Medical device with echo enhancement features

Abstract

A medical device shaft includes a rigid elongated shaft, an end effector form coupled to a distal end of the elongated shaft, and a backscatter additive associated with at least one of the elongated shaft and the end effector. The shaft exhibits improved backscatter properties and is suitable for use in devices that are manipulated or positioned under backscatter guidance.

Description

[0001] Related Applications

[0002] This application claims the benefit of U.S. Patent Application No. 62 / 895,650, filed September 4, 2019, and U.S. Patent Application No. 63 / 054,751, filed July 21, 2020, the entire disclosures of which are incorporated herein by reference for all purposes. TECHNICAL FIELD

[0003] The present disclosure relates generally to the field of medical devices and procedures. BACKGROUND

[0004] Certain medical procedures can be assisted by the use of echogenic imaging technology. The echogenicity of devices used in such medical procedures can affect the visibility of such devices under echogenic imaging. SUMMARY

[0005] Methods and devices that facilitate the visibility of medical device shafts and other devices under echogenic imaging are described herein. In some embodiments, the present disclosure relates to a medical device shaft comprising a rigid elongated shaft, an end effector form coupled to a distal end of the elongated shaft, and an echogenic additive associated with at least one of the elongated shaft and the end effector form.

[0006] The echogenic additive can comprise microspheres. For example, the microspheres can be gas-filled glass spheres. In some examples, the echogenic additive is embedded in the end effector form. The echogenic additive can be mixed with a coating material disposed on at least a portion of the elongated shaft. For example, the coating material can have an extruded sleeve form. The end effector form is unitarily formed with the extruded sleeve. For example, the end effector form can be die cut from the extruded sleeve. In some examples, the echogenic additive comprises microparticles mixed into a polymeric material, and the microparticles are denser or less dense than the polymeric material. For example, the microparticles can comprise one or more of zinc oxide, iron oxide, titanium dioxide, platinum oxide, and silver oxide.

[0007] In some embodiments, the present disclosure relates to a method of manufacturing a medical instrument. The method comprises providing a rigid elongated shaft and coupling an end effector form to the elongated shaft. The end effector form comprises an echogenic enhancement feature.

[0008] The method can further include adding a backscatter additive to the polymeric material. The method can further include applying the polymeric material with the backscatter additive to at least a portion of the shaft. The method can further include applying the polymeric material with the backscatter additive to at least a portion of the end effector form. In some examples, coupling the end effector form to the elongated shaft involves molding the end effector form from the polymeric material onto the elongated shaft. For example, the method can further include applying a liquid to one or more of the elongated shaft and a mold used to mold the end effector form prior to said molding the end effector form to the elongated shaft to create the backscatter surface feature in the end effector.

[0009] The method can further include creating a rough surface on one or more of the elongated shaft and the end effector form using an abrasive surface, where the rough surface is configured to create backscatter scattering. In some examples, the end effector form includes a porous material having a greater backscatter characteristic than the elongated shaft. For example, the porous material can be an aerogel.

[0010] In some implementations, the present disclosure is directed to a medical device shaft including a rigid elongated shaft, an end effector form coupled to a distal end of the elongated shaft, and a metallic backscatter enhancement feature coupled to the end effector form.

[0011] In some examples, the metallic backscatter enhancement feature includes one or more wire loops secured to one or more of the elongated shaft and the end effector form. In some cases, the metallic backscatter enhancement feature includes a grommet form coupled to a distal end of the end effector form. For example, the grommet form can be at least partially embedded in the end effector form.

[0012] In some implementations, the present disclosure is directed to a medical device shaft including an elongated shaft and an end effector form coupled to a distal end of the elongated shaft, the elongated shaft having one or more channels formed on an outer surface of the shaft.

[0013] The medical device shaft can further include an outer covering disposed about at least a portion of the shaft and covering at least a portion of the one or more channels. The outer covering can include a polymeric tube. In some examples, the one or more channels are helical in length along the shaft.

[0014] For purposes of summarizing the disclosure, certain aspects, advantages, and novel features are described herein. It is to be understood that not necessarily all such advantages can be achieved in accordance with any particular embodiment. Thus, embodiments disclosed herein can be performed in an implementation that achieves or optimizes one advantage or a group of advantages as taught herein without necessarily achieving other advantages as can be taught or suggested herein. BRIEF DESCRIPTION OF DRAWINGS

[0015] Various embodiments are depicted in the drawings for purposes of illustration only and are not intended to be limiting of the scope of the application. Moreover, the various features of the disclosed embodiments can be combined in additional embodiments that are part of the disclosure. Throughout the drawings, the same reference numerals can be used for corresponding or similar features across different drawings. However, it is to be understood that like reference numerals do not imply common or identical features in all embodiments. Rather, like reference numerals are often used to indicate common or similar features across different embodiments or instances of the disclosure. Additionally, it is to be understood that the features shown in the drawings are not necessarily drawn to scale and that the dimensions of the same can be presented for purposes of illustration and to present an understanding of the inventive aspects of the disclosure. In general, certain features of the illustrated features can be relatively smaller than those shown in some embodiments or configurations.

[0016] Figure 1 is a cutaway view of a human heart.

[0017] Figure 2 is a perspective view of a tissue anchor delivery device according to one or more examples.

[0018] Figure 3 is a cutaway view of a tissue anchor delivery device at least partially disposed within a heart chamber according to one or more examples.

[0019] Figure 4 shows a perspective view of a dilator and introducer system according to one or more examples.

[0020] Figure 5 shows an introducer device and tissue anchor delivery shaft according to one or more examples.

[0021] Figure 6 is a close-up view of a distal portion of a tissue anchor delivery device shaft assembly positioned against a target heart valve leaflet according to one or more examples.

[0022] Figure 7 is a close-up view of a distal portion of a tissue anchor delivery device shaft having a needle and tissue anchor suture form extending therefrom through a target heart valve leaflet according to one or more examples.

[0023] Figure 8 is a close-up view of a distal portion of a tissue anchor delivery device shaft assembly positioned against a target heart valve leaflet and an associated tissue anchor deployed distally on the leaflet according to one or more examples.

[0024] Figure 9 shows a cutaway view of a leaflet anchor deployed in a heart according to one or more examples.

[0025] Figure 10A and Figure 10BA side view of certain imaging probes positioned in a location to generate echo images of a patient is shown in accordance with one or more examples.

[0026] Figure 11 A perspective view of a distal portion of a multi-lumen medical device shaft is shown in accordance with one or more examples.

[0027] Figure 12 A side view of a multi-lumen medical device shaft is shown in accordance with one or more examples of Figure 11

[0028] Figure 13 A front axial view of a multi-lumen medical device shaft is shown in accordance with one or more examples of Figure 11

[0029] Figure 14 is a flowchart illustrating a process of aiming at a heart valve leaflet using a multi-lumen shaft in accordance with one or more examples.

[0030] Figure 15 is a perspective view of a distal portion of a multi-lumen medical device shaft in accordance with one or more examples.

[0031] Figure 16 is a perspective view of a distal portion of a multi-lumen medical device shaft in accordance with one or more examples.

[0032] Figure 17 is a perspective view of a distal portion of a multi-lumen medical device shaft in accordance with one or more examples.

[0033] Figure 18 is a perspective view of a distal portion of a multi-lumen medical device shaft in accordance with one or more examples.

[0034] Figure 19 is a flowchart illustrating a process of manufacturing a multi-lumen medical device shaft using an extrusion process in accordance with one or more examples.

[0035] Figure 20 is a perspective view of a distal portion of a multi-lumen medical device shaft in accordance with one or more examples.

[0036] Figure 21 is a perspective view of a distal portion of a multi-lumen medical device shaft in accordance with one or more examples having a needle and tissue anchor suture form extending from a working lumen thereof.

[0037] Figure 22 A perspective view of a portion of an image enhancing sleeve for association with a medical device shaft is shown in accordance with one or more examples.

[0038] Figure 23 A medical device shaft having one or more coils wrapped around the shaft is shown in accordance with one or more examples.​​

[0039] Figure 24A close-up view of a distal portion of a medical device shaft in accordance with one or more examples Figure 23

[0040] Figure 24B Figure 24A

[0041] Figure 25 illustrates a medical device shaft having one or more coils with non-uniform spacing wrapped around the shaft in accordance with one or more examples

[0042] Figure 26 illustrates an imaging window showing a representation of a medical device shaft in accordance with one or more examples

[0043] Figure 27 is a flowchart illustrating a process for manufacturing a medical device shaft having image-enhancing features in accordance with one or more examples

[0044] Figure 28 is a perspective view of a portion of a medical device shaft having an image-enhancing channel formed therein using a die tool in accordance with one or more examples

[0045] Figure 29 close-up view of a distal portion of a medical device shaft in accordance with one or more examples Figure 28

[0046] Figure 30 illustrates a side view of a medical device shaft having one or more image-enhancing channels implemented therein in accordance with one or more examples

[0047] Figure 31A close-up view of a distal portion of a medical device shaft in accordance with one or more examples Figure 30

[0048] Figure 31B Figure 31A

[0049] Figure 32 is a perspective view of a portion of a multi-lumen medical device shaft in accordance with one or more examples

[0050] Figure 33 close-up view of a distal portion of a medical device shaft in accordance with one or more examples Figure 32

[0051] Figure 34 ​​​​​​​​It is a cross-sectional side view of the axis of a medical device having one or more image-enhancing balloon features, based on one or more examples.

[0052] Figure 35 A perspective view of the axis of a medical device having one or more image-enhancing balloon features, based on one or more examples.

[0053] Figure 36 It is based on one or more examples Figure 35 A close-up view of the distal part of the axis of the medical device.

[0054] Figure 37 This is a flowchart illustrating the process of axially aiming at a leaflet using a multi-chamber / room medical device containing echogenic contrast media, based on one or more examples.

[0055] Figure 38 The illustration shows a valve repair system and implanter including a guidewire port, according to one or more examples.

[0056] Figure 39 Showing based on one or more examples Figure 38 The importer shown is a cross-sectional view.

[0057] Figure 40 This is a flowchart illustrating the process of advancing the axis of a medical device using a guidewire, according to one or more examples.

[0058] Figure 41 A perspective view of the distal portion of a medical device shaft, including a guidewire engagement feature, according to one or more examples.

[0059] Figure 42A A side view of a medical device, including an axis and an end effector associated with the distal portion of the axis, is provided according to one or more examples.

[0060] Figure 42B Provided based on one or more examples Figure 42A The image shows an end view of the end effector of a medical device.

[0061] Figure 43 Cross-sectional views of certain cardiac anatomy structures are provided based on one or more examples.

[0062] Figure 44A and Figure 44B Showing examples based on one or more examples respectively Figure 43 The image shows a double-jointed cross-section and echo imaging view of the cardiac anatomy.

[0063] Figure 45A and Figure 45B Showing examples based on one or more examples respectivelyFigure 43 longitudinal cross-section and echo imaging view of the heart anatomy shown in FIG. 1.

[0064] Figure 46 side and end views of a shaft of a medical instrument having a relative echo sleeve disposed thereon, according to one or more examples.

[0065] Figure 47 side and end views of a shaft of a medical instrument having a relative echo sleeve disposed thereon, according to one or more examples.

[0066] Figure 48 side and end views of a shaft of a medical instrument having a relative echo sleeve disposed thereon, according to one or more examples.

[0067] Figure 49 side and end views of a shaft of a medical instrument having a relative echo sleeve disposed thereon, according to one or more examples.

[0068] Figure 50 side and end views of a shaft of a medical instrument having a relative echo sleeve disposed thereon, according to one or more examples.

[0069] Figure 51 side and end views of a shaft of a medical instrument having a relative echo sleeve disposed thereon, according to one or more examples.

[0070] Figure 52 side and end views of a shaft of a medical instrument having a relative echo sleeve disposed thereon, according to one or more examples.

[0071] Figure 53 side and end views of a shaft of a medical instrument having a relative echo sleeve disposed thereon, according to one or more examples.

[0072] Figure 54 side and end views of a shaft of a medical instrument having a relative echo sleeve disposed thereon, according to one or more examples.

[0073] Figure 55 side and end views of a shaft of a medical instrument having a relative echo sleeve disposed thereon, according to one or more examples.

[0074] Figure 56 A side view, perspective view, and end view of a shaft of a medical instrument including an end effector having one or more relatively echogenic wires and / or rings associated therewith is shown in accordance with one or more examples.

[0075] Figure 57A and Figure 57B Echo images of relatively low and high echogenic shafts and / or end effectors associated with medical instruments are shown in accordance with one or more examples.

[0076] Figure 58 is a flowchart of a process for manufacturing an echogenic medical instrument shaft in accordance with one or more examples.

[0077] Figure 59 A side view of a shaft having one or more grooves formed therein is shown in accordance with one or more examples.

[0078] Figure 60 A side view of a shaft having an echogenic molding / form disposed on a portion thereof is shown in accordance with one or more examples.

[0079] For further clarification of the various aspects of the embodiments of the present disclosure, certain embodiments will be described in further detail by reference to the various aspects of the drawings. It should be appreciated that these drawings depict only typical embodiments of the present disclosure and are therefore not to be considered limiting of its scope. Additionally, although the drawings represent embodiments of various only to some embodiments can be drawn to scale. The embodiments of the present disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings in which: DETAILED DESCRIPTION

[0080] The following description refers to the accompanying drawings, which illustrate specific embodiments. Other embodiments having different structures and operations do not depart from the scope of the disclosure. Embodiments of the disclosure relate to devices and methods for improving the visibility of one or more components of a medical device or system under echogenic imaging. The terms "echogenic," "echogenic imaging," "echogenic image," "cardiac echogenic," "echocardiography," "echocardiogram," "medical ultrasound," "ultrasound," and similar terms are used herein according to their broad and ordinary meanings and can refer to any type of ultrasound (e.g., medical ultrasound), diagnostic ultrasound examination, sonography, or any other type of sound wave / sound-based imaging technology or modality and / or one or more images generated in association therewith, whether or not related to images of cardiac anatomy or other anatomy or subject matter. Embodiments of the disclosure relate to echogenic features, components, and / or devices associated with delivery devices or systems for performing tissue anchor delivery and / or valve repair, such as mitral valve repair, on a beating heart. Such delivery devices / systems can be referred to herein as tissue anchor delivery devices / systems and / or valve repair devices / systems. The terms "echogenic" and "echogenicity" are used herein according to their broad and ordinary meanings and can refer to the ability of a material, device, component, or surface to reflect, return, or bounce back sound waves (e.g., echos). As used herein, echogenicity is considered relatively high when a surface reflecting sound waves / echos reflects relatively high amplitude sound waves. Generally, materials, devices, components, or surfaces described herein as echogenic or having image-enhancing properties can be considered to have relatively higher echogenicity than at least partially convex stainless steel surfaces. The term "associated with" is used herein according to its broad and ordinary meaning. For example, where a first feature, element, component, device, or member is described as being "associated with" a second feature, element, component, device, or member, such description should be understood to indicate that the first feature, element, component, device, or member is physically coupled, attached, or connected to, integrated with, or otherwise physically related to the second feature, element, component, device, or member.

[0081] Real-time echogenic (e.g., ultrasound) guidance for certain interventions / procedures (e.g., mitral valve repair procedures) can be implemented at least in part in reliance on visualization of certain surgical components, such as tissue anchor delivery device shafts and the like. For example, visibility of a shaft under echogenic imaging can be critical when the medical device shaft is advanced and positioned toward a target anchor deployment site (e.g., a mitral leaflet). Embodiments of the disclosure provide enhanced echogenicity / visibility for medical device shafts and other devices under echogenic imaging to enable echocardiogram technicians and surgeons to relatively safely and / or quickly maneuver and navigate the shafts in a target anatomical cavity (e.g., a heart chamber) and allow for precise targeting of the shafts to improve success rates associated with surgical procedures.

[0082] The following includes a general description of the anatomy of the human heart and is included to provide context for certain features and examples disclosed herein related to certain inventive features. In humans and other vertebrates, the heart generally includes a muscular organ having four pumping chambers, wherein flow is at least partially controlled by various heart valves, namely the aortic valve, the mitral (or bicuspid) valve, the tricuspid valve, and the pulmonary valve. The valves can be configured to open and close in response to pressure gradients present during various stages of the cardiac cycle (e.g., diastole and systole) to at least partially control the flow of blood to respective regions of the heart and / or to blood vessels (e.g., the lungs, the aorta, etc.).

[0083] Figure 1 An example representation of a heart 1 having various features related to certain aspects of the present disclosure is illustrated. The heart 1 includes four chambers, namely a left ventricle 3, a left atrium 2, a right ventricle 4, and a right atrium 5. A muscular wall 17, called the septum, separates the left atrium 2 and the right atrium 5, as well as the left ventricle 3 and the right ventricle 4. The lower tip 19 of the heart 1 is referred to as the apex and is typically located on the midclavicular line in the fifth intercostal space. The apex 19 can be considered part of a larger apical region 39.

[0084] The left ventricle 3 is the primary pumping chamber of the heart 1. A healthy left ventricle is generally conical or apically tapered in shape, as its length (along a longitudinal axis extending in a direction from the aortic valve 7 to the apex 19) is greater than its width (along a transverse axis extending between opposing walls 25, 26 at the widest point of the left ventricle) and gradually decreases in cross-sectional circumference to a point or apex 19 descending from the base 15. Generally, the apical region 39 of the heart is a region of the heart located within the left or right ventricular region but away from the mitral valve 6 and the tricuspid valve 8 and toward the apex of the heart. More specifically, the apical region 39 can be considered to be within about 20 cm to the right or left of the central axis 27 of the heart 1.

[0085] Pumping of blood from the left ventricle is accomplished by a squeezing motion and a twisting or torsional motion. The squeezing motion occurs between the lateral wall 18 of the left ventricle and the septum 17. The twisting motion is a result of the myocardial fibers extending around the heart in a circular or spiral direction. When these fibers contract, they produce a gradient of angular displacement of the myocardium from the apex 19 to the base 15 around the longitudinal axis of the heart. The resultant vector extends at an angle of about 30-60 degrees to the flow of blood through the aortic valve 7. When viewed from the apex 19, the contraction of the heart appears as a counterclockwise rotation of the apex 19 relative to the base 15. Due to the spiral contractile force of the heart, a healthy heart can pump blood from the left ventricle in a very efficient manner.

[0086] The heart 1 further includes four valves for aiding in the circulation of blood therethrough, including the tricuspid valve 8 that separates the right atrium 5 from the right ventricle 4. The tricuspid valve 8 can generally have three cusps or leaflets and can generally close during ventricular contraction (e.g., systole) and open during ventricular dilation (e.g., diastole). The valves of the heart 1 further include the pulmonary valve 9 that separates the right ventricle 4 from the pulmonary artery 11 and can be configured to open during systole to pump blood toward the lungs and close during diastole to prevent blood from leaking back from the pulmonary artery into the heart. The pulmonary valve 9 generally has three cusps / leaflets, each of which can have a crescent shape. The heart 1 further includes the mitral valve 6, which generally has two cusps / leaflets and separates the left atrium 2 from the left ventricle 3. The mitral valve 6 can generally be configured to open during heart diastole so that blood in the left atrium 2 can flow into the left ventricle 3 and advantageously close during heart diastole to prevent blood from leaking back into the left atrium 2. The aortic valve 7 separates the left ventricle 3 from the aorta 12. The aortic valve 7 is configured to open during systole to allow blood to exit the left ventricle 3 into the aorta 12 and close during diastole to prevent blood from leaking back into the left ventricle 3.

[0087] The atrioventricular (e.g., mitral and tricuspid) heart valves can include a collection of chordae tendinae (13, 16) and papillary muscles (10, 15) for securing the leaflets of the respective valve to facilitate and / or promote proper coaptation of the valve leaflets and prevent prolapse thereof. For example, the papillary muscles can generally include finger-like projections from the ventricular wall. With respect to the tricuspid valve 8, a normal tricuspid valve can include three leaflets and three corresponding papillary muscles 10 Figure 1 two of which are shown in FIG. 1). The leaflets of the tricuspid valve can be referred to as an anterior leaflet, a posterior leaflet, and a septal leaflet, respectively. The valve leaflets are connected to the papillary muscles 10 by chordae tendinae 13, which are disposed in the right ventricle 4 with the papillary muscles 10.

[0088] Surrounding the ventricles (3, 4) are some arteries (not shown) that supply oxygenated blood to the heart muscle, and some veins that return blood from the heart muscle. The coronary sinus (not shown) is a relatively large vein that generally extends around the upper portion of the left ventricle 3 and provides a return conduit for blood returning to the right atrium 5. The coronary sinus terminates at the coronary orifice (not shown) through which blood enters the right atrium.

[0089] With respect to the mitral valve 6, a normal mitral valve can include two leaflets (anterior and posterior) and two corresponding papillary muscles 15. The papillary muscles 15 originate from the left ventricular wall and extend into the left ventricle 3. Generally, the anterior leaflet can cover about two-thirds of the annulus. Although the anterior leaflet covers a greater portion of the annulus, in some anatomies the posterior leaflet can include a greater surface area.

[0090] Various disease processes impair the normal function of one or more heart valves. These disease processes include degenerative processes (e.g., Barlow's disease, fibroelastic deficiency), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis). In addition, damage to the ventricle from a previous heart attack (e.g., myocardial infarction secondary to coronary artery disease) or other heart disease (e.g., cardiomyopathy) can distort the geometry of the valve, leading to dysfunction. However, the vast majority of patients who undergo valve surgery, such as mitral valve surgery, have degenerative disease that causes one or more leaflets of the valve to become dysfunctional, leading to prolapse and regurgitation.

[0091] The mitral valve 6 and tricuspid valve 8 can be divided into three parts: the annulus, the leaflets, and the sub-valvular apparatus. The sub-valvular apparatus can be considered to include the papillary muscles 10, 15 and chordae 13, 16, which can elongate and / or rupture. If the valve functions normally, the free edges or margins of the leaflets come together and form a firm coaptation when closed, the arc of which is called the line of coaptation, coaptation plane, or coaptation zone in the mitral valve. When the ventricle relaxes, the normal mitral and tricuspid valves open, allowing blood from the atrium to fill the de-pressurizing ventricle. When the ventricle contracts, the chordae advantageously position or tighten the valve leaflets appropriately so that the increase in pressure within the ventricle causes the valve to close, preventing blood from leaking into the atrium and ensuring that substantially all of the blood exiting the ventricle is ejected through the aortic valve 7 or pulmonary valve 9 and into the body's arteries. Thus, the normal function of the valve depends on the complex interaction between the annulus, the leaflets, and the sub-valvular apparatus. Pathologies in any of these components can lead to valve dysfunction, resulting in valve regurgitation.

[0092] Generally, there are three mechanisms of heart valve regurgitation or dysfunction: they include Carpentier's Type I, Type II, and Type III dysfunction. Carpentier's Type I dysfunction involves dilation of the annulus, causing normally functioning leaflets to separate from each other and fail to form a tight seal (e.g., fail to coapt properly). Type I mechanism dysfunction includes perforation of the valve leaflets, such as endocarditis. Carpentier's Type II dysfunction includes prolapse of one or both leaflets above the coaptation plane. This is the most common cause of mitral regurgitation and is usually caused by stretching or rupture of the chordae that normally tether the leaflets. Carpentier's Type III dysfunction involves restriction of the motion of one or more leaflets, causing the leaflets to be abnormally restricted below the level of the annular plane. Rheumatic disease (IIIa) or ventricular dilation (IIIb) can cause restriction of the leaflets.

[0093] One or more chambers in the heart 1 can be accessed according to certain heart valve repair procedures and / or other interventions. Chambers in the heart can be accessed at any suitable access site. In some embodiments, chambers of the heart are accessed through the apex region 39, such as a target ventricle (e.g., left ventricle) associated with a diseased heart valve. For example, accessing the left ventricle 3 (e.g., to perform mitral valve repair) can be through a relatively small incision made in the apex region 39 near the mid-axis 27 of the heart (or slightly to the left of the mid-axis 27). Accessing the right ventricle 4 (e.g., to perform tricuspid valve repair) can be through a small incision made in the apex region 39 near the mid-axis 27 of the heart or slightly to the right of the mid-axis 27 of the heart. Thus, a ventricle can be accessed directly via the apex, or via an extracardiac location in the apex region 39 but slightly away from the tip / apex, such as via the lateral wall of the ventricle, the region between the apex and the base of the papillary muscles, or even directly at the base of the papillary muscles. In some embodiments, the length of the incision formed to access the appropriate heart chamber is no more than about 1 mm to about 5 cm, 2.5 mm to about 2.5 cm, or about 5 mm to about 1 cm. When a percutaneous approach is sought, rather than incising the apex region of the heart, a suitable repair instrument can be advanced through a needle (e.g., through an 18 gauge needle) that is directly needled into the apex region 39.

[0094] Certain inventive features disclosed herein relate to certain heart valve repair systems and devices, and / or systems, processes, and devices for repairing any other type of target organ tissue. In some embodiments, a tissue anchor delivery device can be used to repair a mitral valve of a patient suffering from degenerative mitral insufficiency or other conditions. In some embodiments, a transapical off-pump echo-guided repair procedure is performed in which at least a portion of a valve repair system (e.g., a shaft portion / component) is inserted into the left ventricle and guided to the surface of a diseased portion of a target mitral leaflet and used to deploy / implant a tissue anchor in the target leaflet. The tissue anchor (e.g., in the form of a suture forming a large knot) can advantageously be associated or coupled with one or more artificial / synthetic cords that function similarly to chordae tendinae. Such artificial cord(s) can include the suture(s) and / or suture tails associated with the knot-type tissue anchor, and can comprise any suitable or desired material, such as expanded polytetrafluoroethylene (ePTFE) or the like. The term "suture" is used herein according to its broad and ordinary meaning, and can refer to any elongated cord, strip, strand, thread, tie, string, ribbon, tape, or portion thereof, or other type of material used in a medical procedure. Those of ordinary skill in the art will appreciate that a wire or other similar material can be used in place of a suture. Moreover, in some contexts herein, the terms "cord," "chordae tendinae," and "suture" can be used substantially interchangeably. Furthermore, use of the singular form of any suture-related term listed above, including the terms "suture" and "cord," can be used to refer to a single suture / cord, or a portion thereof. For example, where a suture knot or anchor is deployed distal to a portion of tissue, and where two suture portions extend from the knot / anchor proximal to the tissue, either of the suture portions can be referred to as a "suture" or "cord," whether or not the two portions are part of a single suture or cord.

[0095] A process for repairing a target organ tissue, such as repairing a mitral valve leaflet to address mitral regurgitation, can include inserting a tissue anchor delivery device into the body, and extending a distal end of the delivery device proximal to a target tissue (e.g., a leaflet), the delivery device being such as described in PCT Application No. PCT / US2012 / 043761 (published as WO2013 / 003228, referred to herein as the "'761 PCT Application") and / or in PCT Application No. PCT / US2016 / 055170 (published as WO2017 / 059426, referred to herein as the "'170 PCT Application"), the entire disclosures of which are incorporated herein by reference.

[0096] The '761 PCT application and the '170 PCT application describe methods and devices for performing non-invasive procedures to repair heart valves, such as the mitral valve. Such procedures include procedures to repair regurgitation that occurs when the leaflets of the mitral valve fail to properly coapt under peak systolic pressure, resulting in undesirable backflow of blood from the ventricle to the atrium. As described in the '761 PCT application and the '170 PCT application, after assessing a dysfunctional heart valve and verifying the source of the dysfunction, a corrective procedure can be performed. Various procedures can be performed to effect heart valve repair according to the methods described therein, which can depend on the particular abnormality and tissue involved.

[0097] Figure 2 is a perspective view of a tissue anchor delivery system 100 according to one or more examples. The tissue anchor delivery system 100 can be used to repair a heart valve, such as the mitral valve, and improve its function. For example, the tissue anchor delivery system 100 can be used to reduce the degree of mitral insufficiency in a patient suffering from mitral insufficiency caused by mid-segment prolapse of the leaflets resulting from, for example, degenerative mitral valve disease. To repair such a valve, the tissue anchor delivery system 100 can be used to deliver and anchor a tissue anchor, such as a suture knot type tissue anchor, in a prolapsed valve leaflet. As described in detail below, such procedures can be performed on a beating heart.

[0098] The delivery system 100 includes a rigid elongate tube 110 that forms at least one internal working lumen. Although described in certain examples and / or contexts as including a rigid elongate tube, it should be understood that the tubes, shafts, lumens, catheters, and the like disclosed herein can be rigid, at least partially rigid, at least flexible, and / or at least partially flexible. Thus, any such component described herein, whether or not referred to herein as rigid, should be interpreted as possibly being at least partially flexible. In accordance with the present disclosure, the rigid elongate tube 110 can be referred to as a shaft for simplicity. Embodiments of valve repair procedures performed with the delivery system 100 can be performed in conjunction with certain imaging techniques designed to provide visibility of the shaft 110 of the delivery system 100 according to some imaging modality, such as echogenic imaging. Typically, when performing a valve repair procedure using the tissue anchor delivery system 100, the operating physician can advantageously work in conjunction with an imaging technician who can coordinate with the physician to facilitate successful performance of the valve repair procedure.

[0099] In addition to the delivery shaft 110, the delivery system 100 can include a plunger feature 140 that can be used or actuated to manually deploy a pre-formed knot, such as a large knot as detailed below. The tissue anchor delivery system 100 can further include a plunger locking mechanism 145 that can be used as a safety lock to lock the valve delivery system until ready to use or deploy the leaflet anchors as described herein. The plunger 140 can have a suture release mechanism associated therewith that can be configured to lock a pair of suture tails 195 associated with a pre-formed knot anchor (not shown) to be deployed in an opposed position. For example, the suture portions 195 can be ePTFE (expanded polytetrafluoroethylene) sutures. The system 100 can further include a flush port 150 that can be used to de-gas the lumen of the shaft 110. For example, a heparinized saline flush or the like can be connected to the flush port 150 using a female luer fitting to de-gas the valve repair system 100. The term "lumen" is used herein according to its broad and ordinary meaning and can refer to a physical structure that forms a cavity, void, passageway, or other channel, such as an at least partially rigid elongated tubular structure, or can refer to the cavity, void, passageway, or other channel itself that occupies space within an elongated structure (e.g., a tubular structure). Thus, with respect to an elongated tubular structure, such as a shaft, tube, or the like, the term "lumen" can refer to the elongated tubular structure and / or the passageway or space within the elongated tubular structure.

[0100] The lumen of the shaft 110 can house a needle (not shown) that is at least partially encircled by a pre-formed knot suture form anchor as detailed herein. In some examples, the shaft 110 presents a relatively low profile. For example, the shaft 110 can have a diameter of about 3 mm or less (e.g., 9 Fr). The shaft 110 is associated with atraumatic tip 114 features. The atraumatic tip 114 can be an echo leaflet positioner component that can be used to deploy and / or position a suture-type tissue anchor. As described herein, the atraumatic tip 114 disposed at the distal end of the shaft 110 can be configured to deploy a pre-formed suture knot (e.g., suture form) encircled therefrom.

[0101] The atraumatic tip 114 can be referred to as an "end effector." In addition to the pre-formed knot suture form and associated needle, the shaft 110 can house an elongated knot pusher tube (not shown; also referred to herein as a "pusher") that can be actuated using the plunger 140 in some examples. As described in further detail below, the tip 114 provides a surface against which a target valve leaflet associated with deployment of a leaflet anchor can be held.

[0102] As described in more detail below, delivery device 100 can be used to deliver a "knot"-type tissue anchor. For example, delivery device 100 can be used to deliver a tissue anchor (e.g., a knot) distal to the mitral valve leaflet. A tip 114 (e.g., an end effector) can be positioned to contact the ventricular side of the mitral valve leaflet. Tip 114 can be coupled to a distal portion of shaft 110, wherein a proximal portion of shaft 110 can be coupled to a handle portion 120 of delivery device 100, as shown. Typically, an elongated pusher (not shown) can be movably disposed within the lumen of shaft 110 and coupled to a pusher hub (not shown), which is movably disposed within handle 120 and releasably coupled to plunger 140. A needle (not shown) carrying a pre-formed tissue anchor suture can be movably disposed within the lumen of the pusher and coupled to a needle hub (not shown) also coupled to plunger 140. The plunger 140 can be used to actuate or move the needle and pusher during the deployment of the distal anchor (see example). Figure 8 and Figure 9 And is at least partially movably disposed within the handle 120. For example, the handle 120 may define a lumen in which the plunger 140 may move. During operation, the plunger may also move within the lumen of the handle 120. The plunger lock 145 may be used to prevent the plunger 140 from moving within the handle 120 during storage and before performing the procedure for deploying the organizational anchor.

[0103] The needle may have a preformed knot disposed around its distal portion and maintained within the shaft 110. For example, the preformed knot may be formed by one or more sutures configured to be coiled around the suture (see...). Figure 7 The suture form has multiple wraps / loops around the needle tip on a portion of the needle tip associated with a longitudinal slot extending from its distal end. Although the term "suture form" is used herein, it should be understood that such a component / form may include suture, wire, or any other elongated material wrapped or formed in a desired configuration. The coiled suture form may be supplied or transported to be positioned around the needle tip. In some cases, two suture tails extend from the coiled suture form. Suture tails 195 may extend through the lumen of the needle tip and / or through the channel of the plunger 140 and may exit the plunger 140 at their proximal portions. As described in more detail below, the coiled suture form may advantageously be configured to incorporate an anchor deployment procedure formed in a suture-type tissue anchor (referred to herein as a "large knot"). The coiled suture form may be configured as a knot / deployment configuration by bringing the opposite ends of its coiled portions close together to form one or more loops.

[0104] The delivery device can further include a suture / cord capture mechanism (not shown) coupled to the plunger 140 at the proximal end of the delivery device 100, which can be configured to releasably hold or secure a suture 195 extending through the delivery device 100 during delivery of a tissue anchor as described herein. The suture catch can be used to hold the suture 195 by friction fit or clamping force, and can have a lock that can be released after the tissue anchor has been deployed / formed into a knot, as described herein.

[0105] As described herein, the anchor delivery device 100 can be used for a beating heart mitral valve repair procedure. In some cases, the shaft 110 of the delivery device 100 can be configured to stretch and contract with the beating of the heart. During systolic contraction, the central axis of the heart generally shortens. For example, in some patients, the distance from the apex 19 of the heart to the valve leaflets 52, 54 can vary by about 1 centimeter (cm) to about 2 centimeters (cm) with each heartbeat. In some cases, the length of the shaft 110 protruding from the handle 120 can vary with the length of the central axis of the heart. That is, the distal end of the shaft 110 can be configured to float such that the shaft can stretch and contract with the beating of the heart, thereby maintaining contact with the target mitral valve leaflet.

[0106] The advancement of the delivery device 100 can be performed in conjunction with echo imaging, direct visualization (e.g., direct transvascular visualization), and / or any other suitable remote visualization technique / modality. For example, for a cardiac procedure, the delivery device 100 can be advanced in conjunction with transesophageal (TEE) guidance and / or intracardiac echocardiography (ICE) guidance to facilitate and guide movement and proper positioning of the device to contact the appropriate target cardiac region and / or target cardiac tissue (e.g., valve leaflets, annulus, or any other suitable cardiac tissue). A typical procedure that can be implemented using echo guidance is set forth in Suematsu, Y. in J. Thorac. Cardiovasc. Surg. 2005; 130: 1348-56 (“Suematsu”), the entire disclosure of which is incorporated herein by reference.

[0107] Figure 3is a cross-sectional view of a tissue anchor delivery device 100 according to one or more examples disposed at least partially within a heart chamber. According to some embodiments of a valve repair procedure, an incision is made in the apical region 39 of the appropriate heart chamber 33. For example, an introducer port device 200 containing one or more fluid retention valves to prevent loss of blood and / or air from entering the heart chamber 33 can be inserted into the access site. Once within the chamber 33, the shaft 110 of the delivery device 100 can be advanced through the lumen 220 of the introducer 200. In some examples, a sheath can be inserted through the introducer 200 through which one or more other instruments are advanced. For example, an endoscope can first be advanced into the chamber 33 to visualize the chamber, valve 36, and / or subvalvular apparatus. With the use of a suitable endoscope, the malfunctioning valve 36 can be carefully analyzed. Each segment of each leaflet can be carefully evaluated to determine its flexibility, integrity, and motion. Based on this evaluation, the physician can determine whether the valve can indeed be repaired or must be replaced. The motion of the leaflets 52, 54 can be classified as mild dysfunction, prolapse, or restricted, and based on the classification, the necessary steps for repair can be determined.

[0108] Mitral valve insufficiency generally increases the workload of the heart and, if left untreated, can lead to very serious conditions such as decreased ventricular function, pulmonary hypertension, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. Because the left heart is primarily responsible for circulating blood flow throughout the body, malfunction of the mitral valve 36 is particularly problematic and often life threatening. Methods and devices for performing non-invasive procedures to repair heart valves such as the mitral valve are provided herein as well as in the '761 PCT application and the '170 PCT application. Such procedures include procedures to repair regurgitation that occurs when the leaflets of the mitral valve fail to properly coapt under peak systolic pressure, resulting in undesirable blood flow from the ventricle back into the atrium. As described in the '761 PCT application and the '170 PCT application, after the malfunctioning heart valve is assessed and the source of the malfunction is verified, a corrective procedure can be performed. Various procedures can be performed to achieve heart valve repair according to the methods described therein, which will depend on the specific abnormality and tissue involved.

[0109] After a determination that a minimally invasive approach is desirable, one or more incisions can be formed near the thoracic cavity to provide areas of surgical access. The total number and length of the incisions to be formed depends on the number and type of instruments to be used and the procedure(s) to be performed. The incision(s) can advantageously be formed in a minimally invasive manner. As referred to herein, the term "minimally invasive" means a manner in which internal organs or tissues can be accessed with relatively little damage to the anatomical structure sought to be accessed. For example, a minimally invasive procedure can involve accessing a body cavity through a small incision, e.g., about 5 cm or less, formed in the skin of the body. The incision can be vertical, horizontal, or slightly curved. If the incision is positioned along one or more ribs, it can advantageously follow the contour of the ribs. The opening can advantageously extend deep enough to allow access to the thoracic cavity between the ribs or under the breastbone, and is preferably positioned close to the rib cage and / or diaphragm, depending on the chosen point of entry.

[0110] In one example method, access to the heart can be through one or more openings formed by one or more small incisions in body parts proximate to the thoracic cavity, such as between one or more of the ribs of the rib cage of the patient, proximate to the xiphoid appendage, or via the abdomen and diaphragm. Access to the thoracic cavity can be sought to allow insertion and use of one or more thoracoscopic instruments, while access to the abdomen can be sought to allow insertion and use of one or more laparoscopic instruments. Access to the heart can then be through the diaphragm after insertion of one or more visualization instruments. In addition, access to the heart can be through the heart by direct puncture from the xiphoid region (e.g., via a needle of appropriate size, such as an 18 gauge needle). Thus, one or more incisions should be formed in such a way as to provide a suitable surgical field and access to the heart in a manner that is as minimally invasive as possible. Access can also be achieved using a percutaneous approach, further reducing the invasiveness of the procedure. See, e.g., Doty et al., Annals of Thoracic Surgery 1998; 65(2):573-7, "Full-Spectrum Cardiac Surgery Through a Minimal Incision Mini-Sternotomy (Lower Half) Technique" and Barbero-Marcial et al., Annals of Thoracic Surgery 1998; 65(3):771-4, "Transxiphoid Approach Without Median Sternotomy for the Repair of Atrial Septal Defects," the entire disclosures of each of which are incorporated herein by reference.

[0111] Figure 4 A perspective view of a dilator 228 and introducer 200 useful in a valve repair procedure according to one or more examples is shown. Figure 5 An introducer device 200 and tissue anchor delivery device shaft 110 according to one or more examples are shown.

[0112] The hemostatic introducer 200 can be inserted into a target heart chamber at a tip 221 associated with a lumen 220 of the introducer 200. The lumen 220 of the introducer 200 can be used to guide the shaft 110 of a tissue anchor delivery device according to examples of the present disclosure during a valve repair procedure. The body or hub 210 of the introducer 200 can be used to secure the introducer 200 to the pericardium of the heart to stabilize the access of the shaft 110 of the tissue anchor delivery device and / or control the amount of blood backflow during a valve repair procedure. In some cases, a female luer fitting can be used to de-gas the introducer 200 through a port 225 prior to use and / or connect a fluid flush, such as a heparin flush, during a valve repair procedure. A dilator 228 can be used to guide the introducer into the target heart chamber. For example, the dilator 228 can be used to guide the introducer 200 into the left ventricle outside the apex, as described in detail herein. In some embodiments, a tie-down eyelet is used to secure the introducer 200 during a valve repair procedure.

[0113] The introducer lumen 220 provides a conduit for access to a target surgical region or chamber, such as a heart chamber. In some cases, the introducer 200 includes one or more hemostatic valves associated with a passage / lumen port 222. Such hemostatic valve(s) can include silicone or other flexible material configured to prevent blood flow out of the passage / lumen port 222. The port 222 can be used as a tissue anchor delivery device lumen insertion port, where an inserted delivery device shaft can pass through the lumen 220 of the introducer 200 and out of the distal end 221 thereof for access to a target chamber. The port 222 can be further sized to accommodate insertion of a dilator device 228 used to guide the introducer into a target chamber (e.g., left ventricle, outside the apex). The distal end 221 of the introducer 200 can have a tapered shape to seal the delivery system lumen.

[0114] The shaft 110 can have a relatively low profile delivery device that can be sized to fit within the lumen 220 of the introducer 200. For example, the shaft 110 can be a 3 mm (9 Fr) shaft. Further, the tip (e.g., end effector) 114 can advantageously be flexible to allow insertion into the lumen 220 even if the diameter of the lumen 220 is smaller than the extended diameter of the tip 114.

[0115] Once a suitable entry point is determined, the surgeon can use one or more suturing threads to make a series of sutures in one or more concentric circles in the myocardium at the desired location to form a "purse-string" closure. Seldinger technique can be used to access the left ventricle in the area surrounded by the purse-string thread by puncturing the myocardium with a small, sharp, hollow needle ("trocar") over a guide wire in the lumen of the trocar. Once the ventricle is accessed, the guide wire can be advanced and the trocar removed. The introducer 200 with a valve (e.g., introducer 200 with dilator 228 extending through the lumen 220 of the introducer) can be advanced over the guide wire to access the left ventricle. Throughout the procedure, the guide wire (not shown) and dilator 228 can be removed with or without insertion of a suitable delivery device, while the introducer 200 maintains hemostasis. Alternatively, the surgeon can make a small incision in the myocardium and insert the introducer 200 into the heart via the incision. After the introducer is properly placed, the purse-string thread can be tightened to reduce bleeding around the introducer lumen.

[0116] A suitable tissue anchor delivery device, such as the delivery devices described in the '761 PCT application and / or the '170 PCT application, can be advanced into the body in a manner that accesses the left ventricle and through the introducer with a valve. The advancement of the device can be performed in conjunction with echo imaging and / or direct visualization (e.g., direct transvascular visualization). For example, the delivery device can be advanced in conjunction with transesophageal echocardiography (TEE) guidance or intracardiac echo (ICE) to facilitate and guide movement and proper positioning of the device to contact the appropriate apical region of the heart. A typical procedure using echo guidance is set forth in Suematsu.

[0117] In some embodiments, after the subject is prepared and placed under anesthesia, echo imaging or other imaging modalities can be performed to assess the heart, heart valve, and / or one or more tissue anchor delivery device components, such as involving TEE (two-dimensional (2D) and / or three-dimensional (3D)), transthoracic echocardiography (TTE), ICE, and / or direct visualization of the heart (e.g., via infrared vision from a 7.5F catheter tip). For example, echo imaging can be used to guide positioning of the tissue anchor(s) (e.g., suture knots) onto the target valve leaflets. However, it can be difficult to perform under echo guidance to guide the anchor delivery device shaft onto the appropriate location on the mitral valve leaflets, for example, due to resolution levels of the echo guidance technology and / or equipment or software limitations. As described herein, since certain mitral valve leaflet repair procedures using tissue anchors can be performed on a beating heart, the movement of the beating heart, including the mitral valve leaflets, can also interfere with the desired visualization under echo.

[0118] While the procedures described herein are with reference to repairing a heart mitral or tricuspid valve by implanting one or more leaflet anchors and associated cord(s), the methods presented are readily adaptable to various types of tissue, leaflet, and annulus repair procedures. For example, the methods described herein can be performed to selectively access two or more portions of tissue to limit the gap between the portions. That is, generally speaking, the methods herein are described with reference to a mitral valve, but should not be understood as limited to procedures involving a mitral valve.

[0119] Figure 6 A close-up view of a shaft 110 of a tissue anchor delivery device 100 according to one or more examples of the present disclosure is shown, the shaft 110 inserted into a ventricle 33 (e.g., a left ventricle) and in proximity to a target valve leaflet 54 associated with a valve repair procedure. For example, the valve 36 can be a mitral valve. The anchor delivery device shaft 110 can be configured to deliver a tissue anchor (not shown; see, e.g., FIG. 1) such as a tassel to the valve leaflet 54. By way of example, Figure 7-9 Figure 6 A valve leaflet 54 is shown, which can represent a posterolateral leaflet of a mitral valve. It should be appreciated that the anchor delivery device shaft 110 can also deliver a tissue anchor to an anteromedial mitral valve leaflet. While the following Figure 6-9 description is presented in the context of a mitral valve, it should be appreciated that the principles disclosed herein are applicable to other valves or biological tissues, such as a tricuspid valve.

[0120] With reference to Figure 3 and Figure 6-9 , the anchor delivery device shaft 110 can include one or more elongated lumens configured to allow delivery of an anchor 190 to the valve leaflet 54. The shaft 110 can be configured to facilitate performance of one or more functions such as grasping, suctioning, irrigating, cutting, suturing, or otherwise engaging the valve leaflet. A distal or tip end 114 of the shaft 110 can be configured to contact the mitral valve leaflet 54 without substantially damaging the leaflet to facilitate repair of the valve 36. For example, a handle (e.g., handle 120) coupled to the shaft 110 can be manipulated during a valve repair procedure in such a way that the leaflet 54 is in contact with a functional distal portion of the shaft 110 and the repair is completed.

[0121] Echo imaging guidance, such as transesophageal echocardiography (TEE) (2D and / or 3D), transthoracic echocardiography (TTE), and / or intracardiac echo (ICE), can be used to assist in the advancement and desired positioning of the anchor delivery device shaft 110 within the ventricle 33. The distal end 114 of the shaft 110 can contact a proximal surface of the mitral valve leaflet 54 (e.g., relative to Figure 3 and Figure 6-9 ​without or substantially without damaging the leaflet 54. For example, the end / tip portion or component 114 can have a relatively blunt form or configuration. The end / tip portion or component 114 can be configured to maintain proximal contact with the valve leaflet 54 while the heart is beating to facilitate reliable delivery of the anchor 191 / 190 to the target site on the leaflet 54.

[0122] In some cases, one or more perforating devices 130 (e.g., one or more needles) can be delivered through a working lumen (not shown) of the shaft 110 to the valve leaflet 54 to puncture the valve leaflet 54 and extend the suture form 191, including the plurality of strands of suture protruding into the atrium 32 around the distal portion of the needle 130 (see Figure 7 ), wherein the suture is deployed to form Figure 8 and Figure 9 the large knot tissue anchor 190 shown. For example, as shown in Figure 7 , a slotted needle 130 can be deployed from the distal end of the shaft 110 to puncture the leaflet 54 and extend into the atrium 32, with the slotted needle 130 wrapped with the suture form 191 (e.g., PTFE suture) in a particular configuration (see the '761 PCT application for further details regarding example suture wrapping configurations and needles for suture anchor deployment devices and methods). In some cases, a pusher or hollow guidewire (not shown) is provided on or at least partially around the needle 130 within the shaft 110, such that the needle can be withdrawn, leaving the pusher and the wound suture form 191. When the pusher is used to apply a withdrawal force to the suture form 191, the suture form 191 can form a large knot type anchor (e.g., anchor 190), after which the pusher can be withdrawn, leaving the permanent knot 190 anchoring the suture(s) 195 to the leaflet 54.

[0123] Figure 6 The shaft 110 of the tissue anchor delivery device 100 is shown positioned on a target valve leaflet 54 (e.g., mitral valve leaflet). For example, the target site of the valve 54 can be slowly approached from its ventricular side by advancing the distal end of the shaft 110 along or proximate to the posterior wall of the ventricle 33 (e.g., left ventricle) without contacting the ventricular wall. Successful targeting and contact of the target location on the leaflet 54 can depend at least in part on accurate visualization of the shaft 110 and / or the tip / end effector 114 throughout the process of advancing the tip 114 to the target site. Typically, echocardiography equipment can be used to provide the necessary or desired intraoperative visualization of the shaft 110 and / or the tip 114.

[0124] Once the tip 114 is positioned in the desired location, the distal end of the shaft 110 and the tip 114 can be used to overhang or "tent" the leaflet 54 to better secure the tip 114 in the desired location, as shown in FIG. 6. Overhanging / tenting can advantageously facilitate contact of the tip 114 with the leaflet 54 over one or more cardiac cycles, thereby providing for safer or proper deployment of the leaflet anchor(s). The target location can advantageously be positioned relatively close to the free edge of the target leaflet 54 to minimize the likelihood of undesirable intra-atrial wall deployment of the anchor. Echo imaging can be used to assist navigation of the tip 114 to the desired location on the underside of the target valve leaflet 54, as described in detail herein. Echo imaging can be relied upon to confirm proper positioning of the tip 114 prior to anchor / nodule deployment. Figure 6

[0125] As the shaft 110 is positioned against the target leaflet 54, the plunger 140 of the tissue anchor delivery device 100 can be actuated to move the needle 130 and the pusher disposed within the shaft 110, such that the coiled suture form portion 191 of the suture anchor slides off of the needle 130. When the plunger 140 is actuated, the distal piercing portion of the needle 130 pierces the leaflet 54 and creates an opening in the leaflet. Figure 7 A close-up view of the distal portion of the delivery device shaft 110 is shown, according to one or more examples, showing the needle 130 and the tissue anchor suture form 191 extending therefrom through the target leaflet 54. In some cases, the needle 130 is extended distally beyond the distal end of the shaft 130 (e.g., beyond the tip 114) by a distance of about 5-8 mm (about 0.2-0.3 inches) or less. In some cases, the needle 130 is extended by a distance of about 4-10 mm (about 0.15-0.4 inches). In some cases, the needle 130 is extended by a distance of about 25 mm (about 1 inch) or more. In some cases, the needle 130 is extended until the distal tip of the needle and the entire coiled suture form 191 extend through the leaflet 54. When the needle 130 and suture form 191 are extended into the atrial side 32 of the leaflet 54, the shaft 110 and tip 114 advantageously remain entirely on the ventricular side 33 of the leaflet 54.

[0126] ​As the pusher (not shown) within the tissue anchor delivery device shaft 110 is moved distally, the distal end of the pusher advantageously moves or pushes the distal coiled suture form 191 (e.g., a pre-deployed coiled portion of a suture anchor) past the distal end of the needle 130 and further within the atrium 32 of the heart distal of the leaflet 54, such that the suture form extends distally beyond the distal end of the needle 130. For example, in some cases at least half of the length of the suture form 191 extends beyond the distal end of the needle 130. In some cases at least three-quarters of the length of the suture form 191 extends beyond the distal end of the needle 130. In some cases the entire coiled suture form 191 extends beyond the distal end of the needle 130.

[0127] After the suture form 191 has been pushed off of the needle 130, pulling the suture tail(s) 195 (e.g., suture strands extending from the coiled portion of the suture) associated with the tissue anchor 190 proximally can cause the suture form 191 to form a knot anchor 190, as shown in Figure 8 Figure 8 A close-up view of the suture anchor 190 formed on the atrial side 32 of the leaflet 54 is provided. For example, the knot suture anchor 190 can be formed by bringing the opposite ends of the loops of the suture form 191 (see Figure 7 ) proximate to one another to form one or more loops. After the suture form 191 has formed the knot 190, the delivery device 100 can be withdrawn proximally, leaving the tissue anchor 190 disposed on the distal atrial side of the leaflet 54, as shown in Figure 9 In some cases, two suture tails 195 can extend from the proximal / ventricular side 33 of the leaflet 54 and out of the heart 1. For example, the delivery device shaft 110 can slide / withdraw over the suture tail(s) 195.

[0128] Figure 9 A cross-sectional view of a deployed leaflet anchor 190 according to one or more examples of the present disclosure is shown. The suture tails 195 coupled to the anchor 190 can be secured on the outside of the heart through which the suture tails 195 can extend using a pledget 71 or other suture securing / locking device or mechanism at a desired tension. Further, a knot or other suture securing mechanism or device can be implemented to hold the suture at the desired tension and secured to the pledget 71. As the suture tail(s) 195 are secured to the ventricular wall 11, the ventricular portions 195a of the suture tail(s) 195 can advantageously act as a replacement leaflet chord (e.g., chordae tendinae) configured to cinch the target leaflet 54 in a desired manner.

[0129] ​In certain examples, the small pledget 71 is a low porosity and relatively stiff small pledget. Such a small pledget can advantageously allow the desired tension of the suture tail 195a to be maintained for an extended period of time post-operatively. In some examples, the suture tying or securing can be implemented using one or more soft tissue retractors and / or right angle clamps, which can be rubberized to reduce the risk of damaging the replacement cord.

[0130] In certain embodiments, testing of the position and / or tension of the anchor 190 and / or suture tail(s) 195 can be performed by gently pulling the suture tails tight until leaflet motion is felt and / or observed. Echo imaging techniques can be used to view and verify placement of the anchors and resulting leaflet function. The steps and procedures outlined above for placing suture knot type tissue anchors can be repeated as needed until the desired number of anchors have been implanted onto the target valve leaflets. In some embodiments, tension adjustment in the suture tail(s) / cord(s) associated with multiple leaflet anchors can be performed simultaneously. A suitable number of leaflet anchors can advantageously be determined to produce the desired coaptation of the target valve leaflets 54, 52. All deployed leaflet anchors can advantageously be located below the coaptation surface. With respect to posterior mitral leaflet repair, the anterior leaflet can advantageously contact the posterior leaflet base to one or more leaflet anchors. The small pledget 71 can be pulled against the epicardial surface, and all suture tails / cords 195b can be inserted through a tourniquet so that all cords can be tensioned to achieve the desired effective coaptation together.

[0131] In some embodiments, one or more leaflet anchors are deployed in each mitral valve leaflet, wherein the sutures / cords coupled to the individual leaflets are secured together in the heart, either by tying them together with knots or by another suitable attachment means, thereby forming an edge-to-edge repair to reduce the septal lateral distance of the mitral valve orifice.

[0132] Further reference is made to Figure 2-9Generally, the shaft 110 of the tissue anchor delivery device 100 can be slowly advanced into the introducer 200 until the tip 114 has flushed the introducer 200 and entered the heart chamber 33. In doing so, it can be desirable to advance the shaft 110 within the heart chamber 33 in such a way as to avoid passing through the region occupied by the papillary muscle and / or associated chordae tendinae to avoid entanglement therewith. To facilitate or ensure avoidance of such anatomical structures, imaging techniques can be advantageously implemented to provide at least partial visibility of the shaft 110 within the heart chamber 33 and certain anatomical features within the heart chamber. With respect to visibility of the shaft 110 in the heart chamber 33, the echogenic properties of the shaft 110 can affect its visibility using echogenic imaging modalities. Thus, a shaft having relatively high echogenicity as described in detail herein can advantageously allow for more accurate and / or simplified advancement of the shaft 110 and placement of the tip 114 at a target implantation site at the valve leaflet 54 (e.g., the anterior leaflet or posterior leaflet of the mitral valve). In some embodiments, hybrid imaging techniques can be used in which echogenic imaging is used in conjunction with a different imaging modality. Multiple imaging modalities can provide improved visibility of the anatomy and / or delivery system components.

[0133] When echogenic imaging is relied upon, problems and / or difficulties can arise from a loss of visibility of one or more components of the tissue anchor delivery device, such as a loss of visibility of the tip of the anchor delivery shaft. In such cases, it can be necessary to restart the anchor placement procedure. Because the tissue anchor delivery device is inserted through a port in the heart, restarting the delivery of the leaflet anchor can involve additional manipulation of the heart entry side, which can result in increased trauma to the heart tissue with adverse effects. Examples of the present disclosure advantageously allow for rapid movement of the shaft of the tissue anchor delivery device from the introducer to a target position on the target valve leaflet with improved visibility of the delivery shaft and / or other components of the tissue anchor delivery device.

[0134] Echo imaging is often used for cardiothoracic procedures. For example, for procedures that implement transcardiac apical access rather than venous access, according to examples of the present disclosure, fluoroscopy imaging can not provide a practical or standing solution for imaging. Moreover, since fluoroscopy can involve exposing the patient to radiation, in some cases, such imaging can be undesirable in conjunction with a valve repair procedure. Thus, according to examples of the present disclosure, echo imaging can provide a preferred solution for visibility in valve repair procedures. However, for tissue anchor delivery device shafts that include relatively low-echoing shafts and / or other components, these components can only produce their relatively weak images under echo. Thus, the images of the anchor delivery device shafts can be mixed or obscured with background anatomy and / or the image. Thus, examples of the present disclosure that provide improved echogenicity and / or imaging visibility for components of a tissue anchor delivery device can allow relatively easy navigation of the delivery shaft from a port into a target heart chamber to a target leaflet(s) of a valve (e.g., a mitral valve leaflet). Moreover, such improved visibility can facilitate the operator avoiding anatomy or areas where the delivery shaft and / or related components of the tissue anchor delivery device can become entangled or stuck. For example, examples of the present disclosure can facilitate avoidance of native chordae tendinae, thereby reducing the risk of injury or damage to native anatomy / tissue. Moreover, improved visibility of the anchor delivery shaft and / or other components of the tissue anchor delivery device can facilitate improved targeting of a target leaflet, which can result in improved engagement and / or outcomes of the valve repair intervention.

[0135] Echo surface / volume

[0136] Examples of the present disclosure provide echo shafts and / or related components of tissue anchor delivery devices for certain medical procedures, such as mitral valve repair procedures, which can improve the health prospects of patients with degenerative mitral valve insufficiency. As described in detail above, such procedures can involve transapical, off-pump, echo-guided repair, in which a tissue / leaflet anchor delivery device shaft is inserted into the left ventricle and guided to the surface of a target mitral valve leaflet lesion for deployment / implantation of a leaflet anchor, such as a suture knot-type anchor, which can advantageously be coupled to one or more suture tails that provide artificial leaflet chord function. In some cases, such suture can include expanded polytetrafluoroethylene (ePTFE).

[0137] According to the leaflet anchor deployment process outlined herein, a delivery device shaft can be passed through an introducer device and advanced under echo (e.g., ultrasound) guidance into the heart chamber. Such imaging implementation can utilize, for example, a transthoracic echocardiogram (TTE) probe device or a transesophageal echocardiogram (TEE) probe device. However, it should be appreciated that the inventive features disclosed herein can be applicable to any type of imaging device / modality.

[0138] Figure 10A A side view of a TTE imaging probe 69 is shown disposed proximate to a patient's chest wall 60, according to one or more examples. Figure 10A A medical device shaft 110 is shown inserted into the heart 10 for deployment of a tissue anchor, as described herein. For example, the shaft can be configured to transport and deploy a needle having a distal portion that is wrapped with suture or wire in a coiled pre-formed knot suture form / configuration in its lumen. As the shaft 110 is positioned against a diseased prolapsed valve leaflet or other tissue, a delivery device (not shown) associated with the shaft can be actuated to pierce the leaflet, push the coiled suture form through the leaflet to deploy it on the atrial side of the leaflet. For example, the coiled suture form can form a relatively large width / diameter large knot on the atrial side of a mitral valve leaflet. The length of the suture tail(s) associated with the knot anchor can be adjusted under real-time echo guidance, and the proximal end of the suture tail can be secured to an outer ventricular wall of the heart.

[0139] To reliably navigate through the ventricle and place the leaflet anchor(s) at precise target locations on the target segment of the mitral valve, it can be necessary or desirable for the anchor delivery device shaft to be clearly visible with respect to the ultrasound images of the surrounding structures. However, during a procedure, the appearance of the medical device shaft can become faint, blurry, and the focus in the field of view can vary from far to near, thereby providing a misleading and inaccurate impression of the shape and / or location of the shaft or causing confusion between the shaft and the artifact(s). In particular, when the echogenicity of the shaft 110 is not relatively high during its operation, the tracking and visualization of the shaft can be very challenging.

[0140] Examples of the present disclosure provide medical device shafts with relatively high echogenicity to improve visibility during surgical procedures. Examples of the present disclosure can implement any suitable or desirable echogenicity-enhancing features (also referred to herein as "image-enhancing" features) in the medical device shaft and / or other devices. For example, devices and surfaces with echogenicity-enhancing features according to the present disclosure can include texturing or roughening of the device surface, adhering microparticles to the device surface, utilizing reflectors, creating indentations or holes in the device / surface, using different materials in the device, and other image-enhancing mechanisms or techniques.

[0141] Echocardiography utilizes sound wave imaging to provide sound wave map images of the heart or portions thereof. Generally, echocardiography can utilize two-dimensional, three-dimensional, and / or Doppler ultrasound waves to create images of the heart, including real-time images. In some implementations, echocardiography can involve the use of ultrasound pulse-echo imaging or other techniques. With respect to Figure 10A , the echogenicity-improved medical device shafts can be used in conjunction with echocardiography. For example, an echogenicity-improved medical device shaft can be used in conjunction with a TTE imaging probe 69 to provide improved echocardiography images. The echogenicity-improved medical device shafts can be used in conjunction with a TTE imaging probe 69 to provide improved echocardiography images. Figure 10AThe system shown can advantageously provide non-invasive real-time imaging of the heart 10 during valve repair procedures as described herein.

[0142] In some embodiments, valve repair imaging according to examples of this disclosure can be combined with three-dimensional (3D) echocardiography, which can be implemented with a matrix array ultrasound probe in conjunction with a suitable processing system. This imaging modality enables a detailed anatomical assessment of cardiac pathology, including valvular defects and cardiomyopathy. Real-time 3D echocardiography can be used to guide the position of the tissue anchor delivery device axis within the cardiac chambers (such as the left ventricle for mitral valve leaflet repair), as described in detail herein. Thus, echo imaging can be used to provide intraoperative assessment of cardiac anatomy and (one or more) repair system components.

[0143] exist Figure 10A In this configuration, the inserted shaft 110 is inserted at an angle θ relative to the surface plane 67 of the probe / transducer 69; sound waves emitted by the transducer 69, such as wave 61, can typically propagate orthogonally (e.g., at right angles) relative to the surface plane 67. For non-echo medical device shafts, the reflection angle of the sound wave can typically be equal to the angle of incidence relative to the shaft surface. For example, as... Figure 10A As shown, for the non-return axis, the transmitted acoustic wave 61 from transducer 69 can be determined according to the relative... Figure 10A The angled incident angle of the axis shown is reflected, resulting in the reflected wave 65 shown. The reflected wave 65 can typically be at least partially directed away from the transducer 69, resulting in an undesirably attenuated reflected signal 65. When the reflected signal is directed directly back to the transducer, the imaging visualization can typically be larger, such that the incident angle is at or near 0°. In some examples, this disclosure provides medical device axes and means comprising chambers or lumens (or surfaces, chambers, and / or lumens) at least partially filled with fluid / gas, wherein the fluid / gas is used to provide a multifaceted reflector that reflects most of the acoustic waves incident upon it directly back to the signal source (e.g., an echo transducer) 69, thereby providing a relatively clear and more defined image, as shown by the reflected signal 63. Such means may include multicavity axes, wherein one or more lumens thereon are at least partially filled with fluid (e.g., air or other gas) or other echo media.

[0144] Figure 10B A side view of a transesophageal echocardiography (TEE) imaging probe 99 implemented to generate echo images is shown. Figure 10BThe TEE implementation shown in FIG. 1 represents a relatively more invasive form of cardiac ultrasound (e.g., echocardiography), in which the ultrasound transducer / probe 99 is placed below the patient’s throat and into the esophagus. Images generated from a location within the patient’s esophagus can provide relatively more detailed, clear imaging of the heart 10 and medical device shaft 110, as compared to typical cases using transthoracic echocardiography (TTE) imaging. For example, the location of the probe 99 can allow for clearer imaging of certain soft tissues that can not be visible in some TTE implementations. When the shaft 110 includes echogenic contrast and / or image-enhancing lumen(s), as disclosed in detail herein, at least a portion of the transmitted signal 67 can be substantially directly reflected back to the transducer 99, such as reflected signal 68 as shown. The echogenic imaging generation disclosed herein can involve TTE, TEE, or any other type of echogenic imaging generation.

[0145] Multi-lumen medical device shaft

[0146] Multi-lumen shafts according to examples of the present disclosure can be used in conjunction with contrast echocardiography to provide improved imaging and / or visibility during a valve repair procedure or other medical intervention. For example, in some cases, an ultrasound contrast or imaging agent can be contained within a lumen or chamber of a medical device shaft and / or flowed therethrough during a valve repair procedure to provide improved imaging / visibility.

[0147] The degree to which a material and medium reflects sound waves can be referred to as “echogenicity,” as described and used herein according to its broad and ordinary meaning, which generally refers to the ability of a material or surface to reflect echoes (e.g., return sound / ultrasound wave signals). That is, a material / surface can be considered more echogenic when it reflects increased sound waves back as reflected sound echoes. Materials / surfaces with relatively higher echogenicity can be referred to as “low echogenic” or simply “echogenic,” and generally appear lighter in color on echogenic imaging. Conversely, materials / surfaces with relatively lower echogenicity can be referred to herein as “low echogenic” or “non-echogenic.”

[0148] By using one or more chambers or lumens provided therein with certain gases / fluids and / or other medium or surface properties that provide increased reflection of sound waves, anchor delivery shafts according to examples of the present disclosure can have improved echogenic properties. For example, examples disclosed herein provide multi-lumen shafts in which one or more lumens or chambers thereof are filled with a gas or other contrast agent. Such a gas / medium can provide a density interface between the shaft and the gas / fluid disposed in one or more lumens thereof. For example, shafts according to examples of the present disclosure can include a substantially solid / rigid material, such as stainless steel or the like, having one or more portions filled with a fluid or medium having a density less than that of the solid / rigid material of the shaft, thereby providing a reflective interface between the materials.

[0149] Referring back Figure 10A and Figure 10B For gases with echogenic properties, such as air, or microbubble or other contrast agents, the angle of reflection of the sound wave can thus be substantially equal to the angle of incidence. Generally, visualization is best when the angle of incidence of the reflected wave 63 relative to the transducer surface 67 is 0°, while relative to signals reflected away from the transducer, the visualizability can be relatively low. The use of a gas or other contrast agent in a medical device shaft in accordance with examples of the present disclosure can advantageously provide improved imaging, where the gas or other contrast agent disposed within one or more lumens or chambers of the shaft acts as a multi-faceted reflector that continuously and perpendicularly reflects sound waves (e.g., ultrasound waves) back to the source of the waves (e.g., ultrasound probe 69), thereby providing a relatively clear and more defined image. Thus, as shown in FIGS. 6A and 6B, a shaft 110 disposed at an angle Θ relative to the angle of incidence of the ultrasound waves 61 provided by the ultrasound probe 69 can include air / gas or other contrast agents that reflect the signals 61 at an angle substantially equal to the angle of incidence of the ultrasound waves on amorphous media, which can provide improved reception by the ultrasound transducer 69 as compared to signals 65 reflected off the surface of the shaft 110, which can generally reflect at an angle equal to the angle of incidence on the shaft. That is, regardless of the angle at which the shaft 110 is currently oriented relative to the ultrasound probe 69, certain reflected echoes can be reflected directly back to the signal source, which advantageously includes a receiving function in addition to a transmitting function. This quality of reflection can be used to reduce or eliminate the presence of blind spots in the echogenic image with respect to the portion of the shaft 110 associated with the gas or other contrast agent as described herein. Although examples of the present disclosure describe gas-filled chambers or lumens of an anchor delivery device shaft, it should be appreciated that a liquid medium can be used in addition to, or as an alternative to, a gas. Figure 10A and Figure 10B As shown in FIGS. 6A and 6B, a shaft 110 disposed at an angle Θ relative to the angle of incidence of the ultrasound waves 61 provided by the ultrasound probe 69 can include air / gas or other contrast agents that reflect the signals 61 at an angle substantially equal to the angle of incidence of the ultrasound waves on amorphous media, which can provide improved reception by the ultrasound transducer 69 as compared to signals 65 reflected off the surface of the shaft 110, which can generally reflect at an angle equal to the angle of incidence on the shaft. That is, regardless of the angle at which the shaft 110 is currently oriented relative to the ultrasound probe 69, certain reflected echoes can be reflected directly back to the signal source, which advantageously includes a receiving function in addition to a transmitting function. This quality of reflection can be used to reduce or eliminate the presence of blind spots in the echogenic image with respect to the portion of the shaft 110 associated with the gas or other contrast agent as described herein. Although examples of the present disclosure describe gas-filled chambers or lumens of an anchor delivery device shaft, it should be appreciated that a liquid medium can be used in addition to, or as an alternative to, a gas.

[0150] Examples of echogenic medical device shafts in accordance with the present disclosure can advantageously include one or more fluid / medium-filled image-enhancing lumens or chambers, as well as one or more working lumens for transporting repair devices and / or tools associated with a medical procedure. Some examples of the present disclosure relate to multi-lumen anchor delivery shafts that provide improved echogenic properties as compared to certain other tissue anchor deployment solutions. Figure 11 A perspective view of a distal portion of a multi-lumen medical device shaft 410 in accordance with one or more examples is shown. As shown, the shaft 410 can include a rigid elongate tube forming at least one internal lumen. Figure 12 A side view of a multi-lumen medical device shaft is shown in FIG. 6C, while Figure 11 a front axial view of the multi-lumen medical device shaft 410 is shown in FIG. 6D. Figure 13 Figure 11

[0151] ​​Figure 11 The shaft 410 can include one or more image-enhancing lumens / chambers designed to continuously reflect ultrasound energy back to the signal source (e.g., the echogenic transducer). To this end, in addition to the working lumen 405, the shaft 410 includes fluid-filled lumens 402, 404. The fluid-filled lumens 402, 404 can act as a resonator along at least a portion of the longitudinal length of the shaft 410. The fluid in the lumens 402, 404 can advantageously optimize the angle of incidence between ultrasound waves impinging on the shaft 410, allowing the sound waves to be continuously reflected back to the signal source orthogonally / perpendicularly, regardless of the angular orientation of the shaft relative to the signal source. The enhanced echogenicity provided by the multi-lumen shafts disclosed herein can provide improved safety and efficacy of, for example, heart valve repair procedures.

[0152] The working lumen 405 can be used to enclose the needle and pusher components of the tissue anchor delivery device, as described in detail above. In some examples, the working lumen 405 can be disposed substantially centrally about the longitudinal central axis of the shaft 410, while one or more of the image-enhancing lumens 402, 404 can be disposed in a periphery about at least a portion of the working lumen and adjacent at least a portion of the working lumen, as shown. Figure 11-13

[0153] The shaft 410 is a multi-lumen shaft in which one or more lumens associated with the shaft are shaped and / or configured to receive and / or contain echogenic contrast / gas, as described in detail herein. Figure 11 The shaft 410 of the illustrated embodiment includes a working lumen 405 through which a leaflet anchor can be advanced to a target implantation site. In addition, the working lumen 405 can be used to hold and / or advance the suture of a leaflet anchor or suture associated therewith, as well as a needle and / or other tool(s) to facilitate deployment of one or more leaflet anchors. In some examples, the central lumen 405 is configured to enclose one or more of a needle, a coiled suture form anchor, and a pusher component of the tissue anchor delivery device, as described above. The lumens 402, 404 can be configured to contain air, or other gas or media contrast fluid, as described in detail herein. In some examples, the proximal and / or distal ends of the lumens 402, 404 can be closed such that the lumens 402, 404 are effectively fluid-tight. Thus, the lumens 402, 404 can hold a substantially stagnant fluid therein and can advantageously be at least partially fluid-tight such that blood and / or other environmental fluids or solids cannot enter therein during performance of a surgical procedure.

[0154] ​The shaft 410 may be associated with or coupled to a substantially non-invasive leaflet contact tip 414 (also referred to herein as an "end effector"). The tip 414 may advantageously be at least partially flexible, such that during insertion of the shaft 410 through the inserter device into the target ventricle, the tip 414 may be configured to bend posteriorly in a direction proximal to the shaft 410, such that the diameter of the inserter channel through which the shaft 410 is advanced does not necessarily have to be as large as the diameter of the tip 414. By using the flexible leaflet contact tip 414 and appropriately sized lumens 402, 404, 405, Figure 11 The axis 410 can advantageously have a relatively small profile, which allows for a relatively larger range of motion of the axis 410 within the target ventricle and / or (one or more) other anatomical chambers. For example... Figure 12 As shown, Figure 12 Show Figure 11 The side view of the distal portion of shaft 410 is shown. The diameter of shaft 410 may be approximately 0.120 inches. Figure 13 Show Figure 11 and 12 The front view of the distal end of shaft 410 and (one or more) associated components shown.

[0155] Because one or both of lumens 402, 404 contain air or other gas or a contrast agent with relatively high echo characteristics, shaft 410 may appear relatively brighter in echocardiographic images compared to similar shafts without such additional lumens(s). Shaft 410 may have any size or shape. In some examples, multi-lumen shafts may be formed using an extrusion process.

[0156] Figure 11-13 The embodiments illustrate an example of a multi-cavity axis having two kidney-shaped outer cavities 402, 404 located outside the central working lumen 405. However, the fluid-filled echo lumen of the embodiments according to this disclosure can have any suitable or desired shape, form, or configuration relative to the working lumen. In some examples, such as in Figure 11-13 In the illustrated embodiments, the outer echo cavities 402, 404 may be located on the periphery surrounding the central working cavity 405. In some examples, the echo cavities 402, 404 are not open to external fluid. There may typically be no fluid communication between the fluid-filled echo cavity(s) and the working cavity(s). Therefore, in some examples, any air or other fluid trapped in cavities 402, 404 is completely contained and will not leak, penetrate, or cross into the working cavity 405. Figure 11-13 The multi-cavity shaft 410 can be made of stainless steel or any other medically compatible metal, such as titanium, steel, etc. Switzerland, Montignez, Dumont), any other metal alloy or resin or polymer used to manufacture surgical instruments.

[0157] Figure 14 is a flowchart illustrating a process 1400 of aiming at a heart valve leaflet using a multi-lumen shaft according to one or more examples. According to examples of the present disclosure, the process 1400 can be implemented to advance a multi-lumen shaft of a tissue anchor delivery device to a target heart valve leaflet. At block 1402, the process 1400 includes placing an introducer device with a lumen extending through a heart wall and into a ventricle of the heart. The introducer device can advantageously have one or more valves for preventing blood from flowing back through the lumen of the introducer device from the ventricle.

[0158] At block 1404, the process 1400 includes advancing a multi-lumen shaft of a tissue anchor delivery device through the lumen of the introducer device, thereby introducing a distal portion of the multi-lumen shaft into the ventricle of the heart. The multi-lumen shaft can advantageously include one or more echo at least partially filled lumens. Such lumens can be externally fluid-tight, such that the lumens are fluid-sealed, or can allow fluid to flow through and out of the echo lumen(s).

[0159] At block 1406, the process 1400 includes generating an image of the multi-lumen shaft using echo imaging, as described in detail herein. For example, such imaging can be generated using an echo transducer / probe, which can be placed or disposed at or near the patient’s chest. In contrast to traditional shafts, which can provide echo images that are weak, blurry, and / or come in-and-out of focus in the field of view, thereby misleading surgeons and echocardiographers, the multi-lumen shaft can provide clearer echo images. At block 1408, the process 1400 includes further advancing the multi-lumen shaft while visualizing the shaft on the echo image to contact a target valve leaflet, as described in detail herein.

[0160] Figure 15-18 FIGS. 1-3 illustrate example embodiments of multi-lumen echo shafts according to the present disclosure. Although various shapes and configurations of multi-lumen shafts are shown in Figure 15-18 it should be understood that embodiments of the present disclosure can include any shape, configuration, and / or number of fluid-filled image-enhancing lumens and / or working lumens. Although the fluid-filled image-enhancing lumens shown in Figure 15-18 it should be understood that such lumens can be closed, such that fluid cannot enter or exit the lumens when fluid is placed in the target ventricle or other anatomical structure or chamber. Further, although the fluid-filled image-enhancing lumens shown in Figure 15-18The working lumens of the shafts in FIGS. 1-3 are shown as being generally centrally disposed or positioned relative to the cross-sectional area of the shaft, but it should be understood that in some cases one or more working lumens can be generally disposed outside of the cross-sectional area of the shaft, or in any area that is not aligned with or concentric to the central longitudinal axis of the shaft. Additionally, further fluid-filled image enhancing lumens can be generally disposed outside of the cross-sectional area of the shaft or can be centrally disposed. With respect to Figure 15-18 Each of the examples of FIGS. 1-3, the fluid-filled image enhancing lumens associated therewith are configured such that it can be advantageous for there to be no fluid communication between such lumen(s) and any working lumens associated therewith over the length of the shaft.

[0161] Figure 15 is a perspective view of a distal portion of a multi-lumen medical device shaft 510 in accordance with one or more examples. As shown, the shaft 510 can include a rigid elongate tube forming at least one internal lumen. Figure 15 An embodiment of a shaft 510 including two lumens 501, 502 is illustrated. In some examples, one of the two lumens 501, 502 can be used as a working lumen, as described herein, while the other of the lumens can be used as a fluid-filled image enhancing lumen. The lumens 501, 52 can have a semi-circular shape as shown, or can have any other shape. In some examples, the lumens 501, 502 are substantially equal in size or volume, while in other examples one of the lumens 501, 502 can be larger in size or volume than the other. As shown, the image enhancing lumen can be generally positioned adjacent to the working lumen.

[0162] Figure 16 is a perspective view of a distal portion of a multi-lumen medical device shaft 511 in accordance with one or more examples. As shown, the shaft 511 can include a rigid elongate tube forming at least one internal lumen. Figure 16 An embodiment of a shaft including a central working lumen 504 and a plurality of outer fluid-filled image enhancing lumens 503 is illustrated. For example, a multi-lumen shaft in accordance with the present disclosure can include a working lumen 504 having a substantially circular cross-section, while the fluid-filled image enhancing lumens 503 can have a non-circular cross-sectional shape. Such a configuration can advantageously efficiently utilize the cross-sectional area of the lumen 511, allowing for a greater volume of image enhancing fluid / medium. As shown, the image enhancing lumens 503 can be generally positioned adjacent to the working lumen 504.

[0163] Figure 17 is a perspective view of a distal portion of a multi-lumen medical device shaft 512 in accordance with one or more examples. As shown, the shaft 512 can include a rigid elongate tube forming at least one internal lumen. The shaft 512 includes a central working lumen 506 and a plurality of circular image enhancing lumens 505. In Figure 17In embodiments of the shaft 512 includes four circumferentially spaced apart image intensifier lumens 505. With respect to Figure 18 the illustrated shaft 513 includes a central working lumen 508 and a plurality of image intensifier lumens 507, which in some examples can include more than four image intensifier lumens. With respect to Figure 17 and Figure 18 the cross-sectional area of the image intensifier lumens 505, 507 can generally be smaller than the central working lumens 506, 508, respectively. As shown, the image intensifier lumens 505, 507 can be positioned generally adjacent to the working lumens 506, 508.

[0164] Figure 15-18 The shafts of the present disclosure can be manufactured or formed in any suitable or desired manner. For example, in some embodiments, multi-lumen shafts similar to those represented in Figure 15-18 may be manufactured using an extrusion process. For example, such shafts can be made using any material, such as a polymer or other material suitable for single form extrusion. In particular, an extrusion process can be utilized to produce a continuous tubing line having a plurality of lumens therethrough. Such tubing can be cut into discrete units for use in valve repair system shaft components. In some examples, it can be desirable for the central working lumen to be more rigid and / or have characteristics that are not typically characteristics of extruded tubing. Accordingly, a stainless steel or other relatively rigid inner liner or tube can be incorporated into the extruded multi-lumen structure. That is, in some examples, the multi-lumen shaft can include different sections or portions comprising different materials. For example, a stainless steel inner liner or tube can be used in conjunction with the working lumen and / or one or more other lumens, while one or more lumens can be formed using an extrusion process designed to form a sleeve or other component that can be slid over or otherwise engaged with one or more other lumens / shafts.

[0165] Figure 19 is a flowchart illustrating a process 800 of manufacturing a multi-lumen medical device shaft using an extrusion process in accordance with one or more examples. At block 802, the process 800 includes forming a die having a plurality of lumens in a desired configuration. For example, the die can include a plurality of axially arranged lumens arranged in a generally circular arrangement about an axis. Additionally or alternatively, the die can include one or more lumens having any suitable or desired non-circular cross-sectional shape.

[0166] At block 804, the process 800 includes melting a material used as a base material for a multi-lumen shaft. For example, a polymer / plastic (e.g., a thermoplastic) or any other suitable or desirable material can be melted using a hopper or other type of mechanism or mechanism. At block 806, the process 800 includes forcing the melted material through a die to form a desired multi-lumen shaft / tube. At block 808, the process 800 includes cutting the extruded / molded tube into one or more segments, each of which can serve as a shaft component of a tissue anchor delivery device according to examples of the present disclosure. In some embodiments, the extruded tube can be allowed to cool prior to cutting. The process 800 can optionally further include coupling the extruded tube segments to a relatively rigid shaft / tube lumen, such as a stainless steel shaft. For example, the extruded tube can slide or otherwise engage around the stainless steel shaft. Certain shafts disclosed herein can advantageously include stainless steel, which can provide suitable or desirable strength and / or density, as well as echogenic properties. Moreover, the stainless steel shaft and / or components thereof can advantageously provide a relatively stable platform for deployment of leaflet anchors (e.g., pledget anchors), and stainless steel can also have desirable biocompatible properties.

[0167] While various examples are disclosed herein that include a multi-lumen shaft in a single integrated form, in some examples, the multi-lumen shaft can include a plurality of lumens or a shaft with separate tubes that are coupled together in some manner, with one or more of the tubes serving as a working lumen and one or more of the tubes serving as a fluid-filled image-enhancing lumen.

[0168] Figure 20 is a perspective view of a distal portion of a multi-lumen medical device shaft 514 according to one or more examples. In particular, Figure 20 The multi-lumen shaft 514 is shown to include a central working lumen 516 and one or more outer lumens 509. In some embodiments, the central lumen 516 serves as a working lumen through which anchor deployment devices and / or components can be advanced and deployed, while the outer lumens 509 are fluid-filled image-enhancing lumens. In some examples, the central lumen 516 and the outer lumens 509 can include separate lumens, such as stainless steel lumens, polymer lumens, and / or the like, that are coupled together in some manner, such as by welding, adhesion, or by use of one or more mechanical fasteners or straps. As shown, the image-enhancing lumens 509 can be positioned generally adjacent to the working lumen 516.

[0169] Figure 21is a perspective view of a distal portion of a multi-lumen medical device shaft 861 having a needle 830 and tissue anchors 890 extending from a working lumen 855 thereof, in accordance with one or more examples. For example, the tissue anchors 890 can be configured in a coiled suture form about the needle 130, which can advantageously be a slotted needle. As shown, the anchors 890 can include multiple turns of suture about at least a portion of the needle 830. The lumen 855 can further be used to hold at least a portion of a pusher device (not shown; described above) that can be used to deploy the needle 330 and / or deploy the anchors 890 from the needle 830. In addition to the central working lumen 855, the shaft 861 includes one or more external fluid-filled image enhancement lumens 852, 854. As in some examples, the image enhancement lumens 852, 854 are shown as being closed such that the lumens 852, 854 are effectively fluid tight, and are separated by a partition wall 856, which can extend a portion of the length of the shaft 861.

[0170] As noted above, according to some examples, the image enhancement tube, sleeve or component can be manufactured as a separate component from the working lumen / shaft used for the tissue anchor delivery procedure. For example, Figure 22 An image enhancement sleeve 701 is illustrated, which can have any suitable or desired form or shape. The image enhancement sleeve 701 can include a tube or sleeve having one or more lumens, chambers or passages formed in the wall thereof. The use of a separate image enhancement outer sleeve from the working shaft can optimize the angle of incidence between the sound waves and the wave-reflecting medium. For example, the circumferentially arranged fluid-filled compartments 703 can provide a unique surface area for reflecting sound waves from the fluid in the compartments 703. The fluid-filled compartments / lumens 703 can advantageously be closed on one or more ends of the sleeve 701 such that the compartments / lumens 703 are effectively fluid tight.

[0171] The sleeve 701 can have an elongated tubular shape, with the image enhancement lumens / chambers 703 extending longitudinally through at least a portion of the length of the tube. The sleeve 701 can further include a working shaft-receiving cavity 707 through which a working shaft 715 can be inserted. For example, in some examples, the sleeve component 701 is formed of a polymer or plastic, while the working shaft 715 is formed of a more rigid material such as stainless steel or the like. Such a configuration can be desirable from an echogenicity standpoint when the solid structure of the sleeve 701 (as opposed to the fluid contained in the lumens 703) is formed of a material that reflects sound waves less than the material of the working shaft 715 (e.g., stainless steel). As shown, with the sleeve 701 disposed on the shaft 715, the image enhancement lumens 703 can be positioned generally adjacent to the working lumen 707. As shown, the shaft 715 can include a rigid elongated tube forming at least one internal lumen.

[0172] The working shaft 715 can be used to advance various anchor deployment devices / tools as described herein, while the sleeve component 701 can be incorporated to provide improved imaging as the echogenicity of the fluid-filled lumen 703 is enhanced. While the image-enhancing sleeve and component are described herein as being coupled with a tissue anchor delivery device shaft, it should be appreciated that the image-enhancing sleeve and lumen according to examples of the present disclosure can be used in conjunction with any type of medical device shaft or non-medical device shaft that can benefit from improved visibility under echogenicity. Further, while the sleeve 701 is illustrated as a tubular sleeve, it should be appreciated that an image-enhancing component having features similar to those illustrated and described with respect to the sleeve component 701 can have any suitable or desired form, including a wrap, clip, band, and / or the like. Further, the image-enhancing component 701 can be configured to fit over shafts of any size. With respect to a wrapable image-enhancing device, such a device can be able to provide image enhancement by fitting around shafts or devices having different diameters and / or sizes.

[0173] Shaft with outboard helical wire

[0174] Various examples disclosed above relate to medical device shafts having an image-enhancing lumen or chamber that extends substantially longitudinally along the axis of the shaft. In certain examples, an at least partially circumferentially or horizontally extending lumen or chamber can be utilized to provide improved imaging with respect to a medical device shaft. For example, any of the examples disclosed above having an image-enhancing lumen within a tubular form can be implemented with such a lumen wrapped circumferentially around the tube rather than strictly longitudinally. Such a circumferential / horizontal lumen can be generally helical in shape, with at least a longitudinal segment of the shaft being traversed by a helical lumen formed of multiple turns of wire / coil around the shaft. Alternatively or additionally, the lumen / coil can be generally circular, with the shaft being associated with multiple separate, concentric, hoop-shaped lumens / coils.

[0175] In some examples, a helical coil or tube can be wrapped around an outer working shaft, providing improved imaging visibility as described herein. For example, Figure 23 A medical device shaft assembly 315 is illustrated having a helical coil / wire 317 wrapped around its shaft 310. For example, as illustrated, the helical coil / wire can be wrapped around the outside of the shaft 310. As illustrated, the shaft 310 can include a rigid elongate tube forming at least one internal lumen. In some examples, the helical coil (e.g., in the form of a spring-type wire) can be slidable or disposed over the outer tube 310 of the shaft 310. A covering (not shown in the interest of clarity) such as a shrink tube or the like can cover the shaft 310 and coil 317, which can serve to hold the components together and trap fluid, such as air, between the coils. Figure 23

[0176] ​While helical and other geometric forms, patterns, and devices for enhancing echogenicity are disclosed in accordance with certain examples disclosed herein, such forms, patterns, and devices can be irregularly shaped and / or non-geometric. For example, shaft assembly 315 can have forms, shapes, members, devices, and / or features / components that are non-geometric and / or irregularly shaped or formed that are configured to capture or retain fluid (e.g., air) and / or provide uneven surfaces intended to increase echogenicity. Moreover, such forms, members, devices, and / or features / components can be associated with any other type of device or assembly other than shaft 310 and assembly 315, including other types of medical device shafts or non-medical devices.

[0177] Figure 24A A close-up view of a distal portion of shaft assembly 315 is provided in Figure 23 Figure 24B A cross-sectional view of a portion of shaft assembly 315 is provided in Figure 23 Figure 24A Figure 24B As shown in FIGS. 17-19, coil 317 can have a shrink tube or other covering 319 disposed or wrapped around an outer side thereof such that air or other fluid or contrast agent is captured in space 302 or at least partially prevented from flowing. Fluid disposed between adjacent windings of coil / wire 317 can advantageously increase echogenicity of assembly 315 as described in detail herein. Wire 317 can be wrapped around shaft 310 in a generally helical manner. As shown, image enhancement space 302 can be positioned generally adjacent working lumen 305.

[0178] As described above, Figure 23 Figure 24A Figure 24B Shaft assembly 315 of FIGS. 17-19 can include spring-type coils that are slid or wrapped and / or slid or wrapped around shaft 310 and laminated with a shrink tube or similar, which can incorporate image enhancement features by retaining echogenic fluid (e.g., air) in spaces 302 between windings or wraps of coil 317 that can be visible under echogenic imaging. Additionally or alternatively, coil 317 can include hollow wire itself, with echogenic contrast agent, such as air or other gas, retained within the hollow conduit of the wire, which can provide enhanced imaging for shaft assembly 315. In examples including hollow wire wrapped around shaft 310, there can or can not be spaces between windings / coils of the wire. That is, Figure 24A Figure 24B Space 302 shown in FIGS. 17-19 can not be present in some examples, with wire 317 including a hollow lumen containing image enhancement fluid such that windings / coils of the hollow wire can be substantially contiguous / contacting one another along a longitudinal dimension of shaft 310. Conversely, as shown in​​​​​​Figure 23 , Figure 24A and Figure 24B In the illustrated embodiment, the wire / coil 317 may include a solid wire.

[0179] The outer cover 319 may include a polymer tube that is slidable or otherwise positioned or disposed on the wire / coil 317 and / or shaft 310. In some embodiments, heat may be used to shrink and / or adhere the cover 319 to the wire 317 to provide its lamination. This process may cause air or other fluids to be trapped between the windings / coils of the wire 317, such as in… Figure 24A and Figure 24B In the space 302 shown. In an example where the wire / coil 317 includes a hollow tube with an internal cavity filled with image enhancement fluid, this shaft assembly may not include an outer cover or laminate.

[0180] As with all the examples disclosed herein, the chambers, clearances, channels, lumens, and / or other non-working (and possibly fluid-sealed) compartments associated with shaft 310 and / or shaft assembly 315 may be gas-filled (e.g., air, perfluorocarbon, nitrogen, or the like) or fluid-filled. For example, such a gas- or other fluid-filled compartment may not be in fluid communication with a working (e.g., central) lumen, which may primarily serve as a housing for needle, pusher, and tissue anchor assemblies, as described herein. In some examples, shaft assembly 315 comprises alternating bands of uniformly raised metal, with gas trapped between the bands. Some of these examples, for instance... Figure 23 The embodiment shown in Figure 24 can produce a clear band image of the axial assembly under echo, thereby improving the clarity of the echo image and enabling surgeons to more precisely target one or more target valve leaflets to achieve the desired result.

[0181] Figure 25 A medical device shaft 2515 according to one or more examples is shown, the medical device shaft having one or more coils with non-uniform spacing around the medical device shaft. As shown, shaft 2510 may include a rigid elongated tube forming at least one internal lumen. Figure 25 As shown, the spacing between adjacent coils / wounds of the wire / coil 2517 arranged around the shaft 2510 of the medical device can have varying and / or gradually changing spacing or height. That is, along the length of the medical device shaft, the windings of the wire or coil 2517 wound around the shaft 2510 can have different spacing distances d1 between coils 2517 in at least a portion of a first longitudinal region or portion 2501 of the shaft 2510 and a second spacing distance d2 in at least a portion of another region portion 2502 of the shaft, such as... Figure 25The medical device shaft assembly 2515 is shown. This variation in spacing can produce an image under echo imaging that allows different regions / sections of the shaft 2510 to be distinguished and / or identified relative to one another. For example, as shown in the embodiment of FIG. 27, the proximal end or section 2501 of the shaft assembly 2515 can have a smaller coil-to-coil spacing dl compared to the relatively wider / larger spacing distance d2 between the coils of the wire 2517 at or near the distal end or section 2502 of the shaft assembly 2515. Figure 25

[0182] The variation in pitch between adjacent coils can allow for simplified positioning / identification of the distal end or section 2502 of the shaft assembly 2515 relative to the proximal end or section 2501 of the shaft assembly. In some examples, the spacing between the coils along the length of the shaft 2510 is substantially the same over certain lengths or sections of the shaft. Alternatively, the spacing can increase continuously / gradually from one region of the shaft 2510 to another. Although Figure 25 Although the spacing d2 at or near the distal portion 2502 of the shaft assembly 2515 is shown as being larger than the spacing dl at or near the proximal portion 2501, in some examples, the spacing at the proximal portion 2501 can be larger and narrower at or near the distal portion 2502. In some examples, the spacing can be substantially the same over the proximal and / or distal regions. In some examples, the spacing can be uniform and / or different at the distal region portion 2502. The pattern of spacing between the coils in a medical device shaft assembly as described herein can be any suitable or desired pattern and can advantageously be designed to facilitate a pattern or characteristic that is relatively easily visible and / or identifiable under echo. The variation in spacing can advantageously allow an operator to identify the location of one or more portions of the shaft within a patient in real time.

[0183] Figure 26 An example echo imaging window 2600 is shown, which shows an image of a medical device shaft assembly 2615 in accordance with certain examples of the present disclosure. In particular, the image window 2600 shows an image 2615 of a shaft having a spaced coil design, as shown and described above, or another shaft assembly having a circumferential band in accordance with the present disclosure. Although the image 2615 is shown in black, while the background 2604 of the window 2600 is shown in white, it should be understood that such presentation is for purposes of description, and that under some imaging modalities, the echogenic material can appear as white or other relatively lighter shade on a substantially black or dark background. In some examples, the tip of the shaft assembly is equipped with echogenic material or features, thereby increasing its visibility under echo and producing an image 2614 representative thereof. Figure 23-25

[0184] ​​The shaft image 2615 can appear relatively highly detectable compared to a medical device shaft that does not include image enhancement features as described herein. The image of the shaft 2615 can show the visible band of the coil described above with respect to Figure 23-25 In some embodiments, the atraumatic tip 2614 or other distal component can further be visible in the image window 2600 as well as in the comet tail artifact image 2603, which can appear in the echogenic image due to reverberation from echoes within the shaft 2615. For example, within the tube(s) of the shaft, the tube walls can act as a hollow reflector, which can reflect back to the transducer in the form of an artifact, as shown.

[0185] In general, the images of the shaft 2615 and the artifact 2603 can converge at or near the tip 2614 of the shaft. Thus, the tip 2614 can be used to provide a true positioning of the tip of the shaft 2615, as it is the location of the tip of the shaft 2615 as well as the artifact 2603. Such external coil embodiments can further provide improved imaging / visibility due to the irregular outer surface associated with the shaft and coil, in addition to the image enhancement provided by the fluid-filled spaces between the coils of wire disposed around the shaft 2615. In some embodiments, the working shaft can have an etched outer surface to form an irregular and relatively more reflective outer surface.

[0186] Figure 27 is a flowchart illustrating a process 700 for manufacturing an echogenic shaft assembly according to one or more embodiments of the present disclosure. At block 702, the process 700 includes providing a medical device shaft having a substantially rigid tubular form. For example, the medical device shaft can include a stainless steel working lumen used in a medical procedure. The medical device shaft can be similar in certain respects to the shaft 110 described above with respect to Figure 2 .

[0187] At block 704, the process 700 includes sliding, wrapping, or otherwise disposing a helical wire around at least a portion of an outer surface of the medical device shaft. The helical wire can be a substantially solid wire, or can alternatively include a tubular wire having an internal lumen configured and / or designed to receive and / or hold a fluid, such as air, therein. In some embodiments, the wire is disposed around the medical device shaft in a manner that creates a spacing or gap between adjacent coils / turns of the wire. In some embodiments, substantially no spacing exists between adjacent coils / turns of the wire.

[0188] At block 706, the process 700 includes sliding, wrapping, or otherwise disposing a covering around the medical device shaft and helical wire. Advantageously, the covering can be substantially fluid-tight such that air or other fluid present between adjacent coils of the wire can be substantially captured therein, and additional fluid outside of the shaft assembly can not be permitted to enter within the covering. In some embodiments, disposing the covering around the shaft assembly can include laminating the medical device shaft and helical wire. For example, the covering can include a polymeric sleeve or tube that can be heat set to fit and / or adhere the covering to the helical wire and / or shaft. At block 708, the process 700 can include heat setting the covering to seal the fluid in the covering and / or wire gap / interval. At block 710, the process 700 includes incorporating the shaft assembly including the medical device shaft, wire, and covering into a tissue anchor delivery device or system, or other type of device or system for performing a medical or non-medical procedure.

[0189] Echoed recess / channel in medical device shaft

[0190] The examples disclosed above relate to helical and / or horizontal echoed fluid channels in a medical device shaft assembly, where the form of the fluid channel is the interval between adjacent coils within the lumen of a wire or tubular wire wrapped around a medical device shaft. Alternatively, the echoed fluid channel in a medical device shaft assembly can take the form of a recess that is cut or etched in a tubular shaft to form a channel / groove. For example, Figure 28 A perspective view showing a portion of a medical device shaft 610 and a channel / groove cutting die or tool 609 that is configured to cut an image enhancing helical groove / channel in the shaft 610. Figure 29 A portion of a medical device shaft is shown in axial view in accordance with one or more examples. Figure 28 A portion of a medical device shaft is shown in axial view in accordance with one or more examples.

[0191] In some examples, the die 609 can be operated by rotating the die 609 around the shaft 610, where the rotation relative to the shaft 610 causes a groove or channel to be cut in a helical manner on the outer surface of the shaft 610 having a desired depth and size. Figure 29A direct view of the shaft 610 is shown, which illustrates the depth d3 of the groove 613. In some examples, the depth d3 of the channel / groove is greater than or equal to half, even two-thirds, of the total thickness d4 of the wall of the shaft 610. The channel / groove is advantageously shallow enough to avoid piercing the wall of the shaft 610. Moreover, it can be desirable for the channel / groove to be shallow enough that the structure of the shaft 10 is not significantly weakened. That is, one potential drawback of achieving image enhancement by cutting a channel / groove in the wall of a medical device shaft is that doing so can disadvantageously weaken the mechanical strength / stability of the shaft. As shown, the image enhancement space 613 can be positioned generally adjacent to the working lumen 605.

[0192] Although Figure 28 While grooves / channels are shown that are cut using a die or other tool 609, the channels or grooves in the medical device shaft can be produced or formed in any suitable or desirable manner. For example, such grooves or channels can be molded in the shaft using metal or non-metal molding techniques. In some examples, the shaft can be 3D printed with the desired channels / grooves. Moreover, while helical grooves / channels are shown and described, it should be understood that such grooves / channels can have any shape or form, including intermittent coils or bands.

[0193] Figure 30 A side view of a medical device shaft assembly 615 having one or more image enhancement channels 613 formed in the shaft thereof according to one or more examples of the present disclosure is shown. For example, as shown, the channel(s) 613 can be formed on the exterior of the shaft 610. As shown, the shaft 610 can comprise a rigid elongate tube that forms at least one internal lumen. Figure 31A is Figure 30 is a close-up view of the distal portion of the medical device shaft of Figure 31B is a portion of a medical device shaft portion shown in Figure 31A is a cross-sectional view of a portion of the medical device shaft portion shown in. As shown, the channel(s) 613 can be helical around the exterior of the shaft 610 and can traverse the length of the shaft 610 in a helical configuration. When the channel(s) 613 helically span / across the length of the shaft 610, they can wrap / extend around the circumference of the shaft 610 in a number of winds / coils. In some examples, the channel(s) 610 are formed as one or more loops that encircle a longitudinal / axial segment of the shaft 610. Such loops can not be helical, but rather circular, such that a single loop does not axially traverse the shaft 610 beyond the channel(s) and / or the width of the channel(s).

[0194] While helical and other geometrically shaped channels, grooves, and / or recesses are disclosed according to certain examples disclosed herein to enhance echogenicity, such channels, grooves, and / or recesses can be irregularly shaped and / or non-geometrically shaped. For example, shaft assembly 615 can have channels, grooves, and / or recesses that are non-geometrically shaped and / or irregular or do not have a continuous pattern (e.g., discontinuous channels or indentations / recesses) that are configured to trap or hold fluid (e.g., air) and / or provide a non- smooth surface intended to increase echogenicity. Further, such channels, grooves, and / or recesses can be associated with any other type of device or assembly other than shaft 610 and assembly 615, including other types of medical device shafts or non-medical devices. In some examples, the channels, grooves, and / or recesses are knurled in shape / form or circumferential, longitudinal grooves or some other pattern of material removed from the shaft or other device.

[0195] In some examples, the outer side of shaft 610 (including grooves / channels 613) can have a shrink tube or other covering 619 disposed or wrapped thereon such that air or other fluid or contrast agent is trapped and / or disposed within grooves / channels 613 between the walls of the grooves / channels and covering 619. Grooves / channels 613 can extend in a generally helical manner around the circumference of shaft 610. Figure 30 、 Figure 31A and Figure 31B Shaft assembly 315 of FIG. 1 can incorporate an image enhancement feature by maintaining echogenic fluid (e.g., air) within grooves / channels 613, which can be visible by echogenic imaging. Outer covering 619 can include a polymeric tube that can be slid or otherwise positioned or disposed over shaft 610. In some implementations, heat can be used to shrink and / or adhere covering 619 to the outer side of shaft 610 to provide a laminate thereof. Such a process can cause air or other fluid to become trapped within grooves / channels 613. By using channels / grooves in the medical device shaft 610 itself, as opposed to a helical wire disposed thereon, examples according to Figure 28-3 1 advantageously provide image enhancement functionality without the need for additional assembly components and / or without the need to increase the outer diameter or size of the medical device shaft.

[0196] Medical device shafts containing echogenic contrast agent

[0197] In some examples, the present disclosure relates to multi-lumen medical device shafts that are configured to have echogenic contrast agent injected therein. For example, echogenic microbubbles or other contrast agent can be injected and / or ejected at or near the tip of the medical device shaft, which can allow for the tip of the shaft to be identified by marker at different points in time. Such contrast agent can be injected and / or flowed or maintained within a lumen similar to the lumens disclosed herein, or alternatively can be used in a balloon-type lumen as described in detail below.

[0198] In some examples, the contrast agent can include microbubbles, which can be filled with a gas core and / or have a protein shell. Such microbubbles can advantageously be highly reflective of sound waves and return sound waves from an echo (e.g., ultrasound) probe to produce a highly reflective image. In certain examples, the microbubbles of the contrast agent can be substantially non-harmful when introduced into the cardiovascular system, thus allowing for the flow of the tissue anchor delivery device shaft from the tissue anchor into the heart and cardiovascular system during a valve repair procedure.

[0199] As described in detail herein, the echogenicity of a tissue anchor delivery device shaft can be increased by adding gas-filled microbubble contrast agent within one or more lumens or chambers of the shaft, thus providing contrast-enhanced visibility of the shaft. Due to the characteristic echogenicity of microbubbles to compress, oscillate, and reflect ultrasound frequencies, microbubbles can provide a relatively high degree of echogenicity, thus providing an enhanced sonographic image of the composition containing such contrast agent. The contrast agent according to examples of the present disclosure can include air and / or a heavy gas, such as perfluorocarbons or nitrogen gas, or the like. For example, a relatively heavy gas can be less soluble in water than air, thus can be less likely to leak from the microbubbles to compromise echogenicity. Thus, in some implementations, microbubbles with a heavy gas core can be preferred.

[0200] In addition to the use of contrast agent within a valve repair shaft, according to examples of the present disclosure, the echogenicity of such a shaft can be increased by using the inner or outer surface of the shaft with certain echogenic properties. For example, the outer surface of a shaft according to examples of the present disclosure can have certain texturing, roughening, and / or particle adhesion properties to provide a relatively high echogenic surface of the shaft to improve its visibility under echogenic imaging. Further, the surface and components of an anchor delivery device shaft according to examples of the present disclosure can present an interface between materials of different densities, such as between a stainless steel or other metal or hard surface of the shaft and an air or other gas or medium disposed adjacent to or contained therewith.

[0201] In some examples, mobile lipid-coated echogenic microbubbles are incorporated into the shaft of the device in some manner. For certain medical procedures, a clinician can use an ultrasound contrast agent consisting of lipid-coated echogenic microbubbles filled with octafluoropropane gas to assist in viewing, for example, the left ventricle during a diagnostic procedure. In some implementations, such echogenic microbubble media can be used to assist in echogenic navigation of the device by expelling them out of an inner lumen of the device to position a distal tip, or by injecting them into a balloon at least partially surrounding the shaft of the device.

[0202] With respect to tissue anchor delivery devices according to examples of the present disclosure, in some implementations, by injecting echogenic microbubbles through an inner lumen of the delivery device shaft and from a non-invasive tip or side port, a surgeon and / or echocardiographer can quickly locate a distal tip or portion of the shaft. For example, when the shaft of the anchor delivery device is draped / coated over a target leaflet, as described above, it can in some cases become difficult to distinguish the distal tip of the shaft from the leaflet tissue. Examples of the present disclosure can include sparging echogenic microbubbles from a tissue anchor device shaft prior / during deployment of a tissue anchor therefrom to facilitate relatively easy location of the tip of the shaft based at least in part on contrast in the resulting echogenic signature.

[0203] In some implementations, the present disclosure is directed to medical device shafts having balloon-type materials or structures laminated or otherwise coupled to an outer side of the device shaft, where echogenic contrast agent can be flushed into and out of the balloon to agitate the contrast agent (e.g., microbubbles of the contrast agent) and produce a brightened echogenic signature. This brightened echogenic signature can aid in navigation of the delivery device shaft by making it easier to distinguish from surrounding blood and / or anatomical structures. During insertion and removal of balloon-type echogenic shafts according to the present disclosure, the balloon(s) feature(s) can be compressed to provide a relatively smaller shaft-outer profile for insertion / withdrawal and / or navigation of the shaft.

[0204] Examples disclosed herein can use any suitable or desired echogenic contrast agent. For example, microbubble contrast agents can be desired in some cases. Contrast agents according to examples of the present disclosure can include saline, indocyanine green, hydrogen peroxide, dextrose, renin, autologous blood infusate, cyanoacrylate, and / or one or more other synthetic polymers. Generally, contrast agents according to examples of the present disclosure can advantageously provide a change in acoustic reflection pattern. For example, such contrast agents can increase the backscatter signal. Further, the contrast agent can cause acoustic resonance in a relatively linear manner.

[0205] In some implementations, the contrast agent can include an internal gas encapsulated by a shell that promotes the desired viscoelasticity, including stability and durability. The type of gas used in microbubble contrast agents can at least partially determine the solubility and / or acoustic properties of the gas bubbles. Microbubbles such as perfluorocarbon microbubbles can have a size in the range of about 1-10 pm, which can be suitable for propagation in the systemic circulation. Soft-shell microbubble examples can include phospholipids or other surfactants, while protein shell microbubble examples can include an albumin shell around perfluoropropane gas. Although microbubble contrast agents are described herein, it should be understood that examples disclosed herein can utilize nanobubble contrast agents, which generally can refer to contrast agents that include gas bubbles with a size between 400-800 nm.

[0206] In some embodiments, the acoustic wave reflections associated with the contrast agent and the delivery device shaft can provide improved echogenicity through the use of flow or movement of the contrast agent. That is, for microbubble contrast agents, the reflections of the microbubbles can be enhanced through fluid motion, causing the image to appear brighter in the reverberation. Figure 32 A perspective view of a multi-lumen shaft assembly 915 having one or more non-working lumens 902, 904 is provided, which can be used for injection and propagation / flow of a high-contrast fluid 909. For example, the shaft assembly 915 and / or shaft 910 includes lumens 902, 904 that are not closed at their distal ends, such that fluid contained therein can be allowed and / or inclined to spill out of the shaft assembly 915 at or near their distal ends, particularly under relatively high fluid pressure conditions. As shown, the shaft 910 can include a rigid elongate tube forming at least one internal lumen.

[0207] In some examples, the shaft assembly 915 includes a port 918, such as a side port, which can be used to inject a contrast fluid 909, such as a microbubble fluid, which in turn can be ejected from the shaft assembly 915 at or near its distal end. By ejecting the fluid 909 from the shaft 915, the tip or distal portion of the shaft assembly 915 can be more easily visualized and / or identified. The fluid injection port 918 can be considered to be fluidically coupled or in fluid communication with the first image enhancing lumen, as fluid can flow between the port 918 and the lumen(s) 902, 904.

[0208] By containing the fluid 909 within the shaft 910, a contrast image between the shaft 910 and the surrounding blood in the heart chamber and / or other tissue / anatomy can be apparent. For example, under certain echogenic imaging modalities, the fluid-containing lumens 902, 904 can appear significantly brighter than the surrounding environment. Although Figure 32 The shaft assembly 915 is shown allowing ejection of the contrast fluid 909 from the distal tip of the shaft assembly 915 as described above, but in some examples, the contrast agent can be contained within one or more closed (e.g., fluid-tight) lumens.

[0209] Figure 33 is a portion of a multi-lumen medical device shaft assembly 915 as shown in Figure 32 is a portion of a multi-lumen medical device shaft assembly 915 as shown in Figure 33An internal working lumen 905 is shown, which can be surrounded by one or more image-enhancing lumens or lumen portions 902, 904, which can include contrast fluid 909. The lumen portions 902, 904 can be separate regions of a single circumferential lumen. In some embodiments, the contrast fluid 909 can be introduced into the lumen(s) 902, 904 through an injection port 918. Although the lumens 902, 904 can be separated by one or more structures or components, such as the partition wall 906 shown in FIG. 9B, in some examples, the lumen(s) 902, 904 are in fluid communication at one or more portions or regions of the shaft assembly 915. Injection and / or passage of contrast fluid 909 (e.g., microbubble contrast fluid or other ultrasound contrast agent / media) through the shaft assembly 915 can advantageously facilitate navigation of the shaft assembly 915 under echogenic guidance. Figure 32

[0210] In contrast to certain other imaging solutions that incorporate and rely solely on relatively dense materials (such as stainless steel) to produce echogenic characteristics that form a sufficient contrast with ambient blood and surrounding anatomy, the image-enhancing principles disclosed herein can provide relatively higher echogenic properties by using materials that have a significantly different density than blood or tissue, thereby manipulating how sound attenuates through the material and produces desirable opposing echogenic characteristics. For embodiments that utilize microbubbles, the relatively heavy gas molecules that can be used / captured within such echogenic microbubbles can provide a greater difference in density compared to blood and tissue than some more dense materials (such as stainless steel). Moreover, when such microbubbles are captured in an ultrasonic frequency field, they will tend to compress and oscillate to produce a brighter echogenic characteristic. Echogenic image brightness can be further supplemented by expelling microbubbles from the shaft / device or by flushing through a balloon surrounding the device, as described in detail below. Furthermore, the microbubble contrast fluid disclosed herein is generally advantageously safe for use in certain medical procedures. Although the term "shaft assembly" is used herein to refer to a medical device that includes a shaft associated with one or more additional features or components, it should be understood that such an assembly can be referred to simply as a "shaft" rather than a shaft assembly. That is, references to a "shaft" herein, according to its broad and ordinary meaning, are used herein and should be understood to apply to a shaft component alone or to a shaft assembly that contains or is associated with one or more additional features or components as described herein. Accordingly, use of the term "shaft" can refer to a shaft assembly herein.

[0211] Figure 34 ​is a cross-sectional side view of a medical device shaft assembly 3415 having one or more image-enhancing balloon features 3450 according to one or more embodiments. The shaft assembly 3415 can further include one or more side ports 3452 to inject contrast media 3409 into the balloon feature(s) 3450. In some implementations, the balloon feature(s) 3450 can include a tube or other form implemented on the working lumen 3405 and / or shaft 3410. As shown, the shaft 3410 can include a rigid elongate tube forming at least one internal lumen. In some implementations, the contrast media fluid 3409 can be injected into the balloon feature(s) 3450 from a proximal / region of the shaft assembly 3415 and can flow at least a portion of the length of the shaft 3410 to at least partially fill the balloon feature(s) 3450. In some procedures / implementations, the contrast media fluid 3409 can be continuously injected from the balloon feature(s) 3410, such as from one or more ports 3452 associated with a distal portion of the shaft assembly 3415. As shown, the image-enhancing lumen(s) can be generally positioned proximate to the working lumen 3405.

[0212] Compared to embodiments incorporating rigid image-enhancing lumens, incorporating balloon-type image-enhancing features in a medical device shaft can be advantageously expandable and / or collapsible in certain aspects. Moreover, the flexibility of certain balloon-type image-enhancing features can allow air bubbles in the contrast media fluid to move relatively freely within the balloon(s), without the obstruction that can exist with thicker and / or harder fluid channels, thereby providing improved visibility under echos. In some embodiments, the balloon feature(s) 3450 have a wall thickness of about 70-100 pm (about 0.003 to 0.004 inches). In some implementations, the balloon feature(s) 3450 can allow the shaft assembly 3415 to be inserted into an anatomical chamber in a deflated state, thereby providing a relatively low profile for the shaft assembly 3415. After the shaft 3415 has been inserted into a patient, the balloon feature(s) 3450 can subsequently be at least partially inflated. Thus, embodiments of the present disclosure can advantageously allow a device to provide additional image-enhancing fluid volume when necessary, without having to adjust such volume during device introduction.

[0213] Figure 35 shows a perspective view of a medical device shaft assembly 3515 having one or more image-enhancing balloon features 3550 according to one or more embodiments. Figure 36 is a close-up view of a distal portion of a medical device shaft according to one or more embodiments. Figure 35 is a close-up view of a distal portion of a medical device shaft according to one or more embodiments. Figure 36A balloon-type lumen 3502 can be introduced through the injection port 3555. Injection and / or passage of a contrast fluid 3509 (e.g., a microbubble contrast fluid or other ultrasound contrast agent / medium) through the lumen 3502 can advantageously facilitate navigation of the shaft assembly 3515 under echogenic guidance. The fluid injection port 3555 can be considered to be fluidically coupled or in fluid communication with the first image-enhancing lumen, as fluid can flow between the port 3555 and the lumen(s) 3502.

[0214] The shaft assembly 3515 can further include one or more side ports 3552 to eject the contrast agent 3509 contained in the balloon feature(s) 3550. In some embodiments, the balloon feature(s) 3550 can include a tube or other form implemented on the working lumen 3505 and / or the shaft 3510. In some embodiments, the contrast fluid 3509 can be injected into the balloon feature(s) 3550 from a proximal / region of the shaft assembly 3515 and / or the working lumen 3505 and can flow at least a portion of the length of the shaft 3510 to at least partially fill the balloon feature(s) 3550. In some embodiments, the contrast fluid 3509 can be continuously ejected from the balloon feature(s) 3510, such as from one or more ports 3552 associated with a distal portion of the shaft assembly 3515.

[0215] Figure 37 is a flowchart of a process 3700 of aiming at a leaflet using a multi-lumen / multi-chamber medical device shaft containing echogenic contrast agent, in accordance with one or more embodiments. At block 3702, the process 3700 involves placing an introducer into a target chamber of a patient’s heart (e.g., a left ventricle) or other chamber or vessel. At block 3704, the process 3700 includes advancing a medical device shaft through the introducer into the target chamber, as described in detail herein. At block 3706, the process 3700 includes injecting an echogenic contrast fluid into one or more chambers or lumens associated with the medical device shaft. For example, such chamber(s) / lumen(s) can be substantially rigid lumens / chambers or can be inflatable balloon-type chamber(s) / lumen(s).

[0216] At block 3708, the process 3700 can optionally include expelling or ejecting contrast fluid from the chamber(s) / lumen(s) within the target heart chamber, such as through one or more expelling ports associated with the medical device shaft. At block 3708, the process 3700 includes generating echo imaging of the medical device shaft and / or the fluid-containing chamber(s) / lumen(s) associated therewith, where such imaging can provide guidance for the medical procedure. At block 3710, the process 3700 includes advancing the shaft to the target tissue anchor deployment site, such as a target valve leaflet, while visualizing the shaft under echo.

[0217] Echo-guided wire

[0218] As described in detail herein, navigating a medical device shaft under echo guidance can be challenging in some cases and can require relatively extensive training and / or coordination between the surgeon and the electrocardiogram technician. In many cases, the echo characteristics of the medical device are not optimal, for example, due to various functional design requirements of the device. In particular, with respect to tissue anchor delivery device shafts, as disclosed herein, the visibility of the tip of such a device under echo can be reduced when contacting the target tissue (e.g., mitral valve leaflet tissue). Moreover, the lack of visibility can result in tissue damage and / or entanglement with adjacent anatomy when attempting to advance the medical device shaft within the target heart chamber. Furthermore, according to some embodiments, the navigation of the medical device shaft can have to be repeated for the implantation of a subsequently deployed tissue anchor or other type of device.

[0219] In some embodiments, the present disclosure relates to a medical device shaft associated with a guide wire (e.g., a guidewire) along which the shaft can be deployed, which is relatively more visible than the shaft alone. In some embodiments, similar to certain features disclosed above, the guide wire can include a relatively small hollow tube having fluid, such as air, disposed in the lumen thereof.

[0220] Figure 38 A tissue anchor delivery device shaft 3810 and introducer 3830 including a guide wire port 3870 are shown in accordance with one or more embodiments. Figure 39 A cross-sectional view of the introducer shown in FIG. 38B is shown in accordance with one or more embodiments. Figure 38 The guide wire 3870 can advantageously be relatively echogenic as compared to the shaft 3810 and / or tip 3814. Thus, pre-deployment of the guide wire 3870 to the target tissue anchor deployment site can advantageously create a relatively highly visible path under echo from the introducer lumen 3832 to the target site. For example, the guide wire 3870 can include a solid echogenic wire / rod and provide a rail-type system for guiding the shaft 3810 to the target anatomy / location.

[0221] The introducer 3830 is a multi-port introducer including a port 3853 for insertion of the shaft 3810 and an additional port 3835 for insertion and advancement of a guide wire 3870. Use of a guide wire port and echogenic guide wire can facilitate providing simplified navigation of the device under echogenic guidance. In some embodiments, the guide wire 3870 is atraumatic and highly visible under echogenicity. For example, the guide wire 3870 can have a J-tip form 3875 at its distal end, or any other feature that reduces the risk of tissue damage by the guide wire. The guide wire port can be oriented at a deflection angle relative to the lumen 3832 of the introducer 3830. The dual port of the introducer 3830 can allow the echogenic guide wire 3870 and the shaft 3810 to be inserted into the same site. Further, the dual port can be used to align the guide wire 3870 and the shaft 3810 so that the shaft 3810 extends immediately adjacent to and parallel to the guide wire. The introducer 3830 can advantageously be a hemostatic introducer.

[0222] Figure 40 is a flowchart illustrating a process of advancing a medical device shaft using a guide wire in accordance with one or more embodiments. At block 4002, the process 4000 includes placing a multi-port introducer, such as a hemostatic introducer described herein, in the heart to provide access via one or more lumens thereof into, for example, a target ventricle or other chamber / vessel of the heart. The introducer advantageously includes a primary port configured to have a medical device shaft inserted therethrough, and a secondary port configured to have a guide wire (e.g., guide wire) inserted therethrough. In some implementations, the introducer is inserted through a small incision in the chest at or near the apex of the heart.

[0223] At block 4004, the process 4000 includes advancing an echogenic guide wire into the target ventricle via the secondary port of the introducer and / or one or more lumens or other valved access ports of the introducer. At block 4006, the process 4000 includes advancing a tip of the echogenic guide wire to a target location, such as on the ventricular side of a target heart valve leaflet (e.g., mitral valve leaflet), while visualizing the echogenic guide wire under echogenic imaging. The echogenic guide wire can be advanced to the target location in any suitable or desired manner.

[0224] At block 4008, the process 4000 includes advancing a medical device shaft through the primary port of the introducer and / or one or more lumens of the introducer into the target ventricle, and further advancing the shaft to the target location alongside the echogenic guide wire. The medical device shaft can generally follow the guide wire to the correct target location. It can be beneficial to advance the guide wire prior to advancing the medical device shaft to avoid obscuring / obviating the echogenicity of the guide wire by the medical device shaft. At block 4010, the process 4000 includes deploying a tissue anchor in the target valve leaflet or other target anatomical structure using the medical device shaft.

[0225] At box 4012, process 4000 includes withdrawing the medical device shaft from the heart via an infeeder. The guide wire can also be removed after tissue anchor deployment, or left in an appropriate location at or near the target implantation site if additional tissue anchors are subsequently deployed, allowing for reuse of the guide wire to guide the shaft to the target implantation site. As shown, in the case of deploying one or more additional anchors, process 4000 can loop back to box 4008. Therefore, process 4000 can allow the placement / deployment of multiple tissue anchors without requiring additional echo navigation.

[0226] In some cases, using the guide system disclosed herein without attaching or coupling the guide wire to the shaft in a certain way may lead to confusion of the moving parts due to the thin structure of the guide wire and / or the pulsating flow of a beating heart. In some embodiments, a port or engagement feature may be integrated with the medical device shaft, such as in its non-invasive tip, to help guide the medical device shaft along the guide wire. Figure 41 This diagram shows a perspective view of the distal portion of a medical device shaft 4110, including a guide wire engagement feature 4116, according to one or more embodiments. Typically, the tip of the guide wire is non-invasive to avoid damage to the target tissue (e.g., lobular tissue) it contacts. For example, the guide wire 4170 may have a J-shaped tip form 4175 as shown, or it may have any other feature that prevents tissue damage, such as a ball or other circular feature. Before the shaft 4110 is inserted into the target ventricle, the tip 4114 of the shaft 4110 can be engaged with the guide wire via the engagement feature 4116, eliminating the need for a separate inserter port to introduce the guide wire.

[0227] Compared to some echo enhancement devices, Figure 41 The components of these devices can provide relatively clearer echo signatures, and due to their additional design requirements, these devices are typically not fully optimized. For example, echo guide wires can have highly / fully optimized echo profiles. Furthermore, due to the non-invasive nature of the guide wire, it can be easily navigated within the heart chambers without concern for tissue damage.

[0228] Engagement feature 4116 facilitates the attachment of guide wire 4170 to the tip 4114 of shaft 4110 to improve echo visibility and facilitate guidance to the target implantation site (e.g., mitral valve). The tip 4114 of shaft 4110 may comprise a flexible plastic form (also referred to herein as an "end effector") that is generally circular in shape and allows for non-invasive protrusion of shaft 4110 on the target valve leaflet. Engagement feature 4116 may include a relatively small aperture or port to allow insertion of guide wire 4170, which may serve as a guide system for shaft 4110 during guidance from the implantation site to the ventricular side of the target valve leaflet.

[0229] In some embodiments, the guide wire 4170 can be inserted and removed independently of the delivery device shaft 4110. Once the hemostatic introducer is placed in the heart, the guide wire 4170 can be inserted through the introducer into the target ventricle. In some implementations, the guide wire 4170 can be engaged with the engagement feature 4114 and inserted into engagement with the engagement feature 4116. The shaft 4110 can use the echogenic guide wire as a rail system through the introducer into the target ventricle to navigate up to the target leaflet. In some implementations, the guide wire 4170 can be removed prior to tissue anchor deployment.

[0230] Attaching the guide wire 4170 to the shaft tip 4114 can facilitate relatively precise imaging of the shaft 4110 for the entire guidance from the insertion site to the target leaflet. Moreover, after confirming that the shaft tip 4114 is positioned on the target leaflet, the guide wire 4170 can be removed to allow for normal deployment of the tissue anchor. With the guide wire 4170 actually attached to the tip 4114 during navigation, Figure 41 The device of FIG. 41 can allow for relatively faster procedure times and more accurate deployment. Moreover, attaching the guide wire 4170 to the shaft 4110 can stabilize the guide wire 4170 and / or cause the guide wire 4170 to deflect less in the ventricle, as well as tighter alignment between the guide wire 4170 and the shaft 4110.

[0231] Although the engagement feature 4116 is shown as a circular hole, it should be understood that the engagement feature can have any suitable or desired shape or form. In some embodiments, the engagement feature allows for disengagement of the guide wire 4170 within the ventricle. For example, the engagement feature can have a hook-type form with a radial disengagement path through which the guide wire can be pulled radially out of the engagement feature 4114 relative to the axis of the shaft 4110.

[0232] Using a removable, atraumatic guide wire rail system as disclosed herein can provide a relatively simple solution to improve echogenic guidance while maintaining the integrity of certain tissue anchor delivery devices. Attaching the guide wire to the shaft can also facilitate the guide wire maintaining parallel alignment with the shaft. Although Figure 41 Although the engagement feature 4116 of FIG. 41 is shown as being integrated with the tip portion 4114, it should be understood that the engagement feature can be coupled to or otherwise associated with any portion of the shaft 4110. Moreover, in some embodiments, more than one engagement feature can be used.

[0233] Echogenic enhanced end effector and shaft

[0234] Figure 42AA side view of a medical device 4200 according to one or more embodiments of the present disclosure is provided. The medical device 4200 includes a rigid elongated shaft 4210 and an end effector 4214 associated with a distal portion of the shaft 4210. Figure 42B One or more embodiments according to this disclosure are provided. Figure 42A The end effector 4214 of the illustrated medical device 4200 includes an end view of its distal side / surface 4216. As described above, the medical device 4200 can be a cardiac valve repair device for delivering / deploying suture anchors and / or the like. However, it should be understood that the principles disclosed herein regarding the enhanced echo characteristics of medical devices and / or their components are applicable to any type of medical device.

[0235] In some embodiments, the end effector 4214 may include a generally circular tip having a diameter of, for example, about 1 / 4 inch. In some embodiments, the shaft 4210 comprises an elongated tubular form of stainless steel. The shaft 4210 may have an outer diameter of, for example, about 2 mm (about 0.083 inches) and / or an inner diameter of about 1.6 mm (about 0.063 inches). In some embodiments, the shaft 4210 is coated with urethane or other (e.g., polymer) materials, which may be advantageously designed to enhance the echo of the shaft 4210 at least in part based on the density interface between the shaft and the coating.

[0236] In some embodiments, shaft 4210 and / or end effector 4214 may include a material to which certain echo additives have been added. For example, the form of shaft 4210 and / or end effector 4214 and / or coatings / covers applied thereto may include embedded particles and / or cavitation, which can create a non-uniform coating / surface that increases the reflectivity of the material, thereby increasing echogenicity. Typically, end effectors and / or shaft covers according to embodiments of this disclosure may exhibit discontinuities in material density, such as between flexible forms / materials of the end effector and / or shaft covers (e.g., thermoplastic rubber or the like) and certain additives associated therewith, such as between inflated and / or hollow glass spheres (e.g., inflated microspheres), metal microparticles, or any other embodiments disclosed herein.

[0237] Compared to stainless steel shafts with homogeneous / uniform thermoplastic rubber end effectors, shaft 4210 and / or end effector 4214 may have features or characteristics that provide relatively high echo characteristics for such components. Regarding Figure 42A and Figure 42BThe graphs show the relative high-echo characteristics of shaft 4210 and / or end effector 4214, represented by corresponding fill patterns showing the fill patterns of shaft 4210 and end effector 4214, respectively. Although essentially the entire shaft 4210 and end effector 4214 are shown with high-echo fill patterns, it should be understood that in some embodiments, these components / parts of the medical device 4200 may have high-echo characteristics associated only with that portion. Furthermore, while different high-echo fill patterns are shown for shaft 4210 and end effector 4214, it should be understood that in some embodiments, similar echo characteristics / features may be implemented with respect to shaft 4210 and end effector 4214. In some embodiments, high-echo characteristics may be implemented in combination with shaft 4210 or end effector 4214, but not with both.

[0238] The description herein concerning axes with enhanced echo characteristics may apply to other types of devices, including flexible catheters, sheaths, and / or other tubular and / or lumen-forming devices. Therefore, it should be understood that the various embodiments disclosed herein are applicable to any type of medical device that may require enhanced echo characteristics. Furthermore, as with other embodiments disclosed herein, the following description of axes and / or end effectors with echo-enhancing characteristics applies to non-medical axes and end effectors. Regarding end effector 4214, high echo characteristics may be implemented with respect to its distal surface 4216, lateral surface 4218, and / or any other region (e.g., the region beneath one or more surfaces of end effector 4214).

[0239] In some embodiments, the medical device / instrument shaft includes a tubular form comprising stainless steel or other at least partially rigid materials. In some embodiments disclosed herein, an echo overlay or coating may be applied / applied to at least a portion of the medical device shaft to provide enhanced echo characteristics of the shaft. For example, further reference... Figure 42A Thermoplastic elastomers / rubbers (e.g., polyether block amides (e.g., Elastomer) or other compounds (e.g., Fluorinated Ethylene Propylene (FEP)) can be extruded in a tubular form and disposed about the shaft 4210, where heat shrink can be implemented to secure and / or bond the tube to the shaft 4210. In instances where the covering / coating applied to the shaft 4210 has different density properties than the shaft 4210, or where the material of the coating / covering includes certain echogenicity enhancing additives and / or other echogenic materials or surface properties as described below with respect to various embodiments of the present disclosure, the echogenicity of the shaft 4210 can be at least partially enhanced by the application / disposition of the coating / covering to / on the shaft 4210. It will be appreciated that any of the echogenicity enhancing materials and / or features disclosed herein can be applied to the shaft or end effector in any suitable or desired manner, including through the use of thermoformed tubes and / or other material application process(es). In some implementations, the echogenicity enhancing materials are overmolded on the shaft and / or end effector. The end effector can also be formed by overmolding on the shaft.

[0240] In some embodiments, the end effector 4214 is initially formed as part of an extrusion for covering at least a portion of the shaft 4210, where the illustrated shape of the end effector can be die cut from a distal portion of the extrusion. In some embodiments, the end effector 4214 includes a thermoplastic rubber (e.g., Elastomer). For any of the embodiments disclosed herein, the shaft coating / covering can be based on certain medical grade polyurethanes and / or similar materials, which can be formed using, for example, a blowing agent or similar. In some implementations, such coatings / coverings can become reactive in relatively wet tissue environments. Examples of materials that can be used for end effector and / or shaft coverings / coatings in accordance with embodiments of the present disclosure include various types of urethane (e.g., ReoFlex 2000® by Bentley Advanced Materials of Kidderminster, United Kingdom), TM 20urethane), Elastomer, silicone, silica aerogel, expanded polytetrafluoroethylene (ePTFE), metal (e.g., a grommet or wire), or similar.

[0241] Medical device shafts for use in, for example, heart valve repair procedures are often more visible at certain angles than others. Embodiments of the present disclosure can advantageously increase the range of angles at which a medical device shaft and / or end effector is visible, such as within a chamber of a patient’s heart. Some embodiments of the present disclosure relate to medical device shafts that can be visible under echo within a chamber of a patient’s heart. In some embodiments, such devices can be particularly visible under echo between about 40° and 80° relative to the x-plane axis in a bicommissural view. Medical device shafts and / or end effectors associated with embodiments of the present disclosure can be particularly visible and / or particularly suitable for viewing in connection with certain valve repair procedures from a variety of views described below with respect to Figure 43 、 Figure 44A 、 Figure 44B 、 Figure 45A and Figure 45B .

[0242] High echo shafts and end effectors disclosed herein can be highly visible under echo imaging and can advantageously remain visible over a range of viewing angles between 0° and 90° relative to the x-plane axis / line, which can cover the range of angles that can be expected and / or relevant to certain valve repair procedures described herein. Such embodiments can provide a significant increase in visibility as compared to other solutions in which a shaft and / or end effector can only be visible from angles of about 0° to 63° or less. Visibility over a relatively wider range of angles can be achieved through increased scatter provided by discontinuities and material densities associated with the end effector and / or shaft.

[0243] Figure 43 Cross-sectional views of certain heart anatomy are provided in accordance with one or more embodiments of the present disclosure. In particular, Figure 43 the cross-sectional views provided in FIGS. 1-3 illustrate axial cross-sectional views of a heart 1 showing the valves of the heart, i.e., the mitral valve 6, the tricuspid valve 8, the aortic valve 7, and the pulmonary valve 9. When viewing a heart using echo imaging, such as can be implemented in connection with certain valve repair procedures described herein, it can be necessary to generate echo images between about 40° and 80° relative to the x-plane access / line to provide a bicommissural view, and / or 135° or about 135° to provide a long axis view. One or both of the bicommissural view and the long axis view can advantageously provide a suitable viewing configuration to visualize a medical instrument shaft and / or associated end effector for a mitral valve repair procedure. Accordingly, the medical instrument shafts and / or end effectors described below with respect to Figure 44A / Figure 44B and Figure 45A / Figure 45B may be suitable for and / or relevant to mitral valve repair. However, it should be understood that the echo concepts disclosed herein are applicable to medical instruments used in connection with any suitable or desired medical procedure.

[0244] Figure 44A and Figure 44B One or more embodiments according to this disclosure are shown respectively. Figure 43 The image shows a double-jointed cross-section and echo imaging view of the cardiac anatomy. Figure 44A and Figure 44B The double-panel view can advantageously be between 40° and 80°, which can provide a view of the cardiac anatomy essentially in plane. For example, the double-panel view can advantageously keep the left heart and axis 4420 in the field of view.

[0245] Figure 44A The cross-sectional anatomical view shows the left ventricle 3 of the heart 1, and the mitral valve 6, which provides an interface between the left ventricle 3 and the upper left atrium 2. Figure 44A The double-jointed view further shows one or more papillary muscles 15, and associated chordae tendineae 16, which physically couple the papillary muscles 15 to one or more leaflets of the mitral valve 6. Figure 44A The view shows an inlet device 4405 that provides a channel through which the shaft 4420 of the medical device can enter the left ventricle 3.

[0246] exist Figure 44A In the image, the distal portion of shaft 4420 may have an end effector associated with its distal apex, shown as extending into ventricle 3. In some procedures, shaft 4420 may be advanced into one or more leaflets of valve 6 to perform a repair procedure with respect to mitral valve 6.

[0247] Figure 44B Showing the corresponding Figure 44A The echo window of the cross-sectional view shown in image 4400. It is evident from image 4400 that the visibility of relevant anatomical structures (e.g., one or more chambers of heart 1) may be somewhat blurred and / or relatively difficult to interpret compared to a photographic image / representation or the like. Furthermore, the visibility of axis 4420 may be important and / or necessary for the effective performance of relevant medical procedures (e.g., valve repair procedures). For example, as shown in image 4400, the representation of axis 4420 in diagram 4422 may generally be relatively difficult to identify and / or determine, especially in the presence of certain image artifacts (not shown) that may occur when using an echo imaging modality.

[0248] Figure 45A and Figure 45B One or more embodiments according to this disclosure are shown respectively. Figure 43 The image shows a long-axis cross-section and echo imaging view of the cardiac anatomy. The long-axis view provides a valid side view for observing the valve leaflets 52 and 54, and can provide a view similar to... Figure 44A and Figure 44BThe double-ended views shown are views that are up to 90° apart. Where the distal end of the end effector and / or shaft 4520 is visible in the double-ended view, it can also be roughly visible in the long-axis view. Typically, some artifact representation of the shaft may occur along the echo probe (not shown; see [link to image]). Figure 10A Aligned centerlines appear. In some embodiments, the echo enhancement features of this disclosure can improve the ability of an echo technician to distinguish a true representation of the axis and / or end effector relative to one or more existing artifacts.

[0249] Figure 45A The cross-sectional long-axis anatomical view shows the left ventricle 3 of the heart 1, as well as the mitral valve 6 and the aortic valve 7, which can enter from the left ventricle 3. Figure 45A The long axis view further shows the papillary muscle 15 and the associated chordae tendineae 16. Figure 45A The view further shows the infeeder device 4505, through which the axis 4520 of the medical device is advanced to enter the left ventricle 3. Figure 45A In the image, the distal portion of shaft 4520 may have an end effector associated with its apex, and the distal portion of shaft 4520 is shown extending into ventricle 3. In some procedures, shaft 4520 may be advanced into one or more leaflets of valve 6 to perform a repair procedure on mitral valve 6.

[0250] Figure 45B Showing the corresponding Figure 45A The long axis view shown is the echo imaging window 4500. As can be clearly seen from image 4500, the visibility of relevant anatomical structures (e.g., one or more chambers of heart 1) may be somewhat obscured and / or relatively difficult to interpret compared to photographic images / representations or the like. Furthermore, the visibility of axis 4420 may be important and / or necessary for the effective performance of relevant medical procedures (e.g., valve repair procedures). For example, as shown in image 4500, when the axis comprises stainless steel that does not have the echo enhancement features described in detail herein, the representation diagram 4522 of axis 4520 is generally relatively difficult to identify and / or determine, especially in the presence of certain image artifacts (not shown) that may be related to the echo imaging modality.

[0251] Figure 46 Side, perspective, and end views of a shaft 4620 and an end effector 4614 of a medical device according to one or more embodiments of the present disclosure are shown, the shaft 4620 and the end effector 4614 having an echo coating 4616 applied thereon. In some embodiments, the coating 4616 may comprise a urethane compound or the like. In some embodiments, the compound for the coating 4616 comprises echo microbubbles / microspheres, as described in more detail below.

[0252] Coating 4616 can be applied in conjunction with any step or portion of the manufacturing process associated with shaft 4620 and / or end effector 4614. In some embodiments, shaft 4620 and / or end effector 4614 can be immersed in at least partially fluid (e.g., liquid) material that is configured to at least partially adhere to the surface of shaft 4620 and / or end effector 4614 such that coating 4616 can substantially cover one or more surface portions thereof. In some embodiments, coating 4616 can be configured to harden over time and / or in response to exposure to certain temperatures and / or environmental conditions; coating 4616 can be subjected to such conditions for purposes of producing a desired hardening or other chemical / material change. In some embodiments, the illustrated "coating" 4616 can not actually be a coating, but can be molded, extruded, or otherwise formed.

[0253] Coating 4616 can have any suitable or desired echogenic properties and / or characteristics. For example, coating 4616 can have any of the characteristics disclosed herein with respect to any other embodiment of the present disclosure. In some embodiments, coating 4616 can include and / or have associated therewith certain echogenic particles, microspheres, bubbles, surfaces, and / or other materials or features that cause echogenic scattering and / or are more visible under echography than stainless steel or thermoplastic rubber alone. Various materials used in conjunction with embodiments of the present disclosure to provide echogenic coverings for shafts and / or end effectors can include echogenic polymer materials, including, for example, ePTFE, compliant polymeric foams, porous fluoropolymers, polyethylene terephthalate (PET), polyurethane, polyether block amide (e.g., PEBAX®), and / or composites thereof. Elastomers).

[0254] Figure 47 A side view, perspective view, and end view of a shaft 4720 of a medical instrument having a relatively echogenic sleeve 4740 disposed thereon is shown in accordance with one or more embodiments of the present disclosure. For example, the sleeve can be formed using an extrusion process.

[0255] Shaft 4720 can be any type of shaft, including medical and / or non-medical device shafts. Sleeve 4740 can be configured and / or shaped to be disposed on at least a portion of shaft 4720, where sleeve 4740 includes materials, properties, and / or compositions that are more echogenic than shaft 4720 alone when disposed thereon. Shaft 4720 can include stainless steel or other at least partially rigid material, where sleeve 4740 is relatively less rigid and / or dense.

[0256] Sleeve 4740 may have any echo characteristics disclosed herein with respect to any other embodiment of this disclosure. For example, sleeve 4740 may include and / or associated with certain echo particles, microspheres, bubbles, surfaces and / or other materials or features that are more visible under echo than stainless steel or thermoplastic rubber alone.

[0257] In some embodiments, the sleeve 4740 has an associated end effector molding 4740, which may be a single integrated form of the tube / lumen portion with the sleeve 4740, or may be attached to or otherwise associated with the tube / lumen portion of the sleeve 4740. For example... Figure 47 As illustrated in the schematic diagram, sleeve 4740 may be constructed and / or sized to slide / pass through at least a portion of shaft 4720. In some embodiments, sleeve 4740 is sized to provide a frictional engagement with shaft 4720 to prevent undesirable slippage of sleeve 4740 after it has been mounted on shaft 4720. In some embodiments, once sleeve 4740 has been mounted on shaft 4720, thermal or other environmental or mechanical conditions may be applied to sleeve 4740 to further fasten, adhere, and / or otherwise secure sleeve 4740 to shaft 4720. In some embodiments, sleeve 4740 may include a polymer mesh, such as... Biological materials (WLGore, Newark, Delaware) or similar.

[0258] Figure 48 Side and perspective views of axis 4820 of a medical device having an associated relative echo band 4801 according to one or more embodiments of the present disclosure are shown. In some embodiments, band 4801 can advantageously be used as a depth gauge when viewed under echo.

[0259] One or more strips 4801 may comprise any type of strip, band, strip, wrap, or such (e.g., with a lower or higher density than shaft 4820) of relative echo material, which may be attached to shaft 4820 in any suitable or desired manner. As described herein, relative echo material refers to the material itself, or the echo characteristics associated with the difference / interface between the material and another material disposed in its vicinity and / or in contact with it. For example, the relative echo material described herein may be a material that, when alone, does not exhibit relative echo visibility compared to stainless steel and / or thermoplastic rubber. However, when disposed on and / or in contact with another material having different density characteristics, such a material may provide relatively high echo and / or echo characteristics. Thus, such a relative echo material may provide this relatively high echo characteristic only in combination with shafts, end effectors, or other structures disposed thereon, at least in part due to density interfaces.

[0260] Bands 4801 can be wrapped around one or more portions of shaft 4820 or can slide / pass over shaft 4820 and be secured or positioned to shaft 4820 in any suitable or desired manner. Bands 4801 can have any echogenic features disclosed herein with respect to any other embodiments of the present disclosure. For example, sleeve 4740 can include and / or have associated therewith certain echogenic particles, microspheres, bubbles, surfaces, and / or other materials or features that are more visible under echography than stainless steel or thermoplastic rubber alone.

[0261] One or more individual bands 4801 can be implemented on shaft 4820. For example, where multiple bands are implemented, each band can be disposed at a different axial / longitudinal position of shaft 4820, as shown in Figure 48 Furthermore, in some embodiments, different echogenic bands 4801 can have different axial lengths, as shown in Figure 48 Such different axial lengths can be used to inform a physician or technician viewing echographic images thereof as to the position (e.g., depth) of shaft 4020. For example, identification of a relatively longer or shorter band can inform the user / technician as to what portion(s) of shaft 4820 are being viewed and / or visible in the echographic images. Although three bands 4801 are shown in Figure 48 it is understood that any number of bands can be used / implemented, including one band, two bands, or more than three bands, in some embodiments.

[0262] Figure 49 Side, perspective, and end views of a shaft 4920 and end effector 4914 of a medical instrument having relative echogenic microsphere additives 4933 associated with one or more portions thereof are shown in accordance with one or more embodiments of the present disclosure. Generally, small air bubbles trapped within spheres 4933 associated with shaft 4920 and / or end effector 4914 can increase the echogenicity of these components, at least in part due to the non-uniform surfaces provided by such spheres / bubbles enhancing scattering of echographic images. As a result, shaft 4920 and / or end effector 4914 can be made more readily visible from a relatively wide range of angles.

[0263] Microspheres 4933 can be substantially solid or can be spheres filled with air or other gas. Although microspheres of varying sizes are shown in the detailed view of Figure 49 it is understood that, in some embodiments, microspheres 4933 are substantially uniform in size, shape, and / or with respect to one or more other dimensions thereof. Microspheres 4933 advantageously have an appropriate pressure rating with respect to the relevant manufacturing process, thereby preventing instances of microsphere rupture or damage, which can lead to certain health risks.

[0264] In some embodiments, microspheres 4933 can be embedded in and / or mixed with a coating 4931, which can comprise any suitable or desired material. For example, shaft 4920 can be composed of material 4931, or material 4931 can be applied to and / or disposed on shaft 4920.

[0265] In some embodiments, only end effector 4914 is associated with microspheres 4933, which can be disposed substantially on the surface of and / or within the structure of end effector 4914. For embodiments that include microspheres 4933 disposed on and / or within shaft 4920, microspheres 4933 can be applied to shaft 4920 and / or integrated with the radial thickness thereof. That is, shaft 4920 can be formed of a material having microspheres 4933 at least partially embedded therein, or can be coated or covered with a coating / covering associated therewith of microspheres. As with other embodiments, end effector 4914 can be particularly desired to have enhanced echogenic properties due to its location relative to the deployment of the device from the working channel of the shaft.

[0266] Microspheres 4933 can include microsphere capsules (e.g., URE-FIL TM 15filler), which can be added to, for example, urethane / urethane and other materials to form relatively lightweight castings for use with shaft 4920 and / or end effector 4914. In some embodiments, microspheres 4933 can include glass spheres, or other small and / or hollow spheres. In some embodiments, microspheres 4933 are mixed with polyurethane rubber and poured into a mold to form end effector 4914.

[0267] Reference is made to Figure 49 In some embodiments, microspheres 4933 can have a diameter of about 0.005 inches or less. In some embodiments, microspheres 4933 have a circumference of about 0.01 inches or less. In some embodiments, the coating of shaft 4920 can include embedded bubbles embedded in, for example, a polyurethane catheter tube, which can be achieved by adding a gas during the extrusion process associated therewith. In some implementations, the bubbles can be formed using chlorine gas, hydrogen chloride gas, or other gas in, for example, rubber or other material used as a coating for shaft 4920. Such gas can be sonicated to produce the desired bubbles.

[0268] Figure 50Side, perspective, and end views of a shaft 5020 and end effector 5014 of a medical instrument having relatively echogenic microsphere roughened / roughened surfaces 5025, 5015 associated with one or more portions thereof are shown in accordance with one or more embodiments of the present disclosure. The roughened surfaces can produce acoustic wave reflections that are more visible under echography than the more uniform reflections that can typically be produced by smooth surfaces. That is, the non-smooth / roughened surface(s) of the shaft 5020 and / or end effector 5014 can cause a relatively large amount of scattering of acoustic waves / signals represented in echographic images, making it easier to locate the shaft and / or end effector under echographic guidance, particularly over a relatively wide range of angles.

[0269] One or more portions of the shaft 5020 and end effector 5014 can have outer and / or inner surfaces associated therewith that are configured in a roughened (e.g., non-smooth) configuration / manner. For example, the surfaces of the shaft and / or end effector 5014 can be treated with an abrasive surface / material to produce a relatively roughened surface. In some embodiments, the roughened surfaces of the shaft 5020 and / or end effector 5014 can be produced by applying a material to the shaft 5020 and / or end effector 5014. For example, such a material can be applied in a non-smooth manner, resulting in a surface topology that is uneven and / or at least partially jagged. In some embodiments, the material used to form and / or cover one or more portions of the shaft 5020 and / or end effector 5014 can include a composition that is shaped and / or sized to produce its uneven surface. The roughened surfaces 5025 can have certain grooves, ridges, teeth, or other non-smooth surface features. In some embodiments, such features can have a height that is greater than the relevant wavelength of the echogenic transducer used.

[0270] Figure 51 Side, perspective, and end views of a shaft 5120 and end effector 5114 of a medical instrument having relatively echogenic particulate additives 5133 associated with one or more portions thereof are shown in accordance with one or more embodiments of the present disclosure. The particulates 5133 can be any suitable or desired shape, size, and / or type. The particulates 5133 can advantageously be relatively more dense or less dense than the surrounding material (e.g., thermoplastic rubber, such as a polyether block amide (e.g., The elastomer) and / or silicone), creating a density interface between the particulates and the surrounding material that can increase acoustic wave reflections.

[0271] Examples of microparticles / additives that can be implemented in connection with embodiments of the present disclosure include, but are not limited to, white pigments, microspheres, glass beads, or the like, which can be at least partially embedded within silicone or other similar materials, can be used as a covering and / or form for the shaft and / or end effector. In some embodiments, the microparticles 5133 include particles of metal, zinc oxide, iron oxide, titanium dioxide, platinum oxide, silver oxide, or the like. In some embodiments, the microparticles 5133 include a form of stainless steel and fine powder. The microparticles 5133 can include a white pigment, such as a form of titanium dioxide, which can represent a relatively dense material that provides the desired echogenic properties.

[0272] The microparticles 5133 can have any chemical or structural properties. Further, the microparticles 5133 can have any size, and can have a uniform or non-uniform size across at least a portion of the shaft 5120 and / or end effector 5114. In some embodiments, the microparticles 5133 can be embedded in and / or mixed with a coating 5131, which can comprise any suitable or desired material. For example, the shaft 5120 can be constructed of the material 5131, or the material 5131 can be applied to and / or disposed on the shaft 5120. The microparticle solution can be provided in a liquid form and mixed with a rubber or other material to create an echogenic material. The echogenic material can be mixed within and / or added to a mold / die when forming the covering 5131 of the end effector 5114 and / or shaft 5120.

[0273] In some embodiments, only the end effector 5114 is associated with the microparticles 5133, which can be generally disposed on a surface of the end effector 5114 and / or within a structure / form of the end effector 5114. For embodiments that include microparticles 5133 disposed on and / or within the shaft 5120, the microparticles 5133 can be applied to the shaft 5120 and / or integrated within a radial thickness thereof. That is, the shaft 5120 can be formed of a material having microparticles 5133 at least partially embedded therein / mixed therewith, or can be coated or covered with a coating / covering associated therewith.

[0274] Figure 52 A side view, perspective view, and end view of a shaft 5220 and end effector 5214 of a medical instrument having a relatively echogenic aerogel material 5240 associated with one or more portions thereof are shown in accordance with one or more embodiments of the present disclosure. Although described as an aerogel material, it should be understood that the material 5240 can be any type of porous material. Generally, the porous material can include air pockets that increase scattering of an echo signal, resulting in enhanced echogenicity as described in detail herein. Example types of porous materials that can be used include, for example, silica aerogels, ePTFE, various foams, and the like.

[0275] Aerogel material 5240 can be integrated with the structure of shaft 5220 and / or can be applied as a coating thereon. In addition, aerogel material 5240 can be applied as a coating to end effector 5214, or end effector form 5214 can be formed substantially of aerogel material 5240, as shown. Figure 52

[0276] Figure 53 A side view, perspective view, and end view of a shaft 5320 of a medical device having a relatively echogenic collar-type end effector 5314 in accordance with one or more embodiments of the present disclosure is shown. In some embodiments, collar-type end effector 5314 can comprise a metal or other substantially rigid and / or conductive (e.g., thermally and / or electrically) material.

[0277] Collar-type end effector 5314 can be secured or attached to shaft 5320 in any suitable or desirable manner, such as using an adhesive and / or mechanical fastening mechanism. In some embodiments, end effector 5314 can be in the form of an integral part of shaft 5320 and / or at least one distal portion thereof.

[0278] While collar-type end effector 5314 is shown as having a substantially flat disc-type form having a substantially annular or torus-type shape, it should be understood that a collar-type end effector in accordance with aspects of the present disclosure can have any suitable or desirable shape. In addition, such an end effector can have any radial thickness. For example, the radial thickness of end effector 5314 can be determined to produce a desired level of echogenicity visibility.

[0279] Figure 54 A side view, perspective view, and end view of a shaft 5420 of a medical device having an end effector 5414 with a relatively echogenic collar-type component 5430 at least partially embedded therein in accordance with one or more embodiments of the present disclosure is shown.

[0280] In some embodiments, end effector 5414 can comprise a thermoplastic rubber and / or another at least partially flexible material. Collar 5430 can be at least partially attached to and / or embedded into the material (e.g., rubber) of end effector 5414. For example, collar 5430 can be substantially covered by the material of the end effector on the distal end of end effector 5414, or can be at least partially exposed on one or more end portions or sides of end effector 5414.

[0281] ​In some embodiments, the end effector 5414 can be formed using a die or mold, where the gasket 5430 is disposed in the die / mold as the end effector 5414 is formed, thereby securing the gasket 5430 within / to the end effector 5414. In some embodiments, the gasket 5430 is at least partially embedded within a thermoplastic polymer end effector, which can include, for example, a polyaryletherketone (e.g., polyether ether ketone (PEEK)), or other semi-crystalline thermoplastics with desirable mechanical and / or chemical resistance properties. For example, the thermoplastic polymer can be melted around the gasket (e.g., metal gasket) 5430, thereby providing an effector with two different densities through which sound waves can pass in one or more dimensions / axes.

[0282] Figure 55 A side view, perspective view, and end view of a shaft 5520 and end effector 5514 of a medical instrument having certain relatively echogenic air pockets and / or surface defects 5533 associated with one or more portions or surfaces thereof are shown in accordance with one or more embodiments of the present disclosure. The uneven surfaces associated with the air pockets and / or surface defects 5533 can produce sound wave reflections / scattering, which increases the visibility of the shaft 5520 and / or end effector 5514 under echogenic imaging. The mold and / or other components can be sprayed or brushed with water or other fluids, which create air pockets / indentations in the polymeric material of the end effector and / or shaft covering as the material is applied to the mold / component, where the air pockets / indentations create a density difference between the air occupying the space and the polymer producing echogenic scattering.

[0283] In some embodiments, air pockets and / or surface defects 5533 can be formed by brushing, spraying, or otherwise disposing water or other fluids on the surface of a shaft, end effector, or mold(s) in which one or more components associated with the mold are formed. For example, by brushing water on a mold / die prior to forming an end effector 5514 and / or shaft covering 5520 using the mold / die, the water / fluid brushed on the surface of the mold / die and / or shaft 5520 exerts a material (e.g., urethane) from which the end effector 5514 and / or shaft covering 5520 is formed, forming air pocket formations within the material and / or crater / indentation formations within one or more portions or surfaces of the material. For example, air pockets can be formed in an uneven pattern between a covering material 5521 and a shaft 5520 at locations associated with water / fluid droplets present on the shaft 5520 at the time the covering material 5521 is applied. Further, in embodiments in which water / fluid is brushed or otherwise applied to the interior surface of a mold prior to applying the material from which an end effector 5514 and / or shaft covering 5521 is to be formed to the interior surface of the mold, air pockets can be formed between the molded material and the interior surface of the mold, where such air pockets can present as crater / indentation type defects on the exterior surface of the formed product (e.g., end effector 5514 and / or shaft covering 5521) after the mold / die product is removed from the mold / die.

[0284] Figure 56 A side view, perspective view, and end view of a shaft 5620 of a medical instrument including an end effector 5614 having one or more relatively echogenic wires and / or loops 5632 associated therewith is shown in accordance with one or more embodiments of the present disclosure. For example, the wires 5632 can include a metal or other relatively dense material, where the material of the wires 5632 is advantageously denser (or less dense) than the material(s) making up the end effector 5614.

[0285] The wires / loops 5632 can be attached to the end effector 5614 and / or shaft 5620 in any suitable or desired manner. For example, in some embodiments, the wires 5632 are glued or otherwise attached to the proximal / rear side of the end effector 5614 in some manner, as shown. Figure 56 In some embodiments, the wires 5632 can be attached to the distal side of the end effector 5614, or to one or more longitudinal portions of the shaft 5620. Although the wires 5632 are shown in Figure 56 as being in the shape of a loop, it should be appreciated that any type of wire shape or form can be implemented in accordance with aspects of the present disclosure.

[0286] Figure 57A and Figure 57BEcho images of a relatively low echo 5701 and high echo 5703 shaft 5720 and / or end effector 5714 associated with a medical instrument are shown in accordance with one or more embodiments of the present disclosure.

[0287] For example, Figure 57A Image 5701 can represent the visibility of a shaft and / or representative image 5720a of an end effector 5714a associated therewith that does not include echo enhancement in accordance with embodiments of the present disclosure. In contrast, Figure 57B Image 5703 can represent the visibility of a shaft and / or representative image 5720b of an end effector 5714b associated therewith that includes one or more echo enhancements in accordance with any one or more embodiments disclosed herein. As is evident from a comparison of images 5701 and 5703, the visibility of the shaft and / or end effector represented in image 5703 can be significantly enhanced as compared to image 5701.

[0288] Figure 58 is a flowchart illustrating a process 580 for manufacturing an echo medical device component in accordance with aspects of the present disclosure. In some medical device shaft manufacturing processes, a stainless steel or other at least partially rigid shaft can have a polymer (e.g., a polyether block amide (PEBAX®) elastomer) extrusion disposed / formed thereon, where an end effector is formed from the polymer extrusion using a die. Alternatively, an end effector can be overmolded onto a tube structure of the shaft, such as overmolded on a polymer extrusion or directly overmolded on a rigid tube of the shaft. Process 580 can be similar in certain respects to such a process as described below.

[0289] At block 582, process 580 includes providing a rigid shaft, which can include stainless steel or other metal or plastic. At block 583, process 580 includes providing / producing an echo material configured to be applied (e.g., molded) to the rigid shaft. In some embodiments, process 580 includes adding certain echo additives to a polymeric material at block 583 to enhance echo properties of the material, resulting in the echo material referenced at block 583.

[0290] Process 580 can include a sub-process 584 for applying the echo material to the shaft to provide enhanced echo properties thereto. For example, at block 586, process 580 includes molding the echo material to / on the shaft, which can include exposing at least a portion of the shaft to a mold and pouring the echo material over at least a portion thereof such that the echo material assumes the form of the mold walls and at least partially adheres to the shaft.

[0291] In alternative implementations, the process 580 can include extruding the length of echo material tube provided at block 583 at block 587, and further sliding the extruded sleeve over a rigid tube / shaft (block 588). The extruder can have the length of the tube and can or can not have an end effector formed therewith. For example, in some embodiments, the end effector can be welded at the end of the extruder and / or rigid shaft. In some embodiments, the process 580 includes heat shrinking the extruder to the shaft and / or end effector. Due to wall thickness considerations, using an extruded sleeve / tube can be a desirable alternative to overmolding an echo tube over a shaft. For example, in some embodiments, the desired wall thickness of the echo material around the shaft can be relatively thin such that overmolding thereof can be difficult.

[0292] In some embodiments, the echo material can be applied to the shaft by brush or dip coating, as shown at block 585. In some cases, the echo material can be applied to only a portion of the shaft.

[0293] At block 589, the process 580 includes forming the end effector and / or coupling it to the shaft in some manner. Although shown as the last block in the flowchart of Figure 58 process 580, it should be understood that the forming of the end effector can be performed at any point in the process 580 and / or in conjunction with any other operation of the process 580. For example, at block 586, the forming of the end effector can be implemented in conjunction with molding the echo material over the shaft. Further, while the sub-process 584 is described as relating to the application of echo material to the shaft, the application of echo material according to the process 580 can be limited to the distal end of the shaft and / or the end effector. That is, in some implementations, the process 580 results in a shaft having an echo-enhanced end effector, with the portion of the shaft proximal to the end effector not being significantly enhanced in echo. In some implementations, the end effector can be molded or otherwise manufactured separately from the shaft and glued, crimped, heat shrunk, or otherwise attached to the shaft.

[0294] Figure 59 A side view of a medical device shaft 5920 having one or more channels 5905 formed therein is shown, in accordance with one or more examples of the present disclosure. The shaft 5920 can include a rigid elongate tube forming at least one internal lumen. The channel(s) 5920 can be configured as helical / spiral grooves that provide improved adhesion of one or more end effectors or other type(s) of formations / forms to the rigid (e.g., metallic) tube 5920. As shown, the channel(s) 5920 can be formed on the exterior of the shaft 5920. The channel(s) 5920 can cover the entire length of the shaft 5920, or only a portion thereof. For example, the channel(s) 5920 can cover a distal portion dl of the shaft 5920, as shown in FIG. 59A.Figure 59 as shown.

[0295] The channel(s) 5905 can provide image enhancement due to acoustic wave reflection (e.g., echos) off of their various surfaces. In addition, the channel(s) 5905 can be used to provide improved adhesion, engagement, or purchase of a polymer or similar form / molding applied to the shaft 5920 to secure such molding in place on the shaft. Figure 60 A shaft device 5900 is shown with a molding 5940 applied to a shaft 5920. The molding can have certain echogenicity-enhancing properties. In some examples, the molding 5940 can be associated with a distal portion d2 of the shaft 5920. The molding 5940 can cover some or all of a length dl of the shaft 5920 that is covered by the channel(s) 5905. In some examples, only a portion of the length of the shaft 5920 that is covered by the channel(s) 5905 is covered by the molding 5940. For example, in some cases, the channel(s) 5905 can span substantially the entire length of the shaft 5920, while only a distal portion of the shaft is covered by the molding 5940.

[0296] In examples where the molding 5940 is disposed on a distal end of the shaft 5920, the molding 5940 can include a shaft portion 5942 and an end effector portion 5944 that projects radially outward and provides an atraumatic tissue-contacting surface, as described in detail herein. The shaft portion 5942 can have any suitable or desired axial length and / or radial thickness.

[0297] While helical and other geometrically shaped channels, grooves, and / or recesses are disclosed in accordance with certain examples disclosed herein to enhance echogenicity and / or improve physical coupling between the shaft 5920 and an echogenic molding 5940, such channels, grooves, and / or recesses can be irregular and / or non-geometric in shape in some implementations. For example, the shaft 5920 can have channels, grooves, and / or recesses that are non-geometric and / or irregular or lack a continuous pattern (e.g., discontinuous channels or indentations / recesses) that are configured to provide a textured surface of features intended to increase echogenicity and / or surface / feature roughness for physical engagement with a polymer form on the shaft to increase coupling. In addition, such channels, grooves, and / or recesses can be associated with any other type of device or assembly other than the shaft 5920, including other types of medical or non-medical devices. In some examples, the channels, grooves, and / or recesses are knurled in shape / form or circumferential, longitudinal grooves, or some other pattern of material removal from the shaft or other device.

[0298] The formed piece 5940 can include a polymer or other material and can be similar in some respects to various other examples of shaft coverings or components including end effectors and the like disclosed herein. In some implementations, hollow glass microspheres are compounded into a plastic, rubber, or other polymer and injected into a mold or extruded to form the echogenic formed piece 5940.

[0299] The formed piece 5940 can be used to enhance echogenicity of the shaft device 5900 and / or can provide atraumatic distal contact for the device to reduce the risk of tissue damage during use. In some examples, the formed piece 5940 includes a polymer 5931 having relative echogenic microsphere additives 5933 associated with one or more portions thereof, in accordance with one or more examples of the present disclosure. As noted above, small air bubbles trapped within the spheres 5933 associated with the formed piece 5940 can increase echogenicity of the formed piece 5940, and thus the echogenicity of the device 5900, at least in part due to the inhomogeneous surface provided by such spheres / bubbles that enhances scattering of the echogenic image. As a result, the shaft device 5900 can be made more readily visible from a relatively wide range of angles.

[0300] The microspheres 5933 can be substantially solid, or can be spheres filled with air or other gas. Although shown in the detailed view of FIG. 6A as including microspheres of non-uniform size, it should be appreciated that in some examples the microspheres 5933 are substantially uniform in size, shape, and / or relative to one or more other dimensions thereof. The microspheres 5933 desirably have an appropriate pressure rating with respect to the relevant manufacturing process, thereby preventing or reducing instances of microsphere rupture or damage that can lead to certain health risks. Figure 60

[0301] In some cases, the microspheres 5933 can be embedded in and / or mixed with a base material 5931 of the formed piece 5940, which can include any suitable or desired material such as a polymer. For example, the shaft 5920 can be constructed of the material 5931, or the material 5931 can be applied to and / or disposed on the shaft 5920, as shown in FIG. 6B. Figure 60

[0302] The microspheres 5933 can be applied to and / or integrated with the thickness of the formed piece 5940. That is, the formed piece 5940 can be formed of a material having the microspheres 5933 at least partially embedded therein, or can be coated or covered with a coating / covering of microspheres associated therewith. As with other examples, it is particularly desirable for the distal end of the shaft 5920 to have enhanced echogenic properties. For example, the formed piece 5940 can be used as an end effector.

[0303] The microspheres 5933 can include microsphere capsules (e.g., UREFIL TM ​​15 filler) that can be added to, for example, urethane and / or one or more other materials to form a relatively lightweight cast that is used at least with the distal portion of the shaft 5920. In some examples, the microspheres 5933 can include glass spheres, or other small and / or hollow spheres. In some examples, the microspheres 5933 are mixed with polyurethane rubber and poured into a mold to form the shaped piece 5940.

[0304] Referring to Figure 60 In more detail with respect to the microspheres 5933, in some examples the microspheres 5933 can have a diameter of about 0.005 inches or less. In some examples, the microspheres 5933 have a circumference of about 0.01 inches or less. In some examples, the microspheres 5933 have a particle size (e.g., diameter) of between 2-25 microns. In some examples, the average particle size of the microspheres can be about 12 microns. The microspheres 5933 can have a maximum working pressure of about 70 MPa (about 10,000 pounds per square inch (psi)) or more. An example type of microsphere that can be used in conjunction with example embodiments is borosilicate glass hollow microsphere, such as Microsphere® (PQ Corporation of Malvern, Pennsylvania). In some embodiments, the microspheres can be used according to a loading percentage of between 10%-40%. For example, the microspheres can be used according to a loading percentage of 20%-30%, which can provide a suitable or desirable balance between visibility and malleability. In some embodiments, the shaped piece 5940 includes URE-FIL® TM resin of microspheres. In some embodiments, the shaped piece 5940 includes Elastoprene® (Arkema of Colombo, France) and 110P8 hollow microspheres.

[0305] In some examples, the shaped piece 5940 can include embedded air bubbles that are embedded in, for example, a polyurethane shaped piece that is adhered to the shaft 5920, which can be achieved by adding a gas during one or more extrusion or molding processes related thereto. In some embodiments, chlorine gas, hydrogen chloride gas, or other gas can be used to form air bubbles in, for example, rubber or other material used for the shaped piece 5940. Such a gas can be sonicated to produce the desired air bubbles. Adding microspheres or air bubbles to a plastic or rubber shaped piece can advantageously improve its visibility under an echo. In some embodiments, the shaped piece 5940 is injection molded. Plastic / rubber with composite hollow microspheres can be injection molded or extruded into almost any suitable or desirable shape. For example, it can be extruded into a tube for a catheter, or can be injection molded into a satellite disc shape that points toward an echo probe, or any other configuration for use with a shaft-like medical implement.

[0306] Additional Embodiments

[0307] Depending on the embodiment, certain acts, events, or functions of any of the processes described herein can be performed in a different sequence, can be added, merged, or left out altogether. Thus, in certain embodiments, not all described acts or events are necessary for the practice of the processes.

[0308] Conditional language used herein, such as, among others, “can,” “could,” “might,” “may,” “e.g.,” and like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and / or steps. Thus, such conditional language is not generally intended to imply that one or more features, elements and / or steps are required to one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and / or steps are included or are to be performed in any particular embodiment. The terms “comprising,” “including,” “having” and the like are synonymous and are used in their broadest sense in that they include the item(s) following the term and any further or additional items. In an embodiment, as is true of all embodiments, unless otherwise specified, the terminology includes the item(s) following the term, and does not exclude additional, unrecited item(s). Additionally, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, in a list of two or more items, the term “or” means one, some, or all of the elements in the list. Conjunctive language such as the phrase “at least one of’ is to be understood in its inclusive sense (and not in its exclusive or exhaustive sense) unless otherwise specifically stated. Conjunctive language such as the phrase “at least one of’ is to be understood in its inclusive sense (and not in its exclusive or exhaustive sense) unless otherwise specifically stated.

[0309] It should be understood that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description for the purposes of streamlining the disclosure and aiding in the understanding of one or more aspects of various inventive aspects. However, this method of disclosure should not be interpreted as reflecting an intention that the claimed embodiments require more features than are explicitly recited in each claim. Moreover, any of the components, features, or steps in any of the embodiments described herein can be applied to any other embodiment or used in any other embodiment in combination with any other component, feature, or step. Also, no component, feature, step or combination of components, features or steps is essential or indispensable to the practice of the practice of the claimed invention. Thus, the scope of the present invention should not be limited to any specific embodiment described herein, but should be determined by a fair reading of the claims in light of the teachings herein.

[0310] It should be understood that certain ordinal terms, such as “first” or “second,” can be provided for ease of reference and do not necessarily imply a physical priority or order. Thus, as used herein, ordinal terms for modifying elements of a structure, component, operation, etc. (e.g., “first,” “second,” “third,” etc.) do not necessarily denote a priority or order of the elements relative to each other, but rather can distinguish the element from another element having a similar or identical name (but for the ordinal term). Further, as used herein, the indefinite articles “a” and “an” can mean “one or more” rather than “one.” Further, an operation performed “based on” a condition or event can also be performed based on one or more other conditions or events that are not explicitly listed.

[0311] Unless otherwise defined, all terms used in this document, including technical and scientific terms, have the same meaning as commonly understood by one of ordinary skill in the art to which example embodiments belong. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

[0312] Spatially relative terms “outer,” “inner,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” and similar terms, as used herein, can be used to describe a relationship of one element or component to another element or component as depicted in the figures. It will be understood that spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientations depicted in the figures. For example, if a device is turned over in the figures, elements described as “below” or “beneath” other elements or components would then be oriented “above” the other elements or components. Thus, the illustrative terms “below” and “beneath” can encompass both an orientation of below and above. The device can also be oriented in the other direction, so that the spatially relative terms can encompass both orientations.

[0313] Comparative and / or quantitative terms, such as “less,” “more,” “greater,” etc., are intended to encompass the concept of equality unless expressly stated otherwise. For example, “less” can mean “less than” in the strictest mathematical sense, but can also mean “less than or equal to.”

Claims

1. A medical device shaft, comprising: a rigid elongated shaft; an end effector form coupled to a distal end of the elongated shaft; and a backscatter additive associated with at least one of the elongated shaft and the end effector form, wherein the backscatter additive is mixed with a coating material disposed on at least a portion of the elongated shaft, wherein the coating material has an extruded sleeve form, and wherein the end effector form is integrally formed with the extruded sleeve.

2. The medical device shaft of claim 1, wherein the backscatter additive comprises microspheres.

3. The medical device shaft of claim 2, wherein the microspheres are gas-filled glass spheres.

4. The medical device shaft of any one of claims 1 to 3, wherein the backscatter additive is embedded within the end effector form.

5. The medical device shaft of claim 1, wherein the end effector form is die cut from the extruded sleeve.

6. The medical device shaft of any one of claims 1 to 5, wherein: the backscatter additive comprises microparticles mixed into a polymeric material; and the microparticles are denser than the polymeric material.

7. The medical device shaft of claim 6, wherein the microparticles comprise one or more of zinc oxide, iron oxide, titanium dioxide, platinum oxide, and silver oxide.

8. A method of manufacturing a medical device shaft according to any one of claims 1 to 7, the method comprising: providing a rigid elongated shaft; and coupling an end effector form to the elongated shaft; wherein the end effector form comprises a backscatter enhancing feature.

9. The method of claim 8, further comprising adding a backscatter additive to a polymeric material.

10. The method of claim 9, further comprising applying the polymeric material with the backscatter additive to at least a portion of the elongated shaft.

11. The method of claim 9, further comprising applying the polymeric material with the backscatter additive to at least a portion of the end effector form.

12. The method of claim 9, wherein coupling the end effector form to the elongated shaft comprises molding the end effector form from the polymeric material to the elongated shaft.

13. The method of claim 12, further comprising, prior to molding the end effector form to the elongated shaft, applying a liquid to one or more of the elongated shaft and a mold used to mold the end effector form to create a backscatter surface feature in the end effector.

14. The method of any one of claims 8 to 13, further comprising creating a rough surface on one or more of the elongated shaft and the end effector form using an abrasive surface, wherein the rough surface is configured to create backscatter scattering.

15. The method of any one of claims 8 to 13, wherein the end effector form comprises a porous material having a greater backscatter characteristic than the elongated shaft. ​ ​ 16. The method of claim 15, wherein the porous material is an aerogel.

17. The method of claim 8, further comprising forming one or more channels on an outer surface of the elongate shaft.

18. The method of claim 17, wherein the end effector form is disposed at least partially within the one or more channels.

Images