Patent Application
20220265426
The present disclosure generally relates to the field of medical devices and processes.
Certain medical procedures can be aided by the use of echo imaging technology. Echogenicity of devices used in such medical procedures can affect visibility of such devices under echo imaging.
Described herein are methods and devices that facilitate visibility of medical device shafts and other devices under echo imaging. In some implementations, the present disclosure relates to a medical device shaft comprising a rigid, elongate shaft, an end effector form coupled to a distal end of the elongate shaft, and echogenic additives associated with at least one of the elongate shaft and the end effector.
The echogenic additives can comprise microspheres. For example, the microspheres can be gas-filled glass spheres. In some examples, the echogenic additives are embedded within the end effector form. The echogenic additives can be mixed with a coating material disposed on at least a portion of the elongate shaft. For example, the coating material can have an extruded sleeve form. The end effector form is a unitary form with the extruded sleeve. For example, the end effector form can be die-cut from the extruded sleeve. In some examples, the echogenic additives comprise particulates mixed into a polymeric material and the particulates are more, or less, dense than the polymeric material. For example, the particulates can comprise one or more of zinc oxide, iron oxide, titanium dioxide, platinum oxide, and silver oxide.
In some implementations, the present disclosure relates to a method of manufacturing a medical instrument. The method comprises providing a rigid, elongate shaft and coupling an end effector form to the elongate shaft. The end effector form includes echogenicity-enhancing features.
The method may further comprise adding echogenic additives to a polymeric material. The method may further comprise applying the polymeric material with the echogenic additives to at least a portion of the shaft. The method may further comprise applying the polymeric material with the echogenic additives to at least a portion of the end effector form. In some examples, coupling the end effector form to the elongate shaft involves molding the end effector form from the polymeric material to the elongate shaft. For example, the method may further comprise, prior to said molding the end effector form to the elongate shaft, applying a liquid to one or more of the elongate shaft and a mold used to mold the end effector form to produce echogenic surface features in the end effector.
The method may further comprise using an abrasive surface to produce a rough surface on one or more of the elongate shaft and the end effector form, wherein the rough surface is configured to produce echo scattering. In some examples, the end effector form comprises porous material having greater echogenicity characteristics than the elongate shaft. For example, the porous material may be aerogel.
In some implementations, the present disclosure relates to a medical device shaft comprising a rigid, elongate shaft, an end effector form coupled to a distal end of the elongate shaft, and a metal echogenic-enhancement feature coupled to the end effector form.
In some examples, the metal echogenic-enhancement feature comprises one or more loops of wire secured to one or more of the elongate shaft and the end effector form. In some instances, the metal echogenic-enhancement feature comprises a washer form coupled to a distal end of the end effector form. For example, the washer form may be at least partially embedded in the end effector form.
In some implementations, the present disclosure relates to a medical device shaft comprising an elongate shaft having one or more channels formed in an exterior surface of the shaft and an end effector form coupled to a distal end of the elongate shaft.
The medical device shaft can further comprise an outer covering disposed around at least a portion of the shaft and covering at least a portion of the one or more channels. The outer covering can comprise a polymer tube. In some examples, the one or more channels are helical over a length of the shaft.
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 may be achieved in accordance with any particular embodiment. Thus, the disclosed examples may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.
Various embodiments are depicted in the accompanying drawings for illustrative purposes and should in no way be interpreted as limiting the scope of the inventions. In addition, various features of different disclosed embodiments can be combined to form additional embodiments, which are part of this disclosure. Throughout the drawings, reference numbers may be reused to indicate correspondence between reference elements. However, it should be understood that the use of similar reference numbers in connection with multiple drawings does not necessarily imply similarity between respective embodiments associated therewith. Furthermore, it should be understood that the features of the respective drawings are not necessarily drawn to scale, and the illustrated sizes thereof are presented for the purpose of illustration of inventive aspects thereof. Generally, certain of the illustrated features may be relatively smaller than as illustrated in some embodiments or configurations.
To further clarify various aspects of embodiments of the present disclosure, a more particular description of certain embodiments will be made by reference to various aspects of the appended drawings. It is appreciated that these drawings depict only typical embodiments of the present disclosure and are therefore not to be considered limiting of the scope of the disclosure. Moreover, while the figures can be drawn to scale for some embodiments, the figures are not necessarily drawn to scale for all embodiments. Embodiments of the present disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings.
The following description refers to the accompanying drawings, which illustrate specific embodiments. Other embodiments having different structures and operation do not depart from the scope of the disclosure. Embodiments of the present disclosure relate to devices and methods for improving visibility of component(s) of medical devices or systems under echo imaging. The terms “echo,” “echo imaging,” “echo image,” “cardiac echo,” “echocardiography,” “echocardiogram,” “medical ultrasound,” “ultrasound,” and like terms are used herein according to their broad and ordinary meanings and may refer to any type of ultrasound (e.g., medical ultrasound), diagnostic sonography, ultrasonography, or any other type of sonic/sound-based imaging technology or modality and/or image(s) generated in connection therewith, whether related to images of cardiac anatomy or other anatomy or subject matter. Embodiments of the present disclosure relate to echogenic features, components, and/or devices associated with a delivery device or system for implementing tissue anchor delivery and/or valve repair, such as mitral valve repair, on a beating heart. Such delivery devices/systems may 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 may refer to the ability of a material, device, component, or surface to reflect, return, or bounce a sound wave (e.g., an echo). As used herein, echogenicity is considered relatively higher when the surface reflecting the sound wave/echo reflects relatively higher-amplitude sound waves. Generally, a material, device, component, or surface described herein as echogenic, or as having image-enhancement characteristics, may be considered to have a relatively higher echogenicity than an at least partially convex stainless-steel surface. 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 as indicating 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.
Real-time echo (e.g., ultrasound) guidance for certain interventions/procedures (e.g., mitral valve repair procedures) can be implemented in reliance at least in part on visualization of certain surgical components, such as tissue anchor delivery device shafts, and the like. For example, as a medical device shaft is advanced towards and positioned onto the target anchor deployment site (e.g., mitral valve leaflet), visibility of the shaft under echo can be critical. Instances of the present disclosure provide enhanced echogenicity/visibility for medical device shafts and other devices under echo imaging to enable the echo cardiographer and surgeon to relatively safely and/or quickly steer and navigate the shaft in the target anatomical cavity (e.g., cardiac ventricle) and to allow for precise targeting of the shaft to improve success rates associated with surgical procedures.
The following includes a general description of human cardiac anatomy that is relevant to certain inventive features and examples disclosed herein and is included to provide context for certain aspects of the present disclosure. In humans and other vertebrate animals, the heart generally comprises a muscular organ having four pumping chambers, wherein the flow thereof is at least partially controlled by various heart valves, namely, the aortic, mitral (or bicuspid), tricuspid, and pulmonary valves. The valves may be configured to open and close in response to a pressure gradient present during various stages of the cardiac cycle (e.g., relaxation and contraction) to at least partially control the flow of blood to a respective region of the heart and/or to blood vessels (e.g., pulmonary, aorta, etc.).
The left ventricle 3 is the primary pumping chamber of the heart 1. A healthy left ventricle is generally conical or apical in shape in that it is longer (along a longitudinal axis extending in a direction from the aortic valve 7 to the apex 19) than it is wide (along a transverse axis extending between opposing walls 25, 26 at the widest point of the left ventricle) and descends from a base 15 with a decreasing cross-sectional circumference to the point or apex 19. Generally, the apical region 39 of the heart is a bottom region of the heart that is within the left or right ventricular region but is distal to the mitral 6 and tricuspid 8 valves and toward the tip of the heart. More specifically, the apical region 39 may be considered to be within about 20 cm to the right or to the left of the median axis 27 of the heart 1.
The 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 heart muscle fibers that extend in a circular or spiral direction around the heart. When these fibers contract, they produce a gradient of angular displacements of the myocardium from the apex 19 to the base 15 about the longitudinal axis of the heart. The resultant force vectors extend at angles from about 30-60 degrees to the flow of blood through the aortic valve 7. The contraction of the heart is manifested as a counterclockwise rotation of the apex 19 relative to the base 15, when viewed from the apex 19. A healthy heart can pump blood from the left ventricle in a very efficient manner due to the spiral contractility of the heart.
The heart 1 further includes four valves for aiding the circulation of blood therein, including the tricuspid valve 8, which separates the right atrium 5 from the right ventricle 4. The tricuspid valve 8 may generally have three cusps or leaflets and may generally close during ventricular contraction (e.g., systole) and open during ventricular expansion (e.g., diastole). The valves of the heart 1 further include the pulmonary valve 9, which separates the right ventricle 4 from the pulmonary artery ii and may be configured to open during systole so that blood may be pumped toward the lungs, and close during diastole to prevent blood from leaking back into the heart from the pulmonary artery. The pulmonary valve 9 generally has three cusps/leaflets, wherein each one may have a crescent-type 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 may generally be configured to open during diastole so that blood in the left atrium 2 can flow into the left ventricle 3, and advantageously close during 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 leaving the left ventricle 3 to enter the aorta 12, and close during diastole to prevent blood from leaking back into the left ventricle 3.
The atrioventricular (e.g., mitral and tricuspid) heart valves may comprise a collection of chordae tendineae (13, 16) and papillary muscles (10, 15) for securing the leaflets of the respective valves to promote and/or facilitate proper coaptation of the valve leaflets and prevent prolapse thereof. The papillary muscles, for example, may generally comprise finger-like projections from the ventricle wall. With respect to the tricuspid valve 8, the normal tricuspid valve may comprise three leaflets and three corresponding papillary muscles 10 (two shown in
Surrounding the ventricles (3, 4) are a number of arteries (not shown) that supply oxygenated blood to the heart muscle and a number of veins that return the blood from the heart muscle. The coronary sinus (not shown) is a relatively large vein that extends generally 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 ostium (not shown) through which the blood enters the right atrium.
With respect to the mitral valve 6, a normal mitral valve may comprise two leaflets (anterior and posterior) and two corresponding papillary muscles 15. The papillary muscles 15 originate in the left ventricle wall and project into the left ventricle 3. Generally, the anterior leaflet may cover approximately two-thirds of the valve annulus. Although the anterior leaflet covers a greater portion of the annulus, the posterior leaflet may comprise a larger surface area in certain anatomies.
Various disease processes can impair the proper functioning of one or more of the valves of the heart. 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). Additionally, damage to the ventricle from prior heart attacks (e.g., myocardial infarction secondary to coronary artery disease) or other heart diseases (e.g., cardiomyopathy) can distort the valve's geometry causing it to dysfunction. However, the vast majority of patients undergoing valve surgery, such as mitral valve surgery, suffer from a degenerative disease that causes a malfunction in one or more leaflets of the valve which results in prolapse and regurgitation.
The mitral valve 6 and tricuspid valve 8 can be divided into three parts: an annulus, leaflets, and a sub-valvular apparatus. The sub-valvular apparatus can be considered to include the papillary muscles 10, 15 and the chordae tendineae 13, 16, which can elongate and/or rupture. If a valve is functioning properly, when closed, the free margins or edges of the leaflets come together and form a tight junction, the arc of which, in the mitral valve, is known as the line, plane or area of coaptation. Normal mitral and tricuspid valves open when the ventricles relax allowing blood from the atrium to fill the decompressed ventricle. When the ventricle contracts, the chordae tendineae advantageously properly tether or position the valve leaflets such that the increase in pressure within the ventricle causes the valve to close, thereby preventing blood from leaking into the atrium and assuring that substantially all of the blood leaving the ventricle is ejected through the aortic valve 7 or pulmonic valve 9 and into the arteries of the body. Accordingly, proper function of the valves depends on a complex interplay between the annulus, leaflets, and sub-valvular apparatus. Lesions in any of these components can cause the valve to dysfunction and thereby lead to valve regurgitation.
Generally, there are three mechanisms by which a heart valve becomes regurgitant or incompetent; they include Carpentier's type I, type II and type III malfunctions. A Carpentier type I malfunction involves the dilation of the annulus such that normally functioning leaflets are distracted from each other and fail to form a tight seal (e.g., do not coapt properly). Included in a type I mechanism malfunction are perforations of the valve leaflets, as in endocarditis. A Carpentier's type II malfunction involves prolapse of one or both leaflets above the plane of coaptation. This is the most common cause of mitral regurgitation and is often caused by the stretching or rupturing of chordae tendineae normally connected to the leaflet. A Carpentier's type III malfunction involves restriction of the motion of one or more leaflets such that the leaflets are abnormally constrained below the level of the plane of the annulus. Leaflet restriction can be caused by rheumatic disease (IIIa) or dilation of the ventricle (IIIb).
One or more chambers in the heart 1 may be accessed in accordance with certain heart valve-repair procedures and/or other interventions. Access into a chamber in the heart may be made at any suitable site of entry. In some implementations, access is made to a chamber of the heart, such as a target ventricle (e.g., left ventricle) associated with a diseased heart valve, through the apical region 39. For example, access into the left ventricle 3 (e.g., to perform a mitral valve repair) may be gained by making a relatively small incision at the apical region 39, close to (or slightly skewed toward the left of) the median axis 27 of the heart. Access into the right ventricle 4 (e.g., to perform a tricuspid valve repair) may be gained by making a small incision into the apical region 39, close to or slightly skewed toward the right of the median axis 27 of the heart. Accordingly, the ventricle can be accessed directly via the apex, or via an off-apex location that is in the apical region 39 but slightly removed from the tip/apex, such as via lateral ventricular wall, a region between the apex and the base of a papillary muscle, or even directly at the base of a papillary muscle. In some implementations, the incision made to access the appropriate ventricle of the heart is no longer than about 1 mm to about 5 cm, from 2.5 mm to about 2.5 cm, or from about 5 mm to about 1 cm in length. When a percutaneous approach is sought, no incision into the apex region of the heart may be made, but rather access into the apical region 39 may be gained by direct needle puncture, for instance by an 18-gauge needle, through which an appropriate repair instrument can be advanced.
Certain inventive features disclosed herein relate to certain heart valve repair systems and devices, and/or systems, process, and devices for repairing any other type of target organ tissue. In some implementations, a tissue anchor delivery device may be employed in repairing a mitral valve in patients suffering from degenerative mitral regurgitation or other condition. In some implementations, a transapical off-pump echo-guided repair procedure is implemented in which at least part (e.g., a shaft portion/assembly) of a valve repair system is inserted in the left ventricle and steered to the surface of the diseased portion of a target mitral valve leaflet and used to deploy/implant a tissue anchor in the target leaflet. The tissue anchor (e.g., sutureform formed into a bulky knot) may advantageously be integrated or coupled with one or more artificial/synthetic cords serving a function similar to that of chordae tendinea. Such artificial cord(s) may comprise suture(s) and/or suture tail portions associated with a knot-type tissue anchor and may comprise any suitable or desirable material, such as expanded polytetrafluoroethylene (ePTFE) or the like. The term “suture” is used herein according to its broad and ordinary meaning and may refer to any elongate cord, strip, strand, line, tie, string, ribbon, strap, or portion thereof, or other type of material used in medical procedures. One having ordinary skill in the art will understand that a wire or other similar material may be used in place of a suture. Furthermore, in some contexts herein, the terms “cord,” “chordae,” and “suture” may be used substantially interchangeably. In addition, use of the singular form of any of the suture-related terms listed above, including the terms “suture” and “cord,” may be used to refer to a single suture/cord, or to a portion thereof. For example, where a suture knot or anchor is deployed on a distal side of a tissue portion, and where two suture portions extend from the knot/anchor on a proximal side of the tissue, either of the suture portions may be referred to as a “suture” or a “cord,” regardless of whether both portions are part of a unitary suture or cord.
Processes for repairing a target organ tissue, such as repair of mitral valve leaflets to address mitral valve regurgitation, can include inserting a tissue anchor delivery device, such as a delivery device as described in PCT Application No. PCT/US2012/043761, (published as WO 2013/003228, and referred to herein as “the '761 PCT Application”) and/or in PCT Application No. PCT/US2016/055170 (published as WO 2017/059426 and referred to herein as “the '170 PCT Application”), the entire disclosures of which are incorporated herein by reference, into a body and extending a distal end of the delivery device to a proximal side of the target tissue (e.g., leaflet).
The '761 PCT Application and the '170 PCT Application describe in detail methods and devices for performing non-invasive procedures to repair a cardiac valve, such as a mitral valve. Such procedures include procedures to repair regurgitation that occurs when the leaflets of the mitral valve do not coapt properly at peak contraction pressures, resulting in an undesired backflow of blood from the ventricle into the atrium. As described in the '761 PCT Application and the '170 PCT Application, after the malfunctioning cardiac valve has been assessed and the source of the malfunction verified, a corrective procedure can be performed. Various procedures can be performed in accordance with the methods described therein to effectuate a cardiac valve repair, which may depend on the specific abnormality and the tissues involved.
The delivery system 100 includes a rigid elongate tube no forming at least one internal working lumen. Although described in certain examples and/or contexts as comprising a rigid elongate tube, it should be understood that tubes, shafts, lumens, conduits, and the like disclosed herein may be either rigid, at least partially rigid, at least flexible, and/or at least partially flexible. Therefore, any such component described herein, whether or not referred to as rigid herein should be interpreted as possibly being at least partially flexible. In accordance with the present disclosure, the rigid elongate tube 110 may be referred to as a shaft for simplicity. Implementation of a valve-repair procedure utilizing the delivery system 100 can be performed in conjunction with certain imaging technology designed to provide visibility of the shaft 110 of the delivery system 100 according to a certain imaging modality, such as echo imaging. Generally, when performing a valve-repair procedure utilizing the tissue anchor delivery system 100, the operating physician may advantageously work in concert with an imaging technician, who may coordinate with the physician to facilitate successful execution of the valve-repair procedure.
In addition to the delivery shaft no, the delivery system 100 may include a plunger feature 140, which may be used or actuated to manually deploy a pre-formed knot, such as a bulky knot as described in detail below. The tissue anchor delivery system 100 may further include a plunger lock mechanism 145, which may serve as a safety lock that locks the valve delivery system until ready for use or deployment of a leaflet anchor as described herein. The plunger 140 may have associated therewith a suture-release mechanism, which may be configured to lock in relative position a pair of suture tails 195 associated with a pre-formed knot anchor (not shown) to be deployed. For example, the suture portions 195 may be ePTFE sutures. The system 100 may further comprise a flush port 150, which may be used to de-air the lumen of the shaft no. For example, heparinized saline flush, or the like, may be connected to the flush port 150 using a female Luer fitting to de-air the valve repair system 100. The term “lumen” is used herein according to its broad and ordinary meaning, and may refer to a physical structure forming a cavity, void, pathway, or other channel, such as an at least partially rigid elongate tubular structure, or may refer to a cavity, void, pathway, or other channel, itself, that occupies a space within an elongate structure (e.g., a tubular structure). Therefore, with respect to an elongate tubular structure, such as a shaft, tube, or the like, the term “lumen” may refer to the elongate tubular structure and/or to the channel or space within the elongate tubular structure.
The lumen of the shaft no may house a needle (not shown) that is wrapped at least in part with a pre-formed knot sutureform anchor, as described in detail herein. In some examples, the shaft no presents a relatively low profile. For example, the shaft no may have a diameter of approximately 3 mm or less (e.g., 9 Fr). The shaft no is associated with an atraumatic tip 114 feature. The atraumatic tip 114 can be an echogenic leaflet-positioner component, which may be used for deployment and/or positioning of the suture-type tissue anchor. The atraumatic tip 114, disposed at the distal end of the shaft no, may be configured to have deployed therefrom a wrapped pre-formed suture knot (e.g., sutureform), as described herein.
The atraumatic tip 114 may be referred to as an “end effector.” In addition to a pre-formed knot sutureform and associated needle, the shaft no may house an elongated knot pusher tube (not shown; also referred to herein as a “pusher”), which may be actuated using the plunger 140 in some examples. As described in further detail below, the tip 114 provides a surface against which the target valve leaflet may be held in connection with deployment of a leaflet anchor.
The delivery device 100 may be used to deliver a “bulky knot” type tissue anchor, as described in greater detail below. For example, the delivery device 100 may be utilized to deliver a tissue anchor (e.g., bulky knot) on a distal side of a mitral valve leaflet. The tip 114 (e.g., end effector), can be placed in contact with the ventricular side of a leaflet of a mitral valve. The tip 114 can be coupled to the distal end portion of the shaft no, wherein the proximal end portion of the shaft no may be coupled to a handle portion 120 of the delivery device 100, as shown. Generally, the elongate pusher (not shown) may be movably disposed within a lumen of the shaft no and coupled to a pusher hub (not shown) that is movably disposed within the handle 120 and releasably coupled to the plunger 140. A needle (not shown) carrying a pre-formed tissue anchor sutureform can be movably disposed within a lumen of the pusher and coupled to a needle hub (not shown) that is also coupled to the plunger 140. The plunger 140 can be used to actuate or move the needle and the pusher during deployment of a distal anchor (see, e.g.,
The needle may have the pre-formed knot disposed about a distal portion thereof while maintained in the shaft no. For example, the pre-formed knot may be formed of one or more sutures configured in a coiled sutureform (see
The delivery device can further include a suture/tether catch mechanism (not shown) coupled to the plunger 140 at a proximal end of the delivery device 100, which may 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 with a friction fit or with a clamping force and can have a lock that can be released after the tissue anchor has been deployed/formed into a bulky knot, as described herein.
As described herein, the anchor delivery device 100 can be used in beating heart mitral valve repair procedures. In some instances, the shaft 110 of the delivery device 100 can be configured to extend and contract with the beating of the heart. During systolic contraction, the median axis of the heart generally shortens. For example, 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 patients. In some instances, the length of the shaft 110 that protrudes from the handle 120 can change with the length of the median axis of the heart. That is, distal end of the shaft 110 can be configured to be floating such that the shaft can extend and retract with the beat of the heart so as to maintain contact with the target mitral valve leaflet.
Advancement of the delivery device 100 may be performed in conjunction with echo imaging, direct visualization (e.g., direct transblood visualization), and/or any other suitable remote visualization technique/modality. With respect to cardiac procedures, for example, the delivery device 100 may be advanced in conjunction with transesophageal (TEE) guidance and/or intracardiac echocardiography (ICE) guidance to facilitate and to direct the movement and proper positioning of the device for contacting the appropriate target cardiac region and/or target cardiac tissue (e.g., a valve leaflet, a valve annulus, or any other suitable cardiac tissue). Typical procedures that can be implemented using echo guidance are set forth in Suematsu, Y., J. Thorac. Cardiovasc. Surg. 2005; 130:1348-56 (“Suematsu”), the entire disclosure of which is incorporated herein by reference.
Mitral valve regurgitation generally increases the workload on the heart and may lead to very serious conditions if left untreated, such as decreased ventricular function, pulmonary hypertension, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. Since the left heart is primarily responsible for circulating the flow of blood throughout the body, malfunction of the mitral valve 36 is particularly problematic and often life threatening. Methods and devices are provided herein, as well as in the '761 PCT Application and the '170 PCT Application, for performing non-invasive procedures to repair a cardiac valve, such as a mitral valve. Such procedures include procedures to repair regurgitation that occurs when the leaflets of the mitral valve do not coapt properly at peak contraction pressures, resulting in an undesired backflow of blood from the ventricle into the atrium. As described in the '761 PCT Application and the '170 PCT Application, after the malfunctioning cardiac valve has been assessed and the source of the malfunction verified, a corrective procedure can be performed. Various procedures can be performed in accordance with the methods described therein to effectuate a cardiac valve repair, which will depend on the specific abnormality and the tissues involved.
After a minimally invasive approach is determined to be advisable, one or more incisions may be made proximate to the thoracic cavity to provide a surgical field of access. The total number and length of the incisions to be made depend on the number and types of the instruments to be used as well as the procedure(s) to be performed. The incision(s) may advantageously be made in such a manner as to be minimally invasive. As referred to herein, the term “minimally invasive” means in a manner by which an interior organ or tissue may be accessed with relatively little damage being done to the anatomical structure through which entry is sought. For example, a minimally invasive procedure may involve accessing a body cavity by a small incision of, for example, approximately 5 cm or less made in the skin of the body. The incision may be vertical, horizontal, or slightly curved. If the incision is located along one or more ribs, it may advantageously follow the outline of the rib. The opening may advantageously extend deep enough to allow access to the thoracic cavity between the ribs or under the sternum and is preferably set close to the rib cage and/or diaphragm, dependent on the entry point chosen.
In one example method, the heart may be accessed through one or more openings made by one or more small incision in a portion of the body proximal to the thoracic cavity, such as between one or more of the ribs of the rib cage of a patient, proximate to the xyphoid appendage, or via the abdomen and diaphragm. Access to the thoracic cavity may be sought to allow the insertion and use of one or more thorascopic instruments, while access to the abdomen may be sought to allow the insertion and use of one or more laparoscopic instruments. Insertion of one or more visualizing instruments may then be followed by transdiaphragmatic access to the heart. Additionally, access to the heart may be gained by direct puncture (e.g., via an appropriately sized needle, for instance an 18-gauge needle) of the heart from the xyphoid region. Accordingly, the one or more incisions should be made in such a manner as to provide an appropriate surgical field and access site to the heart in the least invasive manner possible. Access may also be achieved using percutaneous methods, further reducing the invasiveness of the procedure. See, e.g., “Full-Spectrum Cardiac Surgery Through a Minimal Incision Mini-Sternotomy (Lower Half) Technique,” Doty et al., Annals of Thoracic Surgery 1998; 65(2): 573-7 and “Transxiphoid Approach Without Median Sternotomy for the Repair of Atrial Septal Defects,” Barbero-Marcial et al., Annals of Thoracic Surgery 1998; 65(3): 771-4, the entire disclosures of each of which are incorporated herein by reference.
The hemostatic introducer 200 may be inserted into the target ventricle at a tip 221 associated with a lumen 220 of the introducer 200. The lumen 220 of the introducer 200 may be used to guide the shaft 110 of a tissue anchor delivery device in accordance with examples of the present disclosure during a valve-repair procedure. The body or hub 210 of the introducer 200 may be used to secure the introducer 200 to the pericardium of the heart for stable entry of the shaft 110 of the tissue anchor delivery device and/or to control the amount of bleed-back during the valve-repair procedure. In some instances, a female Luer may be used to de-air the introducer 200 through a port 225 prior to use and/or to connect a fluid flush, such as a heparin flush, during a valve-repair procedure. The dilator 228 may be used to guide the introducer into the target ventricle. For example, the dilator 228 may be used to guide the introducer 200 into the left ventricle off-apex, as described in detail herein. In some implementations, a tie-down eyelet is used to secure the introducer 200 during the valve-repair procedure.
The introducer lumen 220 provides a conduit into a target surgical area or chamber, such as a ventricle of a heart. In some instances, the introducer 200 comprises one or more hemostasis valves associated with a channel/lumen port 222. Such hemostasis valve(s) may comprise silicone or other flexible material configured to keep blood from flowing out of the channel/lumen port 222. The port 222 may serve as a tissue anchor delivery device lumen insertion port, wherein an inserted delivery device shaft may pass through the lumen 220 of the introducer 200 and out the distal end 221 thereof for access to the target chamber. The port 222 may further be dimensioned to accommodate insertion of the dilator device 228 used to guide the introducer into the target chamber (e.g., left ventricle, off-apex). The distal end 221 of the introducer 200 may have a tapered shape to seal against the delivery system lumen.
The shaft 110 may present a relatively low-profile delivery device, which may be dimensioned to fit within the lumen 220 of the introducer 200. For example, the shaft 110 may be an about 3 mm (9 Fr) shaft. Furthermore, the tip (e.g., end effector) 114 may advantageously be flexible to allow for insertion into the lumen 220 even where the lumen 220 has a smaller diameter than the extended diameter of the tip 114.
Once a suitable entry point has been established, the surgeon can use one or more sutures to make a series of stiches in one or more concentric circles in the myocardium at the desired location to create a “purse-string” closure. The Seldinger technique can be used to access the left ventricle in the area surrounded by the purse-string suture by puncturing the myocardium with a small sharp hollow needle (a “trocar”) with a guidewire in the lumen of the trocar. Once the ventricle has been accessed, the guidewire can be advanced, and the trocar removed. The valved introducer 200 (e.g., the introducer 200 with dilator 228 extending through the lumen 220 of the introducer) can be advanced over the guidewire to gain access to the left ventricle. The guidewire (not shown) and dilator 228 can be removed while the introducer 200 maintains hemostasis, with or without a suitable delivery device inserted therein, throughout the procedure. Alternatively, the surgeon can make a small incision in the myocardium and insert the introducer 200 into the heart via the incision. Once the introducer is properly placed, the purse-string suture can be tightened to reduce bleeding around the lumen of the introducer.
A suitable tissue anchor delivery device, such as a delivery device as described in the '761 PCT Application and/or the '170 PCT Application, may be advanced into the body and through the valved introducer in a manner to access the left ventricle. The advancement of the device may be performed in conjunction with echo imaging and/or direct visualization (e.g., direct transblood visualization). For example, the delivery device may be advanced in conjunction with transesophageal echocardiogram (TEE) guidance or intracardiac echo (ICE) to facilitate and direct the movement and proper positioning of the device for contacting the appropriate apical region of the heart. Typical procedures for use of echo guidance are set forth in Suematsu.
In some implementations, after prepping and placing the subject under anesthesia, echo imaging, such as involving TEE (two-dimensional (2D) and/or three-dimensional (3D)), transthoracic echocardiography CITE), ICE, and/or cardio-optic direct visualization (e.g., via infrared vision from the tip of a 7.5 F catheter), or other imaging modality, may be performed to assess the heart, heart valves, and/or tissue anchor delivery device component(s). For example, echo imaging can be used to guide positioning of tissue anchor(s) (e.g., suture knots) onto a target valve leaflet. However, guidance of an anchor delivery device shaft to the proper position on a mitral valve leaflet as performed under echo guidance can be difficult due, for example, to the level of resolution of the echo guidance technology, and/or equipment or software limitations. As certain mitral valve leaflet repair procedures using tissue anchors, as described herein, can be performed on a beating heart, motion of the beating heart, including the mitral valve leaflets, can also interfere with desired visualization under echo.
Although the procedures described herein are with reference to repairing a cardiac mitral valve or tricuspid valve by the implantation of one or more leaflet anchors and associated cord(s), the methods presented are readily adaptable for various types of tissue, leaflet, and annular repair procedures. The methods described herein, for example, can be performed to selectively approximate two or more portions of tissue to limit a gap between the portions. That is, in general, the methods herein are described with reference to a mitral valve but should not be understood to be limited to procedures involving the mitral valve.
With reference to
Echo imaging guidance, such as transesophageal echocardiogram (TEE) (2D and/or 3D), transthoracic echocardiogram (TTE), and/or intracardiac echo (ICE), may 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 (e.g., underside surface with respect to the illustrated orientation of
In some instances, one or more perforation devices 130 (e.g., needle(s)) can be delivered through a working lumen (not shown) of the shaft no to the valve leaflet 54 to puncture the valve leaflet 54 and project a sutureform 191 including a plurality of winds of suture about a distal portion of a needle 130 into the atrium 32 (see
Once the tip 114 is positioned in the desired position, the distal end of the shaft no and the tip 114 may be used to drape, or “tent,” the leaflet 54 to better secure the tip 114 in the desired position, as shown in
With the shaft 110 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 a pusher disposed within the shaft no, such that the coiled sutureform portion 191 of the suture anchor slides off the needle 130. As the plunger 140 is actuated, a distal piercing portion of the needle 130 punctures the leaflet 54 and forms an opening in the leaflet.
As the pusher (not shown) within the tissue anchor delivery device shaft no is moved distally, a distal end of the pusher advantageously moves or pushes the distal coiled sutureform 191 (e.g., pre-deployment coiled portion of the suture anchor) over the distal end of the needle 130 and further within the atrium 32 of the heart on a distal side of the leaflet 54, such that the sutureform extends distally beyond a distal end of the needle 130. For example, in some instances, at least half a length of the sutureform 191 extends beyond the distal end of the needle 130. In some instances, at least three quarters of the length of the sutureform 191 extends beyond the distal end of the needle 130. In some instances, the entire coiled sutureform 191 extends beyond the distal end of the needle 130.
After the sutureform 191 has been pushed off the needle 130, pulling one or more of 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 sutureform 191 to form a bulky knot anchor 190, as shown in
In certain examples, the pledget 71 is a low-porosity and relatively stiff pledget. Such a pledget may advantageously allow for the desired tension of the suture tails 195a to be sustained over an extended post-operative period of time. In some examples, suture tying or fixation may be implemented using one or more soft tissue retractors and/or right-angle clamps, which may be rubber-shod to reduce the risk of damage to the replacement cords.
In certain implementations, testing of location and/or tension of the anchor 190 and/or suture tail(s) 195 may be performed by gently tensioning the suture tails until leaflet motion is felt and/or observed. Echo imaging technology may be used to view and verify the anchor placement and resulting leaflet function. The steps and processes outlined above for placing a suture-knot-type tissue anchor may be repeated as necessary until the desired number of anchors have been implanted on the target valve leaflet. In some implementations, tension adjustment in the suture tail(s)/cord(s) associated with multiple leaflet anchors may be performed simultaneously. The appropriate number of leaflet anchors may advantageously be determined to produce the desired coaptation of the target valve leaflets 54, 52. All deployed leaflet anchors may advantageously be below the surface of coaptation. With respect to posterior mitral valve leaflet repair, the anterior leaflet may advantageously touch the posterior leaflet basal to the leaflet anchor(s). The pledget 71 may be drawn against the epicardial surface, and all the suture tails/cords 195b, may be inserted through a tourniquet so that all cords can be tension to the desired effective coaptation together.
In some implementations, one or more leaflet anchors is deployed in each of the mitral valve leaflets, wherein sutures/cords coupled to separate leaflets are secured together in the heart by tying them together with knots or by another suitable attachment device, creating an edge-to-edge repair to decrease the septal-lateral distance of the mitral valve orifice.
With further reference to
When relying upon echo imaging, problems and/or difficulties may result from loss of visibility of one or more components of the tissue anchor delivery device, such as loss of visibility of the tip of the anchor-delivery shaft. In such instances, it may be necessary to re-start the anchor-placement procedure. Because the tissue anchor delivery device is inserted through a port in the heart, re-starting delivery of a leaflet anchor can involve additional manipulation on the entry side of the heart, which may result in increased trauma that may have detrimental effects on the cardiac tissue. Examples of the present disclosure advantageously allow for quickly moving the shaft of a tissue anchor delivery device from an introducer to a target location on a target valve leaflet through improved visibility of the delivery shaft and/or other components of the tissue anchor delivery device.
Echo imaging is commonly used with cardiothoracic procedures. For example, for procedures implementing transapical access, rather than intravenous access, in accordance with examples of the present disclosure, fluoroscopy imaging may not provide a practical or tenable solution for imaging. Furthermore, as fluoroscopy can involve exposure of the patient to radiation, such imaging may be undesirable in connection with valve-repair procedures in some situations. Therefore, echo imaging can provide a preferable solution for visibility in valve-repair procedures in accordance with examples of the present disclosure. However, for tissue anchor delivery devices comprising relatively low-echogenicity shafts and/or other components, such components may produce only relatively faint images thereof under echo. Therefore, images of anchor delivery device shafts can become blended or obscured with/by background anatomy and/or images. Therefore, examples of the present disclosure that provide improved echogenicity and/or imaging visibility for components of a tissue anchor delivery device may allow for relatively easy navigation of the delivery shaft from the port of entry into the target ventricle to the target valve leaflet(s) (e.g., mitral valve leaflets). Furthermore, such improved visibility may facilitate avoidance by the operator of anatomy or areas in which the delivery shaft and/or associated components of the tissue anchor delivery device may become entangled or caught. For example, examples of the present disclosure may facilitate avoidance of native chordae tendoneae, thereby reducing the risk of injury or damage to native anatomy/tissue. Furthermore, improved visibility of anchor delivery shafts and/or other components of the tissue anchor delivery device may facilitate improved targeting of the target leaflet, which may result in improved coaptation and/or results from valve repair intervention.
Examples of the present disclosure provide echogenic shafts and/or associated components of tissue anchor delivery devices for certain medical procedures, such as mitral valve repair procedures, which may improve health prospects of patients suffering from degenerative mitral regurgitation. As described in detail above, such procedures may involve transapical, off-pump, echo-guided repair, wherein a tissue/leaflet anchor delivery device shaft is inserted in the left ventricle and steered to the surface of the diseased portion of the target mitral valve leaflet for deployment/implantation of a leaflet anchor, such as a suture-knot-type anchor, which may advantageously be coupled to one or more suture tails that provide artificial leaflet cord functionality. Such sutures may comprise expanded polytetrafluoroethylene (ePTFE) in some instances.
In accordance with leaflet anchor deployment processes outlined herein, a delivery device shaft can be passed through an introducer device and advanced inside the ventricle under echo (e.g., ultrasound) guidance. Such imaging implementation may utilize, for example, Transthoracic Echocardiography (TTE) probe device or a Transesophageal Echocardiography (TEE) probe device. However, it should be understood that inventive features disclosed herein may be applicable to any type of imaging devices/modalities.
In order to reliably navigate through the ventricle and place the leaflet anchor(s) in precise targeted locations on the target segment of the mitral valve, it may be necessary or desirable for the ultrasound image of the anchor delivery device shaft to be clearly visible in relation to the surrounding structures. However, during surgery, the appearance of a medical device shaft can be faint, blurry, and come in-and-out of focus in the field of view, thereby providing a misleading and inaccurate impression of the shape and/or location of the shaft or create confusion between the shaft and artifact(s). Specifically, when the echogenicity of the shaft no during its operation is not relatively high, tracking and visualization of the shaft can be very challenging.
Examples of the present disclosure provide medical device shafts having relatively high echogenicity in order to improve visibility during surgical procedures. Examples of the present disclosure may implement any suitable or desirable echogenicity-enhancement features (also referred to herein as “image-enhancement” features) in medical device shafts and/or other devices. For example, devices and surfaces having echogenicity-enhancement features in accordance with the present inventive disclosure can include texturing or roughening of device surfaces, adhering particles to device surfaces, utilization of reflectors, creating indentations or holes in the device/surface, using dissimilar materials in a device, and other image-enhancement mechanisms or techniques.
Echocardiography utilizes sonic imaging to provide sonogram images of the heart, or portion thereof. Generally, echocardiography can utilize two-dimensional, three-dimensional, and/or Doppler ultrasound to create images of the heart, including real-time images. In some implementations, echocardiography can involve the use ultrasonic pulse echo imaging, or other technology. With respect to
In some implementations, valve-repair imaging in accordance with examples of the present disclosure may incorporate three-dimensional (3D) echocardiography technology, which may implement a matrix array ultrasound probe in combination with appropriate processing system. Such imaging modality may enable detailed anatomical assessment of cardiac pathology, including valvular defects and cardiomyopathies. Real-time 3D echocardiography can be used to guide the location of a tissue anchor delivery device shaft, as described in detail herein, within a chamber of the heart, such as the left ventricle for mitral valve leaflet repair. Therefore, echo imaging may be used to provide intraoperative assessment of cardiac anatomy and repair system component(s).
In
Multi-lumen shafts in accordance with examples of the present disclosure may be used in association with contrast echocardiography to provide improved imaging and/or visibility during valve-repair procedures, or other medical interventions. For example, in some instances, ultrasound contrast medium, or imaging agent, may be contained within a lumen or chamber of a medical device shaft and/or flow therethrough during a valve-repair procedure to provide improved imaging/visibility.
The degree to which materials and media reflect soundwaves may be referred to as “echogenicity,” as described and used herein in accordance with its broad and ordinary meaning, which generally refers to the ability of a material or surface to bounce an echo (e.g., return a sound/ultrasound signal). That is, echogenicity may be considered higher when the surface bouncing the sound echo reflects increased sound waves. Materials/surfaces having relatively higher echogenicity may be referred to as “hypoechogenic,” or simply “echogenic,” and may usually present visually with lighter colors on echo imaging. In contrast, materials/surfaces with relatively lower echogenicity may be referred to as “hypoechogenic,” or “non-echogenic,” herein.
Anchor delivery shafts in accordance with instances of the present disclosure may have improved echogenicity characteristics through the use of one or more chambers or lumens having disposed therein certain gas/fluid and/or other media or surface characteristics that provide increased reflection of sound waves. For example, examples disclosed herein provide multi-lumen shafts, wherein one or more lumens or chambers thereof are filled with gas or other contrast media. Such gas/media may provide a density interface between the shaft and the gas/fluid disposed in one or more lumens thereof. For example, a shaft in accordance with examples of the present disclosure may comprise a substantially solid/rigid material, such as stainless steel or the like, that has one or more portions thereof that are filled with fluid or media that is less dense than the solid/rigid material of the shaft, thereby providing a reflection interface between the materials.
With reference back to
Examples of echogenic medical device shafts in accordance with the present disclosure may advantageously comprise one or more fluid-/media-filled image-enhancing lumens or chambers, as well as one or more working lumens for transporting repair devices and/or tools in connection with a medical procedure. Some examples of the present disclosure relate to multi-lumen anchor-delivery shafts that provide improved echogenicity characteristics compared to certain other tissue anchor deployment solutions.
The working lumen 405 may be used to encapsulate needle and pusher components of a tissue anchor delivery device, as described in detail above. In some examples, the working lumen 405 may be disposed generally centrally about a longitudinal central axis of the shaft 410, whereas one or more of the image-enhancement lumens 402, 404 may be dispose in the periphery around at least a portion of the working lumen 405 and adjacent thereto, as shown in
The shaft 410 is a multi-lumen shaft, wherein one or more lumens associated with the shaft are to be shaped and/or configured to receive and/or contain echogenic contrast media/gas, as described in detail herein. The shaft 410 of the illustrated embodiment of
The shaft 410 may be associated with or coupled to a substantially atraumatic 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 an introducer device to gain access to the target heart ventricle, the tip 414 may be configured to flex backward in the direction of the proximal end of the shaft 410, such that the channel of the introducer through which the shaft 410 is advanced need not necessarily be as large in diameter as the tip 414. Through use of a flexible leaflet-contact tip 414 and appropriately dimensioned lumens 402, 404, 405, the shaft 410 of
With one or both of the lumens 402,404 having disposed therein air or other gas or contrast media that has relatively high echogenicity characteristics, the shaft 410 may appear relatively brighter visually in an echocardiography image compared to a similar shaft not having such additional lumen(s). The shaft 410 may have any size or shape. In some examples, the multi-lumen shaft may be formed using an extrusion process.
The embodiment of
At block 1404, the process 1400 involves advancing a multi-lumen shaft of the tissue anchor delivery device through the lumen of the introducer device to thereby introduce a distal portion of the multi-lumen shaft into the ventricle of the heart. The multi-lumen shaft may advantageously comprise one or more echogenic at least partially fluid-filled lumens. Such lumens may be closed-off to outside fluids, such that the lumens are fluid-tight, or may allow for fluid flow through and out the echogenic lumen(s).
At block 1406, the process 1400 involves generating an image of the multi-lumen shaft using echo imaging, as described in detail herein. For example, such imaging may be generated using an echo transducer/probe, which may be placed or disposed at or near the chest of the patient. Compared to traditional shafts, which can be associated with echo images that are faint, blurry, and/or come in-and-out of focus in the field of view, and thereby mislead the surgeon and echo cardiographer, the multi-lumen shaft may provide a clearer echo image. At block 1408, the process 1400 involves 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.
The shafts of
At block 804, the process 800 involves melting the material that is used as the substrate for the multi-lumen shaft. For example, a polymer/plastic (e.g., thermoplastic), or any other suitable or desirable material may be melted using a hopper or other type of machinery or mechanism. At block 806, the process 800 involves forcing the melted material through the die to form the desired multi-lumen shaft/tube. At block 808, the process 800 involves cutting the extruded/formed tube into one or more sections, each of which may serve as a shaft component of a tissue anchor delivery device in accordance with examples of the present disclosure. The extruded tube may be permitted to cool prior to cutting in some implementations. The process 800 may optionally further involve coupling the extruded tube section to a relatively-rigid shaft/lumen, such as a stainless-steel shaft. For example, the extruded tube may be slid or otherwise engaged around the stainless-steel shaft. Certain shafts disclosed herein may advantageously comprise stainless steel, which may provide suitable or desirable strength and/or density, as well as echogenicity characteristics. Furthermore, stainless-steel shafts and/or components thereof may advantageously provide a relatively stable platform for deploying leaflet anchors (e.g., bulky knot anchors), and furthermore, stainless steel may have desirable biocompatibility characteristics as well.
Although various examples are disclosed herein of multi-lumen shafts that comprise a single integrated form, in some examples, a multi-lumen shaft may comprise a plurality of lumens or shafts having separate tubes that are coupled together in some manner, wherein one or more of the tubes is used as a working lumen and one or more of the tubes is used as a fluid-filled image-enhancement lumen.
As described briefly above, according to some examples, an image-enhancement tube, sleeve, or component may be manufactured as a separate component from a working lumen/shaft used for a tissue anchor delivery procedure. For example,
The sleeve 701 may have an elongated tubular shape, wherein the image-enhancement lumens/compartments 703 run longitudinally through at least a portion of the length of the tube. The sleeve 701 may further include a working-shaft-receiving lumen 707 through which a working shaft 715 may be inserted. For example, in some examples, the sleeve component 701 is formed of a polymer or plastic, whereas the working shaft 715 is formed of a more rigid material, such as stainless steel or the like. Such a configuration may 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 is less reflective of sound waves than that 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 may generally be positioned adjacent to the working lumen 707. The shaft 715 may comprise a rigid elongate tube forming at least one internal lumen, as shown.
The working shaft 715 may be used to advance various anchor-deployment devices/tools, as described herein, whereas the sleeve component 701 may be incorporated to provide improved imaging due to enhanced echogenicity of the fluid-filled lumens 703. Although image-enhancement sleeves and components are described herein as being coupled with tissue anchor delivery device shafts, it should be understood that image-enhancement sleeves and lumens in accordance with examples of the present disclosure may be utilized in connection with any type of medical device shaft, or non-medical device shafts that can benefit from improved visibility under echo. Furthermore, although the sleeve 701 is illustrated as a tubular sleeve, it should be understood that image-enhancement components having features similar to those shown and described with respect to the sleeve component 701 may have any suitable or desirable form, including a wrap, clip, band, and/or the like. Furthermore, the image-enhancement component 701 may be configured to fit over any size shaft. With respect to wrappable image-enhancement devices, such devices may be able to provide image-enhancement by fitting around shafts or devices having different diameters and/or sizes.
Shaft with Outer Helical Wire
Various examples disclosed above relate to medical device shafts having image-enhancement lumens or chambers that run substantially longitudinally along the axis of the shaft. In certain examples, at least partially circumferentially- or horizontally-running lumens or chambers may be utilized to provide improved imaging with respect to a medical device shaft. For example, any of the examples disclosed above having image-enhancement lumens within a tubular form may be implemented with such lumens winding circumferentially around the tube as opposed to strictly longitudinally. Such circumferential/horizontal lumens may be generally helical in shape, wherein at least a longitudinal segment of the shaft is traversed by a helical lumen forming a plurality of winds of coil/channel about the shaft. Alternatively or additionally, the lumens/channels may be generally circular, wherein the shaft is associated with a plurality of separate concentric hoop-shaped lumens/channels.
In some examples, a helical coil or tube may be wrapped around an outer working shaft to thereby provide improved imaging visibility as described herein. For example,
Although helically-shaped, and other geometrically-shaped, forms, patterns, and devices are disclosed for enhancing echogenicity in accordance with certain examples disclosed herein, such forms, patterns, and devices may be irregularly-shaped and/or non-geometrical in shape. For example, the shaft assembly 315 may have forms, shapes, members, devices, and/or features/components that are non-geometric in shape and/or irregular in shape or form that are configured to trap or hold fluid (e.g., air) and/or provide uneven surfaces designed to increase echogenicity. Furthermore, such forms, members, devices, and/or features/components may be associated with any other type of device or assembly other than the shaft 310 and assembly 315, including other types of medical device shafts or non-medical devices.
The wire 317 may be wrapped around the shaft 310 in a generally helical fashion. As shown, the image-enhancement spaces 302 may generally be positioned adjacent to the working lumen 305.
The shaft assembly 315 of
The outer cover 319 may comprise a polymer tube, which may be slid or otherwise positioned or disposed over the wire/coil 317 and/or shaft 310. In some implementations, heat may be used to cause the cover 319 to shrink and/or adhere to the wire 317 to provide lamination thereof. Such process may result in air or other fluid being trapped between the wraps/coils of the wire 317, such as in the spaces 302 illustrated in
As with all examples disclosed herein, the chambers, gaps, channels, lumens, and/or other non-working (and possibly fluid-sealed) compartments associated with the shaft 310 and/or shaft assembly 315 can be gas-filled (e.g. air, perfluorocarbon, nitrogen, or the like) or liquid-filled. For example, such gas- or other fluid-filled compartments may have no fluid communication with the working (e.g., central) lumen, which may primarily serve as a housing for a needle, pusher, and tissue anchor assembly, as described herein. In some examples, the shaft assembly 315 comprises alternating bands of uniform raised metals with gas trapped in between the bands. Certain of these examples, like the embodiment of
Variation in pitch between adjacent coils may allow for simplified location/identification of the distal end or portion 2502 of the shaft assembly 2515 relative to the proximal end or portion 2501 of the shaft assembly. In some examples, the spacings between coils along the length of the shaft 2510 are substantially uniform across certain lengths or sections of the shaft. Alternatively, the spacings may increase continuously/gradually from one area to another area of the shaft 2510. Although
The shaft image 2615 may present as relatively highly detectable compared to medical device shafts not including image-enhancement characteristics as described herein. The image of the shaft 2615 may show bands of visibility corresponding to the coil banding described above with respect to
Generally, the image of the shaft 2615 and the artifact 2603 may converge at or near the tip 2614 of the shaft. Therefore, the tip 2614 may serve 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. In addition to the image-enhancement provided by the fluid-filled spaces between coils of the wire disposed around the shaft 2615, such outer coil embodiments may further provide improved imaging/visibility due to the irregular outer surfaces associated with the shaft and coil. In some embodiments, the working shaft may have an etched outer surface to form an irregular and relatively more reflective outer surface.
At block 704, the process 700 involves sliding, wrapping, or otherwise disposing a helical wire around at least a portion of the outer surface of the medical device shaft. The helical wire may be a substantially-solid wire or may alternatively comprise a tubular wire having an internal lumen configured and/or designed to receive and/or maintain fluid, such as air, therein. In some embodiments, the wire is disposed about the medical device shaft in such a way as to produce spacing or gaps between adjacent coils/turns of the wire. In some embodiments, substantially no spacing is present between adjacent coils/turns of the wire.
At block 706, the process 700 involves sliding, wrapping, or otherwise disposing a covering about the medical device shaft and helical wire. The covering may advantageously be substantially fluid-tight, such that air or other fluid present between adjacent coils of the wire may be substantially trapped therein, and further fluid external to the shaft assembly may not be permitted to enter within the covering. In some embodiments, disposing the covering about the shaft assembly may comprise laminating the medical device shaft and helical wire. For example, the covering may comprise a polymer sleeve or tube that may be heat-set to fit and/or adhere the covering to the helical wire and/or shaft. At block 708, the process 700 may involve heat-setting the covering to seal the covering and/or fluid in the wire gaps/spacings. At block 710, the process 700 involves incorporating the shaft assembly including the medical device shaft, the wire, and the covering in a tissue anchor delivery device or system, or other type of device or system used for performing a medical or non-medical procedure.
Examples disclosed above relate to helical and/or horizontal echogenic fluid channels in medical device shaft assemblies, wherein the fluid channels are in the form of spacings between adjacent coils of a wire or structure and/or within a lumen of a tubular wire wrapped around a medical device shaft. Alternatively, echogenic fluid channels in a medical device shaft assembly may take the form of recesses cut or etched into a tubular shaft to form channels/grooves. For example,
In some examples, the die 609 may be operated by rotating the die 609 about the shaft 610, wherein rotation relative to the shaft 610 causes a groove or channel of the desired depth and dimensions to be cut into the outer surface of the shaft 610 in a helical fashion.
Although
In some examples, the outside of the shaft 610, including the grooves/channels 613, may have shrink tubing or other covering 619 disposed or wrapped thereon, such that air or other fluid or contrast media is trapped and/or disposed within the grooves/channels 613 between the walls of the grooves/channels and the covering 619. The grooves/channels 613 may run around the circumference of the shaft 610 in a generally helical fashion. The shaft assembly 315 of
In some examples, the present disclosure relates to multi-lumen medical device shafts configured to have echogenic contrast media injected therein. For example, echogenic microbubbles, or other contrast media, may be injected and/or ejected at or near the tip of a medical device shaft, which may allow for marking identification of the tip of the shaft at different points in time. Such contrast media may be injected, and/or flow or be maintained within, a lumen similar to lumens disclosed herein, or alternatively may be used in balloon-type lumens, as described in detail below.
In some examples, the contrast medium may comprise microbubbles, which may be filled with a gas core and/or have a protein shell. Such microbubbles may advantageously be highly reflective of sound waves and return the sound waves from an echo (e.g., ultrasound) probe to create a highly-reflective image. In certain examples, microbubbles of a contrast medium may be substantially benign when introduced into the cardiovascular system, and therefore may be allowed to flow from a tissue anchor delivery device shaft into the heart and cardiovascular system during a valve-repair procedure.
As described in detail herein, echogenicity of tissue anchor delivery device shafts can be increased by adding gas-filled microbubble contrast media within one or more lumens or chambers of the shaft, to thereby provide contrast-enhanced visibility of the shaft. Microbubbles can provide a relatively high degree of echogenicity due to their ability to compress, oscillate, and reflect a characteristic echo of an ultrasonic frequency, thereby providing an enhanced sonogram of components containing such contrast media. Contrast media in accordance with examples of the present disclosure may comprise air and/or heavy gases, such as perfluoro carbon or nitrogen, or the like. For example, relatively heavy gases may be less water-soluble than air, and may therefore be less likely to leak out from the microbubble to impair echogenicity. Therefore, microbubbles with heavy gas cores may be preferable in some implementations.
In addition to the use of contrast media within valve repair shafts, echogenicity of such shafts may be increased in accordance with examples of the present disclosure through use of interior or exterior surfaces of the shaft that have certain echogenic characteristics. For example, the outside surface of a shaft in accordance with examples of the present disclosure may have certain texturing, roughening, and/or particle-adhesion characteristics to provide a relatively highly echogenic surface of the shaft to improve visibility thereof under echo imaging. Furthermore, surfaces and components of an anchor delivery device shaft in accordance with examples of the present disclosure may have improved echogenicity characteristics by presenting interfaces between materials of different densities, such as between stainless steel or other metal or hard surface of the shaft and air or other gas or medium disposed or contained adjacent thereto.
In some examples, moving lipid-coated echogenic microbubbles are incorporated in some manner into the shaft of a device. In connection with certain medical procedures, clinicians can use ultrasound contrast agents comprised of lipid-coated echogenic microbubbles filled with octafluoropropane gas to aid in the view of, for example, the left ventricle during diagnosis. In some implementations, such echogenic microbubble media can be used to aid in the echo navigation of a device by ejecting them through the inner lumen of the device to locate the distal tip or by injecting them into a balloon that at least partially surrounds the device shaft.
With respect to tissue anchor delivery devices in accordance with examples of the present disclosure, in some implementations, by injecting echogenic microbubbles through an inner lumen of a delivery device shaft, and either out of the atraumatic tip or out of a side port, a surgeon and/or echocardiographer can quickly locate the distal tip or portion of the shaft. For example, when the shaft of an anchor delivery device is draped/tented against a target leaflet, as described above, it can become difficult to distinguish the distal tip of the shaft from the leaflet tissue in some situations. Examples of the present disclosure can involve the ejecting of echogenic microbubbles from a tissue anchor device shaft before/during deployment of a tissue anchor therefrom to facilitate relatively easy location of the tip of the shaft based at least in part on the contrast in echo signature created thereby.
In some implementations, the present disclosure relates to medical device shafts having a balloon-type material or structure laminated or otherwise coupled to the outside of the device shaft, wherein echogenic contrast media can be flushed in and out of the balloon to agitate the contrast media (e.g., microbubbles of the contrast media) and create a brightened echo signature. This brightened echo signature can aid in the navigation of the delivery device shaft by making it more easily distinguishable from the surrounding blood and/or anatomy. During the insertion and removal of a balloon-type echogenic shaft in accordance with the present disclosure, the balloon feature(s) may be compressed to provide a relatively smaller shaft outer profile for insertion/withdrawal and/or navigation of the shaft.
Examples disclosed herein may utilize any suitable or desirable echogenic contrast media. For example, microbubble contrast media may be desirable in some situations. Contrast media in accordance with examples of the present disclosure may comprise saline, indocyanine green, hydrogen peroxide, dextrose, renografin, autologous blood injections, cyanoacrylate and/or other synthetic polymer(s). Generally, contrast media in accordance with examples of the present disclosure may advantageously provide alterations in the reflection pattern of sound waves. For example, such contrast media may increase the backscattered signal. In addition, contrast media may resonate sound waves in a relatively linear manner.
In some implementations, the contrast media may comprise an inner gas encapsulated by a shell that promotes desirable viscoelastic properties, including stability and durability. The type of gas used in microbubble contrast media may determine at least in part solubility and/or acoustic properties of the bubbles. Microbubbles, such as perfluoro carbon microbubbles may range from approximately 1-10 μm in size, which may be suitable for propagation in the systemic circulation. Soft-shell microbubble examples can comprise phospholipids or other surfactants, whereas protein-shelled microbubble examples can comprise an albumin shell around perfluoro propane gas. Although microbubble contrast media is described herein, it should be understood that the examples disclosed herein may utilize nano-bubble contrast media, which may generally refer to contrast media comprising bubbles having a size of between 400-800 nm.
In some implementations, the sonic reflection of contrast media in connection with delivery device shafts may provide improved echogenicity characteristics through the use of flow or movement of the contrast media. That is, for microbubble contrast media, reflection off the microbubbles may be enhanced by fluid motion, causing images to appear brighter in reverberation.
In some examples, the shaft assembly 915 includes a port 918, such as a side port, which may be utilized to inject contrast media fluid 909, such as microbubble fluid, which may in turn be ejected from the shaft assembly 915 at or near a distal end thereof. By ejecting the fluid 909 from the shaft 915, it may be easier to visualize and/or identify the tip or distal portion of the shaft assembly 915. The fluid-injection port 918 can be considered to be fluidly coupled to, or in fluid communication with, the first image-enhancement lumen in that fluid may flow between the port 918 and the lumen(s) 902, 904.
By containing the fluid 909 within the shaft 910, a contrasting image between the shaft 910 and the surrounding blood within the ventricle and/or other tissue/anatomy may be apparent. For example, under certain echo imaging modalities, the fluid-containing lumens 902, 904 may present as significantly brighter than the surrounding environment. Although
Compared to certain other imaging solutions incorporating and relying solely on relatively dense materials like stainless steel in order to create an echo signature that contrasts sufficiently with environmental blood and surrounding anatomy, image-enhancement principles disclosed herein can provide relatively higher echogenicity properties by using materials with a density significantly different from blood or tissue, thereby manipulating how sound attenuates through the material and creating desirable contrasting echo signatures. For microbubble-utilizing embodiments, the relatively heavy gas molecules that may be used/trapped inside such echogenic microbubbles can offer a relatively greater magnitude of difference in density compared to blood and tissue than some denser materials like stainless steel. In addition, when such microbubbles are caught in an ultrasonic frequency field, they can be inclined to compress and oscillate to create an even brighter echosignature. Echo image brightness can further be supplemented by ejecting the microbubbles out of the shaft/device or flushing them through a balloon that surrounds the device, as described in detail below. Furthermore, the microbubble contrast fluids disclosed herein are generally advantageously safe for use in certain medical procedures. Although the term “shaft assembly” is used herein to refer to medical devices comprising a shaft associated with one or more additional features or components, it should be understood that such assemblies may be referred to simply as “shafts,” rather that shaft assemblies. That is, references herein to a “shaft,” which is used herein according to its broad and ordinary meaning, should be understood to apply to a shaft component alone or to a shaft assembly incorporating, or associated with, one or more additional features or components as described herein. Therefore, use of the term “shaft” may refer herein to a shaft assembly.
Compared to embodiments incorporating rigid image-enhancement lumens, incorporation of balloon-type image-enhancement features in medical device shafts may advantageously be expandable and/or collapsible in certain respects. Furthermore, the flexibility of certain balloon-type image-enhancement features may allow for gas bubbles in contrast fluid to move relatively freely within the balloon(s) without obstruction that may be present with thicker and/or more rigid fluid channels, thereby providing improved visibility under echo. In some embodiments, the balloon feature(s)3450 have a wall thickness of approximately 70-100 μm (about 0.003 to 0.004 inches). In some implementations, the balloon feature(s)3450 may allow for insertion of the shaft assembly 3415 into an anatomical chamber in a deflated state, thereby providing a relatively low profile for the shaft assembly 3415. The balloon feature(s)3450 may subsequently be inflated at least in part after the shaft 3415 has been inserted into the patient. Therefore, embodiments of the present disclosure may advantageously allow for devices providing additional image-enhancement fluid volume when necessary without requiring accommodation for such volume during device introduction.
The shaft assembly 3515 may further include one or more side ports 3552 to eject contrast media 3509 contained in the balloon feature(s) 3550. In some implementations, the balloon feature(s) 3550 may comprise a tube or other form implemented over the working lumen 3505 and/or shaft 3510. In some implementations, the contrast fluid 3509 may be injected into the balloon feature(s) 3550 from the proximal end/area of the balloon feature(s) 3550 and/or shaft assembly 3515 and may 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 may be continuously ejected from the balloon feature(s)3510, such as out of one or more ports 3552 associated with a distal portion of the shaft assembly 3515.
At block 3708, the process 3700 may optionally involve expelling or ejecting contrast fluid from chamber(s)/lumen(s) within the target ventricle, such as through one or more ejection ports associated with the medical device shaft. At block 3708, the process 3700 involves generating echo imaging of the medical device shaft and/or the fluid-containing chamber(s)/lumen(s) associated therewith, wherein such imaging may provide guidance for the medical procedure. At block 3710, the process 3700 involves advancing the shaft to a target tissue anchor deployment site, such as a target valve leaflet, while visualizing the shaft under echo.
As described in detail herein, navigation of medical device shafts under echo guidance can be challenging in some situations and can require relatively extensive training and/or coordination between the surgeon and the electrocardiographer. In many instances, the echo signature of the medical device is less than optimal due to, for example, the various functional design requirements for the device. In particular, with respect to tissue anchor delivery device shafts, as disclosed herein, the tips of such devices can suffer from reduced visibility under echo when contacting target tissue (e.g., mitral valve leaflet tissue). Furthermore, lack of visibility can contribute to tissue damage and/or entanglement with neighboring anatomy when attempting to advance a medical device shaft within a target cardiac chamber. In addition, according to some implementations, navigation of medical device shafts may necessarily be repeated for subsequently-deployed tissue anchors or implantation of other types of devices.
In some implementations, the present disclosure relates to medical device shafts that are associated with a guideline (e.g., guidewire) that the shaft can be deployed alongside that is relatively more visible than the shaft alone. In some embodiments, the guideline may comprise a relatively small hollow tube having fluid, such as air, disposed in the lumen thereof, similarly to certain features disclosed above.
The introducer 3830 is a multi-port introducer, including a port 3853 for inserting the shaft 3810 as well as an additional port 3835 for inserting and advancing the guideline 3870. Use of a guideline port and echogenic guideline may help provide simplified navigation of devices under echo guidance. In some embodiments, the guideline 3870 is atraumatic and highly visible under echo. For example, the guideline 3870 may have a J-tip form 3875 at a distal end thereof, or any other feature that reduces the risk of tissue damage by the guideline. The guideline port may be oriented at a deflected angle with respect to the lumen 3832 of the introducer 3830. The dual ports of the introducer 3830 can allow the echogenic guideline 3870 and the shaft 3810 to be inserted at the same site. Furthermore, the dual ports may serve to align the guideline 3870 and the shaft 3810 so the shaft 3810 runs next to and parallel to the guideline. The introducer 3830 may advantageously be a hemostatic introducer.
At block 4004, the process 4000 involves advancing an echogenic guideline 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 involves advancing a tip of the echogenic guideline to a target location, such as on a ventricular side of a target heart valve leaflet (e.g., mitral leaflet) while visualizing the echogenic guideline under echo imaging. The echogenic guideline may be advanced to the target location in any suitable or desirable way.
At block 4008, the process 4000 involves advancing a medical device shaft through the main 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 guideline. The medical device shaft may generally follow the guideline to the proper target location. It may be beneficial to advance the guideline prior to advancing the medical device shaft in order to avoid masking/obscuring the echogenicity of the guideline in view of the medical device shaft. At block 4010, the process 4000 involves deploying a tissue anchor in the target valve leaflet or other target anatomy using the medical device shaft.
At block 4012, the process 4000 involves withdrawing the medical device shaft from the heart through the introducer. After tissue anchor deployment, the guideline may also be removed, or if additional tissue anchors are to be subsequently deployed, the guideline may be left in place at or near the target implantation site to allow the guideline to be re-used to guide a shaft to the target implantation site. Where additional anchor(s) are to be deployed, the process 4000 may loop back to block 4008, as shown. Therefore, the process 4000 may allow for placement/deployment of multiple tissue anchors without requiring additional echo navigation.
In some situations, using a guideline rail system as disclosed herein without having the guideline be attached or coupled to the shaft in some way may result in confusion of moving components due to the thin structure of the guideline and/or the pulsatile flow of the beating heart. In some embodiments, a port or engagement feature can be integrated with the medical device shaft, such as in the atraumatic tip thereof, to assist in the guidance of the medical device shaft along the guideline.
The device assembly of
The engagement feature 4116 facilitates attachment of the guideline 4170 to the tip 4114 of the shaft 4110 for improved echogenic visibility and ease of guidance up to the target implantation site (e.g., mitral valve). The tip 4114 of the shaft 4110 can comprise a flexible plastic form (also referred to herein as an “end effector”) that is generally circular in shape and allows atraumatic tenting of the shaft 4110 on the target valve leaflet. The engagement feature 4116 may comprise a relatively small hole or port to allow insertion of the guideline 4170, which can act as a rail system for the shaft 4110 during guidance from the introducer site up to the ventricular side of the target valve leaflet.
In some embodiments, the guideline 4170 can be inserted and removed independently from the delivery device shaft 4110. Once the hemostatic introducer is placed in the heart, the guideline 4170 may be inserted into the target ventricle through the introducer. In some implementations, the guideline 4170 may be engaged with the engagement feature 4114 and inserted engaged with the engagement feature 4116. The shaft 4110 may be passed through introducer into the target ventricle using the echogenic guideline as a rail system to navigate up to the target leaflet. In some implementations, the guideline 4170 may be removed prior to tissue anchor deployment.
Having the guideline 4170 attached to the shaft tip 4114 can facilitate relatively precise imaging of the shaft 4110 for the entirety of guidance from the insertion site up to the target leaflet. Furthermore, after confirmation that the shaft tip 4114 is positioned on the target leaflet, the guideline 4170 can be removed to allow normal deployment of the tissue anchor. With the guideline 4170 actually attached to the tip 4114 during navigation, the device of
Although the engagement feature 4116 is shown as a circular hole, it should be understood that the engagement feature may have any suitable or desirable shape or form. In some embodiments, the engagement feature allows for disengagement of the guideline 4170 within the ventricle. For example, the engagement feature may have a hook-type form with a radial disengagement path through which the guideline can be drawn out of the engagement feature 4114 radially with respect to the axis of the shaft 4110.
Using a removable, atraumatic guideline 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 guideline to the shaft can also facilitate maintenance of the guideline in a parallel alignment with the shaft. Although the engagement feature 4116 of
In some embodiments, the end effector 4214 may comprise a generally circular tip having a diameter of, for example, approximately ¼ of an inch. In some embodiments, the shaft 4210 comprises an elongate tubular form of stainless steel. The shaft 4210 can have, for example, an outer diameter of approximately 2 mm (about 0.083 inches) and/or an inner diameter of approximately 1.6 mm (about 0.063 inches). In some embodiments, the shaft 4210 is coated in urethane or other (e.g., polymeric) material, which may advantageously be designed to enhance echogenicity of the shaft 4210 based at least in part on the density interface between the shaft and the coating.
In some embodiments, the shaft 4210 and/or end effector 4214 can comprise materials with certain echogenic additives added thereto. For example, the forms of the shaft 4210 and/or end effector 4214, and/or coatings/coverings applied thereto, can comprise embedded particles and/or air pockets therein, which can create non-homogeneous coating/surfaces that increase the reflection coefficient of the material, thereby increasing echogenicity. Generally, end effectors and/or shaft coverings in accordance with embodiments of the present disclosure may present discontinuity in material densities, such as between the flexible form/material of the end effector and/or shaft covering (e.g., thermoplastic rubber or the like) and certain additives associated therewith, such as air-filled and/or hollow glass spheres (e.g., gas-filled microspheres), metal particulates, or any of the other implementations disclosed herein.
The shaft 4210 and/or end effector 4214 may have features or characteristics that provide relatively high echogenicity for such components when compared to a stainless-steel shaft with a homogeneous/uniform thermoplastic rubber end effector. With respect to the diagrams of
Description herein of shafts having enhanced echogenicity characteristics may relate to other types of devices, including flexible catheters, sheaths, and/or other tubular and/or lumen-forming devices. Therefore, the various embodiments disclosed herein should be understood to be applicable to any type of medical device for which enhanced echogenicity may be desired. Furthermore, as with other embodiments disclosed herein, description below of shafts and/or end effectors with echogenicity-enhancing characteristics are applicable to non-medical shafts and end effectors. With respect to the end effector 4214, high-echogenicity characteristics may be implemented with respect to a distal end surface 4216 thereof, side surface 4218, and/or any other area (e.g., area below the surface(s) of the end effector 4214).
In some embodiments, medical device/instrument shafts comprise tubular forms comprising stainless steel or other at least partially rigid material. In some embodiments disclosed herein, echogenic coverings or coatings may be disposed/applied over at least a portion of a medical instrument shaft to provide enhanced echogenicity for the shaft. For example, with further reference to
In some embodiments, the end effector 4214 is formed initially as part of an extrusion used for covering at least a portion of the shaft 4210, wherein the illustrated shape of the end effector can be die-cut from the distal portion of the extrusion. In some embodiments, the end effector 4214 comprises thermoplastic rubber (e.g., PEBAX® elastomer). As with any of the embodiments disclosed herein, shaft coatings/coverings may be based on certain medical grade polyurethane and/or similar materials, which may be formed using, for example, blowing agents or the like. In some implementations, such coatings/coverings may become reactive in a relatively moist tissue environment. Examples of materials that may be used for end effectors and/or shaft coverings/coatings in accordance with embodiments of the present disclosure include various types of urethane (e.g., ReoFlex™ 20 urethane, Bentley Advanced Materials, Kidderminster, UK), PEBAX® elastomer, silicone, silica aerogel, expanded polytetrafluoroethylene (ePTFE), metal (e.g., washer or wire), or the like.
A medical device shaft used for, for example, heart valve repair procedures, may generally be more visible at some angles than others. Embodiments of the present disclosure may advantageously increase the range of angles at which a medical device shaft and/or end effector may be visible, such as within the ventricle of the heart of a patient. Some embodiments of the present disclosure relate to medical device shafts that may be viewable under echo within the ventricle of the patient's heart. In some embodiments, such devices may be particularly visible under echo between approximately 40 and 80° with respect to the x-plane axis in a bicommissural view. The various views from which medical device shafts and/or end effectors associated with embodiments of the present disclosure may be particularly visible and/or particularly suitable for viewing in connection with certain valve-repair procedures are described below with respect to
The high-echogenicity shafts and end effector's disclosed herein may be highly-visible under echo imaging, and may advantageously remain visible through the viewing range of between 0° and 90° with respect to the x-plane axis/line, which may cover a range of angles that may be expected and/or associated with certain valve-repair procedures as described herein. Such embodiments may provide a substantial increase in visibility over other solutions in which shafts and/or end effectors may only be visible from angles of approximately 0° to 63°, or less. Visibility over a relatively wider range of angles may be enabled by the increased scattering provided by discontinuity and material densities associated with an end effector and/or shaft.
The cross-sectional anatomical view of
In the image of
The cross-sectional long-axis anatomical view of
The coating 4616 may be applied in connection with any step or portion of a manufacturing process associated with the shaft 4620 and/or end effector 4614. In some embodiments, the shaft 4620 and/or end effector 4614 may be dipped in at least partially fluid (e.g., liquid) material configured to adhere at least in part to the surface of the shaft 4620 and/or end effector 4614, such that the coating 4616 may substantially cover one or more surface portions thereof. In some embodiments, the coating 4616 may be configured to harden over time and/or in response to exposure to certain temperature and/or environmental conditions; the coating 4616 may be subjected to such conditions for the purpose of producing a desired hardening or other chemical/material change. In some embodiments, the illustrated “coating” 4616 may not actually be a coating, but may be molded, extruded, or otherwise formed.
The coating 4616 may have any suitable or desirable echogenic characteristics and/or features. For example, the coating 4616 may have any of the features disclosed herein with respect to any of the other embodiments of the present disclosure. In some embodiments, the coating 4616 may comprise and/or have associated therewith certain echogenic particulates, microspheres, bubbles, surfaces, and/or other materials or features that cause echo scattering and/or are more visible under echo than stainless steel or thermoplastic rubber alone. The various materials used in connection with embodiments of the present disclosure to provide echogenic coverings for shafts and/or end effectors may comprise echogenic polymer materials, including, for example, ePTFE, compliant polymeric foams, porous fluoropolymers, polyethylene terephthalate (PET), polyurethane, polyether block amide (e.g., PEBAX® elastomer), and/or composites thereof.
The shaft 4720 may be any type of shaft, including medical and/or non-medical device shafts. The sleeve 4740 may be configured and/or shaped to be disposed over at least a portion of the shaft 4720, wherein the sleeve 4740 includes materials, characteristics, and/or constituents that are relatively more echogenic when disposed on the shaft 4720 than the shaft 4720 would be alone. The shaft 4720 may comprise stainless steel or other at least partially rigid material, wherein the sleeve 4740 may be relatively less rigid and/or dense.
The sleeve 4740 may have any of the echogenicity features disclosed herein with respect to any of the other embodiments of the present disclosure. For example, the sleeve 4740 may comprise and/or have associated therewith certain echogenic particulates, microspheres, bubbles, surfaces, and/or other materials or features that are more visible under echo than stainless steel or thermoplastic rubber alone.
In some embodiments, the sleeve 4740 has associated therewith an end effector form 4740, which may be a single integrated form with the tube/lumen portion of the sleeve 4740, or may be attached to or otherwise associated with the tube/lumen portion of the sleeve 4740. As shown in the diagrams of
The band(s)4801 may comprise any type of tape, band, strap, wrap, or the like, of relatively echogenic material (e.g., less dense or more dense than the shaft 4820), which can be secured to the shaft 4820 in any suitable or desirable manner. Relatively echogenic materials, as described herein, refer to the material described, itself, or to the echogenic characteristics associated with a difference/interface between the material and another material disposed adjacent thereto and/or in contact therewith. For example, a relatively echogenic material described herein may be a material that, standing alone, does not present relatively echogenic visibility compared to stainless steel and/or thermoplastic rubber. However, such material may provide relatively high echogenicity and/or echogenic characteristics when disposed on and/or in contact with another material having different density characteristics. Therefore, such relatively echogenic materials may provide such relatively high echogenicity only in combination with a shaft, end effector, or other structure on which it is disposed due at least in part to the density interface.
The band(s)4801 may be wrapped around one or more portions of the shaft 4820 or may be slid/passed over the shaft 4820 and secured or positioned thereon/thereto in any suitable or desirable manner. The band(s)4801 may have any of the echogenicity features disclosed herein with respect to any of the other embodiments of the present disclosure. For example, the sleeve 4740 may comprise and/or have associated therewith certain echogenic particulates, microspheres, bubbles, surfaces, and/or other materials or features that are more visible under echo than stainless steel or thermoplastic rubber alone.
One or more individual bands 4801 may be implemented on the shaft 4820. For example, where multiple bands are implemented, each band may be disposed at a different axial/longitudinal position of the shaft 4820, as shown in
The microspheres 4933 may be substantially solid, or may be air- or other gas-filled spheres. Although illustrated in the detailed view of
In some embodiments, the microspheres 4933 may be embedded and/or mixed-in with a coating 4931, which may comprise any suitable or desirable material. For example, the shaft 4920 may be composed of the material 4931, or the material 4931 may be applied thereto and/or disposed thereon.
In some embodiments, only the end effector 4914 is associated with the microspheres 4933, which may be disposed generally on a surface of the end effector 4914 and/or within the structure thereof. With respect embodiments including microspheres 4933 disposed on and/or within the shaft 4920, the microspheres 4933 may be applied to the shaft 4920 and/or integrated with the radial thickness thereof. That is, the shaft 4920 may be formed of material having microspheres 4933 embedded at least partially therein or may be coated or covered with a coating/covering having microspheres associated therewith. As with other embodiments, it may be particularly desirable for the end effector 4914 to have enhanced echogenicity characteristics due to the position of the end effector relative to the deployment of a device from a working channel of the shaft.
The microspheres 4933 may comprise micro balloons (e.g., URE-FIL™ 15 filler, Smooth-On, Macungie, Pa.), which may be added to, for example, urethane and other materials to create a relatively lightweight casting for use with the shaft 4920 and/or end effector 4914. The microspheres 4933 may comprise glass spheres in some embodiments, or other small and/or hollow spheres. In some embodiments, the microspheres 4933 are mixed with urethane rubber and poured into a mold to form the end effector 4914.
With reference to the detailed view of the microspheres 4933 in
One or more portions of the shaft 5020 and the end effector 5014 may have exterior and/or interior surfaces associated therewith configured in a rough (e.g., non-smooth) configuration/manner. For example, the surfaces of the shaft and/or end effector 5014 may be treated with an abrasive surface/material in order to produce relatively rough surfaces. In some embodiments, the rough surfaces of the shaft 5020 and/or end effector 5014 may be produced through application of a material to the shaft 5020 and/or end effector 5014. For example, such material may be applied in a non-smooth manner, resulting in uneven and/or at least partially jagged surface topology. In some embodiments, material used to form and/or cover one or more portions of the shaft 5020 and/or end effector 5014 may comprise constituents that are shaped and/or dimensioned to result in uneven surfaces thereof. The rough surface 5025 may have certain grooves, ridges, teeth, or other non-smooth surface features. In some embodiments, such features may have a height that is greater than the relevant wavelength of the echo transducer that is used.
Examples of particulates/additives that may be implemented in connection with embodiments of the present disclosure include, but are not limited to, white pigment, micro balloons, glass beads, or the like, which may be embedded at least partially within silicone or other similar material, which may be used as a covering and/or form for a shaft and/or end effector. In some embodiments, the particulates 5133 comprise particles of metal, zinc oxide, iron oxide, titanium dioxide, platinum oxide, silver oxide, or the like. In some embodiments, the particulates 5133 comprise stainless steel and a fine powder-type form. The particulates 5133 may comprise white pigment, such as in the form of titanium dioxide, which may represent a relatively dense material providing desirable echogenicity characteristics.
The particulates 5133 may have any chemical or structural characteristics. Furthermore, the particulates 5133 may have any size, and may have uniform or non-uniform size throughout at least a portion of the shaft 5120 and/or end effector 5114. In some embodiments, the particulates 5133 may be embedded and/or mixed-in with a coating 5131, which may comprise any suitable or desirable material. For example, the shaft 5120 may be composed of the material 5131, or the material 5131 may be applied thereto and/or disposed thereon. A particulate solution may be provided in liquid form and mixed with rubber or other material to produce an echogenic material. The echogenic material may be mixed within and/or added to a mold/die when forming the end effector 5114 and/or covering 5131 of the shaft 5120.
In some embodiments, only the end effector 5114 is associated with the particulates 5133, which may be disposed generally on a surface of the end effector 5114 and/or within the structure/form of the end effector 5114. With respect embodiments including particulates 5133 disposed on and/or within the shaft 5120, the particulates 5133 may be applied to the shaft 5120 and/or integrated within the radial thickness thereof. That is, the shaft 5120 may be formed of material having particulates 5133 embedded/mixed at least partially therein, or may be coated or covered with a coating/covering having particulates associated therewith.
The aerogel material 5240 may be integrated with the structure of the shaft 5220, and/or may be applied as a coating thereon. Furthermore, the aerogel material 5240 may be applied as a coating to the end effector 5214, or the end effector form 5214 may be formed substantially of the aerogel material 5240, as shown in
The washer-type end effector 5314 may be secured or attached to the shaft 5320 in any suitable or desirable manner, such as with an adhesive and/or mechanical fastening mechanism. In some embodiments, the end effector 5314 may be of a unitary form with the shaft 5320 and/or with at least a distal portion thereof.
Although the washer-type end effector 5314 is shown as a substantially flat disc-type form having a substantially annular or torus-type shape, it should be understood that washer-type end effectors in accordance with aspects of the present disclosure may have any suitable or desirable shape. Furthermore, such end effectors may have any radial thickness. For example, the radial thickness of the end effector 5314 may be determined to produce a desired level of echogenic visibility.
In some embodiments, the end effector 5414 can comprise thermoplastic rubber and/or another at least partially flexible material. The washer 5430 may be attached to and/or embedded in the material (e.g., rubber) of the end effector 5414, at least in part. For example, the washer 5430 may be substantially covered on the distal end of the end effector 5414 by the material of the end effector, or may be at least partially exposed on one more ends or sides of the end effector 5414.
In some embodiments, the end effector 5414 may be formed using a die or mold, wherein the washer 5430 is disposed in the die/mold when the end effector 5414 is formed, to thereby secure the washer 5430 within/to the end effector 5414. In some embodiments, the washer 5430 is embedded at least partially within a thermoplastic polymer end effector, which may comprise, for example, polyaryletherketone (e.g., polyether ether ketone (PEEK)), or other semi-crystalline thermoplastic having desirable mechanical and/or chemical resistance properties. For example, the thermoplastic polymer may be melted around the washer (e.g., metal washer)5430, thereby providing an effector having two different densities through which sonic waves may pass in one or more dimensions/axes.
The air pockets and/or surface imperfections 5533 may be formed in some implementations by brushing, spraying, or otherwise disposing water or other fluid on a surface of a shaft, end effector, or mold(s) in which one or more components associated therewith his formed. For example, by brushing water on a mold/die prior to use thereof for formation of the end effector 5514 and/or shaft covering 5520, application of the material (e.g., urethane) from which the end effector 5514 and/or shaft covering 5520 is formed to the water-/fluid-brushed surface of the mold/die and/or the shaft 5520 and results in pocket formation within the material and/or crater/divot formation and one or more portions or surfaces of the material. For example, air pockets may form in a nonuniform pattern between the covering material 5521 and the shaft 5520 in positions associated with water/fluid droplets present on the shaft 5520 at the time of application of the covering material 5521. Furthermore, in implementations in which water/fluid is brushed or otherwise applied to the inside surface of a mold prior to application thereto of material to be formed into the end effector 5514 and/or shaft covering 5521, air pockets may form between the molded material and the inner surface of the mold, wherein after removal of the mold/die product from the mold/die, such air pockets may present as crater-/divot-type imperfections in the exterior surface of the molded product (e.g., end effector 5514 and/or shaft covering 5521).
The wires/loops 5632 may be attached to the end effector 5614 and/or shaft 5620 in any suitable or desirable way. For example, in some embodiments, the wires 5632 are glued or attached in some manner to a proximal/back side of the end effector 5614, as illustrated in
For example, the image 5701 of
At block 582, the process 580 involves providing a rigid shaft, which may comprise stainless steel or other metal or plastic. At block 583, the process 580 involves providing/producing an echogenic material that is configured to be applied (e.g., molded) to the rigid shaft. In some embodiments, the process 580 involves, at block 583 adding certain echogenic additives to a polymer material to enhance the echogenicity characteristics of the material, to thereby produce the echogenic material referred to at block 583.
The process 580 can include a subprocess 584 for applying the echogenic material to the shaft to provide enhanced echogenicity therefor. For example, at block 586, the process 580 involves molding the echogenic material to/over the shaft, which may involve exposing at least a portion of the shaft in a mold and pouring the echogenic material over at least a portion thereof, such that the echogenic material assumes the form of the mold walls and adheres at least in part to the shaft.
In an alternative implementation, the process 580 may involve, at block 587, extruding a length of tube of the echogenic material provided at block 583, and further sliding the extruded sleeve over the rigid tube/shaft (block 588). The extrusion may have a length of tube and may or may not have an end effector formed therewith. For example, in some embodiments, an end effector may be welded at an end of the extrusion and/or to the rigid shaft. In some embodiments, the process 580 involves heat shrinking the extrusion to the shaft and/or to the end effector. Use of an extruded sleeve/tube may be a desirable alternative to over-molding the echogenic tube over the shaft due to wall thickness considerations. For example, in some embodiments, the desired wall thickness of the echogenic material around the shaft may be relatively thin, such that over molding thereof may be difficult.
In some embodiments, the echogenic material may be applied to the shaft through brush or dip application, as shown at block 585. The echogenic material may be applied to only a portion of the shaft in some cases.
At block 589, the process 580 involves forming an end effector and/or coupling the same to the shaft in some manner. Although shown as a final block in the flow diagram of
The channel(s)5905 can provide image-enhancement due to sonic reflections (e.g., echo) off of the various surfaces thereof. Furthermore, the channel(s)5905 can serve to provide improved adhesion, engagement, or purchase for a polymer or similar form applied to the shaft 5920 to secure such form in place on the shaft.
In examples in which the form 5940 is disposed on a distal end of the shaft 5920, the form 5940 may include a shaft portion 5942 and an end effector portion 5944 that projects radially outward and provides an atraumatic tissue-contact surface, as described in detail herein. The shaft portion 5942 may have any suitable or desirable axial length and/or radial thickness.
Although helically-shaped, and other geometrically-shaped, channels, grooves, and/or recesses are disclosed for enhancing echogenicity and/or improving physical coupling between the shaft 5920 and the echogenic form 5940 in accordance with certain examples disclosed herein, such channels, grooves, and/or recesses may be irregularly-shaped and/or non-geometrical in shape in some implementations. For example, the shaft 5920 may have channels, grooves, and/or recesses that are non-geometric in shape and/or irregular or without continuous pattern (e.g., non-contiguous channels or divots/recesses) in shape or form that are configured to provide uneven surfaces designed to increase echogenicity and/or surfaces/features to physically engage with a polymer form on the shaft for increased coupling. Furthermore, such channels, grooves, and/or recesses may 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 removed material from a shaft or other device.
The form 5940 may comprise polymer or other material and may be similar in certain respects to various other examples disclosed herein for shaft coverings or components, including end effectors and the like. In some implementations, hollow glass micro-spheres are compounded into a plastic, rubber, or other polymer and injected into a molding or extruded to form the echogenic form 5940.
The form 5940 may serve to enhance echogenicity for the shaft device 5900 and/or may provide an atraumatic distal contact for the device to reduce the risk of tissue damage during use. In some examples, the form 5940 comprises polymer 5931 having relatively echogenic microsphere additives 5933 associated with one or more portions thereof in accordance with one or more examples of the present disclosure. As described above, small air bubbles trapped within the spheres 5933 associated with the form 5940 can increase the echogenicity of the form 5940, and therefore the device 5900, due at least in part to the non-homogeneous surfaces provided by such spheres/bubbles that enhance the scattering of the echo image. Therefore, the shaft device 5900 may be rendered more easily visible from a relatively wider range of angles.
The microspheres 5933 may be substantially solid, or may be air- or other gas-filled spheres. Although illustrated in the detailed view in
In some instances, the microspheres 5933 may be embedded and/or mixed-in with a base material 5931 of the form 5940, which may comprise any suitable or desirable material, such as a polymer. For example, the shaft 5920 may be composed of the material 5931, or the material 5931 may be applied thereto and/or disposed thereon, as shown if
The microspheres 5933 may be applied to the form 5940 and/or integrated with the thickness thereof. That is, the form 5940 may be formed of material having microspheres 5933 embedded at least partially therein or may be coated or covered with a coating/covering having microspheres associated therewith. As with other examples, it may be particularly desirable for the distal end of the shaft 5920 to have enhanced echogenicity characteristics. For example, the form 5940 may serve as an end effector.
The microspheres 5933 may comprise micro balloons (e.g., UREFIL™ 15 filler), which may be added to, for example, urethane and/or other material(s) to create a relatively lightweight casting for use with at least the distal portion of the shaft 5920. The microspheres 5933 may comprise glass spheres in some examples, or other small and/or hollow spheres. In some examples, the microspheres 5933 are mixed with urethane rubber and poured into a mold to form the form 5940.
With reference to the detailed view of the microspheres 5933 in
In some examples, the form 5940 may comprise embedded gas bubbles embedded in, for example, a polyurethane form adhered to the shaft 5920, which may be achieved by adding gas during the extrusion or molding process(es) associated therewith. In some implementations, gas bubbles may be formed in, for example, rubber or other material used for the form 5940 using chlorine, hydrogen chloride gas, or other gas. Such gas may be sonicated to produce the desired bubbles. Adding the microspheres or bubbles to a plastic or rubber form can advantageously enhance its visibility under echo. In some implementations, the form 5940 is injection molded. The plastic/rubber with the compounded hollow microspheres can be injection molded or extruded into nearly 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 dish shape that points at the echo probe, or any other configuration for use with a shaft-like medical instrument.
Depending on the embodiment, certain acts, events, or functions of any of the processes or algorithms described herein can be performed in a different sequence, may 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.
Conditional language used herein, such as, among others, “can,” “could,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is intended in its ordinary sense and 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 features, elements and/or steps are in any way required for 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, are used in their ordinary sense, and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Conjunctive language such as the phrase “at least one of X, Y and Z,” unless specifically stated otherwise, is understood with the context as used in general to convey that an item, term, element, etc. may be either X, Y or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require at least one of X, at least one of Y and at least one of Z to each be present.
It should be appreciated that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, Figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than are expressly recited in that claim. Moreover, any components, features, or steps illustrated and/or described in a particular embodiment herein can be applied to or used with any other embodiment(s). Further, no component, feature, step, or group of components, features, or steps are necessary or indispensable for each embodiment. Thus, it is intended that the scope of the inventions herein disclosed and claimed below should not be limited by the particular embodiments described above but should be determined only by a fair reading of the claims that follow.
It should be understood that certain ordinal terms (e.g., “first” or “second”) may be provided for ease of reference and do not necessarily imply physical characteristics or ordering. Therefore, as used herein, an ordinal term (e.g., “first,” “second,” “third,” etc.) used to modify an element, such as a structure, a component, an operation, etc., does not necessarily indicate priority or order of the element with respect to any other element, but rather may generally distinguish the element from another element having a similar or identical name (but for use of the ordinal term). In addition, as used herein, indefinite articles (“a” and “an”) may indicate “one or more” rather than “one.” Further, an operation performed “based on” a condition or event may also be performed based on one or more other conditions or events not explicitly recited.
Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which example embodiments belong. It 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 not be interpreted in an idealized or overly formal sense unless expressly so defined herein.
The spatially relative terms “outer,” “inner,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” and similar terms, may be used herein for ease of description to describe the relations between one element or component and another element or component as illustrated in the drawings. It be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation, in addition to the orientation depicted in the drawings. For example, in the case where a device shown in the drawing is turned over, the device positioned “below” or “beneath” another device may be placed “above” another device. Accordingly, the illustrative term “below” may include both the lower and upper positions. The device may also be oriented in the other direction, and thus the spatially relative terms may be interpreted differently depending on the orientations.
Unless otherwise expressly stated, comparative and/or quantitative terms, such as “less,” “more,” “greater,” and the like, are intended to encompass the concepts of equality. For example, “less” can mean not only “less” in the strictest mathematical sense, but also, “less than or equal to.”
This application is a continuation of International Patent Application No. PCT/US2020/049115, filed Sep. 3, 2020, which claims the benefit of U.S. Patent Application No. 62/895,650, filed on Sep. 4, 2019, and of U.S. Patent Application No. 63/054,751, filed on Jul. 21, 2020, the entire disclosures all of which are incorporated by reference for all purposes.
| Number | Date | Country | |
|---|---|---|---|
| 63054751 | Jul 2020 | US | |
| 62895650 | Sep 2019 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2020/049115 | Sep 2020 | US |
| Child | 17653082 | US |
