Patent Application
20240148506
The present disclosure generally relates to the field of cardiac valve repairs, and more particularly to minimally invasive cardiac valve repair operations.
Cardiac valve abnormalities can contribute to various heart conditions, adversely affecting supply of oxygenated blood to the rest of the body. Insufficient supply of oxygen can produce any number of symptoms, adversely affecting quality of life. Cardiac valve repair procedures can be performed to treat the abnormalities and alleviate the symptoms.
Described herein are methods and devices relating to providing an artificial chordae system configured to provide regenerated native tissue tethering for one or more leaflets of a heart valve so as to tether the leaflets to a ventricular wall.
In some implementations, an artificial chordae system can comprise a surgical pad configured to be externally positioned over an opening formed in a portion of a heart wall adjacent to a heart ventricle; and a tether comprising a cord and a tissue ingrowth promoting coating over at least a portion of the cord. The tether can comprise a distal portion configured to couple to a heart valve leaflet, the tether being dimensioned to extend from the heart valve leaflet through the heart ventricle to the opening in the heart wall, and through the opening in the heart wall, a proximal portion of the tether being configured to be coupled to the surgical pad. The tissue ingrowth promoting coating can be configured to promote native tissue growth over the cord to provide regenerated native tissue over the cord for coupling the heart valve leaflet to the heart wall.
In some examples, the surgical pad can be biodegradable. In some examples, the surgical pad can comprise decellularized animal tissue. In some examples, the surgical pad can comprise bovine tissue. In some examples, the surgical pad can comprise porcine tissue. In some examples, the surgical pad can comprise blood vessel tissue. In some examples, the surgical pad can be a sheet of the decellularized animal tissue.
In some examples, the surgical pad can comprise a second tissue ingrowth promoting coating over at least a portion of a decellularized animal tissue membrane. In some examples, at least a portion of the tether extending between the heart valve leaflet and the portion of the heart wall can comprise the tissue ingrowth promoting coating over the cord. In some examples, at least one of the tissue ingrowth promoting coating of the tether and the second tissue ingrowth promoting coating of the surgical pad can comprise a protein. In some examples, the protein can comprise an extracellular matrix (ECM) protein. The protein can comprise fibronectin. The protein can comprise laminin. The protein can comprise collagen. In some examples, the protein can comprise an insect protein. In some examples, the protein can comprise a spider protein. In some examples, the protein can comprise a synthetic animal protein.
In some examples, the cord can comprise a biomimetic micropattern on at least a portion thereof. The biomimetic micropattern can comprise a plurality of grooves.
In some examples, the cord can be non-biodegradable. The cord can be an expanded polytetrafluoroethylene (ePTFE) cord.
In some examples, the cord can be biodegradable. The cord can comprise a biodegradable polymer. In some examples, the cord can comprise a core portion and an outer layer portion surrounding the core portion, the core portion comprising a composition configured to have a degradation rate slower than that of the outer layer portion. In some examples, the cord can comprise a middle portion between a first end portion and a second end portion, the middle portion comprising a composition configured to have a degradation rate slower than that of the first and the second end portions.
In some examples, the distal portion of the tether can comprise an anchor configured to be positioned over a surface of the heart valve leaflet oriented away from the heart ventricle to couple the tether to the heart valve leaflet, the anchor comprising the tissue ingrowth promoting coating thereon. In some examples, the anchor can comprise a bulky-knot, the bulky-knot being formed using a portion of the tether.
In some implementations, a tether can comprise a cord; and a tissue ingrowth promoting coating over at least a portion of the cord, the tissue ingrowth promoting coating being configured to promote native tissue growth over the cord to provide regenerated native tissue over the cord for coupling a heart valve leaflet to a ventricular heart wall. The tether can comprise a distal portion configured to couple to the heart valve leaflet, and the tether being configured to extend proximally from the heart valve leaflet through a heart ventricle to a portion of the ventricular heart wall to couple the heart valve leaflet to the ventricular heart wall.
In some examples, the tissue ingrowth promoting coating can comprise an extracellular matrix (ECM) protein. In some examples, the tissue ingrowth promoting coating can comprise an insect protein. In some examples, the tissue ingrowth promoting coating can comprise a spider protein. In some examples, the tissue ingrowth promoting coating can comprise a synthetic animal protein.
In some examples, the cord can comprise a biomimetic micropattern on at least a portion thereof. In some examples, the cord can be an expanded polytetrafluoroethylene (ePTFE) cord. In some examples, the cord can comprise a biodegradable polymer.
In some implementations, a method of deploying an artificial chordae system can comprise coupling a distal portion of a tether to a heart valve leaflet, the tether comprising a tissue ingrowth promoting coating over at least a portion of a cord. The method can include extending the tether from the heart valve leaflet through a heart ventricle to a portion of a heart wall adjacent to the heart ventricle, the heart valve leaflet controlling blood flow into and out of the heart ventricle. The method can include extending the tether through an opening formed on the portion of the heart wall; and coupling a proximal portion of the tether to a surgical pad positioned over an externally oriented surface of the heart wall and the opening formed in the portion of the heart wall.
In some examples, the surgical pad can comprise decellularized animal tissue. In some examples, the surgical pad can comprise a second tissue ingrowth promoting coating on at least a portion thereof. In some examples, the cord can be biodegradable.
In some examples, at least one of the tissue ingrowth promoting coating of the tether and the second tissue ingrowth promoting coating of the surgical pad can comprise an extracellular matrix (ECM) protein.
In some examples, coupling the distal portion of the tether to the heart valve leaflet can comprise providing an anchor on an atrial facing surface of the heart valve leaflet.
In some examples, providing the anchor can comprise forming a bulky-knot anchor over the atrial facing surface of the heart valve leaflet using the tether.
Methods and structures disclosed herein for treating a patient also encompass analogous methods and structures performed on or placed on a simulated patient, which is useful, for example, for training; for demonstration; for procedure and/or device development; and the like. The simulated patient can be physical, virtual, or a combination of physical and virtual. A simulation can include a simulation of all or a portion of a patient, for example, an entire body, a portion of a body (e.g., thorax), a system (e.g., cardiovascular system), an organ (e.g., heart), or any combination thereof. Physical elements can be natural, including human or animal cadavers, or portions thereof; synthetic; or any combination of natural and synthetic. Virtual elements can be entirely in silica, or overlaid on one or more of the physical components. Virtual elements can be presented on any combination of screens, headsets, holographically, projected, loud speakers, headphones, pressure transducers, temperature transducers, or using any combination of suitable technologies.
For purposes of summarizing the disclosure, certain aspects, advantages and novel features have been described herein. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular instance. Thus, the disclosed instances 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 instances 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 instances can be combined to form additional instances, 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 instances 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 instances or configurations.
The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.
The present disclosure relates to devices and methods for providing regenerated native tissue tethering to couple one or more leaflets of a heart valve to a ventricular portion of the heart wall.
Although certain preferred instances and examples are disclosed below, inventive subject matter extends beyond the specifically disclosed instances to other alternative instances and/or uses and to modifications and equivalents thereof. Thus, the scope of the claims that may arise herefrom is not limited by any of the particular instances 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 instances; 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 instances, certain aspects and advantages of these instances are described. Not necessarily all such aspects or advantages are achieved by any particular instance. Thus, for example, various instances 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.
Certain standard anatomical terms of location are used herein to refer to the anatomy of animals, and namely humans, with respect to the preferred instances. 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 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. It should be understood that 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 may 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.
In a healthy heart, the heart valves can properly 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. Deoxygenated blood arriving from the rest of the body generally flows into the right side of the heart for transport to the lungs, and oxygenated blood from the lungs generally flows into the left side of the heart for transport to the rest of the body. During ventricular diastole, deoxygenated blood arrive in the right atrium 5 from the inferior vena cava 15 and superior vena cava 16 to flow into the right ventricle 4, and oxygenated blood arrive in the left atrium 2 from the pulmonary veins to flow into the left ventricle 3. During ventricular systole, deoxygenated blood from the right ventricle 4 can flow into the pulmonary trunk ii for transport to the lungs (e.g., via the left 14 and right 13 pulmonary arteries), and oxygenated blood can flow from the left ventricle 3 to the aorta 12 for transport to the rest of the body.
A number of conditions can contribute to a higher than normal pressure in the left atrium. Dysfunction of the mitral valve can contribute to elevated left atrial pressure. Conditions such as mitral valve regurgitation and/or stenosis may result in difficulty in pumping blood from the left atrium to the left ventricle, contributing to elevated pressure in the left atrium. Valve stenosis can cause a valve to become narrowed or obstructed. Mitral valve stenosis can restrict blood flow from the left atrium to the left ventricle. Valve regurgitation occurs when a valve does not close properly. For example, regurgitation can occur due to improper coaptation of the valve leaflets, such as due to prolapse of one or more of the valve leaflets. Mitral valve regurgitation can result in blood flow leakage back into the left atrium 2 from the left ventricle 3 when the left ventricle 3 contracts. Restricted flow of blood from the left atrium 2 into the left ventricle 3, and blood flow leakage from the left ventricle 3 back into the left atrium 2 can both contribute to elevated atrial pressure. Dysfunction in the left ventricle 3 can also contribute to elevated left atrial pressure. Elevated left atrial pressure may lead to left atrial enlargement, producing symptoms such as shortness of breath during exertion, fatigue, chest pain, fainting, abnormal heartbeat, and swelling of the legs and feet.
The disclosure herein provides one or more devices and methods related to providing an artificial chordae system configured to provide regenerated native tissue tethering for one or more leaflets of a heart valve. The artificial chordae system can comprise a tether which has a cord and a tissue ingrowth promoting coating over at least a portion of the cord. The tether can be configured to couple a heart valve leaflet to a ventricular heart wall. A distal portion of the tether can be configured to couple the heart valve leaflet and a proximal portion of the tether can be configured to be coupled to the ventricular heart wall. In some instances, the tether can have a cord extending therethrough and a tissue ingrowth promoting coating over the entire or substantially entire length of the cord.
The artificial chordae system can comprise a surgical pad. The surgical pad can be configured to be positioned externally of the heart over an opening formed in a portion of a heart wall adjacent to the heart ventricle. The tether can be dimensioned to extend from the heart valve leaflet through the heart ventricle to the opening in the heart wall, and through the opening in the heart wall, such that the proximal portion of the tether can be coupled to the surgical pad. The surgical pad can comprise a biodegradable membrane. For example, the surgical pad can comprise an antigen removal processed animal tissue membrane, including bovine tissue and/or porcine tissue. In some instances, the surgical pad can comprise a tissue ingrowth promoting coating. For example, the surgical pad can comprise a tissue ingrowth promoting coating over an antigen removal processed animal tissue membrane. In some instances, the surgical pad does not have a tissue ingrowth promoting coating. The surgical pad can be an antigen removal processed animal tissue membrane, including an antigen removal processed bovine tissue membrane or an antigen removal processed porcine tissue membrane.
The tissue ingrowth promoting coating can be configured to promote native tissue growth over the cord and/or the surgical pad. After deployment of the tether and surgical pad to their respective target sites, native tissue adjacent to the tether and/or surgical pad can migrate onto and grow on the tether and/or surgical pad. Growth of the native tissue over the tether and/or surgical pad can provide tethering for the heart valve leaflet comprising regenerated native tissue. The artificial chordae system described herein can be configured to provide regenerated native tissue to couple the heart valve leaflet to the ventricular wall for treating improper coaptation of the valve leaflets.
A heart valve repair procedure to improve or restore valve function can comprise deploying an artificial chordae system as described herein. The artificial chordae system can be delivered using a minimally invasive technique. In some instances, the delivery can be performed while the heart is beating. For example, the procedure to deliver the artificial chordae system can be a minimally invasive beating heart procedure. In some instances, mitral valve repair procedures can comprise deploying an artificial chordae system as described herein to alleviate mitral valve dysfunction, including mitral valve prolapse.
The methods, operations, steps, etc. described herein can be performed on a living animal or simulated on a human or animal cadaver, cadaver heart, simulator (e.g., with the body parts, tissue, etc. being simulated), etc. For example, methods for treating a patient include methods for simulating the treatment on a simulated patient or anthropogenic ghost, which can include any combination of physical and virtual elements. Examples of physical elements include human or animal cadavers; any portions thereof, including organ systems, whole organs, or tissue; and manufactured elements, which can simulate the appearance, texture, resistance, or other characteristic. Virtual elements can include visual elements provided on a screen, or projected on a surface or volume, including virtual reality and augmented reality implementations. Virtual elements can also simulate other sensory stimuli, including sound, feel, and/or odor.
It will be understood that one or more components of the systems described herein can undergo various processes in preparation for use in the procedures, including for example sterilization processes. One or more components of the systems can be sterilized. For example, surgical pads and/or tethers as described herein can be sterilized surgical pads and/or sterilized tethers.
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.
The artificial chordae system 100 can facilitate regeneration of tethering for the heart valve leaflet using native heart tissue. Native tissue adjacent to the tether 200 and the surgical pad no can migrate onto and grow on the tether 200 and surgical pad no, respectively. Native tissue can migrate onto and grow on the tether 200 and surgical pad 110 to provide tethering comprising regenerated tissue for the heart valve leaflet to the heart wall 17. At least a portion of each of the tether 200 and surgical pad 110 may be biodegradable. For example, at least a part of each of the tether 200 and surgical pad 110 can degrade and/or be consumed as the native tissue grows over the tether 200 and surgical pad no. In some instances, the tether 200 can be completely or substantially completely biodegradable. For example, both the cord and the tissue ingrowth promoting coating can be biodegradable. As the native tissue grows over the tether 200, the cord and the tissue ingrowth promoting coating can be consumed and/or degrade over time. Native tissue can completely replace the tether 200, and/or the tether 200 can be integrated as part of the newly formed native tissue tethering. A regenerated native tissue chordae can replace the tether 200 for coupling the heart valve leaflet to the heart wall 17. In some instances, the surgical pad no can be completely or substantially completely biodegradable. For example, the animal tissue membrane and the tissue ingrowth promoting coating can be biodegradable. As the native tissue grows over the surgical pad no, the animal tissue membrane and the tissue ingrowth promoting coating can be consumed and/or degrade over time such that native tissue completely replaces the surgical pad 110, and/or the surgical pad 110 can be integrated as part of newly formed native tissue. The artificial chordae system 100 can provide a regenerated native tissue tethering system that couples the heart valve leaflet to the heart wall 17. The tethering system can entirely or substantially entirely be regenerated native tissue. A tethering system that is entirely or substantially entirely of regenerated native tissue can provide desired mechanical strength while reducing or eliminating biocompatibility issues.
In some examples, at least a portion of the tether 200 can be non-biodegradable. For example, the cord may be non-biodegradable. The tissue ingrowth promoting coating can be consumed and/or degrade over time as native heart tissue migrates onto and grow on the cord, while the cord remains coupled to the heart valve leaflet and the heart wall. The remaining cord can provide additional strength for the coupling between the heart valve leaflet and the heart wall.
As shown in
In some instances, the anchor 270 can be a knot formed using the same material as the elongate portion 280. In some instances, the elongate portion 280 and the anchor 270 can be an integral piece. In some instances, the elongate portion 280 and the anchor 270 can be formed using a single tether. For example, the tether tails and the anchor 270 can be formed using an integral piece of tether, where the tether comprises a cord extending through an entire or substantially entire length thereof and a tissue ingrowth promoting coating over an entire or substantially entire length of the cord. The tether can comprise a respective portion configured to form the anchor 270 and a respective portion configured to form the elongate portion 280. For example, the anchor 270 and the elongate portion 280 can be formed using a unitary piece of tether such that while the tether is in the deployed state, a respective portion of the tether forms the anchor 270, and a respective portion of the tether forms the elongate portion 280.
As described in further detail herein, in some cases, a transapical approach can be used to gain access into the heart 1 to deploy the tether 200. The heart wall 17 can be punctured in the apical region 19 to form an opening so as to allow delivery of the tether 200 into a heart ventricle, such as to couple the distal portion 202 of the tether 200 to a heart valve leaflet which facilitates control blood flow into and out of the heart ventricle. The apical region 19 is schematically shown in
The heart wall 17 can be punctured in the apical region 19 of the heart wall 17 adjacent to the left ventricle 3 to form the opening 40 so as to allow delivery of the tether 200 to the mitral valve 6. The distal portion 202 of the tether 200 can be coupled to a leaflet of the mitral valve 6. The tether 200 can be dimensioned to extend from the leaflet of the mitral valve 6 through the left ventricle 3 to the heart wall 17, such as to the opening 40 formed in the heart wall 17. The tether 200 can extend through the opening 40. The proximal portion 204 of the tether 200 can be coupled to the surgical pad no positioned externally over the opening 40. The distal portion 202 of the tether 200 can be delivered to an atrial facing surface of the mitral valve leaflet. For example, the mitral valve leaflet can be punctured such that the anchor 270 can be positioned at least partially over an upper surface of the leaflet. The anchor 270 can be positioned over the atrial facing surface of the mitral valve leaflet, such as a surface of the leaflet facing the left atrium. The elongate portion 280 of the tether 200 can extend proximally from the anchor 270. The elongate portion 280 of the tether 200 can be dimensioned to extend from the leaflet of the mitral valve 6 through the left ventricle 3 to the opening 40 in the heart wall 17, and through the opening 40 in the wall 17 to couple to the surgical pad no. For example, the two tether tails 280a, 280b can extend from the anchor 270, through the leaflet and the left ventricle 3 to the opening 40, and through the opening 40 to couple to the surgical pad no. The surgical pad no can be positioned over the opening 40 formed in the heart wall 17 and/or over a portion of the heart wall 17 adjacent to the left ventricle 3. In some instances, the surgical pad no can be positioned over a pericardium layer of the heart 1.
As described herein, the surgical pad no can be positioned externally of the heart. The surgical pad no can be configured to be positioned over an opening formed in a ventricular heart wall and/or a portion of the heart wall adjacent to the opening, such that a first surface 112 of the surgical pad no is oriented toward the heart and a second surface 114 is oriented away from the heart. The second surface 114 can have an opposing orientation relative to the first surface 112. The surgical pad 110 can be configured to be coupled to one or more tethers as described herein. In some instances, the one or more tethers can extend through surgical pad no to be secured to the surgical pad no. For example, the one or more tethers can extend through the opening in the heart wall, and extend from the first surface 112 through the surgical pad 110 to the second surface 114 of the surgical pad 110. In some instances, the one or more tethers can form one or more knots over the second surface 114 to secure the tethers to the surgical pad no.
The surgical pad no can comprise a biodegradable membrane 130. In some examples, the surgical pad no is the biodegradable membrane 130. For example, a first surface 132 of the biodegradable membrane 130 can be positioned over and/or on and in contact with an externally oriented surface of the heart and a second opposing surface 134 of the biodegradable membrane 130 can be oriented away from the heart. The biodegradable membrane 130 can comprise a material configured to facilitate migration of native tissue onto and/or growth of native tissue on the biodegradable membrane 130 such that native tissue can replace the biodegradable membrane 130.
The biodegradable membrane 130 can comprise an animal tissue, including an animal tissue which has undergone an antigen removal process, such as a sheet of antigen removal processed animal tissue. The biodegradable membrane 130 can comprise any one of a number of animal tissues which can undergo an antigen removal process, including one or more of bovine tissue, porcine tissue, and/or blood vessel tissue which has undergone an antigen removal process. The biodegradable membrane 130 can be an antigen removal processed bovine tissue, porcine tissue, or blood vessel tissue. For example, the biodegradable membrane 130 can be a sheet of bovine tissue, porcine tissue, or blood vessel tissue which has undergone antigen removal process. In some instances, the biodegradable membrane 130 can comprise a decellularized tissue membrane. For example, the biodegradable membrane 130 can be a decellularized bovine tissue, porcine tissue, or blood vessel tissue. The biodegradable membrane 130 can be a sheet of decellularized bovine tissue, porcine tissue, or blood vessel tissue. One or more tethers as described herein can be threaded through the sheet of antigen removal processed tissue to secure the tethers to the heart wall.
In some examples, the surgical pad no can optionally include a tissue ingrowth promoting coating 150. The surgical pad 110 can comprise the biodegradable membrane 130 and the tissue ingrowth promoting coating 150 over one or more surfaces of the biodegradable membrane 130.
Surgical pads as described herein can have a number of different shapes. Although the surgical pad no is shown in
The elongate portion 280 can comprise two tether tails 280a, 280b. The anchor 270 and/or the tether tails 280a, 280b can comprise respective portions of the cord 220 and the tissue ingrowth promoting coating 250 over the respective portions of the cord 220. In some instances, at least a portion of the elongate portion 280, such as the tether tails 280a, 280b, can comprise the tissue ingrowth promoting coating 250 over the cord 220. In some instances, at least a portion of the elongate portion 280, such as the tether tails 280a, 280b, extending between the heart valve leaflet and the heart wall can comprise the tissue ingrowth promoting coating 250 over the cord 220. In some instances, the tissue ingrowth promoting coating 250 can be on the entirety or substantially entirety of the cord portions 220a, 220b of the elongate portion 280. For example, the tether tails 280a, 280b can comprise respective tissue ingrowth promoting coating portions 250a, 250b over the cord portions 220a, 220b. Alternatively, the tissue ingrowth promoting coating 250 can be on less than the entirety of the cord portions 220a, 220b of the elongate portion 280. In some instances, the ingrowth promoting coating 250 can be on only portions of the cord portions 220a, 220b configured to be within the heart, including portions of the cord portions 220a, 220b configured to be between the heart valve leaflet and the heart wall. In some examples, the tissue ingrowth promoting coating 250 can be on the anchor 270, including an entirety or substantially entirety of the anchor 270. For example, the anchor 270 can comprise a cord portion 220C extending therethrough and a tissue ingrowth promoting coating 250c over the cord portion 220C.
In some instances, the tissue ingrowth promoting coating 250 can be over all or substantially all externally oriented surfaces of the cord 220 along an entire or substantially entire length of the cord 220. In some instances, the tether 200 can comprise the cord 220 extending therethrough and the tissue ingrowth promoting coating 250 can be over an entire or substantially entire length of the cord 220. As described herein, the anchor 270 can comprise a suture-knot-style anchor. For example, the anchor 270 can be a bulky-knot. The bulky-knot can be formed using a portion of the tether 200. In some examples, both the anchor 270 and the elongate portion 280, including the tether tails 280a, 280b, can be formed using one tether. The anchor 270 and the elongate portion 280 can be a unitary piece. For example, the cord 220 can extend through an entire or substantially entire length of the tether 200 and the tissue ingrowth promoting coating 250 can be over an entire or substantially entire length of the cord 220, where the anchor 270 is formed using a portion of the tether 200 and the elongate portion 280 is formed using another portion of the tether, such that the anchor 270 and the elongate portion 280 are formed using a single integral tether 200.
The cord 220 can comprise one or more indentations and/or recesses 260 on at least a portion thereof configured to facilitate migration and/or growth of native tissue cells onto the cord 220. For example, the indentations and/or recesses 260 can be on one or more portions of an externally oriented surface of the cord 220. The one or more indentations and/or recesses 260 can be in a pattern configured to enhance the ability of native heart tissue cells from adjacent portions of the heart to migrate onto the cord 220, thereby facilitating growth of native tissue over the cord 220. The one or more indentations and/or recesses 260 can advantageously enhance cell migration onto and/or proliferation on the cord 220, thereby expediting the regeneration process. In some examples, the one or more indentations and/or recesses 260 can be one or more micropatterns. The micropatterns can be biomimetic micropatterns configured to facilitate cell migration and/or tissue growth over the cord 220. In some examples, the micropatterns can comprise a plurality of grooves, including microgrooves, such as biomimetic microgrooves. In some instances, the one or more indentations and/or recesses 260 can be on an entire or substantially entire length of the cord 220. The one or more indentations and/or recesses 260 can be on an entire or substantially entire length of the cord 220 of the elongate portion 280 and/or anchor 270. For example, indentations and/or recesses 260 can be on all of the externally oriented surface portions of the cord 220 of the elongate portion 280 and/or anchor 270. Alternatively, the one or more indentations and/or recesses 260 can be only on a portion of the length of the cord 220. For example, indentations and/or recesses 260 can be only on a portion of the externally oriented surface of the cord 220 of the elongate portion 280 and/or anchor 270.
In some instances, the cord portions 220a, 220b of both the tether tails 280a, 280b can comprise respective indentations and/or recesses 260a, 260b. The indentations and/or recesses 260a, 260b can be on externally oriented surface portions of the cord portions 220a, 220b along the entire or substantially entire length of each of the cord portions 220a, 220b. In some instances, the cord portion 220C of the anchor 270 can comprise respective indentations and/or recesses 260c (not shown). The one or more indentations and/or recesses 260c of cord portion 220C can be on externally oriented surface portions along an entire or substantially entire length of the cord portion 220C of the anchor 270. In some instances, the tether 200 can comprise the one or more indentations and/or recesses 260a, 260b on a part or an entire length of the cord portions 220a, 220b of the elongate portion 280, without being on any portion of the cord portion 220C of the anchor 270. For example, biomimetic micropatterns can be over all or part of any portion of the cord portions 220a, 220b, 220C of the elongate portion 280 and/or anchor 270.
The cord 220 may or may not be biodegradable. In some examples, the cord 220 is not biodegradable. The cord 220 can comprise a non-biodegradable polymer, including expanded polytetrafluoroethylene (ePTFE). The cord 220 can be an expanded polytetrafluoroethylene (ePTFE) suture. The expanded polytetrafluoroethylene (ePTFE) suture can comprise one or more other features as described herein, including for example a plurality of indentations and/or recesses. Native tissue can grow on the expanded polytetrafluoroethylene (ePTFE) suture over time. The native tissue can cover or substantially cover the expanded polytetrafluoroethylene (ePTFE) suture. The expanded polytetrafluoroethylene (ePTFE) suture can remain and provide added durability and/or mechanical strength to the tether 200. For example, regenerated native tissue over the expanded polytetrafluoroethylene (ePTFE) suture can couple a heart valve leaflet to a ventricular portion of the heart wall.
In some examples, the cord 220 can be at least partially biodegradable. The cord 220 can comprise a biodegradable polymer. In some instances, the cord 220 can be entirely biodegradable. For example, the cord 220 can be a biodegradable polymer. The cord 220 can be a synthetic biodegradable polymer. The cord 220 can be a biodegradable polymer suture. The biodegradable polymer can be selected to provide desired strength for tethering the heart valve leaflet to the heart wall, while having a predetermined degradation rate based at least in part on the rate of native tissue growth on the cord 220. In some instances, the cord 220 can be fully biodegradable such that native tissue can grow on and replace the cord 220, such that regenerated native tissue couples a heart valve leaflet to a ventricular portion of the heart wall without or substantially without any portion of the cord 220 remaining.
A composition of a tissue ingrowth promoting coating as described herein can be selected to facilitate migration and/or tissue growth onto the respective substrate, such as the surgical pad no or the cord 220. The tissue ingrowth promoting coating 150 of the surgical pad no and/or the tissue ingrowth promoting coating 250 of the tether 200 can comprise one or more proteins, including animal and/or insect proteins. The protein coating can be configured to confer the biochemical cues for native tissue cells to migrate onto, grow on, and produce extracellular matrix (ECM) for additional growth of native tissue cells thereon, such that native tissue cells can gradually provide at least a part of the tether for the heart valve leaflet. The protein can comprise an extracellular matrix (ECM) protein. In some instances, the protein can comprise one or more of collagen, fibronectin and laminin. In some instances, the protein can comprise a spider protein. In some instances, the protein can comprise a synthetic animal protein. The tissue ingrowth promoting coating 150 of the surgical pad no and the tissue ingrowth promoting coating 250 of the tether 200 can have the same or different composition.
In some instances, a core portion 530 of the cord 520 can have a degradation rate slower than that of an outer layer 540 of the cord 520. For example, the core portion 530 can be a center portion of the cord 520 extending along the longitudinal axis of the cord 520. The outer layer 540 can comprise a portion of the cord 520 disposed over and around the core portion 530. The outer layer 540 can be a portion of the cord 520 concentric with the core portion 530. The outer layer 540 can completely surround and/or wrap around an outer circumference of the core portion 530. In some instances, the cord 520 can have two degradation rates, such as the degradation rate of the core portion 530 and that of the outer layer 540. In some instances, the core portion 530 and the outer layer 540 can extend along an entire or substantially entire length of the cord 520.
Only a portion of an elongate portion 580 of the tether 500 is shown in
It will be understood that although only two layers of the cord 520 are described with reference to
The tether 500 can one or more other characteristics of the tether 200 described with reference to
A distal portion 602 of the tether 600 can comprise an anchor 670. The distal portion 602 can be configured to be coupled to a heart valve leaflet. A proximal portion 604 of the tether 600 can be configured to be coupled to a heart ventricular wall. The tether 600 can comprise an elongate portion 680 coupled to the anchor 670. The elongate portion 680 can comprise at least a portion configured to extend between a heart valve leaflet and a heart wall portion. Portions of the elongate portion 680 configured to be closer to native tissue while the tether 600 is in the deployed state can have a faster degradation rate than that of portions further away from native tissue. In some instances, first and second end portions of the elongate portion 680 configured to be closer to native while the tether 600 is in the deployed state can degrade at a faster rate than a middle portion between the first and second end portions. For example, a proximal portion 684 of the elongate portion 680 configured to be proximate and/or adjacent to ventricular heart wall tissue, and a distal portion 682 of the elongate portion 680 configured to be proximate and/or adjacent to heart valve leaflet tissue, can degrade more quickly than a middle portion 686 further away from the ventricular wall tissue and heart valve leaflet tissue. A cord 620 can extend through at least a portion of the tether 600, including the elongate portion 680 and/or the anchor 670. In some instances, the tether 600 can comprise the cord 620 extending through an entire or substantially entire length thereof. The elongate portion 680 can comprise two tether tails 680a, 680b. Each of the tether tails 680a, 680b can comprise a respective cord portion 620a, 620b. In some instances, the cord 620 can extend through the entirety or substantially entirety of the elongate portion 680. For example, cord portions 620a, 620b can extend through an entire or substantially entire length of the tether tails 680a, 680b. Portions of the cord 620 configured to be positioned closer to native tissue while the tether 600 is in the deployed state can have degradation rates faster than those of portions further away from the native tissue. For example, degradation rates of respective middle portions 626a, 626b of the cord portions 620a, 620b can be slower than those of respective proximal portions 624a, 624b and distal portions 622a, 622b of the cord portions 620a, 620b. The middle portions 626a, 626b can be further away from native tissue when the tether 600 is deployed at its target site, while the proximal portions 624a, 624b and distal portions 622a, 622b are closer to native tissue. For example, the proximal portions 624a, 624b can be oriented toward, and be adjacent and/or proximate to ventricular wall tissue. The distal portions 622a, 622b can be oriented toward, and be adjacent and/or proximate to heart valve leaflet tissue. Tissue growth over the proximal portions 624a, 624b and distal portions 622a, 622b can occur earlier as native tissue migrates onto the cord portions 620a, 620b initially along the proximal portions 624a, 624b and distal portions 622a, 622b prior to reaching the middle portions 626a, 626b. The proximal portions 624a, 624b and the distal portions 622a, 622b can degrade and/or be consumed first as the regenerated native tissue first form the proximal and distal portions of the tethering between the heart valve leaflet and the heart wall. At least a portion of the middle portions 626a, 626b can remain while the native tissue continue to migrate onto and/or grow on the middle portions 626a, 626b.
The proximal portions 624a, 624b can have a degradation rate the same as or similar to one another. The distal portions 622a, 622b can have a degradation rate the same as or similar to one another. The middle portions 626a, 626b can have a degradation rate the same as or similar to one another. In some instances, the proximal portions 624a, 624b and the distal portions 622a, 622b can have a degradation rate the same as or similar to one another. The proximal portions 624a, 624b and distal portions 622a, 622b can degrade at a faster rate as native tissue initially migrate onto and grow over the proximal portions 624a, 624b and distal portions 622a, 622b, leaving the middle portions 626a, 626b.
In some instances, the cord 620 can extend through at least a portion of the anchor 670, including the entirety or substantially entirety of the anchor 670. For example, the anchor 670 can comprise a cord portion 620c extending therethrough. In some instances, the cord portion 620c can be biodegradable.
In some instances, the cord portions 620a, 620b, 620c can comprise a biodegradable polymeric material. The composition of the polymeric material can be selected to provide the desired degradation gradient along the longitudinal axis. The cord portions 620a, 620b can be polymeric suture portions comprising a composition selected to provide the desired degradation gradient along the longitudinal axis. Although
The tether boo can one or more other characteristics of the tether 200 described with reference to
The delivery system 700 can include an elongate rigid tube 710 forming at least one internal working lumen. Although described in certain examples and/or contexts as comprising an elongate rigid 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 addition to the elongate rigid tube 710, the delivery system 700 may include a plunger 740, which may be used or actuated to manually deploy the tether. The delivery system 700 may further include a plunger lock mechanism 745, which may serve as a safety lock that locks the delivery system 700 until ready for use or deployment of a tether as described herein. The plunger 740 may have associated therewith a suture-release mechanism, which may be configured to lock in relative position a pair of tether tails 280a, 280b associated with a pre-formed knot anchor (not shown) to be deployed. The delivery system 700 may further comprise a flush port 750, which may be used to de-air the lumen of the elongate rigid tube 710. For example, heparinized saline flush, or the like, may be connected to the flush port 750 using a female Luer fitting to de-air the delivery system 700. 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 elongate rigid tube 710 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 elongate rigid tube 710 presents a relatively low profile. For example, the elongate rigid tube 710 may have a diameter of about 3 millimeters (mm) or less (e.g., about 9 French (Fr) or less). The elongate rigid tube 710 is associated with an atraumatic tip 714 feature. The atraumatic tip 714 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 714, disposed at and/or coupled to the distal end of the elongate rigid tube 710, may be configured to have deployed therefrom a wrapped pre-formed suture knot (e.g., sutureform), as described herein.
The atraumatic tip 714 may be referred to as an “end effector.” In addition to housing a pre-formed knot sutureform and associated needle, the elongate rigid tube 710 may house an elongated knot pusher tube (not shown; also referred to herein as a “pusher”), which may be actuated using the plunger 740 in some examples. As described in further detail below, the atraumatic tip 714 provides a surface against which the target valve leaflet may be held in connection with deployment of a leaflet anchor.
The delivery system 700 may be used to deliver a “bulky knot” type tissue anchor, as described in greater detail below. For example, the delivery system 700 may be utilized to deliver an anchor as described herein (e.g., bulky knot, such as the anchor 270 described with reference to
The needle may have the pre-formed knot disposed about a distal portion thereof while maintained in the elongate rigid tube 710. For example, the pre-formed knot sutureform 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 740 at a proximal end of the delivery system 700, which may be configured to releasably hold or secure the tether 200 extending through the delivery system 700 during delivery of a tissue anchor as described herein. The suture catch can be used to hold the tether 200 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 delivery system 700 can be used in beating heart mitral valve repair procedures. In some examples, the elongate rigid tube 710 of the delivery system 700 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 18 of the heart to the valve leaflets 62, 64 can vary by about 1 centimeter (cm) to about 2 centimeters (cm) with each heartbeat in some patients. In some examples, the length of the elongate rigid tube 710 that protrudes from the handle 720 can change with the length of the median axis of the heart. That is, distal end of the elongate rigid tube 710 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.
Implementation of a valve-repair procedure utilizing the delivery system 700 can be performed in conjunction with certain imaging technology designed to provide visibility of the elongate rigid tube 710 according to a certain imaging modality, such as echo imaging. Advancement of the delivery system 700 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 system 700 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.
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/opening of, for example, about 5 centimeters (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 for all purposes.
Generally, the elongate rigid tube 710 of the delivery system 700 may be slowly advanced into the introducer port device 800 until the atraumatic tip 714 and/or a needle 730 (e.g., the needle 730 is shown in
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 suture(s)/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 a mitral valve. Furthermore, aspects of the present disclosure applicable to non-biological structures and devices. For example, other cord or suture tensioning applications not involving biological tissue may incorporate aspects of the pension balancing and/or distribution devices, systems, and processes disclosed herein.
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 elongate rigid tube 710 within the left ventricle 3. The atraumatic tip 714 of the elongate rigid tube 710 can contact a proximal surface (e.g., underside surface with respect to the illustrated orientation of
In some examples, one or more perforation devices, such as a needle 730 (e.g., needle(s)) can be delivered through a working lumen (not shown) of the elongate rigid tube 710 to the valve leaflet 64 to puncture the valve leaflet 64 and project a sutureform 290 including a plurality of winds of suture about a distal portion of the needle 730 into the left atrium 2 (see
Once the atraumatic tip 714 is positioned in the desired position, the distal end of the elongate rigid tube 710 and the atraumatic tip 714 may be used to drape, or “tent,” the mitral valve leaflet 64 to better secure the atraumatic tip 714 in the desired position, as shown in
After the atraumatic tip 714 is desirably positioned on the underside of the mitral valve leaflet 64, the plunger 740 can be actuated and a distal piercing portion of the needle 730 can puncture the leaflet 64 to form an opening in the leaflet 64.
With the elongate rigid tube 710 positioned against the mitral valve leaflet 64, the plunger 740 of the delivery system 700 can be actuated to move the needle 730 and a pusher disposed within the elongate rigid tube 710, such that the coiled sutureform portion 290 of the suture anchor slides off the needle 730. As the pusher (not shown) within the tissue anchor delivery device elongate rigid tube 710 is moved distally, a distal end of the pusher advantageously moves or pushes the distal coiled sutureform 290 (e.g., pre-deployment coiled portion of the suture anchor) over the distal end of the needle 730 and further within the left atrium 2 of the heart on a distal side of the mitral valve leaflet 64, such that the sutureform 290 extends distally beyond a distal end of the needle 730. For example, in some examples, at least half a length of the sutureform 290 extends beyond the distal end of the needle 730. In some examples, at least three quarters of the length of the sutureform 290 extends beyond the distal end of the needle 730. In some examples, the entire coiled sutureform 290 extends beyond the distal end of the needle 730.
After the sutureform 290 has been pushed off the needle 730, pulling one or more of the tether tail(s) 280a, 280b (e.g., strands extending from the coiled portion of the tether) associated with the tissue anchor 270 proximally can cause the sutureform 290 to form the anchor 270 (e.g., a bulky knot anchor), as shown in
The tether can comprise one or more characteristics described herein. In some instances, the cord can be biodegradable. For example, the cord can be a biodegradable polymeric suture. In some instances. The cord is non-biodegradable. For example, the cord can be an expanded polytetrafluorethylene (ePTFE) suture.
In block 904, the process an involve extending the tether from the heart valve leaflet through a heart ventricle to a portion of a heart wall adjacent to the heart ventricle, where the heart valve leaflet controls the flow of blood into and out of the heart ventricle. In block 906, the process can involve extending the tether through an opening formed on the portion of the heart wall. As described herein, an opening can be formed on a portion of the ventricular wall to allow access into the ventricle so as to deploy the tether onto the heart valve leaflet. An artificial chordae delivery system as described herein can be inserted into the ventricle through the opening to couple the distal portion of the tether to the heart valve leaflet.
In block 908, the process can involve coupling a proximal portion of the tether to a surgical pad positioned over an externally oriented surface of the heart wall and the opening formed in the portion of the heart wall. The surgical pad can comprise an antigen removal processed animal tissue, including a decellularized animal tissue. For example, the surgical pad can be an antigen removal processed animal tissue membrane, including a decellularized animal tissue membrane. The proximal portion of the tether can be coupled to the animal tissue membrane. Native tissue can migrate onto and grow on the antigen removal processed animal tissue membrane. The antigen removal processed animal tissue can be consumed and/or degrade over time. In some instances, the surgical pad can optionally comprise a tissue ingrowth promoting coating as described herein. For example, the tissue ingrowth coating can be over and/or on one or more surfaces of the antigen removal processed animal tissue membrane.
The biodegradable coating of the tether and/or the biodegradable coating of the surgical pad can comprise a protein, including an extracellular matrix (ECM) protein. The tissue ingrowth promoting coating of the surgical pad can be the same as or different from the tissue ingrowth promoting coating of the tether.
The surgical pad can be biodegradable. The surgical pad can be consumed and/or degrade as native heart tissue migrate onto and grow over the surgical pad. In some instances, the tether can be at least partially biodegradable. As described herein, the tether can comprise an anchor coupled to an elongate portion. The elongate portion and/or the anchor can be biodegradable. In some instances, the tether can be entirely biodegradable such that the tether is consumed and/or degrades as native tissue grow over the tether. Delivering the artificial chordae system as described herein to a target site can facilitate regenerating native tissue tethering for the heart valve leaflet.
Example 1: An artificial chordae system comprising:
Example 2: The system of example 1, wherein the surgical pad is biodegradable.
Example 3: The system of example 2, wherein the surgical pad comprises decellularized animal tissue.
Example 4: The system of example 3, wherein the surgical pad is a sheet of the decellularized animal tissue.
Example 5: The system of example 3 or 4, wherein the surgical pad comprises bovine tissue.
Example 6: The system of any one of examples 3 to 5, wherein the surgical pad comprises porcine tissue.
Example 7: The system of any one of examples 3 to 6, wherein the surgical pad comprises blood vessel tissue.
Example 8: The system of any one of examples 2 to 7, wherein the surgical pad comprises a second tissue ingrowth promoting coating over at least a portion of a decellularized animal tissue membrane.
Example 9: The system of example 8, wherein at least one of the tissue ingrowth promoting coating of the tether and the second tissue ingrowth promoting coating of the surgical pad comprises a protein.
Example 10: The system of example 9, wherein the protein comprises an extracellular matrix (ECM) protein.
Example 11: The system of example 10, wherein the protein comprises fibronectin.
Example 12: The system of example 10 or 11, wherein the protein comprises laminin.
Example 13: The system of any one of examples 10 to 12, wherein the protein comprises collagen.
Example 14: The system of any one of examples 9 to 13, wherein the protein comprises an insect protein.
Example 15: The system of any one of examples 9 to 14, wherein the protein comprises a spider protein.
Example 16: The system of any one of examples 9 to 15, wherein the protein comprises a synthetic animal protein.
Example 17: The system of any one of examples 1 to 16, wherein the cord comprises a biomimetic micropattern on at least a portion thereof.
Example 18: The system of example 17, wherein the biomimetic micropattern comprises a plurality of grooves.
Example 19: The system of any one of examples 1 to 18, wherein the cord is non-biodegradable.
Example 20: The system of example 19, wherein the cord is an expanded polytetrafluoroethylene (ePTFE) cord.
Example 21: The system of any one of examples 1 to 18, wherein the cord is biodegradable.
Example 22: The system of example 21, wherein the cord comprises a biodegradable polymer.
Example 23: The system of example 21 or 22, wherein the cord comprises a core portion and an outer layer portion surrounding the core portion, the core portion comprising a composition configured to have a degradation rate slower than that of the outer layer portion.
Example 24: The system of example 21 or 22, wherein the cord comprises a middle portion between a first end portion and a second end portion, the middle portion comprising a composition configured to have a degradation rate slower than that of the first and the second end portions.
Example 25: The system of any one of examples 1 to 24, wherein at least a portion of the tether extending between the heart valve leaflet and the portion of the heart wall comprises the tissue ingrowth promoting coating over the cord.
Example 26: The system of any one of examples 1 to 25, wherein the distal portion of the tether comprises an anchor configured to be positioned over a surface of the heart valve leaflet oriented away from the heart ventricle to couple the tether to the heart valve leaflet, the anchor comprising the tissue ingrowth promoting coating thereon.
Example 27: The system of example 26, wherein the anchor comprises a bulky-knot, the bulky-knot being formed using a portion of the tether.
Example 28: The system of any one of examples 1 to 27, wherein the surgical pad and the tether are sterilized.
Example 29: A tether comprising:
Example 30: The tether of example 29, wherein the tissue ingrowth promoting coating comprises an extracellular matrix (ECM) protein
Example 31: The tether of example 29 or 30, wherein the tissue ingrowth promoting coating comprises an insect protein.
Example 32: The tether of any one of examples 29 to 31, wherein the tissue ingrowth promoting coating comprises a spider protein.
Example 33: The tether of any one of examples 29 to 32, wherein the tissue ingrowth promoting coating comprises a synthetic animal protein.
Example 34: The tether of any one of examples 29 to 33, wherein the cord comprises a biomimetic micropattern on at least a portion thereof.
Example 35: The tether of any one of examples 29 to 34, wherein the cord is an expanded polytetrafluoroethylene (ePTFE) cord.
Example 36: The tether of any one of examples 29 to 34, wherein the cord comprises a biodegradable polymer.
Example 37: A method of deploying an artificial chordae system, the method comprising:
Example 38: The method of example 37, wherein the surgical pad comprises decellularized animal tissue.
Example 39: The method of example 37 or 38, wherein the surgical pad comprises a second tissue ingrowth promoting coating on at least a portion thereof.
Example 40: The method of example 39, wherein at least one of the tissue ingrowth promoting coating of the tether and the second tissue ingrowth promoting coating of the surgical pad comprises an extracellular matrix (ECM) protein.
Example 41: The method of any one of examples 37 to 40, wherein the cord is biodegradable.
Example 42: The method of any one of examples 37 to 41, wherein coupling the distal portion of the tether to the heart valve leaflet comprises providing an anchor on an atrial facing surface of the heart valve leaflet.
Example 43: The method of example 42, wherein providing the anchor comprises forming a bulky-knot anchor over the atrial facing surface of the heart valve leaflet using the tether.
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 instances, 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 instances include, while other instances 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 instances or that one or more instances 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 instance. 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 instances 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 instances, various features are sometimes grouped together in a single instance, 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 instance herein can be applied to or used with any other instance(s). Further, no component, feature, step, or group of components, features, or steps are necessary or indispensable for each instance. Thus, it is intended that the scope of the inventions herein disclosed and claimed below should not be limited by the particular instances 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 instances 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/US2022/036453, filed Jul. 8, 2022, which claims the benefit of U.S. Patent Application No. 63/223,721, filed Jul. 20, 2021, the entire disclosures all of which are incorporated by reference for all purposes.
| Number | Date | Country | |
|---|---|---|---|
| 63223721 | Jul 2021 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2022/036453 | Jul 2022 | US |
| Child | 18417168 | US |
