Stabilizer for delivery system

Abstract

The invention relates to a stabilizer for a delivery system. Disclosed herein are embodiments of a stabilizer for delivering a replacement heart valve. The stabilizer may receive a portion of a delivery system, such as a handle, to prevent unwanted movement of the delivery system. The stabilizer may include a linear actuator that, once held within the stabilizer, is used to adjust the orientation of the delivery system.

Description

[0001] This application is a divisional application of Chinese patent application 2019800768939 (PCT / US2019 / 053883) filed on September 30, 2019 and entitled “Stabilizer for delivery system”. Technical Field

[0002] Certain embodiments disclosed herein relate generally to delivery systems for prostheses, and in some embodiments to stabilizers for use with delivery systems for delivering replacement heart valves via a transseptal approach. Background Art

[0003] The human heart valves include the aortic valve, pulmonary valve, mitral valve, and tricuspid valve, which essentially function as one-way valves that operate in sync with the pumping heart. These valves allow blood to flow downstream, but prevent blood from flowing upstream. Diseased heart valves exhibit damage such as valve narrowing or regurgitation, which hinders the valve's ability to control blood flow. This damage reduces the heart's pumping efficiency and can be debilitating and life-threatening. For example, valvular insufficiency can lead to conditions such as cardiac hypertrophy and ventricular dilatation. Therefore, extensive efforts have been made to develop methods and devices to repair or replace damaged heart valves.

[0004] Prostheses exist to correct problems associated with damaged heart valves. For example, mechanical and tissue-based heart valve prostheses can be used to replace damaged natural heart valves. Recently, a lot of effort has been invested in developing replacement heart valves, particularly tissue-based replacement heart valves, which are less traumatic to the patient than through open heart surgery. Replacement valves are designed to be delivered through minimally invasive surgical procedures or even percutaneous surgical procedures. Such replacement valves typically include a tissue-based valve body that is connected to an expandable frame, which is then delivered to the annulus of the natural valve.

[0005] The development of prostheses (including, but not limited to, replacement heart valves that can be compacted for delivery and then controllably expanded for controlled placement) has proven to be particularly challenging. Another challenge relates to the ability to secure such prostheses relative to luminal tissue (e.g., tissue within any body cavity or lumen) in an atraumatic manner.

[0006] Delivering a prosthesis to a desired location in the human body, such as delivering a replacement heart valve to the mitral valve, is also challenging. Gaining access to perform a procedure in the heart or other anatomical locations may require percutaneous delivery of the device through a tortuous vasculature or through an open or semi-open surgical procedure. The ability to control the position of the delivery system and the deployment of the prosthesis at the desired location is also challenging. Summary of the invention

[0007] The present disclosure includes, but is not limited to, the following embodiments.

[0008] Embodiment 1: A stabilizer for a delivery system. The stabilizer may include an elongated body. The elongated body may include a proximal end and a distal end and a longitudinal axis extending between the proximal end and the distal end. The elongated body may include a substantially flat base extending between the proximal end and the distal end. The elongated body may include a first angled surface. The first angled surface may be located on top of the base. The first angled surface may slope downward toward the distal end. The elongated body may include a second angled surface. The second angled surface may be located on top of the base. The second angled surface may be longitudinally spaced apart from the first angled surface and proximal to the first angled surface. The second angled surface may slope downward toward the distal end. The stabilizer may further include a hub sleeve. The hub sleeve may be attached to the top of the first angled surface. The hub sleeve may include an extension extending upward from the first angled surface. The extension may be configured to releasably retain a sheath hub of the delivery system. The stabilizer may further include a handle bracket. The handle bracket may be on top of the second angled surface. The handle bracket may include a track attachable to the second angled surface and a delivery system clamp configured to travel longitudinally along the track. The delivery system clamp may be configured to releasably retain a handle of the delivery system. The stabilizer may further include a base adapter, wherein the distal end of the body is configured to releasably connect to the base adapter.

[0009] Embodiment 2: The stabilizer of Embodiment 1, further comprising a pair of attachment clips, wherein each of the pair of attachment clips does not have any sharp ends.

[0010] Embodiment 3: The stabilizer of Embodiment 1 or Embodiment 2, wherein the base adapter comprises a pair of proximally extending arms and an upper lug configured to receive a distally extending lug of the body to prevent upward movement of the body.

[0011] Embodiment 4: The stabilizer of any of Embodiments 1 to 3, wherein the first angled surface and the second angled surface are configured to be independently angularly adjusted relative to the planar substrate.

[0012] Embodiment 5: A stabilizer according to any one of embodiments 1 to 4, wherein the handle bracket comprises: a first knob configured to translate the delivery system clamp longitudinally along the shell; and a second knob configured to open and close the delivery system clamp.

[0013] Embodiment 6: The stabilizer of any one of embodiments 1 to 5, further comprising a travel screw located within the housing, wherein a portion of the delivery system clamp is located within the housing and interfaces with the travel screw.

[0014] Embodiment 7: The stabilizer of any one of Embodiments 1 to 6, wherein a height of the first angled surface relative to the substrate is less than a height of the second angled surface relative to the substrate.

[0015] Embodiment 8: The stabilizer of any of Embodiments 1 to 6, wherein the first angled surface has substantially the same angle on a top surface of the first angled surface as on a top surface of the second angled surface.

[0016] Embodiment 9: The stabilizer of any one of Embodiments 1 to 8, wherein the first angled surface and the second angled surface each have an angle between 5 degrees and 30 degrees.

[0017] Embodiment 10: The stabilizer of any one of Embodiments 1 to 9, wherein the extension comprises a pair of arms.

[0018] Embodiment 11: The stabilizer of Embodiment 10, wherein the pair of arms comprises a spring plunger configured to retain the sheath hub.

[0019] Embodiment 12: The stabilizer of Embodiments 1 to 11, wherein a motor is configured to translate the delivery system clamp along the track, and wherein the motor is configured to open and close the delivery system clamp.

[0020] Embodiment 13: A stabilizer according to Embodiment 12, wherein the motor is configured to be remotely operated.

[0021] Embodiment 14: A stabilizer system, comprising a stabilizer according to any one of embodiments 1 to 13, and further comprising a pair of attachment clamps, wherein the pair of attachment clamps are configured to attach the body to a base; a first attachment clamp of the pair of attachment clamps can be attached to the base adapter; and a second attachment clamp of the pair of attachment clamps can be attached to the body.

[0022] Embodiment 15: A stabilizer system comprising the stabilizer according to any one of embodiments 1 to 13, and further comprising a delivery system.

[0023] Example 16: A stabilizer system according to Example 15, wherein the delivery system includes a handle, wherein a portion of the delivery system distal to the handle is releasably retained within the hub sleeve, and the handle is releasably retained within the delivery system clamp of the handle bracket.

[0024] Example 17: The stabilizer system of Example 15 or Example 16, wherein the delivery system is configured for transseptal delivery of a replacement mitral heart valve.

[0025] Embodiment 18: A stabilizer system comprising the stabilizer of any one of Embodiments 1 to 17, and further comprising a base having a generally flat upper surface and a plurality of legs extending downwardly.

[0026] Embodiment 19: The stabilizer system of Embodiment 18, wherein the stabilizer is configured to clamp onto the substantially planar upper surface of the base.

[0027] Embodiment 20: The stabilizer system of Embodiment 18 or Embodiment 19, and further comprising a substantially planar plate, wherein the plurality of legs are configured to be located on the substantially planar plate.

[0028] Embodiment 21: The stabilizer system of any one of Embodiments 18 to 20, wherein the stabilizer is configured to be magnetically attached to the substantially planar upper surface of the base.

[0029] Embodiment 22: The stabilizer system of Embodiment 21, wherein the magnetically attaching comprises electromagnetic attachment.

[0030] Example 23: A stabilizer for a delivery system. The stabilizer may include a body including a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end. The stabilizer may include a handle bracket. The handle bracket may be provided at a proximal position along the body. The handle bracket may include an angled track that slopes downward toward the distal end of the body. The handle bracket may include a delivery system clamp configured to travel longitudinally along the track. The delivery system clamp may be configured to releasably hold a handle of the delivery system. The stabilizer may include a kit. The kit may be positioned at a distal position along the body. The kit may be configured to releasably hold a portion of the delivery system.

[0031] Embodiment 24: A stabilizer according to Embodiment 23, wherein the body includes: a first angled surface configured to support the kit; and a second angled surface proximal to the first angled surface and configured to support the handle bracket.

[0032] Embodiment 25: The stabilizer of Embodiment 23 or Embodiment 24, further comprising a base adapter releasably attached to the body.

[0033] Embodiment 26: A method of controlling a delivery system using the stabilizer of any of the preceding embodiments.

[0034] Embodiment 27: A universal stabilizer for a delivery system, the universal stabilizer comprising: a longitudinally extending guide rail having an upward facing surface and a downward facing surface; a fixed clamp attached to the downward facing surface of the longitudinally extending guide rail; a movable clamp attached to the downward facing surface of the longitudinally extending guide rail and longitudinally spaced apart from the fixed clamp, wherein the movable clamp is configured to translate along the longitudinally extending guide rail; and a guide rail dock attached to the upward facing surface of the longitudinally extending guide rail, the guide rail dock being configured to cooperate with a delivery system retainer on the upward facing surface of the guide rail dock, wherein the guide rail dock is configured to translate along the longitudinally extending guide rail.

[0035] Embodiment 28: A universal stabilizer according to Embodiment 27, wherein the rail is a Picatinny rail.

[0036] Embodiment 29: The universal stabilizer of Embodiment 27 or 28, wherein the movable clamp comprises a knob configured to adjust the longitudinal orientation of the movable clamp.

[0037] Embodiment 30: The universal stabilizer of any one of Embodiments 27 to 29, wherein the rail dock includes handles connected to plates on opposite sides of the rail dock, wherein activation of the handles prevents the rail dock from translating on the longitudinally extending rails.

[0038] Embodiment 31: A universal stabilizer according to any one of Embodiments 27 to 30, wherein the delivery system retainer includes a handle bracket, the handle bracket includes a track and a delivery system clamp configured to move longitudinally along the track, wherein the delivery system clamp is configured to releasably hold the handle of the delivery system.

[0039] Embodiment 32: A universal stabilizer according to any one of Embodiments 27 to 31, wherein the longitudinally extending guide rail further includes a first pair of outwardly extending protrusions and a second pair of outwardly extending protrusions, a first cavity is formed between the first pair of outwardly extending protrusions, and a second cavity is formed between the second pair of outwardly extending protrusions, and the first pair of outwardly extending protrusions and the second pair of outwardly extending protrusions are located on opposite sides of the guide rail.

[0040] Embodiment 33: A universal stabilizer according to any one of Embodiments 27 to 32, further comprising a second guide rail dock, the second guide rail dock being attached to the upward-facing surface of the longitudinally extending guide rail and being spaced apart from the guide rail dock, the second guide rail dock being configured to cooperate with a second delivery system retainer on the upward-facing surface of the second guide rail dock, wherein the second guide rail dock is configured to translate along the longitudinally extending guide rail.

[0041] Embodiment 34: An electrically controlled stabilizer system for a delivery device having a handle with multiple actuators, the system comprising a knob control system configured to independently operate each of the multiple actuators and a handle control system configured to translate the handle of the delivery device, the knob control system comprising: a container configured to at least partially accommodate the handle; a plurality of fixed sections located within the container and configured to hold the handle in an appropriate position; a plurality of roller sections located within the container, each of the plurality of roller sections comprising at least one roller; and a motor configured to independently operate at least one roller in each of the plurality of roller sections, wherein at least one roller in each of the plurality of roller sections is configured to operate one of the plurality of actuators when operating the at least one roller, the handle control system comprising: a belt configured to at least partially surround the container and rotate the container and handle when the belt translates; a bracket connected to the belt; and a track connected to the bracket, wherein the bracket is configured to translate along the track.

[0042] Embodiment 35: The electrically controlled stabilizer system according to Embodiment 34, further comprising a controller for electronically operating the electrically controlled stabilizer system.

[0043] Embodiment 36: The electrically controlled stabilizer system of Embodiment 34 or 35, wherein the container comprises a distal aperture, and wherein a shaft extending from the handle of the delivery device is configured to extend through the distal aperture. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] Figure 1A to Figure 1B An embodiment of a stabilizer for a delivery system is shown.

[0045] Figure 2 An embodiment of a base that may be used with the stabilizer of FIG. 1 is shown.

[0046] Figure 3 Show that it can be Figure 2 An embodiment of a plate for use in combination with a base.

[0047] Figures 4 to 5 An embodiment of a clamp that may be used with a stabilizer is shown.

[0048] Figure 6 An embodiment of a stabilizer body is shown with certain components removed.

[0049] Figures 7 and 8 An embodiment of a distal end of a stabilizer body and a base adapter is shown.

[0050] Figures 9 to 11 An embodiment of a hub assembly is shown.

[0051] Figure 12 to Figure 14 An embodiment of a linear clamp assembly is shown.

[0052] FIG. 15A to FIG. 15C An embodiment of a clamp for use in a delivery system is shown.

[0053] Figures 16 to 18 Embodiments of a stabilizer are shown in which the delivery system is held at different locations in the stabilizer.

[0054] Fig.19 An embodiment of a universal rail system is shown.

[0055] FIG. 20A to FIG. 20F An embodiment of a guide rail dock is shown.

[0056] FIG. 21A to FIG. 21C An embodiment of a guide rail is shown.

[0057] FIG. 22A to FIG. 22B Embodiments of alternative guide rail cross sections are shown.

[0058] Fig.23 An embodiment of a guide rail and a fixing clamp is shown.

[0059] FIG. 24A to FIG. 24C Embodiments of the fixing clamps are shown attached to different surfaces.

[0060] Fig.25 An embodiment of a movable clamp is shown.

[0061] FIG. 26A to FIG. 26B An embodiment of a removable clamp attached to a surface is shown.

[0062] Fig. 27 An embodiment of a guide rail with wings is shown.

[0063] Fig.28 An embodiment of a universal rail system is shown.

[0064] Fig.29 Shown is the electric knob delivery system rotation mechanism.

[0065] Fig.30 The powered delivery system rotation mechanism is shown. DETAILED DESCRIPTION

[0066] The present specification and the accompanying drawings provide aspects and features of the present disclosure in the context of multiple embodiments of replacement heart valves, delivery systems and methods, which are configured for use in the vasculature of a patient, such as for replacing a natural heart valve in a patient. These embodiments can be discussed in conjunction with replacing a specific valve (such as a patient's aortic valve, tricuspid valve or mitral valve). However, it should be understood that the features and concepts discussed herein can be applied to products other than heart valve implants. For example, the controlled orientation, deployment and fixation features described herein can be applied to medical implants (such as other types of inflatable prostheses) for use elsewhere in the body, such as in an artery, vein or other body cavity or location. In addition, the specific features of valves, delivery systems, etc. should not be considered restrictive, and the features of any one of the embodiments discussed herein can be combined with the features of other embodiments as needed and as appropriate. Although certain embodiments described herein are described in conjunction with a transfemoral (or transseptal) delivery method, it should be understood that these embodiments can be used for other delivery methods, such as transapical or transjugular methods. Furthermore, it should be appreciated that certain features described in conjunction with some embodiments may be combined with other embodiments, including those described in conjunction with different delivery methods.

[0067] Stabilizer

[0068] Figure 1A to Figure 1B An embodiment of a stabilizer 100 is shown, which can be used to hold an embodiment of a delivery system in place when the delivery system is used. Examples of delivery systems that can be held together with a stabilizer are described in detail in U.S. Patent Publication Nos. 2017 / 005616, 2016 / 0317301, 2017 / 005617, and 2019 / 0008640, and the entire contents of each of the above patent applications are incorporated herein by reference as a whole. By allowing fine motor control of the delivery system within the stabilizer, the disclosed stabilizer 100 is advantageous for a transseptal (e.g., transfemoral) method for delivering a replacement heart valve. However, embodiments of the stabilizer 100 disclosed herein can also be used in other methods and other procedures, such as a transapical approach, and are not limited to replacing a heart valve.

[0069] Generally, the stabilizer 100 (e.g., system, stabilizer system, stabilizer station) can be a system used during an implantation / surgical procedure while including certain movable components. Although the particular location is not limited, the stabilizer 100 can be used to hold a delivery system in place, such as above a patient's legs or on a surgical table. As discussed below, a delivery system such as one used to deliver a replacement heart valve can be locked into the stabilizer 100, which allows the delivery system to remain stable during the procedure. In some embodiments, the stabilizer 100 can be used to twist (rotate), advance, and / or retract components of the delivery system (independently or simultaneously) in a controlled manner. As Figure 1A As shown, the distal end 203 of the stabilizer 100 can be the end closest to the delivery site (eg, a patient or a location within the patient's body) where the proximal end 205 of the stabilizer 100 is positioned opposite the distal end 203 .

[0070] Previously, the delivery system was held in place by the operator throughout the procedure. The operator would manually move the delivery system or its components, so the accuracy of the delivery system movement was highly dependent on the stability and skill of the operator. If the operator accidentally moved the device, the correct positioning of the system and associated implants could be lost and / or compromised. Additionally, if the movement was intentional but too rough, the correct orientation could also be lost and / or compromised. Therefore, embodiments of the disclosed stabilizer can provide stability during operation of the delivery system.

[0071] In some embodiments, the disclosed stabilizer 100 is provided as part of a stabilizer system or stabilizer assembly, such as Figure 1B and Figure 2 As shown, the stabilizer system or stabilizer assembly may also include a base, stool or other flat surface 102. In some embodiments, the base 102 may not be used. In some embodiments, such as Figure 2The illustrated base 102 can be placed, for example, over a patient's legs to help support the stabilizer 100. The base 102 can be sized to appropriately interact with the stabilizer 100. In some embodiments, the base 102 can include a generally planar upper surface 106 having a plurality of legs 108 extending downwardly therefrom. Thus, the patient can extend their legs through gaps between adjacent legs 108 as desired. In some embodiments, 2, 3, 4, 5, 6, 7, or 8 legs can be used with the base 102. In some embodiments, the legs 108 can be adjustable to vary the height of the upper surface 106. The legs 108 can be adjustable independently or simultaneously. In some embodiments, the legs 108 can terminate in lockable wheels for transporting the base 102. In some embodiments, the legs 108 can terminate in wheels such as Figure 2 Soft pads or rubber tips 110 are shown, which may provide a grip to the base 102. In some embodiments, the lockable wheels and rubber tips 110 may be removable and interchangeable from the legs 108. In some embodiments, the upper surface 106 may include one or more features for interacting with the stabilizer 100.

[0072] In some embodiments, Figure 3 As shown, the stabilizer system can further include a plate 104 or other hard surface that can be placed under the patient to provide a stable surface 112 for the substrate 102 to be placed thereon. In some embodiments, the plate 104 can be non-sterile. In some embodiments, the plate 104 can be generally flat, or can have a protrusion or other extension. In some embodiments, the plate 104 can include a cutout 114 that can be used as a handle for moving the plate. In addition, the plate 104 can include a notch, a recess or a hole for receiving the legs 108 of the base 102. The plate 104 can be made of metal, plastic or ceramic, and specific materials are not limited to the present disclosure.

[0073] The plate 104 can rest on a table or other surface (e.g., an operating room table) beneath the patient's legs and can provide a rigid surface for the legs 108 of the base 102 to stand on. Thus, the base 102 can rest on top of the plate 104 to provide an elevated rigid surface for the stabilizer 100 above the legs. In some embodiments, the plate 104 and base 102 can be non-sterile and can be located under a sterile drape. In some embodiments, the stabilizer 100 can be sterile and placed on top of a sterile drape.

[0074] In some embodiments, the plate 104 and / or the base 102 may not be used with the stabilizer 100 .

[0075] As in Figure 1A to Figure 1BAs shown in detail in , the stabilizer 100 can be attached to the base discussed above or other table such as a surgical table by using one or more clamps 120. In some embodiments, the base 102 and plate 104 discussed above may not be used in the stabilizer 100, and the stabilizer 100 can be directly attached to a table or other flat surface.

[0076] Figures 4 to 5 Attached at the distal end of the stabilizer 100 ( Figure 4 ) and proximal ( Figure 5 ) of the clamp 120. Advantageously, the disclosed embodiments of the clamp 120 can be a one-piece clamp, although other types of clamps can also be used. In some embodiments, the clamp 120 can be a sterilizable c-shaped clamp. In addition, the clamp 120 can be low profile so as not to interfere with the patient's leg or the surgical field. The clamp 120 can include all or nearly all rounded / atraumatic surfaces so as not to disrupt any sterile field that has been used during the procedure. Thus, as Figures 4 to 5 As shown, the clamp 120 may not include any sharp corners.

[0077] like Figure 1A to Figure 1B As shown, the stabilizer 100 can be attached to the base 102 (or other flat surface) using two clamps 120 (although other numbers of clamps, such as 1, 2, 3, 4, or 5 clamps, can also be used), one at the proximal end and one at the distal end. In some embodiments, the clamps 120 can be identical. In some embodiments, there can be differences between the clamps 120. In some embodiments, the clamps 120 are removable from the stabilizer 100. In some embodiments, the clamps 120 can be permanently connected to the stabilizer 100. In some embodiments, the clamps 120 do not have sharp edges, which can allow them to be compatible with the sterile drapes placed on the base 102 to avoid tearing. The clamps 120 themselves can be spaced apart (longitudinally or laterally) on substantially opposite sides of the stabilizer 100. In some embodiments, the clamps 120 can be physically attached to the stabilizer 100. In some embodiments, the clamps 120 can be removable or movable on the stabilizer 100, allowing them to be moved to the best clamping position.

[0078] like Figures 4 to 5As shown, the clamp 120 can be formed of two spaced-apart legs (an inner leg 122 and an outer leg 124) connected by a connector leg 126 to form a generally C-shape or U-shape (although other shapes may also be used). The inner leg 122 and the outer leg 124 can generally have the same size and shape, although they can be different shapes. The inner leg 122 and the outer leg 124 can also extend generally parallel to each other. The inner leg 122 can include a first pad 121 facing the outer leg 124. The first pad 121 can be rubber or other soft material (cloth, plastic, etc.). The outer leg 124 can receive a threaded screw / bolt 123 between a second pad 125 and a handle 127 to tighten the clamp 120, for example, through a hole (threaded or non-threaded) in the outer leg 124. Thus, a portion of the stabilizer 100 can be located between the pads 121 / 125 and compressed to hold the stabilizer 100 in place. However, other clamps may be used, and the particular clamp is not limited to the present disclosure.

[0079] like Figure 6 As shown, with some components removed for convenience, the stabilizer 100 can include a body 202 (or elongated body). The shape of the body 202 can be generally rectangular, but is not limited to a particular shape, and other shapes such as circular, triangular, etc. can also be used. The body 202 can include a longitudinal axis extending from a proximal end 203 to a distal end 205, for example, generally along the center of the body 202. The body 202 can include some or all of the features disclosed below.

[0080] The body 202 may include a generally flat elongated base 207, a first angled section 130, and a second angled section 150. The body 202 may have a generally flat bottom surface so as to rest flatly on a surface such as the base 102 or other countertop. The body 202 may include grooves, tabs, or other mechanical attachment features on the bottom surface, such as to improve a friction grip and prevent movement. In some embodiments, the proximal end of the body 202 may include a downwardly extending flange (e.g., a lip) 204. The flange 204 may extend over the edge of a base or surface, thereby allowing proper positioning of the base 102. In some embodiments, the flange 204 may be hook-shaped for wrapping around the edge of a surface. In some embodiments, the flange 204 may include some movement so as to lock onto surfaces of different sizes. In addition, the clamp 120 may be attached to the flange 102, such as Figure 5 As shown, in order to keep the stabilizer 100 in place. In some embodiments, the body 202 can also include a flange at the farthest end to wrap completely around the table. In some embodiments, more than one flange 102 can be used on either end. In some embodiments, no flange is used on either end of the stabilizer 100.

[0081] In some embodiments, such as Figure 6 As shown, the body 202 can include one or more cutout sections 206. This can generally reduce the weight of the stabilizer 100. However, in some embodiments, the body 202 does not include a cutout. The cutout 206 can be rectangular, circular, triangular, or any shape. In some embodiments, the body 202 can include two cutouts 206, one at the proximal end 203 and one at the distal end 205. The cutout 206 at the distal end 205 can extend to the farthest end of the stabilizer 100, and therefore the cutout may not be completely surrounded by the stabilizer 100.

[0082] like Figure 6 As shown, the body 202 can include a first angled section (e.g., a distal angled section, a sheath holder) 130 and a second angled section (e.g., a proximal angled section, a handle holder) 150. The first angled section 130 is distal to the second angled section 150. The first angled section 130 has an angled surface, and the second angled section 150 has an angled surface. In some embodiments, the distal angled surface (e.g., on the first angled section 130) is configured to hold a sheath (e.g., an integral sheath) of a delivery system stationary, while a handle of the delivery system can be held on the second proximal angled surface (e.g., on the second angled section 150) and can be moved in and out relative to the sheath (e.g., the delivery system moves through the sheath that remains stationary). Holding the sheath stationary prevents the sheath from accidentally moving, such as moving into and out of the femoral vein, reducing trauma and potentially reducing blood loss. Additionally, embodiments of the disclosed stabilizer 100 may have a low profile and be angled for optimal access to the patient, such as optimal femoral access.

[0083] exist Figures 7 and 8207 at or near the distal end 205 of the base 207. The angled section 130 can be generally angled downward toward the distal end. As shown, the angled section 130 can include an upwardly facing angled surface 132 that is elevated from the base 207 and can be at a specific angle to the flat body 202. For example, the angle relative to the body 202 can be 1°, 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9°, 10°, 15°, 20°, 25°, 30°, 35°, 45°, or 50°. In some embodiments, the angle can be between 5° and 30° (or between about 5° and about 30°). In some embodiments, the angle can be between 5° and 15° (or between about 5° and about 15°). The upwardly facing angled surface 132 can be flat, or generally flat. In some embodiments, the angle of the upwardly facing surface 132 can be adjustable, such as by a knob, screw, motor, or other electronic control. In some embodiments, the angle can be fixed in one orientation. In addition, the upwardly angled surface 132 can be rotated about a vertical axis to provide further repositioning. In some embodiments, the upwardly facing surface 132 can include a slot 134, as further described below, extending generally from proximal to distal (e.g., generally parallel to the longitudinal axis of the stabilizer 100) to attach the hub 160.

[0084] like Figures 7 and 8 As shown, the upwardly facing surface 132 can be attached to the body 202 by a pair of walls 136. In some embodiments, the pair of walls 136 include holes 138, but in some embodiments, the pair of walls 136 do not include any holes. Other shapes and designs can also be used, such as rounded surfaces, generally hemispherical surfaces, etc., and the shape is not limiting.

[0085] Each wall or pair of walls 136 may include a distally extending lug / extension 131, but in some embodiments, only one of the pair of walls 136 may include a distally extending lug / extension 131. The lug 131 may be generally rectangular in shape, but the specific shape is not limiting. The lug 131 may be configured to mate or dock with a base adapter 140 for attaching the stabilizer 100 to a table. In some embodiments, the upwardly facing surface 132 may be attached to the body 202 via a proximal rear wall, but some embodiments may not use a proximal rear wall.

[0086] Although in some embodiments may be connected, Figures 7 and 8The base adapter (e.g., dock) 140 shown in the figure can be a separate piece from the rest of the stabilizer 100. The separate base adapter 140 allows the base adapter 140 to be attached / clamped / set up before the stabilizer 100 is operated. Therefore, when the delivery system is ready to be used, the distal end of the body 202 can be quickly inserted into the base adapter 140, such as the proximal end of the base adapter 140, and only one clamp is required to complete the positioning. As discussed in detail below, once the base adapter 140 is attached to the surface, the base adapter 140 provides features for the stabilizer 100 to slide into. When the stabilizer 100 is secured into the base adapter 140 and all clamps 120 are attached, the base adapter 140 prevents the stabilizer 100 from lifting. Figure 7 The base adapter 140 is shown connected to the main body 202. Figure 8 The base adapter 140 and body 202 are shown separated. Although the base adapter 140 is shown attached at the distal end of the stabilizer 100, the base adapter 140 can be located at the proximal end instead. In some embodiments, two base adapters can be used, one at each end. In some embodiments, the base adapter 140 can be connected to the stabilizer 100, but can include adjustable features such as ratchets, clips, etc. to attach to the table.

[0087] like Figures 7 and 8 As shown, the base adapter 140 may include a downwardly facing flange 142 at its distal end. Figure 4 As shown, the downward facing flange 142 can be used to attach the clamp 120 to the table. However, in some embodiments, the flange may not be used. In some embodiments, the flange 142 can be hook-shaped for wrapping around a surface. Moving proximally from the flange 142, the base adapter 140 can include a generally flat base surface 144 and then a docking feature 146. The docking feature 146 can include an upwardly extending surface 148 having a top surface (or lug) 141 and two flanges (or lugs) 143 extending proximally from the upwardly extending surface 148. The lugs 131 discussed above can mate with the flanges 143. For example, the flanges 143 can be bent outwardly to receive the lugs 131 and thereby provide friction on the lugs 131. In addition, as Figure 7As shown, the lug 131 can be inserted between the flanges 143 so as to abut against the upwardly extending surface 148 on its distal end, thereby docking the lug 131 with the docking feature. Thus, the top surface 141 prevents vertical movement of the lug 131, thereby preventing removal. In some embodiments, screws, bolts, lugs, etc. can be used to removably attach the lug 131 to the docking feature 146. This is an example of a base adapter 140, but other base adapters can also be used. In addition, the base adapter 140 may not be used and the stabilizer 100 can be directly attached to the surface.

[0088] Moving proximally on the stabilizer 100, Figures 9 to 11 An embodiment of a hub fitting or guide fitting 170 is shown. The hub fitting 160 is attached to the upward facing surface 132. The hub fitting 160 may include a generally rectangular hub adapter 162 that may at least partially rest on the upward facing surface 132. Fig.10 As shown, the hub adapter 162 can further include a downward facing longitudinal lug 164 configured to mate with the slot 134 on the upward facing surface 132. In some embodiments, the hub adapter 162 can be moved along the slot 134 and attached to the upward facing surface 132 to properly position the delivery system within the stabilizer 100.

[0089] Typically at the distal end of the hub sleeve adapter 162 is a hub sleeve 166, but the orientation is not limited. In some embodiments, the hub sleeve 166 is attached directly to the upward facing surface 132 and the hub sleeve adapter 162 is not used. The hub sleeve 166 can extend upward from the hub sleeve adapter 162 and can therefore be angled relative to the body 202 of the stabilizer 100. In some embodiments, the orientation and angle of the hub sleeve adapter 162 can be adjusted. The hub sleeve 166 can include a pair of upwardly extending arms 168, which in some embodiments are configured to mate with a sheath hub of a delivery system that is connected to a rigid live-on (or integral) sheath. An example of such a sheath hub 161 is shown in FIG. Fig.11. The sheath hub 161 can be attached to the hub sleeve 166 before the attachment of the delivery system, or can be attached during the attachment of the delivery system. In some embodiments, the upwardly extending arm 168 can be releasably matched with another component of the delivery system (such as the distal portion of the handle or the outer sheath set accessory of the delivery system). In some embodiments, the upwardly extending arm 168 can include a spring plunger 163 on one or two arms of the plurality of arms 168 to lock the sheath hub 161 in place. In addition, the spring plunger 163 can allow rotational movement of the sheath hub 161 relative to the hub sleeve 166. However, other attachment methods can also be used, and the specific attachment is not restrictive. In some embodiments, the hub sleeve 166 can include a mating pawl for the sheath hub. This can provide tactile feedback to the user. Advantageously, the hub sleeve 166 can keep the sheath hub 161 fixed during the surgical procedure and prevent unnecessary movement. This can minimize damage to the access site.

[0090] exist Figures 12 to 15C 203 of the main body 202. The angled section 150 can be angled generally downward toward the distal end. As shown, the angled section 150 can include an angled surface 152 facing upward that is elevated from the substrate 207 and can be at a specific angle to the flat main body 202. For example, the angle can be 1°, 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9°, 10°, 15°, 20°, 25°, 30°, 35°, 45°, or 50°. In some embodiments, the angle can be between 5° and 30° (or between about 5° and about 30°). In some embodiments, the angle can be between 5° and 15° (or between about 5° and about 15°). The angled surface 152 facing upward can be flat, or generally flat. In some embodiments, the angle of the upwardly facing surface 152 can be adjustable, such as by a knob, screw, motor or other electronic control. In some embodiments, the angle can be fixed. In addition, the upwardly angled surface 152 can be rotated about a vertical axis to provide further repositioning.

[0091] In some embodiments, the upwardly facing surface 152 can include a slot 154 extending generally from the proximal side to the distal side. In addition, as shown, the upwardly facing surface 152 can be attached to the body 202 by a pair of side walls 156.

[0092] In some embodiments, the second angled portion 150 can be spaced apart from the first angled portion 130, although alternatively they can be connected. In some embodiments, the first angled portion 130 and the second angled portion 150 are longitudinally aligned.

[0093] In addition, as shown, the height of the second angled segment 150 can be less than the height of the first angled segment 130. However, in some embodiments, they can have the same height. In some embodiments, the second angled segment 150 can have a height greater than the first angled segment 130. In some embodiments, the upwardly facing surface 152 of the second angled segment 150 can be coplanar with the upwardly facing surface 132 of the first angled segment 130. In some embodiments, the upwardly facing surface 152 of the second angled segment 150 is not coplanar with the upwardly facing surface 132 of the first angled segment 130. In some embodiments, the upwardly facing surface 152 of the second angled segment 150 can be parallel to the upwardly facing surface 132 of the first angled segment 130. In some embodiments, the upwardly facing surface 152 of the second angled segment 150 is not parallel to the upwardly facing surface 132 of the first angled segment 130. In some embodiments, the upward facing surface 152 of the second angled segment 150 is parallel but not coplanar with the upward facing surface 132 of the first angled segment 130 .

[0094] As in Figures 12 to 15C As shown in FIG. 1 , the linear clamp assembly 170 is on top of the second angled section 150 and mates with the slot 154. The slot 154 may extend parallel or substantially parallel to the longitudinal axis of the body 202. If the patient is aligned perpendicular to the longitudinal axis of the body 202, the linear clamp assembly 170 allows for medial / lateral adjustment. Fig.13 As shown, the linear clamp assembly 170 may include a track housing 172. In some embodiments, the track housing 172 may include a housing that is generally shaped like a rectangular prism, but the shape is not limited, and has a longitudinally extending lug 174 on the bottom to cooperate with the narrow slot 154. Fig.14 As shown, the track or housing 172 can be hollow to contain the travel screw 176. In some embodiments, the track or housing 172 further contains a handle or knob 178 for turning the travel screw 176. In some embodiments, there may be no housing containing the travel screw 176. In some embodiments, the angled section 150 can be unlocked from the base plate 207. This can allow the angled section 150 and the components on top to slide relative to the base plate. This can allow large adjustments to the handle bracket 180, allowing the ability to readjust when a hard stop is encountered.

[0095] The handle bracket 180 can engage with the travel screw 176, such as engaging with a threaded hole 182 located in the housing 172 and around the travel screw 176. Therefore, when the travel screw 176 is turned, such as by rotation of the knob 178, the handle bracket 180 will travel longitudinally along the housing 172 (e.g., from the proximal side to the distal side and from the distal side to the proximal side). The handle bracket 180 can travel 60mm, 70mm, 80mm, 90mm, 100mm, 110mm, 120mm, or 130mm. In some embodiments, the handle bracket 180 can travel more than 60mm, 70mm, 80mm, 90mm, 100mm, 110mm, 120mm, or 130mm. In some embodiments, the handle bracket 180 can travel less than 60mm, 70mm, 80mm, 90mm, 100mm, 110mm, 120mm, or 130mm. A spring plunger that cooperates with a detent on the knob 178 may be used to control the advancement along the advancement screw 176. This may allow for detent, controlled advancement of the handle bracket 180. The tactile sensation of each "click" as the knob 178 is turned may provide tactile feedback to the operator as to proper advancement along the advancement screw 176 and may facilitate more controlled movement of the delivery system.

[0096] like Fig.15A As shown, a clamp 184 (e.g., a cushioned or rubber overmolded clamp) is attached to the top of the handle bracket 180. In some embodiments, the handle bracket 180 is integrally formed with the first half of the clamp 184. In some embodiments, the handle bracket 180 is formed separately from the clamp 184. For example, if the first half of the clamp is integrally formed with the handle bracket, the first half of the clamp 186 can be relatively fixed relative to the handle bracket 180. The second half of the clamp 188 can be connected to the first half of the clamp 186, for example, by screws or bolts 181. Therefore, the knob 183 can be used to tighten or loosen the two clamp halves 186 / 188. In some embodiments, the second clamp half 188 can be held in a slot 185 in the first clamp half 186 to prevent the second clamp half from rotating. The size of the clamp 182 can be designed and configured to hold the handle of the delivery system. In addition, the clamp 182 can resist the rotational force (such as the knob rotation force) applied to the delivery system.

[0097] Fig. 15B Shows Fig.15A186. As shown, the interior cavity of the first clamp half 186 may include female threading that runs all the way through. Once the bolt 181 is threaded as deeply as possible, the top of the clamp half 188 can bend inwardly toward the half 186 in a fulcrum motion to further compress any delivery system held therein. The handle bracket 180 may further include a pin 189 that can extend through the clamp 186 and be press-fit into the clamp 188. The pin 189 is press-fit into the cushion half to prevent release due to excessive unthreading, thereby acting as a "hard stop" to prevent the half 188 from being released.

[0098] Fig. 15C Show Fig. 15B An alternative embodiment of the handle bracket 180 shown. As shown, the internal threads do not extend all the way through the half 186, so there is a non-threaded cavity 187. This allows the bolt 181 to slide in the cavity 187 without rotating, thereby allowing for faster release when opening. In addition, the handle bracket 180 may include a pin 189 that can extend through the clamp 186 and be press-fit into the clamp 188, again preventing accidental release. The pin 189 may include a spring 191. When the half 188 is pulled apart, the spring 191 is compressed. Once the half 188 is released, similar to the pinball machine handle, the spring 191 decompresses to quickly bring the half 188 to the half 186. When the spring 191 is in a neutral position, the clamp 184 can be docked on the delivery system (e.g., represented by a dotted circle), but is not completely locked.

[0099] In some embodiments, the threads may be replaced with a quarter-turn quick-lock design. Thus, bolt 181 may include a protrusion on one end, and half 186 may include a mating feature for the protrusion. Bolt 181 may then be pushed in and rotated a quarter turn so that the protrusion fits within the mating feature, thereby preventing further movement. Bolt 181 may be released by turning bolt 181 so that the protrusion may slide out of half 186.

[0100] Thus, the clamp 182 and the hub 166 may be generally longitudinally and / or angularly aligned and angled downwardly toward the distal end of the delivery system, such as Figure 16-18 Thus, the delivery system handle 300 can be retained within the clamp 182 and the hub 166 . Fig.16 shows an intermediate orientation of the delivery system, and Fig.17 The most proximal aspect of the delivery system is shown, and Fig.18 The delivery system is shown in the most distal orientation.

[0101] How to operate

[0102] A method of operating an embodiment of the disclosed stabilizer 100 is disclosed for delivering a replacement heart valve, particularly a replacement mitral valve. This may be particularly useful for a transseptal approach, but the stabilizer may also be used with other approaches (e.g., transapical) and other heart valves (e.g., aortic). Furthermore, the stabilizer 100 may be used for other medical procedures and is not limited to replacement heart valves.

[0103] First, the base adapter 140 can be clamped to a surface, such as the table or base 102 discussed above. The table can be located above or beside the patient. In some embodiments, the patient can be aligned approximately perpendicular to the stabilizer 100. In some embodiments, the patient can be aligned approximately parallel to the stabilizer 100. In some embodiments, the patient can be aligned at any angle between parallel to or perpendicular to the stabilizer 100.

[0104] Next, the distal portion of the body 202 can be inserted into the base adapter 140 so that the body 202 is docked with the base adapter 140. With the base adapter 140 already clamped, this can allow the body 202 to be quickly positioned in the proper orientation. Additionally, since there is some space within the base adapter 140, the base adapter 140 can allow the stabilizer 100 to be used on surfaces of different sizes. Thus, if the surface is long, the body 202 can be inserted only a little into the base adapter 140. However, if the surface is short, the body 202 can be inserted as far as possible into the base adapter 140.

[0105] The proximal end of the body 202 can then be clamped to a surface. The delivery system can be attached to the body 202 as discussed below before the body 202 is inserted into the base adapter 140. However, in some embodiments, the delivery system is attached after the body 202 is inserted into the base adapter 140. The clamping and docking procedures can further provide grip and stability.

[0106] To attach the delivery system, the distal end of the delivery system can be slid through the sheath hub 161 so that the delivery system extends distally from the stabilizer 100. The sheath hub 161 can be rotated within the hub sleeve 166 to facilitate the insertion of the delivery system. In some embodiments, the sheath hub 161 is already on the delivery system, and the sheath hub 161 is then snapped into place in the stabilizer 100. Once inserted into the sheath hub 161, the handle of the delivery system can be placed in the clamp 184. The clamp 184 can be adjusted to the appropriate orientation using the knob 178 so that the clamp 184 is properly placed on the handle. This can avoid any interference with any actuator on the handle. In some embodiments, the handle can include a specific slot or area for attaching the clamp 184. The clamp 184 can then be tightened and held in place in the stabilizer 100.

[0107] Using knob 178, the handle of the delivery system can be finely controlled and advanced / retracted along the linear clamp assembly 170 to properly advance (such as from) within the patient's body. Fig.17 The proximal position to Fig.18 The distal orientation of the stabilizer 100). When used in a transseptal approach to replacing a mitral valve, translating the delivery system using knob 178 can advance / retract the distal end of the delivery system axially (or approximately axially) relative to the native mitral valve. The smaller angle used in the stabilizer 100 can make the delivery system easier to use during the procedure. Once the operation is completed, the delivery system can be removed from the stabilizer 100.

[0108] Universal Stabilizer System

[0109] In some embodiments, the stabilizer 100 described above may utilize a general stabilizer system 1000 (eg, Fig.19 ). Alternatively, only certain components of the stabilizer 100 described above (eg, guide assembly 170) may be used with a universal stabilizer. The system may be easily adapted to bases and delivery systems of different sizes.

[0110] Similar to the above, the base 102 and plate 104 can be used with the stabilizer 1000. However, the stabilizer 100 can utilize a universal attachable rail 1010 (instead of the clamp 120 and base plate 107), which can allow for greater flexibility and adaptability. However, in some embodiments, these components can be used in the universal stabilizer system 1000. In some embodiments, the base plate 207 can be directly attached to the rail 1010. In some embodiments, only the guide assembly 170 can be attached to the rail 1010. In some embodiments, the guide assembly 170 and the hub 160 can be attached to the rail 1010.

[0111] Fig.19An embodiment of a stabilizer 1000 is shown. As shown, the stabilizer 1000 can include a rail 1010 that can include a movable clamp 1012 and a fixed clamp 1014 spaced apart in a longitudinal direction. In some embodiments, both clamps can be movable. As discussed in detail below, the movable clamp 1012 can slide along the rail and be locked at a desired orientation on the rail, thereby allowing the rail 1010 to be attached to surfaces of different sizes.

[0112] Stabilizer 1000 may further include a rail dock 1016 that can be used to attach a delivery system holder to rail 1010. In some embodiments, rail dock 1016 can be integrally formed with the delivery system holder. For example, guide assembly 170 can be attached to the upper surface of rail dock 1016. Different clamps on the delivery system holder can be used for different devices, and different delivery system holders can be replaced as needed and attached to rail dock 1016. In some embodiments, multiple rail docks 1016 can be used along rail 1010, for example, guide assembly 170 is maintained in a proximal position and hub sleeve 160 is maintained in a distal position. Rail dock 1016 can include angled surfaces similar to those discussed above with respect to 130 and 150. In some embodiments, rail dock 1016 can have an adjustable upper surface for adjusting the angle.

[0113] like FIG. 20A to FIG. 20F As shown, the rail dock 1016 can have a bottom surface with a protrusion 1009 that at least partially wraps around the top surface of the rail 1010, thereby allowing the rail dock 1016 to slide along the rail 1010 while preventing removal. The rail dock 1016 can further include a lock (such as a quick quarter lock) for attachment to and removal from the rail 1010, and for maintaining the orientation of the rail dock 1016 on the rail. As shown, the lock can include a handle 1017 that is rotatably connected to one side of the rail dock 1016 and is attached to the plate 1015 on the opposite side of the rail dock 1016, for example, by a spring or a pair of springs 1031 and bolts or other attachment members 1033. In some embodiments, the handle 1017 can be assembled in a cutout on the side of the rail dock 1016. Alternatively, in some embodiments, a button, knob or other actuator can be used. The handle 1017 can be in the locked position ( Fig. 20C ) and unlock position ( Fig.20D ). By rotating the handle 1017 to the locked position, the plate 1015 is compressed onto the rail 1010 on the opposite side of the rail dock 1016, for example by compressing a spring (such as Fig.20E), which locks the foot 1007 of the plate 1015. This prevents movement of the rail dock 1016 and further prevents the rail dock 1016 from being removed from the rail 1010. In the unlocked orientation, the rail dock 1016 can slide out of the longitudinal end of the rail 1010 in accordance with the standard Picatinny design, or can be rotated toward the handle 1017 to remove it. In some embodiments, the rail dock 1016 in the locked position or the unlocked position may not be lifted directly from the rail 1010. In some embodiments, the rail dock 1016 may include a Delrin base and a PEEK handle 1017 / plate 1016, although the type of material is not limiting. In some embodiments, the rail dock 1016 can be fixed to the rail 1010 so that a locking system may not be used.

[0114] Fig.19 The guide assembly 170 is shown attached to the upper surface of the guide rail dock 1016. FIG. 20A to FIG. 20F As shown, in a configuration similar to the second angled section 150, the rail dock 1016 can include a groove / slot 1019 on the upper surface for attachment to a protrusion on the bottom surface of the guide assembly 170. Other attachments (such as screws, bolts, or magnets) can be used to more securely attach the guide assembly 170 to the rail dock 1016. However, the upper surface of the rail dock 1016 can be modified, and in some embodiments, the slot may not be included, and any number (1, 2, 3, 4, 5, 6) of screw / bolt holes or other adjustment means for attachment to different fixtures may be included.

[0115] Advantageously, base 102 and plate 104 may be reusable and non-sterile, although still retained within the sterile field. Both rail 1010 and fixed fixture 1014 may be reusable and sterile. In some embodiments, removable fixture 1012 and rail dock 1016 may also be reusable and sterile. In alternative embodiments, one or both of removable fixture 1012 and rail dock 1016 may be disposable and replaceable on rail 1010. This may allow rail 1010 to be modified to accommodate different delivery devices and accessories.

[0116] FIG. 21A to FIG. 21C An embodiment of the guide rail 1010 is shown, which can be formed of a metal such as stainless steel, but the specific material is not limited. In some embodiments, the guide rail 1010 is formed of a clean / autoclaved material that can be designed for repeated use. Fig.21BAs shown, the figure observes the guide rail 1010 along the longitudinal line, and the guide rail 1010 may include a pair of lateral protrusions 1111, which extend outward away from the guide rail on each side orthogonal to the longitudinal axis, thereby forming a cavity 1013 between the lateral protrusions 1111 on each side of the guide rail 1010. The protrusions 1111 can be rectangular or triangular, and the specific shape is not limited. In some embodiments, the upper protrusion 1111 can be triangular, and the lower protrusion 1111 can be rectangular. In some embodiments, the protrusions 1111 on the opposite sides can have different shapes or can be the same. The protrusions 1111 on the same side can have different shapes or can be the same. Therefore, for example, the inwardly extending arms of the guide rail dock 1016 or the movable clamp 1012 can be kept in the cavity 1013 to prevent release from the guide rail 1010. The protrusions 1111 can extend completely along the length of the guide rail 1010. In other embodiments, protrusion 1111 may extend at least 90%, 95%, or 99% along the length of rail 1010 .

[0117] FIG. 22A to FIG. 22B Alternative example embodiments of cross sections of rail 1010 are shown. However, these cross sections are not intended to be limiting in shape, and any type of cross section (such as a rectangular cross section) may be used. Rail 1010' / 1010" may include notches 1022 and extensions 1024 (which may function as protrusions 1111 and cavities 1013).

[0118] Fig.23 A perspective view of the guide rail 1010 and the securing clamp 1014 is shown. As shown, the securing clamp 1014 can be integrated with the guide rail 1010, but in other embodiments, the securing clamp can be available. The securing clamp 1014 can be angled and can be a hook, clamp, or other attachment mechanism. FIG. 24A to FIG. 24C As shown, the fixing clamp 1014 can be flexible to allow attachment to different thicknesses of the surface 1030. Fig. 21C As shown, the fixing clamp 1014 can be inserted into a slot in the bottom surface of the guide rail 1010. The fixing clamp 1014 can be integrally formed with the guide rail 1010, mechanically or chemically adhered.

[0119] Fig. 21CA view of an embodiment of a removable clamp 1012 is shown. As discussed, the removable clamp 1012 can be disposable or reusable. The clamp 1012 can be attached generally at one longitudinal end of the guide rail 1012. The removable clamp 1012 can be formed by a knob 1021, an attachment plate 1023, and a clamp 1025. The attachment plate 1023 can be inserted into a narrow slot in the bottom surface of the guide rail 1010. The attachment plate 1023 can be integrally formed with the guide rail 1010, mechanically or chemically adhered. The attachment plate can retain a screw / bolt 1029 extending from the knob 1021, such as through a hole in the attachment plate 1023. The end of the screw / bolt 1029 opposite the knob 1021 can mate with the clamp 1012. The clamp 1012 can include a protrusion 1027 on the upper surface (at Fig.21B 1010) to fit within cavities 1013 on each side of the side of the rail 1010, allowing the clamp 1012 to slide along the rail 1010 while remaining attached. When the knob 1021 is turned, the clamp 1012 can move longitudinally along the rail 1010. This allows the clamp 1012 to be compressed onto surfaces of different sizes, allowing for versatility of the system 1000.

[0120] Fig.25 An alternative embodiment of a removable fixture 1012 as a fixture 1012' is shown, and therefore some or all of the features discussed above about the removable fixture 1012 can be combined. As discussed, the removable fixture 1012' can be disposable or reusable. As shown, the fixture 1012' can generally include a body 1040, a release 1042 and a fixture 1044. The body 1040 can interact with the guide rail 1010 (e.g., attached to the guide rail, coupled with the guide rail). The body 1040 can slide along the guide rail 1010, such as in the cavity 1013. In addition, the body 1040 can include a mechanism that prevents the body 1040 from moving backwards to prevent accidental release. The body 1040 can further include a release actuator (knob, button, switch, etc.), which can be actuated to release the one-way mechanism, thereby allowing the body 1040 to move away from the fixed fixture 1014. Additionally, the movable clamp 1012' can include a clamp mechanism 1044 as discussed above with respect to the fixed clamp 1014. The clamp mechanism 1044 can be the same as the fixed clamp 1014 or different.

[0121] like FIG. 26A to FIG. 26BAs shown, the movable clamp 1012 can be moved so as to be easily and quickly clamped on the surface 1030. In some embodiments, the movable clamp 1012 can slide along the outer surface of the guide rail 1010. In some embodiments, the guide rail 1010 can include an inner cavity, and the movable clamp 1012 can include a portion that slides in the inner cavity. In some embodiments, the movable clamp 1012 can include a one-way sliding mechanism with a release member to allow the movable clamp 1012 to be moved and locked.

[0122] Fig. 27 An embodiment of a guide rail 1010 is shown with the clamps 1012 / 1014 / 1016 removed. As shown, the guide rail 1010 can include wings or feet 1018. These wings 1018 can be integrated with the guide rail 1010, or can be removable and attachable. The wings 1018 can provide additional support and stability to prevent any rocking of the guide rail 1010. Thus, when the system is in use, the wings 1018 can contact the surface on which the guide rail 1010 is located. As shown, the wings 1018 can be located near the fixed clamps 1014, but the orientation of the wings 1018 is not limited.

[0123] Fig.28 An embodiment of the system 1000 disclosed above is shown on a base 102 .

[0124] Electronic and electric controls

[0125] In some embodiments, stabilizer 100 (or stabilizer 1000) can be electronically controlled. Therefore, once the delivery system is installed and stabilizer 100 / 1000 is attached to the surface to move the delivery system, the user does not need to interact directly with stabilizer 100 / 1000. For example, any knob (127, 178, 183, 1021) or other actuator on stabilizer 100 / 1000 can be electronically controlled such as by a computer, a phone application, a controller (wireless or direct connection) or other operations. In some embodiments, the orientation of guide rail dock 1016 can also be electronically controlled. Therefore, in some embodiments, stabilizer 100 / 1000 can include a motor to manipulate the actuator on stabilizer 100 / 1000. In addition, stabilizer 100 / 1000 can include a motor / sensor / control to remotely operate the delivery system. This can provide options for semi-robotic programs, in which the main function of the stabilizer is more similar to an actuating tool. Since the stabilizer can actuate the knob, the physician can implant the valve via a remote location. Alternatively, if the physician is positioned with the stabilizer 100 / 1000, the electronic controls may assist the physician and / or allow the physician to spend more time observing the visualization.

[0126] As an example, the controller may operate the knob 178 to move the handle bracket 180 along the screw 176 in the stabilizer 100 / 1000 to provide distal and proximal movement of the delivery system. The controller may include a locking feature to prevent accidental movement.

[0127] In some embodiments, feedback from visualization (X-ray, fluoroscopy, etc.) can be used to improve delivery and reduce the chance of vascular damage. For example, the stabilizer 100 / 1000 can automatically stop any movement to avoid contact / damage to the patient's anatomical structure. In some embodiments, sensors and / or visualization can be included to measure and provide feedback (such as the deflection angle of the delivery system). The sensor can be incorporated into the delivery system and can communicate with the stabilizer 100 / 1000, for example, wirelessly. The sensor can be used to detect parameters, including but not limited to force, pressure, orientation, deflection, or rotation. The electronic control system can also utilize artificial intelligence (such as using machine learning) to enhance the program. Data from previous programs, especially data from patients with similar anatomical structures, can be used to help guide the advancement of the catheter and the deployment of the artificial valve. In advanced embodiments, the entire program can be performed autonomously with near-perfect accuracy by utilizing a large amount of data and experience from previously performed programs.

[0128] Fig.29 and Fig.30 Embodiments of electric controls are shown. These controls can utilize any of the above-described electronic / electric controls and can be incorporated into any disclosed stabilizer and delivery system. Alternatively, these controls can be used alone.

[0129] Fig.29 An embodiment of a knob control system 1050 is shown. System 1050 can be designed to fit around part or all of a handle of a delivery system (such as delivery system 300). Fig.29 A flip-top design formed by an upper half 1052 and a lower half 1054 that can form a holder / container is shown. A handle can fit into a cavity 1058 in the lower half 1054, and any shaft can extend out of a hole 160 in the system 150. The upper half 1052 can include a roller 1056 (such as a compression roller) that applies friction to any knob on the delivery system once the system 1050 is closed around the handle. The lower half 1054 can also include a roller 1056, either with the upper half 1052 or in place of the upper half 1052 having the roller 1056. Although the flip-top is an example design, other designs that can partially or completely include a delivery system handle can be used. In addition, other mechanisms for actuating a knob on a delivery system can also be used in place of or in conjunction with the roller.

[0130] System 1050 can include various different sections AE along the length of system 1050. The number of sections is not limited, and can include 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 sections. These sections can be physically isolated from each other, such as by barriers or walls, or can be just separate connection areas with different components. All or some sections can include rotatable components (such as rollers 1056) or can rotate by themselves. The number of rotatable sections can be the same as the number of rotatable knobs on the delivery system. For example, 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 sections can include rotatable components. By rotating rollers 1056 in rotatable sections, these rollers are frictionally pressed against the knobs on the handle, and the rollers will rotate their respective knobs / actuators on the delivery system. Therefore, by rotating rollers 1056 individually in different sections, different knobs can be actuated on the handle. Rollers 1056 in different sections can apply different forces on the handle. Some sections may not include rotatable components and may be able to fit more tightly to hold the handle in place while other sections are rotating, allowing the knob to be actuated. The rotatable sections may rotate individually or together as desired by the user.

[0131] The system 1050 can be attached to a motor (or can include a motor within or outside the system 1050) to rotate the components in different rotatable sections. In some embodiments, the motor can be an encoder that can track the number of revolutions and position of each section. As discussed above, the motor can be operated in a wired or wireless manner.

[0132] Fig.30 An embodiment of an electric control system 1070 for manipulating the handle of a delivery system is shown. Unlike system 1050, system 1070 is used to move the handle as an integral unit. In some embodiments, system 1070 may not be used, and system 1050 may be configured to fully rotate the handle as well as different knobs. System 1070 may include a rotatable band / strip / holder 1072 that may be wrapped around the handle of the delivery system or may be wrapped around a fixed section of system 1050. Band 1072 may frictionally hold the handle or system 1050, or may be mechanically or chemically adhered. Band 1072 may be rotated to fully rotate the delivery system. In addition, system 1070 may include a bracket / base 1074. Base 1074 may be located on a track 1076 or other translatable component. Base 1074 may translate along track 1076 to provide axial / longitudinal motion to the delivery system. Both track 1076 and band 1072 may be operated by a motor such as discussed herein. The same motor can be used to operate system 1070 and system 1050. In some embodiments, different motors are used.

[0133] Thus, if both system 1070 and system 1050 are used simultaneously, a user can manipulate the different knobs individually and rotationally or axially translate the delivery system.The various movable components discussed herein may all be electronically operated.

[0134] Magnetic attachment

[0135] As described above, stabilizer 100 / 1000 utilizes atraumatic clamps (120, 1012, 1014) to attach stabilizer 100 / 1000 to base 102. Base 102 is usually under a sterile drape, and stabilizer 100 / 1000 is on top of the drape, so the connection between the two maintains a sterile area. Preferably, the connection is stable, but also fast, so as not to delay the procedure, while also preventing damage to the sterile drape. In addition, if it is necessary to move stabilizer 100 / 1000 and manually operate the delivery system handle 300, it is useful to be able to quickly remove the connection. Although the clamps discussed above can achieve all these advantages, other attachments / connections can be used instead of clamps or in combination with clamps. Therefore, magnetic attachment can replace any and all of the clamps disclosed above. In some embodiments, magnetic attachment can be used to remove base adapter 140. Additionally, flange 204 may be removed from base plate 207 so that stabilizer 100 / 1000 has a flat bottom surface. For stabilizer 1000, clamps 1012 and 1014 may be removed.

[0136] In some embodiments, magnets (e.g., magnetic clamping mechanisms, magnetic clamps, etc.) can be used to attach the stabilizer 100 / 1000 to the base 102. The magnetic clamp can be easily removed and is a quick, reliable method of attaching the stabilizer 100 / 1000 to the base 102. In some embodiments, the stabilizer 100 / 1000 is put into place after the delivery system has stepped into the native mitral valve, so the speed of connection can be a useful feature. By using a magnetic system, the stabilizer 100 / 1000 can be attached quickly and secured until the end of the procedure.

[0137] In some embodiments, the base 102 can be made of a magnetic material, to which the stabilizer 100 / 1000, which can be at least partially metal, can be easily adhered. For example, the upper surface 106 of the base 102 can be formed of a magnetic material. In some embodiments, the entire upper surface 106 can be formed of a magnetic material. In some embodiments, the upper surface 106 can include a strip of magnetic material. The size of the strip can be equal to, greater than, or less than the size of the footprint of the stabilizer 100 / 1000. In some embodiments, the magnetic material can be attached to the upper surface of the upper surface 106, which can then be covered by a sterile drape. Since the base 102 is located below the drape, away from magnetically sensitive devices, it can be a favorable area for placing magnetic features.

[0138] In some embodiments, magnets may be attached to the bottom surface of the stabilizer 100 / 1000, such as to the bottom surface of the base plate 207 or the rail 1010. In some embodiments, a portion or all of the base plate 207 or the rail 1010 may be made of a magnetic material. The base 102 may then be made of metal or other material that is magnetically attracted to the magnets.

[0139] In some embodiments, the magnetic features disclosed above may be electromagnets or dipole systems. Thus, the user may turn the magnetic field on or off, for example, via a button, switch, controller, computer, application, etc. Thus, the magnetic connection may become more secure, and when the procedure is completed, the operator may turn off the magnetic field and easily remove the stabilizer 100 / 1000.

[0140] From the foregoing description, it will be appreciated that an inventive stabilizer is disclosed. Although several components, techniques and aspects have been described with a certain degree of particularity, it is apparent that many changes may be made in the above specific designs, constructions and methods described above without departing from the spirit and scope of the present disclosure.

[0141] Certain features described in this disclosure in the context of separate embodiments may also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment may also be implemented separately in multiple embodiments or in any suitable subcombination. Moreover, although features are described above as operating in certain combinations, in some cases one or more features of a claimed combination may be excised from that combination, and the combination may be claimed as any subcombination or variation of any subcombination.

[0142] In addition, although the method can be depicted in the drawings or described in the specification in a particular order, it is not necessary to perform such a method in the particular order shown or in a sequential order, and it is not necessary to perform all methods to obtain the desired results. Other methods not depicted or described can be incorporated into the example methods and processes. For example, one or more other methods can be performed before, after, simultaneously or between any described methods. In addition, the method can be rearranged or reordered in other embodiments. In addition, the separation of various system components in the above-mentioned embodiments should not be understood as requiring such separation in all embodiments, and it should be understood that the described components and systems can generally be integrated in a single product or packaged into multiple products. In addition, other embodiments are also within the scope of the present disclosure.

[0143] Unless explicitly stated otherwise or otherwise understood in the context of use, conditional language (e.g., "may," "might," "could," or "can") is generally intended to convey that certain implementations include or exclude certain features, elements, and / or steps. Thus, such conditional language is generally not intended to imply that features, elements, and / or steps are in any way essential to one or more embodiments.

[0144] Unless expressly stated otherwise, linking language such as the phrase "at least one of X, Y, and Z" can be understood in context as generally used to convey that an item, term, etc., can be X, Y, or Z. Thus, such linking language is not generally intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.

[0145] The degree language used herein, such as the terms "about", "approximately", "roughly" and "substantially" used herein, means a value, amount or characteristic that is close to a specified value, amount or characteristic that still performs a desired function or achieves a desired result. For example, the terms "about", "approximately", "roughly" and "substantially" may refer to an amount within 10% of a specified amount, an amount within 5% of a specified amount, an amount within 1% of a specified amount, an amount within 0.1% of a specified amount, and an amount within 0.01% of a specified amount. If the specified amount is 0 (e.g., none, none), the above range may be a specific range and not within a specific percentage of the value. For example, within 10 wt. / vol.% (weight / volume %) of a specified amount, within 5 wt. / vol.% of a specified amount, within 1 wt. / vol.% of a specified amount, within 0.1 wt. / vol.% of a specified amount, and within 0.01 wt. / vol.% of a specified amount.

[0146] Some embodiments have been described in conjunction with the accompanying drawings. The drawings are drawn to scale, but this scale should not be restrictive, because in addition to the dimensions and ratios shown, other dimensions and ratios are all expected and within the scope of the disclosed invention. Distances, angles, etc. are only exemplary and do not necessarily have an exact relationship with the actual size and layout of the equipment shown. Components can be added, deleted and / or rearranged. In addition, the disclosure of any particular feature, aspect, method, performance, characteristic, quality, attribute, element, etc. of the various embodiments can be used in all other embodiments set forth herein. In addition, it will be appreciated that any method described herein can be practiced using any device suitable for performing the steps listed.

[0147] Although multiple embodiments and variations thereof have been described in detail, other modifications and methods of using the embodiments and variations thereof will be apparent to those skilled in the art. Therefore, it should be understood that various applications, modifications, materials, and substitutions of equivalents may be made without departing from the scope of the unique and inventive disclosure or claims herein.

Claims

1. A stabilizer for a delivery system, the stabilizer comprising: An elongated body including a proximal end and a distal end and a longitudinal axis extending between the proximal end and the distal end, the elongated body comprising: a generally planar substrate extending between the proximal end and the distal end; a first angled surface on a top portion of the base plate, the first angled surface sloping downward toward the distal end; and a second angled surface on top of the base plate and longitudinally spaced apart from and proximal to the first angled surface, the second angled surface sloping downwardly toward the distal end; a hub attachable on top of the first angled surface, the hub including an extension extending upwardly from the first angled surface, the extension configured to releasably retain a sheath hub of the delivery system; a handle bracket on top of the second angled surface, the handle bracket comprising a track attachable to the second angled surface and a delivery system clamp configured to travel longitudinally along the track, wherein the delivery system clamp is configured to releasably retain a handle of the delivery system; and A base adapter is provided wherein the distal end of the body is configured to releasably connect with the base adapter.

2. A stabilizer according to claim 1 or claim 2, wherein the base adapter includes a pair of proximally extending arms and an upper lug configured to receive a distally extending lug of the body to prevent upward movement of the body.

3. The stabilizer of any one of claims 1-2, wherein the first angled surface and the second angled surface are configured to be independently angularly adjusted relative to the planar substrate.

4. The stabilizer of any one of claims 1-3, wherein the handle bracket comprises a first knob and a second knob, the first knob being configured to translate the delivery system clamp longitudinally along the housing, the second knob being configured to open and close the delivery system clamp.

5. The stabilizer of any one of claims 1-4, further comprising a travel screw located within the housing, wherein a portion of the delivery system clamp is located within the housing and engages with the travel screw.

6. The stabilizer of any one of claims 1-5, wherein a height of the first angled surface relative to the substrate is lower than a height of the second angled surface relative to the substrate.

7. The stabilizer of any one of claims 1-5, wherein the first angled surface has approximately the same angle on a top surface of the first angled surface as on a top surface of the second angled surface.

8. The stabilizer of any one of claims 1-7, wherein the first angled surface and the second angled surface each have an angle between 5 degrees and 30 degrees.

9. A stabilizer according to any one of claims 1 to 8, wherein the extension comprises a pair of arms.

10. The stabilizer of claim 9, wherein the pair of arms comprises a spring plunger configured to retain the boot hub.

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