Patent Application
20240366378
The present disclosure relates to the field of medical devices and procedures.
An annuloplasty is a procedure to tighten or reinforce the ring (annulus) around a valve in the heart. For example, due to various factors, two or more leaflets of a heart valve may not coapt properly, resulting in regurgitation of the blood flow (e.g., backwards blood flow). An annuloplasty ring may be attached (e.g., sewn) to the annulus of the heart valve to pull the leaflets together for proper coaptation and to re-establish proper valve function.
Some implementations of the present disclosure relate to a device for treating a heart valve including: a curved frame; and a covering at least partially enclosing the curved frame.
In some aspects, the techniques described herein relate to a device, further including a first expandable bladder connected to the curved frame.
In some aspects, the techniques described herein relate to a device, further including a flow tube configured to allow inflow of a fluid into the first expandable bladder.
In some aspects, the techniques described herein relate to a device, wherein the flow tube includes a one-way valve.
In some aspects, the techniques described herein relate to a device, wherein the curved frame is D-shaped and includes a flat portion, and wherein the first expandable bladder is disposed across from the flat portion.
In some aspects, the techniques described herein relate to a device, further including a second expandable bladder.
In some aspects, the techniques described herein relate to a device, further including a first fill tube connected to the first expandable bladder and a second fill tube connected to the second expandable bladder.
In some aspects, the techniques described herein relate to a device, further including one or more eyelets connected to an inner surface of the frame.
In some aspects, the techniques described herein relate to a device, wherein the curved frame includes two or more segments interconnected by one or more joints.
In some aspects, the techniques described herein relate to a device, wherein the one or more joints are configured to facilitate bending of the curved frame.
In some aspects, the techniques described herein relate to a device, wherein the curved frame has a closed form.
In some aspects, the techniques described herein relate to a device, wherein the curved frame has an open form.
In some aspects, the techniques described herein relate to a device, wherein the curved frame includes one or more openings.
In some aspects, the techniques described herein relate to a device, further including one or more tissue anchors within the one or more openings.
In some aspects, the techniques described herein relate to a device, wherein the one or more tissue anchors include cavities configured to receive an anchor driver.
In some aspects, the techniques described herein relate to a device, further including a suture extending at least partially through the covering.
In some aspects, the techniques described herein relate to a device, wherein the suture includes two free ends configured to extend outside the covering.
For purposes of summarizing the disclosure, certain aspects, advantages and novel features have been described. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular example. 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 examples are depicted in the accompanying drawings for illustrative purposes and should in no way be interpreted as limiting the scope of the disclosure. In addition, various features of different disclosed examples can be combined to form additional examples, which are part of this disclosure. Throughout the drawings, reference numbers may be reused to indicate correspondence between reference elements.
The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed subject matter. The present disclosure relates to systems, devices, and methods to determine access for an anatomical feature based on an analysis of one or more images representing a mineral deposit.
Although certain examples are disclosed below, the subject matter extends beyond the specifically disclosed examples to other alternative examples and/or uses, and to modifications and equivalents thereof. Thus, the scope of the claims that may arise here from is not limited by any of the particular examples described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding certain examples; however, the order of description should not be construed to imply that these operations are order dependent. Additionally, the structures, systems, and/or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various examples, certain aspects and advantages of these examples are described. Not necessarily all such aspects or advantages are achieved by any particular example. Thus, for example, various 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 aspects or advantages as may also be taught or suggested herein.
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, embedded at least partially within, or otherwise physically related to the second feature, element, component, device, or member, whether directly or indirectly.
As noted above, an annuloplasty procedure can be performed to tighten or reinforce the ring (annulus) around a valve in the heart. Such procedures involve attaching a structure (e.g., annuloplasty ring) to the annulus of the heart valve. Various types of annuloplasty rings have been developed to satisfy the myriad of contexts in which an annuloplasty ring may be implanted (e.g., different sized heart valves, heart valve abnormalities, physician preferences, etc.). In particular, annuloplasty rings come in different sizes, shapes, materials, suture features for attachment, and so on, which provide physicians with options to implement. In many cases, a physician can use one or more ring sizers to determine a size of an annuloplasty ring to use. The physician can overlay D-shaped plates (e.g., the ring sizers) of different sizes onto the heart valve to identify an optimal size of an annuloplasty ring for the specific heart valve.
In some cases, annuloplasty rings may be replaced and/or supplemented in subsequent procedures by additional implants. For example an annuloplasty ring may be replaced and/or supplemented with a replacement valve implant (e.g., during a transcatheter aortic valve replacement (TAVR) procedure). Some annuloplasty rings may not be designed to be replaced and/or supplemented. For example, some annuloplasty rings may be composed of generally elastic materials that may to return to a formed shape after any applied stresses are relieved and thus may not be mechanically deformed in a significant way (e.g., with a balloon and/or balloon expandable valve). Some annuloplasty rings can provide a very rigid constraint to the annulus that can prevent replacement valves from deploying in an optimal shape (e.g., a parallel shape).
This disclosure describes techniques related to annuloplasty rings having features configured to increase flexibility and/or adjustability of the annuloplasty rings. Some example annuloplasty rings can be configured for surgical delivery. In some examples, following surgical delivery of an example annuloplasty ring and/or repair device, adjustments to the annuloplasty ring and/or repair device can be performed on a beating heart via, for example, one or more sutures extending from the device to outside the body.
In some examples, an annuloplasty ring may comprise one or more segments/body portions having and/or connected by flexible joints and/or portions. Some annuloplasty rings may have a continuous (e.g., a “D-shaped structure) and/or non-continuous structure (e.g., a “C-shaped” structure) that may allow for future implanted devices to be able to expand the annuloplasty ring somewhat. The body portions, which may include any means for treating, tightening, and/or reinforcing an annulus portion of a heart valve, and/or deformable portions may be configured to form a continuous and/or non-continuous implant which may be configured to be attached to an annulus portion of a heart valve.
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 vein, aorta, etc.).
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 11, 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.
Heart valves may generally comprise a relatively dense fibrous ring, referred to herein as the annulus, as well as a plurality of leaflets or cusps attached to the annulus. Generally, the size of the leaflets or cusps may be such that when the heart contracts the resulting increased blood pressure produced within the corresponding heart chamber forces the leaflets at least partially open to allow flow from the heart chamber. As the pressure in the heart chamber subsides, the pressure in the subsequent chamber or blood vessel may become dominant, and press back against the leaflets. As a result, the leaflets/cusps come in apposition to each other, thereby closing the flow passage.
The atrioventricular (e.g., mitral and tricuspid) heart valves may further comprise a collection of chordae tendineae and papillary muscles 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 (two shown in
The right ventricular papillary muscles 10 originate in the right ventricle wall, and attach to the anterior, posterior and septal leaflets of the tricuspid valve, respectively, via the chordae tendineae 13. The papillary muscles 10 of the right ventricle 4 may have variable anatomy; the anterior papillary may generally be the most prominent of the papillary muscles. The papillary muscles 10 may serve to secure the leaflets of the tricuspid valve 8 to prevent prolapsing of the leaflets into the right atrium 5 during ventricular systole. Tricuspid regurgitation can be the result of papillary dysfunction or chordae rupture.
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.
The valve leaflets of the mitral valve 6 may be prevented from prolapsing into the left atrium 2 by the action of the chordae tendineae 16 tendons connecting the valve leaflets to the papillary muscles 15. The relatively inelastic chordae tendineae 16 are attached at one end to the papillary muscles 15 and at the other to the valve leaflets; chordae tendineae from each of the papillary muscles 15 are attached to a respective leaflet of the mitral valve 6. Thus, when the left ventricle 3 contracts, the intraventricular pressure forces the valve to close, while the chordae tendineae 16 keep the leaflets coapting together and prevent the valve from opening in the wrong direction, thereby preventing blood to flow back to the left atrium 2. The various chords of the chordae tendineae may have different thicknesses, wherein relatively thinner chords are attached to the free leaflet margin, while relatively thicker chords (e.g., strut chords) are attached farther away from the free margin.
As described above, with respect to a healthy heart valve 6 as shown in
Heart valve disease represents a condition in which one or more of the valves of the heart fail to function properly. Diseased heart valves may be categorized as stenotic, wherein the valve does not open sufficiently to allow adequate forward flow of blood through the valve, and/or incompetent, wherein the valve does not close completely, causing excessive backward flow of blood through the valve when the valve is closed. In certain conditions, valve disease can be severely debilitating and even fatal if left untreated. With regard to incompetent heart valves, over time and/or due to various physiological conditions, the position of papillary muscles may become altered, thereby potentially contributing to valve regurgitation. For example, as shown in
Several diseases can affect the structure and function of the mitral valve. The mitral valve and, less frequently, the tricuspid valve, are prone to deformation and/or dilation of the valve annulus, tearing of the chordae tendineae, and/or leaflet prolapse, which results in valvular insufficiency wherein the valve does not close properly and allows for regurgitation or back flow from the left ventricle into the left atrium. Deformations in the structure or shape of the mitral or tricuspid valve can be repairable.
Mitral regurgitation is one of the most common valvular malfunctions in the adult population, and typically involves the elongation or dilation of the posterior two-thirds of the mitral valve annulus, the section corresponding to the posterior leaflet. The most common etiology of systolic mitral regurgitation is myxomatous degeneration, also termed mitral valve prolapse (29% to 70% of cases), which afflicts about 5 to 10 percent of the population in the U.S. Women are affected about twice as often as men. Myxomatous degeneration has been diagnosed as Barlow's syndrome, billowing or ballooning mitral valve, floppy mitral valve, floppy-valve syndrome, prolapsing mitral leaflet syndrome, or systolic click-murmur syndrome. The symptoms include palpitations, chest pain, syncope or dyspnea, and a mid-systolic click (with or without a late systolic murmur of mitral regurgitation). These latter symptoms are typically seen in patients with Barlow's syndrome, where extensive hooding and billowing of both leaflets are the rule. Some forms of mitral valve prolapse seem to be hereditary, though the condition has been associated with Marfan's syndrome, Grave's disease, and other disorders.
Myxomatous degeneration involves weakness in the leaflet structure, leading to thinning of the tissue and loss of coaptation. Barlow's disease is characterized by myxoid degeneration and appears early in life, often before the age of fifty. In Barlow's disease, one or both leaflets of the mitral valve protrude into the left atrium during the systolic phase of ventricular contraction. The valve leaflets are thick with considerable excess tissue, producing an undulating pattern at the free edges of the leaflets. The chordae are thickened, elongated and may be ruptured. Papillary muscles are occasionally elongated. The annulus is dilated and sometimes calcified. Some of these symptoms are present in other pathologies as well and, therefore, the present application may refer to myxoid degeneration, which is the common pathologic feature of the various diagnoses, including Barlow's syndrome.
Other causes of mitral regurgitation include ischemic heart disease with ischemic mitral regurgitation (IMR), dilated cardiomyopathy (in which the term “functional mitral regurgitation FMR is used), rheumatic valve disease, mitral annular calcification, infective endocarditis, fibroelastic deficiency (FED), congenital anomalies, endocardial fibrosis, and collagen-vascular disorders. IMR is a specific subset of FMR, but both are usually associated with morphologically normal mitral leaflets. Thus, the types of valve disease that lead to regurgitation are varied and present vastly differently.
As shown in
Various techniques/procedures may be used to repair diseased or damaged heart valves, such as mitral and tricuspid valves. These include, but are not limited to, annuloplasty (e.g., contracting the valve annulus to restore the proper size and/or shape of the valve), quadrangular resection of the leaflets (e.g., removing tissue from enlarged or misshapen leaflets), commissurotomy (e.g., cutting the valve commissures to separate the valve leaflets), shortening and transposition of the chordae tendineae, reattachment of severed chordae tendineae or papillary muscle tissue, and decalcification of valve and annulus tissue.
In some mitral valve repair procedures, mitral annuloplasty procedure (MAP) can be combined with mitral valve leaflet repair and chordal replacements. The purpose of the MAP can be to prevent re-dilation of the annulus and/or secure sufficient leaflet coaptation that affects valve durability. The procedure of sizing repair devices (e.g., annuloplasty rings) can be important. If a device is too large size, the valve may be incompetent. If the device is too small size, systolic anterior motion (SAM) and/or functional mitral stenosis (FMS) may occur. Measuring an area or the distance of an annuloplasty ring by placing a pre-shaped platform to a floppy native valve can be uncertain and/or can depend on the surgeon's experience and intuition.
Some approaches to sizing an annuloplasty ring may not guarantee accuracy. Trial-and-error sizing techniques can be imprecise, tedious, and time-consuming. An annular support ring implant as part of Degenerative Mitral Regurgitation (DMR) repair cases may be configured to stabilize the repair, but it can be difficult for surgeons to accurately predict the ring size implanted on a flaccid (e.g., arrested) heart that may be optimal once the patient is weaned off of by-pass. Sizing annuloplasty rings and/or assessment of chordal length done in a static heart can be a challenge. Inasmuch as there may be post-implant control in place (e.g., based on ventricular saline injection and/or ink test for direct view of valve competence), it may not always be reliable as the control assesses coaptation during non-physiologic conditions.
Some example methods and/or devices described herein may be configured to offer real-time annuloplasty ring and/or chordal adjustment techniques that are technically feasible. The modes of repair described herein can advantageously provide solutions for controlling optimal sizing of annular support and/or chordal repair in on-pump mitral cases to reduce the rate of post-operative complications and/or improve outcomes.
The devices and/or methods described herein can provide adjustability to repair devices and/or systems, which can have various advantages. For example, such devices and/or methods can offer real-time chordal adjustment in a beating heart and/or under physiologic loading conditions to enhance chances of a successful repair. Moreover, some examples may be configured to minimize risk and/or reduce postoperative complications.
In some examples, an annuloplasty repair (e.g., ring) device may be adjustable in situ to facilitate controlling a size of the annulus in a beating heart and/or under echo guidance that can minimize the risk of under-sizing. Some devices can be configured to expand for stability and/or support. In some examples, a repair device can comprise one or more elastic (e.g., semi-rigid) portions while allowing for some degree of annular expansion.
The ability for chordal adjustment can prevent having to estimate the appropriate neochordal length during implantation. Neochords may be inserted to the head of a papillary muscle and/or may be anchored to the external surface of one or more heart adjustments. Some examples may comprise accessory chord papillary muscle implants configured to move and/or relocate one or more papillary muscles to further improve the leaflet coaptation surface.
Some example devices and/or methods may be configured to provide optimum adjustment under echocardiographic guidance based on the reduction of regurgitation. Some examples may be configured to enhance surgical procedure by providing surgeons more control and/or fine-tuning capabilities to enhance repair.
Although various techniques/procedures are discussed herein in the context of mitral valves, the techniques/procedures can be applicable to other types of heart valves and/or anatomical structures/features.
In some examples, annuloplasty rings and/or other implants described herein may be configured for delivery and/or attachment to an annulus portion of a heart valve to treat the heart valve. An implant may be sized slightly smaller than a distended annulus.
Various implants described herein may comprise inner body portions at least partially encapsulated and/or covered by an outer sheath and/or multiple outer sheath portions. In some examples, one or more body portions of an implant may comprise a relatively rigid and/or elastic inner structural support at least partially surrounded by a pliable core material and/or a cover composed of fabric and/or other materials. For example, an implant (e.g., an annuloplasty ring) may comprise an inner skeleton of one or more bands of relatively rigid and/or elastic material (e.g., titanium, cobalt-chromium (e.g., ELIGLOY® alloy), nitinol) surrounded by a suture-permeable core material (e.g., silicone) and/or an outer fabric cover. In some examples, the inner skeleton may comprise multiple bands separated by plastic and/or other relatively low friction material (e.g., PTFE (e.g., TEFLON® PTFE)) to allow the bands to more easily flex with respect to one another.
In some examples, an implant (e.g., an annuloplasty ring) may be configured to implanted at an annulus using any of a variety of attachment means, which can include one or more sutures. For example, one or more sutures may be distributed around body portions of the implant and/or may be tied off to present minimal surface roughness and/or to reduce the chance of thrombi forming thereon.
The inner structural support and/or pliable core material of one or more body portions of an implant may be relatively rigid and/or may be configured to initially resist deformation when subjected to the stress imparted thereon by the valve annulus of an operating human heart and/or by various medical devices (e.g., balloon expandable devices). The term “deformation” is used herein in accordance with its plain and ordinary meaning and may refer to substantial permanent deformation from a predetermined manufactured and/or shape-set shape. A number of generally rigid materials can be utilized, including various bio-compatible polymers, metals, and/or alloys. An implant may comprise one or more deformable portions which may be configured to deform in response to pressure from a medical device and/or growth of a native heart valve.
The device 400 may be configured to provide different flexibilities at various points about the circumference of the valve (e.g., mitral valve 6) annulus. While some annuloplasty rings may have fixed shapes and/or sized and/or may be configured for placement in a flaccid heart, the device 400 may advantageously be adjustable and/or implantable in a beating heart.
In some examples, the device 400 may comprise various features configured to prevent over-tightening and/or over-expansion of the device. If replacement valves are tightened too much, it can result in mitral stenosis and/or systolic anterior motion of the valve, which can cause outflow tract obstruction.
The device 400 can comprise one or more flexible joints interconnecting one or more segments of the device 400. The device 400 may comprise a covering (e.g., flexible material) at least partially enclosing the segments and/or fitting snugly about the segments. The joint structure may provide a mechanism for adjusting the circumference of the device 400. In some examples, the device 400 can comprise multiple flexible joints.
In some examples, the device 400 can be composed of one or more materials with varying degrees of flexibility to allow the individual segments to move independently of each other. A segment can comprise multiple different core materials (e.g., rigid frames for anterior and posterior segments and/or flexible frames for the lateral and medial segments).
The device 400 can be structured in different geometries. For example, the device 400 can have an open (e.g., C-shape) or closed (e.g., circular, D-shaped, C-shaped, etc.) shape. The device 400 may be shaped to improve efficacy in sizing and/or can provide an ability to go up in size. The device 400 may be configured to be adjustable to increase and/or decrease in circumference, diameter, and/or width. Circumferential and/or regional expansion of the device 400 can maintain the physiological shape of the annulus of the valve.
The device 400 can be delivered to the valve via any suitable means. For examples, the device 400 can be delivered surgically via a full and/or mini sternotomy.
In some examples, the device 400 may comprise an inflation tube 404 configured to couple to and/or extend from a ring 402 of the device 400.
The covering 501 may be configured to be at least partially fluid-tight and/or may be inflatable. In some examples, the covering 501 may be configured to at least partially enclose a supporting ring anchored to an annulus. The covering 501 may be configured to be filled with one or more fluids (e.g., a self-curing and/or hardening polymer) via a fill tube to adjust for appropriate ring size. In some examples, the covering 501 may comprise one or more fillable sections and/or chambers. The covering 501 may be composed of one or more fabrics and/or other materials.
The covering 701 may comprise one or more fillable chambers configured to be filled with one or more gases and/or fluids. In some examples, the device may comprise a ring 702. The device may further comprise an inflation tube 704. The inflation tube 704 may be configured to be filled via a syringe 750 and/or similar device.
The inflatable bladder 718 may not extend around a complete circumference of the ring 702 and/or may comprise one or more portions that are not inflatable. For example, an anterior annulus portion 730 of the device may not be inflatable. In some examples, the inflatable bladder 718 may be configured to implanted oversized and/or may be at least partially flexible and/or configured to expand inwardly to reduce a size of the annulus as desired.
The device may be configured to implanted on-pump and/or may be adjusted in a beating heart (e.g., off-pump). Filling of the device and/or inflatable bladder 718 may be configured to performed with imaging (e.g., echo imaging) to enable filling to desired ring 702 size to create a desired level of leaflet coaptation and/or restoration of the valve to a more functional state. The ring 702 and/or inflatable bladder 718 may be configured to expanded and/or to pull in the annulus of the valve.
The various balloons may be configured to be independently and/or individually filled via multiple fill tubes 904. The fill tubes 904 may comprise one or more valves 914 configured to selectively control a direction of flow through the fill tubes 904. The device 903 may additionally or alternatively comprise an inflatable bladder 918 configured to be separately and/or individually inflated via a fill tube 904. The one or more balloons may be disposed internally relative to the inflatable bladder 918. As the balloons and/or inflatable bladder 918 inflate, the device 903 may contract and/or may apply pulling force to the annulus and/or muscle to pull the annulus and/or muscle inwardly (e.g., towards a center point of the device 903.
In some examples, the device 1000 may comprise a distensible annuloplasty ring with expandable segments 1008 to accommodate an annulus of a valve. If the device 1000 is installed undersized, segments 1008 may be expanded (e.g., off-pump) in a beating heart. The increased flexibility of the device 1000 may allow for slight error in sizing pre-delivery.
The device 1000 may be at least partially expandable and/or the joints 1006 and/or segments 1008 may be at least partially flexible. In some example, the segments 1008 may be coupled end-to-end by flexible sheaths and/or joints 1006 enabling relative translation movement. In addition to providing stability and support, these elastic (semi-rigid) portions allow for a degree of annular expansion. In some examples, the segments 1008 may form a ring 1002. The ring segments 1008 coupled together may be relatively movable with respect one another so that the ring 1002 may expand to accommodate expansion.
The ring 1002 is made up of segments 1008 that are linked together with flexible joints 1006 forming the body in a shape to fit a valve (e.g., mitral valve) annulus. When cardiac pressure is applied and exerted against the ring 1002, the joints 1006 may stretch and/or expand the ring 1002 in a circumferential direction. The flexible joints 1006 may be made of one or more shape-memory materials that can return to a pre-determined shape. Example materials can include silicone, polyurethane, expanded polytetrafluoroethylene, etc.
While the ring 1002 is shown comprising six segments 1008, the ring 1002 can be composed of any number of segments 1008. The segments 1008 may be formed from any suitable and/or biologically compatible material. A length of each segment 1008 may be dependent on the shape and/or geometry of the ring 1002.
The joints 1006 can be designed with varying and/or pre-determined degrees of flexibility. In some examples, flexibility of a joint 1006 may be determined based at least part on a location of the joint 1006. For example, joints 1006 at or near a posterior annulus portion 1032 of the device 1000 may have greater flexibility than other joints 1006. Bonding between the segments 1008 and/or joints 1006 can be accomplished with, for example, solvent bonding, ultraviolet (UV) light curing, epoxy resins, and/or ultrasonic welding.
The ring 1002 may be covered at least partially with a covering 1001 comprising one or more stretchable fabrics that can accommodate the expansion of the ring 1002. In some examples, the covering 1001 can serve as a sewing cuff. The covering 1001 can be composed of any suitable materials, which can include Dacron and/or polyester.
The ring 1002 can have any suitable size and/or shape. In some examples, the ring 1002 may be C-shaped and/or may not form a complete ellipse. In other examples, the ring 1002 may have a closed and/or elliptical shape (e.g., D-shaped and/or saddle-shaped).
The one or more joints 1006 may be configured to adjust the circumference and/or shape of the ring 1002. In some examples, the segments 1008 can comprise a core 1009 configured to be bonded to the joints 1006 (e.g., fit at least partially into the joints 1006). The core 1009 can be composed of any suitable material(s), which can include silicone and/or metal. The core 1009 can have a flexible, semi-rigid, and/or generally rigid structure. The cores 1009 of the various segments 1008 may be disconnected from each other to allow angle and/or distance displacement relative to each other.
In some examples, the one or more joints 1006 may be at least partially expandable joints to increase a size of the ring 1002 and/or to accommodate a changing shape of the valve annulus throughout the cardiac cycle. The joints 1006 may be configured to allow for ring expansion. For example, the joins 1006 may be configured to allow the ring 1002 to be sized up to various predetermined sizes in a step-like manner. In some examples, the device 1000 may comprise one or more latching mechanisms to hold the device 1000 and/or ring 1002 in various predetermined sizes. In this way, the device 1000 may advantageously be configured to restore a valve to a more functional state by providing expansion and/or flexibility where it is needed that furthers improve leaflet coaptation to reduce valve regurgitation.
The device 1600 may be configured to be adjustable off-pump and/or in a beating heart. The one or more cords 1611 may be accessible externally through, for example, a ventricular and/or atrial wall to allow for adjustment to the size and/or shape of the ring 1602 to cause reshaping of the annulus. The ring 1602 may be adjusted symmetrically by pulling both cords 1611 and/or cord ends (e.g., purse-string-suture ends) equally. Moreover, the ring 1602 may be adjusted asymmetrical by pulling one cord 1611 end more than the other.
The ring 1602 may comprise one or more openings 1613 configured to receive one or more tissue anchors. The rings 1602 can have any number of openings 1613. In some examples, the device 1600 can comprise two or more openings 1613.
The driver 1805 and/or anchors 1802 may be configured to enhance surgical procedures by providing the surgeon more control to make fine adjustments and achieve the desired annular dimension of a repair device (e.g., annuloplasty ring) and/or to restore a valve to a more functional state and/or facilitate leaflet coaptation to reduce valve regurgitation. In some examples, confirmation of regurgitation reduction can be confirmed off-pump in a beating heart and/or under echo guidance.
The anchor 1902 may comprise one or more openings 1912 (e.g., cavities) configured to receive the one or more cords 1911 and/or a delivery tool (e.g., anchor driver). A tensioning device may be inserted at least partially into the opening 1912 to tighten and/or pull the cords 1911.
A delivered repair device may be composed of any suitable materials, which can include, for example, a polyester sleeve, stainless steel anchors 1902, and/or one or more contraction cords 1911 and/or wires. The sleeve may be attached to tissue anchors 1902 connected to one or more cords 1911 encased in a delivery system.
Prior to a procedure, a patient may undergo a preprocedural examination and/or cardiac computed tomography (CT) to assess anatomical feasibility. Computed tomography scanning can be used to size the mitral annulus and/or to plan the procedure.
During the procedure, the surgeon can determine a starting point on the annulus. An implant (e.g., repair device) may be placed on the desired location. A first anchor 1902 may be implanted through the polyester sleeve and/or into the annulus tissue. The anchor 1902 may be released after proper anchoring is checked with, for example, push-and-pull testing. The surgeon can then move to the next anchoring point along the posterior annulus. These steps can be repeated to complete the implant around the annulus or a section of the annulus. Once the implant is completed, the implant is disconnected from the delivery system.
In some examples, ends of the cords 1911 may be pulled through the anatomy (e.g., atrium). The ends may be connected to a tensioner (e.g., anchor driver) that may be secured to the anatomy (e.g., atrium). The anatomy (e.g., atrium) may be closed and/or the patient may be taken off by-pass.
Under transesophageal echocardiographic (TEE) guidance, the one or more cords 1911 may be tensioned (e.g., with an adjustment tool) to cinch the annulus until the desired appropriate annular size has been reached.
The process 2200 may comprise various preliminary steps, which can include one or more incisions (e.g., at the left atrium), identifying landmarks, and/or placing one or more sutures around an annulus of a target valve.
At step 2202, the process 2200 involves implanting an annuloplasty ring 2302 and/or other repair device at the valve 6 and/or securing one or more cords 2311, tubes, and/or other adjustment apparatus to the ring 2302 and/or anchors, as shown in image 2382 of
In some examples, the ring 2302 may be parachuted to the annulus and sequentially tied via the various cords 2311 and/or traction sutures 2331. Various testing (e.g., hydrodynamic valve testing) may be used to evaluate repair of the valve 6.
At step 2204, the process 2200 involves implanting chordal replacement cords 2311 (e.g., artificial ePTFE sutures) beyond the valve 6 and/or through one or more papillary muscles 15 and/or ventricle walls 18 to replace ruptured or diseased native edge chords, as shown in image 2384 of
At step 2206, the process 2200 involves implanting one or more traction sutures 2331 at a posterior leaflet 41 of the valve 6, as shown in image 2386 of
The traction chords 2331 at the valve leaflets may be tensioned to pull and/or stretch a portion of the posterior leaflet 41 and/or a portion of the posterior annulus anteriorly and/or inwardly to effectively increase coaptation of the valve 6.
At step 2208, the process 2200 involves anchoring the traction sutures 2331 to an apex 45 portion of the heart, as shown in image 2388 of
One or more sutures may be anchored to the papillary muscle 15 and/or to the external ventricular surface apex 45 of the heart. Following anchoring of the sutures, the atrium may be closed and/or the patient may be taken off-pump. The annular ring may be adjusted using the sutures and/or fill tube on the epicardial surface, narrowing the size of the orifice or opening to achieve a desired physiologic effect. The length of the cords 2311 may be shorted and/or the cords 2311 may be tensioned to balance the cords 2311 to correct prolapse. In some examples, the traction sutures 2331 may be tensioned to pull the posterior leaflet 41 anteriorly to enhance the coaptation surface. In some examples, the cords 2311 may be pulled and/or tensioned to relocate the papillary muscle 15.
At step 2210, the process involves anchoring the papillary muscle 15 to one or more ventricle walls 18 (which can include the apex 45 region) using one or more sutures 2321, as shown in image 2390 of
In some examples, steps of the process 2200 may be performed in any order.
In some examples, the one or more sutures 2611 may be configured to extend from the valve 6 and/or through one or more ventricle walls 18. The one or more sutures 2611 may be configured to be anchored at an exterior surface of the ventricle wall 18 to provide anchoring for the sutures 2611. In some examples, the sutures 2611 may be sutured to a posterior leaflet 41 and/or may not be sutured to an anterior leaflet.
While the system of
Provided below is a list of examples, each of which may include aspects of any of the other examples disclosed herein. Furthermore, aspects of any example described above may be implemented in any of the numbered examples provided below.
Depending on the example, 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 examples, not all described acts or events are necessary for the practice of the processes.
The above description of examples of the disclosure is not intended to be exhaustive or to limit the disclosure to the precise form disclosed above. While specific examples, and examples, are described above for illustrative purposes, various equivalent modifications are possible within the scope of the disclosure, as those skilled in the relevant art will recognize. For example, while processes or blocks are presented in a given order, alternative examples can perform routines having steps, or employ systems having blocks, in a different order, and some processes or blocks may be deleted, moved, added, subdivided, combined, and/or modified. Each of these processes or blocks can be implemented in a variety of different ways. Also, while processes or blocks are at times shown as being performed in series, these processes or blocks can instead be performed in parallel or can be performed at different times.
Certain terms of location are used herein with respect to the various disclosed examples. Although certain spatially relative terms, such as “outer,” “inner,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” “top,” “bottom,” and similar terms are used herein to describe a spatial relationship of one device/element or anatomical structure relative to another device/element or anatomical structure, it is understood that these terms are used herein for ease of description to describe the positional relationship between element(s)/structures(s), as illustrated in the drawings. Spatially relative terms are intended to encompass different orientations of the element(s)/structures(s), in use or operation, in addition to the orientations depicted in the drawings. For example, an element/structure described as “above” another element/structure can represent a position that is below or beside such other element/structure with respect to alternate orientations of the subject patient or element/structure, and vice-versa.
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 examples include, while other examples 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 examples or that one or more examples 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 example.
It should be understood that certain ordinal terms (e.g., “first” or “second”) can 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 can 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”) can indicate “one or more” rather than “one.” Further, an operation performed “based on” a condition or event can also be performed based on one or more other conditions or events not explicitly recited. In some contexts, description of an operation or event as occurring or being performed “based on,” or “based at least in part on,” a stated event or condition can be interpreted as being triggered by or performed in response to the stated event or condition.
With respect to the various methods and processes disclosed herein, although certain orders of operations or steps are illustrated and/or described, it should be understood that the various steps and operations shown and described can be performed in any suitable or desirable temporal order. Furthermore, any of the illustrated and/or described operations or steps can be omitted from any given method or process, and the illustrated/described methods and processes can include additional operations or steps not explicitly illustrated or described.
It should be appreciated that in the above description of examples, various features are sometimes grouped together in a single example, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various aspects of the disclosure. 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 example herein can be applied to or used with any other example(s). Further, no component, feature, step, or group of components, features, or steps are necessary or indispensable for each example. Thus, it is intended that the scope of the disclosure should not be limited by the particular examples described above but should be determined only by a fair reading of the claims that follow.
Unless the context clearly requires otherwise, throughout the description and the claims, the terms “comprise,” “comprising,” “have,” “having,” “include,” “including,” and the like are to be construed in an open and inclusive sense, as opposed to a closed, exclusive, or exhaustive sense; that is to say, in the sense of “including, but not limited to.”
The word “coupled”, as generally used herein, refers to two or more elements that can be physically, mechanically, and/or electrically connected or otherwise associated, whether directly or indirectly (e.g., via one or more intermediate elements, components, and/or devices. Additionally, the words “herein,” “above,” “below,” and words of similar import, when used in this application, shall refer to this application as a whole, including any disclosure incorporated by reference, and not to any particular portions of the present disclosure. Where the context permits, words in present disclosure using the singular or plural number can also include the plural or singular number, respectively.
The word “or” in reference to a list of two or more items, that word covers all of the following interpretations of the word: any of the items in the list, all of the items in the list, and any combination of the items in the list. Furthermore, as used herein, the term “and/or” used between elements (e.g., between the last two of a list of elements) means any one or more of the referenced/related elements. For example, the phrase “A, B, and/or C” means “A,” “B,” “C,” “A and B,” “A and C,” “B and C,” or “A, B, and C.”
As may be used herein, the terms “substantially” and “approximately” provide an industry-accepted tolerance for its corresponding term and/or relativity between items. For some industries, an industry-accepted tolerance is less than one percent, while for other industries, the industry-accepted tolerance can be 10 percent or more. Other examples of industry-accepted tolerances range from less than one percent to fifty percent. Industry-accepted tolerances correspond to, but are not limited to, component values, integrated circuit process variations, temperature variations, rise and fall times, thermal noise, dimensions, signaling errors, dropped packets, temperatures, pressures, material compositions, and/or performance metrics. Within an industry, tolerance variances of accepted tolerances can be more or less than a percentage level (e.g., dimension tolerance of less than approximately +1%). Some relativity between items can range from a difference of less than a percentage level to a few percent. Other relativity between items can range from a difference of a few percent to magnitude of differences.
One or more examples have been described above with the aid of method steps illustrating the performance of specified functions and relationships thereof. The boundaries and sequence of these functional building blocks and method steps have been arbitrarily defined herein for convenience of description. Alternate boundaries and sequences can be defined so long as the specified functions and relationships are appropriately performed. Any such alternate boundaries or sequences are thus within the scope and spirit of the claims. Further, the boundaries of these functional building blocks have been arbitrarily defined for convenience of description. Alternate boundaries could be defined as long as the certain significant functions are appropriately performed. Similarly, flow diagram blocks can also have been arbitrarily defined herein to illustrate certain significant functionality.
To the extent used, the flow diagram block boundaries and sequence could have been defined otherwise and still perform the certain significant functionality. Such alternate definitions of both functional building blocks and flow diagram blocks and sequences are thus within the scope and spirit of the claims. One of average skill in the art will also recognize that the functional building blocks, and other illustrative blocks, modules and components herein, can be implemented as illustrated or by discrete components, application specific integrated circuits, processors executing appropriate software and the like or any combination thereof.
The one or more examples are used herein to illustrate one or more aspects, one or more features, one or more concepts, and/or one or more examples. A physical example of an apparatus, an article of manufacture, a machine, and/or of a process can include one or more of the aspects, features, concepts, examples, etc. described with reference to one or more of the examples discussed herein. Further, from figure to figure, the examples can incorporate the same or similarly named functions, steps, modules, etc. that can use the same, related, or unrelated reference numbers. The relevant features, elements, functions, operations, modules, etc. can be the same or similar functions or can be unrelated.
This application claims the benefit of U.S. Patent Application No. 63/499,948, filed on May 3, 2023, the entire disclosures of which are incorporated by reference in their entireties.
| Number | Date | Country | |
|---|---|---|---|
| 63499948 | May 2023 | US |
