For the sake of brevity, the descriptions of many of these elements have been simplified or omitted. The third exemplary myoresection device 210 differs from the first and second exemplary myoresection devices 10 and 110, as will be described below.

[0073] In Figures 10 to 13, the muscle resection device 210 includes a handle 212, a catheter body 214 coupled to the handle 212, a blade housing 227 located at the distal end of the device 10 and coupled to the catheter body 214, and a catheter cap 229 coupled to the blade housing 227. The catheter cap 229 and the blade housing 227 together form the distal end 226 of the muscle resection device 210.

[0074] The muscle resection device 210 comprises a blade assembly 218, a fixing assembly 230, and a suction assembly 222. The user can control each assembly 218, 230, and 222 by operating one or more of several operating elements 215A, 215B, and 215C coupled to the handle 212. The suction assembly 222 comprises an external vacuum source 223 and a suction lumen 242 (Figure 13) that extends through the catheter body 214 and is coupled to the vacuum source 223. The suction assembly 222 is configured to apply suction force at the distal end 226 of the device 210.

[0075] In Figure 13, the fixation assembly 230 includes a helical anchor 272 and an operable rod (not shown) located within the anchor lumen 268 of the catheter body 214. In the extended position, the helical anchor 272 extends through an opening 234 at the distal end 226. The fixation assembly 230 is positioned radially offset from the blade assembly 218 and shares the anchor lumen 268 with the guidewire. For example, when delivering the catheter device 210 to the surgical site, the guidewire extends through the anchor lumen 268 from the opening 234 at the distal end 226. Upon reaching the surgical site, the user can remove the guidewire from the opening and insert the fixation assembly 230 through the anchor lumen 268.

[0076] In other examples, the guidewire may be rigid enough to secure the device 210 in a position adjacent to the target tissue to be resected. Similar to the helical anchor 272, the guidewire can be positioned in the left ventricle and / or potentially snare from the left atrium, allowing the catheter body 214 to travel along the guidewire and resect the tissue.

[0077] In Figures 13 to 16, the blade assembly 218 includes a rotatable blade shaft 254 and a blade 258 coupled to the blade shaft 254. As shown in Figures 13 and 14, when the blade assembly 218 is in the retracted position, the distal end 256 of the blade shaft 254 is positioned within a channel 255 formed in the catheter cap 229, and the blade 258 is oriented horizontally to an opening 238 at the distal end 226. The blade shaft 254 is coupled to a motor 297 located within the handle 212, extends through the blade lumen (not shown) of the catheter body 214, and terminates within the channel 255. In both the retracted and used positions, the blade 258 is positioned within a volume 246 formed in the blade housing 227. The blade 258 is configured to rotate within the volume 246 adjacent to the distal end of the blade lumen. In the used position shown in Figure 15, the blade 258 extends through an opening 238 formed in the side wall of the catheter body 214.

[0078] Referring again to Figure 10, a battery-powered motor 297 that operates the blade assembly 218 is located within the handle 212. The drive shaft of the motor 297 is coupled to the blade shaft 254 of the blade assembly 218. The blade assembly 218 may also be configured to move from its stowed position by pulling a slide 215B within the handle 212, which pulls the blade shaft 254 proximal out of the channel 255 in the catheter cap 229. The speed of the blade assembly 218 can be controlled by operating one of the operating elements 215 (e.g., dial 215C).

[0079] Device 210 also has a washing assembly comprising a flushing lumen 266 and a fluid source 273 (Figure 10) such as saline solution coupled to the flushing lumen 266. As shown in Figure 16, the flushing lumen 266 and the suction lumen 242 terminate within the volume 246 of the blade housing 227 and are in fluid communication with the volume 246. The distal ends of the flushing lumen 266, the suction lumen 242, and the blade lumen are positioned axially recessed compared to the distal ends of the pull wire lumen 262 and the anchor lumen 268. The pull wire lumen 262 and the anchor lumen 268 are fluidly isolated from the volume 246 of the blade housing 227. During use, the crushed tissue and saline wash solution are movable through the opening 238 at the distal end 226.

[0080] Referring again to Figure 10, the device 210 includes a flange 292 located near the handle 212. The flange 292 is coupled to the outer sheath 252 of the catheter body 214 and is configured to move the outer sheath 252 to release the embolic protection device 290. As shown in Figures 10 and 11, the embolic protection device 290 is in a folded state. When the flange 292 is pushed distally (i.e., away from the handle 212), a portion of the outer sheath 252 moves distally, pressing both ends of the embolic protection device 290 and expanding the embolic protection device radially, as shown in Figure 12. To fold the embolic protection device 290 radially for storage, the user can pull the flange 292 proximal (i.e., towards the handle 212), which separates both ends of the embolic protection device 290 from each other.

[0081] In Figure 12, the embolic protection device 290 is deployed radially outward relative to the catheter body 214. Once the embolic protection device 290 is deployed into the patient's artery, it expands radially and engages with the inner wall of the artery. The embolic protection device 290 includes a mesh-like, web-like body that forms multiple openings, allowing blood to flow through the device while capturing tissue fragments larger than 1 mm.

[0082] In Figure 16, the device 210 has two pull wires 295, each positioned within a pull wire lumen 262 radially offset from the central axis X, to control the navigation of the device. The distal end of each pull wire 295 is fixed to the distal end 226 of the catheter 214 to steer the distal end 226 of the catheter 214 in at least two directions with respect to the X axis. Each pull wire 295 extends through the catheter body 214 and is coupled to an operating element 215 (e.g., a knob 215A). Tension can be applied to the pull wire 295 by rotating the knob 215A, for example clockwise, and tension can be released from the pull wire 295 by rotating the knob, for example counterclockwise. The pull wires 295 are used to guide the device 210 to a target site and to position the blade assembly 218 in contact with the target tissue. After extending the anchor 272 into the tissue, the operator can manipulate the pull wire 295 to position the blade assembly 218 in contact with the target tissue. The distal end 226 bends so that the opening 238 of the device 210 contacts the target site (for example, Figure 6). The operator can also rotate the device 210 as the anchor 272 enters or after it has entered the tissue.

[0083] The muscle resection device 10 shown in Figures 1 to 6 includes a fixed assembly coaxially aligned with the blade assembly 18, whereas in other embodiments, the muscle resection device may have a fixed assembly offset from the blade assembly, such as the exemplary muscle resection device 210 shown in Figures 13 and 16.

[0084] In the catheter device 10 shown in Figures 1 to 6, the third lumen 68 is defined by the blade shaft 54, whereas in other examples, the blade shaft 54 ​​does not define a lumen for the fixation assembly. For example, in the exemplary catheter device 210 shown in Figures 10 to 16, the fixation assembly 230 is located within the anchor lumen 268.

[0085] The muscle resection devices 10 and 110 in Figures 1-6, 8 and 9 each have blade assemblies 18 and 118 that are covered by an outer sheath when not in use, but in other examples, the muscle resection device may include a blade assembly 218 that can be positioned without being covered by an outer sheath, as in the exemplary muscle resection device 210 shown in Figures 10-16. As shown in Figures 14-16, the blade 258 includes two blade arms positioned 180 degrees apart from each other. In this way, the blade 258 can remain horizontal (with respect to the X-axis) and stay within the catheter 214 as the catheter is moved toward the incision site, as shown in Figures 14 and 16.

[0086] The muscle resection device 10 shown in Figures 1 to 6 includes multiple markers 64 aligned with multiple ports 50 of the suction assembly 22, while in other examples, the device may include one or more markers located at other positions on the distal end 226 of the device. For example, the exemplary muscle resection device 210 shown in Figure 13 includes first and second markers 264 located within a catheter cap 229.

[0087] The myofascial resection devices shown in Figures 1 to 6 deliver saline solution through a third lumen 68, while in other embodiments, the myofascial resection device may have a separate flushing lumen, such as the device 210 shown in Figures 10 to 16. In Figure 16, the flushing lumen 266 is configured to deliver saline solution and / or suction force through the distal end 226 of the catheter 214 during myofascial resection. The flushing lumen 266 is in fluid communication with the suction lumen 242, the volume 246 of the blade housing 227, and the opening 238 at the distal end 226 of the device 210.

[0088] In other embodiments, the muscle resection device may have different fixation assemblies. For example, the muscle resection device may have an additional suction assembly instead of a helical anchor. In some embodiments, attachment to a hypertrophied segment 88 or a desired tissue mass can be achieved by using one or more devices used when performing cryotherapy (e.g., barbed anchors, suction, helical anchors, etc.). Cryotherapy allows the catheter to be attached to a target area on the septum and the tissue to be exposed to freezing temperatures for tissue resection. In other embodiments, the fixation device may extend from a lateral opening at the distal end of the catheter device rather than through an opening at the distal tip.

[0089] In other embodiments, each of the muscle resection devices 10, 110, and 210 includes expandable filters 90, 190, and 290, respectively, while the filters 90, 190, and 290 may optionally be attached to the catheter bodies 14, 114, and 214 if the tissue fragment is less than 1 mm and the risk of serious stroke is considered low. However, if the tissue fragment is larger than 1 mm, the filters 90, 190, and 290 may be coupled to the devices 10, 110, and 210 so as to deploy and capture the tissue fragment when it is positioned in a predetermined location within the aorta 80.

[0090] Further treatment of the desired tissue segment 88 is also possible by applying a direct current or performing high-frequency ablation.

[0091] Although devices 10, 110, 210 and method 92 are described herein for performing septal muscle resection, devices 10, 110, 210 and method 92 can also be used for other procedures. For example, devices 10, 110, and 210 can be used for localized and highly precise removal of solid organ tumors such as those of the gastrointestinal tract, liver, and kidneys, removal of cardiac tumors such as left atrial myxoma, or removal of bronchial and lung parenchymal tumors.

[0092] The methods described herein 92 and devices 10, 110, 210 can be used by a peripheral approach via a peripheral vessel with sufficient diameter (such as the femoral artery, femoral vein, iliac artery, subclavian artery, or carotid artery), or by a direct aortic approach and / or a transapical approach from the left chest. For example, when approaching the target site transapically, the catheter does not need to pass through the aortic valve.

[0093] While this specification contains many specific implementation details, these should not be construed as limiting the scope of any disclosure or claims, but rather as descriptions of features that may be specific to a particular embodiment relating to a particular disclosure. Features described herein in the context of a separate embodiment may be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment may be implemented individually or in any suitable subcombination in multiple embodiments. Furthermore, features are described herein as acting in a particular combination, and may even be initially claimed as such, but one or more features may be decoupled from the claimed combination, and the claimed combination may cover a subcombination or a variation thereof.

[0094] Similarly, even if operations are illustrated in a specific order in the drawings, it should not be understood that, in order to obtain the desired results, it is necessary to perform the operations in that specific order or sequentially as illustrated, or to perform all illustrated operations. Under certain circumstances, multitasking and parallel processing may be advantageous. Furthermore, although various system modules and components are described separately in the embodiments described herein, such separation should not be understood as essential in all embodiments. In addition, the described program components and systems should generally be understood as being integrated as a single product or packaged as multiple products.

[0095] This specification describes specific embodiments of the subject matter of the present invention. Other embodiments are included in the following claims. For example, the operations described in the claims may still yield favorable results even if performed in a different order. As an example, the steps shown in the accompanying figures do not necessarily have to be performed in the specific illustrated order or sequentially to obtain the desired results. In some implementations, multitasking and parallel processing may be advantageous.

Claims

1. A catheter body having a distal end, a first lumen, and a second lumen, A suction assembly configured to direct the suction force through the first lumen, A blade assembly disposed within the second lumen of the catheter and movable between a retracted position and an extended position relative to the distal end, A catheter-guided myosectomy device equipped with the following features.

2. The device according to claim 1, further comprising a third lumen located within the second lumen of the catheter body.

3. The device according to claim 2, further comprising a fixing assembly disposed within the third lumen of the catheter body.

4. The device according to claim 3, wherein the fixing assembly comprises a helical anchor that is movable between an extended position and a retracted position.

5. The device according to claim 2 or 3, wherein the third lumen is configured to deliver saline solution irrigation through the distal end of the catheter body.

6. The device according to claim 5, wherein the third lumen is configured to deliver suction force through the distal end of the catheter body.

7. The device according to any one of claims 2 to 6, wherein the blade assembly comprises a shaft and a blade coupled to the shaft.

8. The device according to claim 7, wherein the shaft defines the third lumen.

9. The device according to any one of claims 1 to 7, wherein the catheter body comprises a sheath surrounding the blade assembly, and the sheath is movable to expose the blade assembly.

10. The device according to any one of claims 1 to 9, comprising a porous filter coupled to the catheter body and positioned at an interval from the distal end, wherein the filter is configured to engage with the arterial wall when in an expanded configuration.

11. The device according to any one of claims 1 to 10, wherein the distal end of the catheter body is operable.

12. The device according to claim 9, comprising a marker attached to the catheter body and visible under fluoroscopy.

13. The device according to claim 12, wherein the marker is aligned longitudinally with the port formed on the catheter body.

14. The device according to any one of claims 1 to 13, wherein the suction assembly comprises a port that is in fluid communication with the first lumen and is coupled to the catheter body.

15. A method for removing tissue from the heart of a subject, The procedure involves inserting a catheter device through the aortic valve of the subject, wherein the catheter device comprises a body having a distal end, an outer sheath, a blade assembly, and a suction assembly, and the blade assembly and the suction assembly are positioned within the outer sheath during insertion. The distal end of the catheter device is fixed to the tissue of the target site of the heart, Exposing the blade assembly to the tissue, Applying a suction force to the distal end via the suction assembly, Methods that include...

16. The method according to claim 15, wherein fixing the distal end includes extending an anchor from the distal end of the catheter device and inserting the anchor into the tissue.

17. The method according to claim 15, wherein fixing the distal end includes applying suction force to the target site to connect the distal end of the catheter device to the target site.

18. The method according to any one of claims 15 to 17, comprising inserting the catheter device through the femoral vein before inserting the catheter device through the aortic valve.

19. The method according to any one of claims 15 to 18, comprising monitoring the position of the distal end of the catheter device under fluoroscopy, wherein the catheter device comprises a marker that is visible under fluoroscopy and is located at the distal end of the catheter device.

20. The method according to any one of claims 15 to 19, comprising delivering saline solution through the distal end of the catheter device, wherein the saline solution is configured to move through an internal lumen of the catheter device.

21. The method according to any one of claims 15 to 20, comprising deploying an embolic protection device in the aorta of the subject, wherein the embolic protection device is coupled to the outer sheath of the catheter device and configured to engage with the inner wall of the aorta.

22. The method according to any one of claims 15 to 21, wherein exposing the blade assembly includes moving the blade assembly relative to the outer sheath of the body.

23. A catheter body having a distal end that defines an opening and a proximal end opposite to the distal end, A handle is attached to the proximal end of the catheter body, A suction assembly configured to direct suction force towards the opening of the catheter body, A blade assembly having a blade configured to extend through the opening, A catheter-guided myosectomy device equipped with the following features.

24. The device according to claim 23, comprising a helical anchor movable between an extended position and a retracted position, wherein in the extended position, the helical anchor extends through a second opening at the distal end of the catheter body, and in the retracted position, the helical anchor is positioned entirely within the catheter body.

25. The device according to claim 24, comprising a catheter cap that defines the tip of the catheter body, wherein the tip defines the second opening.

26. The device according to claim 23, wherein the distal end of the catheter body comprises a blade housing that defines the internal volume and the opening at the distal end, and the blade is disposed within the internal volume.

27. The device according to claim 26, wherein the suction assembly comprises a first lumen that is in fluid communication with the internal volume of the blade housing.

28. The device according to claim 27, further comprising a second lumen configured to deliver saline solution irrigation through the opening of the catheter body.

29. The device according to claim 28, wherein the second lumen is in fluid communication with the internal volume of the blade housing.

30. The device according to claim 25, comprising a pull wire extending through the catheter body and coupled to the distal end.

31. The device according to claim 30, wherein the pull wire is fixed to the catheter cap.

32. The device according to any one of claims 23 to 31, comprising an embolic protection device configured to move between a retracted position and an unfolded position, wherein in the retracted position the embolic protection device is in a folded configuration, and in the unfolded position the embolic protection device is in a configuration that is radially extended relative to the catheter body.

33. The device according to any one of claims 23 to 32, comprising a motor located within the handle and operably coupled to the blade assembly.

34. The device according to any one of claims 23 to 33, comprising a guide wire configured to anchor the distal end of the catheter body.

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