WATER-SOLUBLE LUBRICANTS AND APPLICATIONS FOR TRANSCATHETER VALVE REPLACEMENT THERAPIES
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional Application No. 63/568,088, filed March 21 , 2024, the contents of which are incorporated herein by reference in their entirety.
FIELD
[0002] The present application relates to implantable valves and delivery systems configured to deliver and position such valves to a patient’s heart via the patient’s vasculature.
BACKGROUND
[0003] Endovascular delivery catheter assemblies are used to implant prosthetic devices, such as a prosthetic valve, at locations inside the body that are not readily accessible by surgery or where access without invasive surgery is desirable. For example, aortic, mitral, tricuspid, and/or pulmonary prosthetic valves can be delivered to a treatment site using minimally invasive surgical techniques.
[0004] For example, the implantable valves, integrated with a balloon-expandable transcatheter valve delivery system, can be delivered to the patient under local anesthesia using fluoroscopic guidance, thereby avoiding general anesthesia and openheart surgery. The stent/valve is deployed across the native diseased valve to permanently hold the valve open, thereby alleviating a need to excise the native valve.
[0005] The systems delivering the implantable valves, in addition to the balloonexpandable transcatheter valve delivery system, can utilize introducer sheaths. Such introducer sheaths can be used to safely introduce a delivery apparatus into a patient’s vasculature (e.g., the femoral artery). An introducer sheath generally has an elongated sleeve that is inserted into the vasculature and a housing that contains one or more sealing valves that allow a delivery apparatus to be placed in fluid communication with the vasculature with minimal blood loss. A conventional introducer sheath typically requires a tubular loader to be inserted through the seals in the housing to provide an unobstructed path through the housing for a valve mounted on a transcatheter valve delivery system. A conventional loader extends from the proximal end of the introducer sheath and, therefore, decreases the available working length of the delivery apparatus that can be inserted through the sheath and into the body.
[0006] Conventional methods of accessing a vessel, such as a femoral artery, prior to introducing the delivery system include dilating the vessel using multiple dilators or sheaths that progressively increase in diameter. This repeated insertion and vessel dilation can increase the amount of time the procedure takes, as well as the risk of damage to the vessel. Radially expanding intravascular sheaths have been disclosed. Such sheaths tend to have complex mechanisms, such as ratcheting mechanisms that maintain the shaft or sheath in an expanded configuration once a device with a larger diameter than the sheath’s original diameter is introduced.
[0007] However, delivery and/or removal of prosthetic devices and other materials to or from a patient still poses a significant risk to the patient. Furthermore, accessing the vessel remains a challenge due to the relatively large profile of the delivery system that can cause longitudinal and radial tearing of the vessel during insertion. These issues can be exacerbated if a higher insertion force is needed due to the high friction existing between various components of the sheath and the valve or the transcatheter valve delivery system.
[0008] Challenges also exist with the valve delivery portion of the procedure due to substantial friction between various elements. The friction is two-fold upon the balloon inflation and subsequent deployment of the valve and includes friction between the pleat & folds of the delivery system that can limit the ability of the balloon-inflatable delivery system to fully inflate the heart valve to the desired cylindrical deployment shape and the friction between the balloon and the elements of the valve itself and an optional axillary component such as a dock. These two aspects of friction during the heart valve delivery procedure may inhibit the ability of the balloon delivery system to fully inflate the valve and may result in a reduced middle "valve waist," inhibiting the desired cylindrical deployment shape of the valve within the dock.
[0009] Accordingly, there remains a need for improved introducer sheaths and valve/stent systems that exhibit low friction and can be delivered with simpler procedures and lower insertion forces.
SUMMARY
[0010] Aspects of the present expandable sheath and valve delivery system can minimize trauma to the vessel and damage to the sheath and medical device by reducing the push force required to advance the medical device through the sheath and/or blood vessel and reducing the number of components and steps of the procedure. Similarly, aspects of the present disclosure allow for minimizing changes in the generally desired cylindrical valve shape when the valve is positioned within the natural anatomy of the subject. Aspects disclosed herein ensure that neither the sheath nor blood vessels are damaged during efforts to advance the medical device therethrough. Furthermore, certain implementations can reduce the length of time a procedure takes and reduce the number of steps required in the procedure, as well as reduce the risk of a longitudinal or radial vessel tear or plaque dislodgement because lower push force is required for sheath dilation in challenging patient anatomy.
[0011] Disclosed herein is an introducer sheath comprising: a variable diameter inner liner comprising a sheet having a first edge and a second edge and is defined by an inner surface and an outer surface, wherein the sheet is wound in a scroll configuration such that at least a portion of the inner surface of the sheet overlays at least a portion of the outer surface of the sheet and wherein the first edge of the sheet is slidable along at least a portion the inner surface of the sheet and the second edge is slidable along at least a portion of the outer surface of the sheet, wherein the inner surface of the sheet defines a lumen of the sheath; an outer layer having an inner surface and an outer surface and circumferentially disposed on at least a portion of the variable diameter inner liner, such that at least a portion of the inner surface of the outer layer is disposed on at least a portion of the outer surface of the inner liner; and wherein the introducer sheath comprises a first water-soluble lubricant disposed between the inner liner and the outer layer.
[0012] Also disclosed herein are aspects directed to a system comprising: a heart valve delivery system comprising: a balloon catheter having a distal end with a balloon thereon, the balloon having a prosthetic-valve receiving portion, wherein the prosthetic- valve receiving portion is configured to have a radially expandable prosthetic heart valve crimped thereon; and a radially expandable prosthetic heart valve configured to be crimped over the balloon, wherein the radially expandable prosthetic valve comprises an inflow portion, an outflow portion, and a middle portion; wherein at least one of the balloon or radially expandable prosthetic heart valve comprise a second water-soluble lubricant.
[0013] In some aspects, the first and the second water-soluble lubricants disclosed herein are substantially fully soluble in water.
[0014] Still further disclosed aspects directed to a method comprising; disposing a water-soluble lubricant on a balloon positioned in a distal end of a balloon catheter; positioning a radially expandable prosthetic heart valve in a prosthetic-valve receiving portion of the balloon and crimping the radially expandable prosthetic heart valve over the balloon; wherein the balloon is configured to be inflated during a deployment of the radially expandable prosthetic heart valve into a natural anatomy of a subject.
[0015] Also disclosed are aspects directed to a method comprising: positioning a docking system in a natural anatomy of a subject; deploying a radially expandable prosthetic heart valve crimped over a balloon, wherein the balloon is positioned in a balloon catheter; wherein the deploying comprises: delivering the balloon catheter to the natural anatomy of the subject; inflating the balloon to radially expand the prosthetic heart valve such that it is immobilized by the docking system; wherein at least one of the balloon or radially expandable prosthetic heart valve comprise a water-soluble lubricant.
[0016] The foregoing and other features and advantages of the disclosure will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] FIGURE 1 is an elevation view of a sheath, according to the present disclosure, along with an endovascular delivery apparatus for implanting a prosthetic valve.
[0018] FIGURES 2A-2H are views of a procedure for delivering an exemplary mitral valve to a natural anatomy.
[0019] FIGURE 3 is a side elevational view of an introducer in accordance with one aspect of the disclosure.
[0020] FIGURE 4 is a perspective view of a valve delivery apparatus in accordance with one aspect of the disclosure.
[0021] FIGURES 5A-5E show section views of various aspects of exemplary sheaths according to one aspect of the disclosure.
[0022] FIGURE 6 is a schematic view of an exemplary valve according to one aspect. [0023] FIGURE 7 is a schematic view of a reference valve positioned in a model of native anatomy.
[0024] FIGURES 8A-8C show a diagram for two exemplary methods according to one aspect of the disclosure (FIG. 8A) and schematics of an exemplary valve positioned in a model of a native anatomy using these two methods (FIG. 8B and FIG. 8C).
DETAILED DESCRIPTION
[0025] The present disclosure can be understood more readily by reference to the following detailed description, examples, drawings, and claims, and their previous and following description. However, before the present articles, systems, and/or methods are disclosed and described, it is to be understood that this disclosure is not limited to the specific or exemplary aspects of articles, systems, and/or methods disclosed unless otherwise specified, as such can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing aspects only and is not intended to be limiting.
[0026] The following description of the disclosure is provided as an enabling teaching of the disclosure in its best, currently known aspect. To this end, those skilled in the relevant art will recognize and appreciate that many changes can be made to the various aspects of the disclosure described herein while still obtaining the beneficial results of the present disclosure. It will also be apparent that some of the desired benefits of the present disclosure can be obtained by selecting some of the features of the present disclosure without utilizing other features. Accordingly, those of ordinary skill in the pertinent art will recognize that many modifications and adaptations to the present disclosure are possible and may even be desirable in certain circumstances and are a part of the present disclosure. Thus, the following description is again provided as illustrative of the principles of the present disclosure and not in limitation thereof. DEFINITIONS
[0027] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Thus, for example, a reference to a “lubricant” includes aspects having two or more such lubricants or a reference to a “polymer” includes aspects having two or more such polymers unless the context clearly indicates otherwise.
[0028] Throughout the description and claims of this specification, the word "comprise" and other forms of the word, such as "comprising" and "comprises," are open, non-limiting terms and mean “including but not limited to,” and are not intended to exclude, for example, other additives, segments, integers, or steps. Furthermore, it is to be understood that the terms “comprise,” “comprising,” and “comprises” as they relate to various aspects, elements, and features of the disclosed invention also include the more limited aspects of "consisting essentially of" and "consisting of."
[0029] For the terms "for example" and "such as" and grammatical equivalences thereof, the phrase "and without limitation" is understood to follow unless explicitly stated otherwise. It is further understood that these phrases are used for explanatory purposes only. It is further understood that the term "exemplary," as used herein, means "an example of" and is not intended to convey an indication of a preferred or ideal aspect.
[0030] The expressions "ambient temperature" and "room temperature" as used herein are understood in the art and refer generally to a temperature from about 20 °C to about 35 °C.
[0031] Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the disclosure are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. Furthermore, when numerical ranges of varying scope are set forth herein, it is contemplated that any combination of these values, inclusive of the recited values, may be used. Further, ranges can be expressed herein as from “about” one particular value and/or to “about” another particular value. When such a range is expressed, another aspect includes from the one particular value and/or to the other particular value.
[0032] Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint and independently of the other endpoint. Unless stated otherwise, the term “about” means within 5% (e.g., within 2% or 1%) of the particular value modified by the term “about.”
[0033] Throughout this disclosure, various aspects of the invention can be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, a description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., as well as individual numbers within that range, for example, 1 , 2, 2.7, 3, 4, 5, 5.3, 6 and any whole and partial increments therebetween. It is further understood that any ranges can be formed between any number within the broadest range, for example, when individual numbers like 1 , 2, 2.7, 3, 4, 5, 5.3, 6, and any whole and partial increments therebetween are disclosed, also ranges from 1 to 5.3, or 2.7 to 5.9, or 2.5 to 6 are also disclosed. This applies regardless of the breadth of the range. [0034] In still further aspects, when the specific values are disclosed between two end values, it is understood that these end values can also be included.
[0035] In still further aspects, when the range is given and exemplary values are provided, it is understood that any ranges can be formed between any exemplary values within the broadest range.
[0036] As used herein, the term “composition” is intended to encompass a product comprising the specified ingredients in the specified amounts, as well as any product that results, directly or indirectly, from a combination of the specified ingredients in the specified amounts.
[0037] References in the specification and concluding claims to parts by weight of a particular element or component in a composition denote the weight relationship between the element or component and any other elements or components in the composition or article for which a part by weight is expressed. Thus, in a mixture containing 2 parts by weight of component X and 5 parts by weight, components Y, X, and Y are present at a weight ratio of 2:5 and are present in such a ratio regardless of whether additional components are contained in the mixture.
[0038] A weight percent (wt.%) of a component, unless specifically stated to the contrary, is based on the total weight of the formulation or composition in which the component is included.
[0039] As used herein, the term “substantially,” when used in reference to a composition, refers to at least about 80%, at least about 85%, at least about 90%, at least about 91 %, at least about 92%, at least about 93%, at least about 94%, at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, or about 100% by weight, based on the total weight of the composition, of a specified feature or component. [0040] As used herein, the term “substantially,” in, for example, the context “substantially free” refers to a composition having less than about 1 % by weight, e.g., less than about 0.5 % by weight, less than about 0.1 % by weight, less than about 0.05 % by weight, or less than about 0.01 % by weight of the stated material, based on the total weight of the composition.
[0041] As used herein, the terms “substantially identical reference composition” or “substantially identical reference article” refer to a reference composition or article comprising substantially identical components in the absence of an inventive component. In another exemplary aspect, the term "substantially," in, for example, the context "substantially identical reference composition," refers to a reference composition comprising substantially identical components and wherein an inventive component is substituted with a common in the art component.
[0042] Further, the terms “coupled” and “associated” generally mean electrically, electromagnetically, and/or physically (e.g., mechanically or chemically) coupled or linked and do not exclude the presence of intermediate elements between the coupled or associated items.
[0043] As used herein, the term “atraumatic” is commonly known in the art and refers to a device or a procedure that minimizes tissue injury.
[0044] As used herein, the term or phrase “effective,” “effective amount,” or “conditions effective to” refers to such amount or condition that is capable of performing the function or property for which an effective amount or condition is expressed. As will be pointed out below, the exact amount or particular condition required will vary from one aspect to another, depending on recognized variables such as the materials employed and the processing conditions observed. Thus, it is not always possible to specify an exact “effective amount” or “condition effective to.” However, an appropriate, effective amount will be readily determined by one of the ordinary skills in the art using only routine experimentation. [0045] It will be understood that when an element is referred to as being "connected" or "coupled" to another element, it can be directly connected or coupled to the other element, or intervening elements may be present. In contrast, when an element is referred to as being "directly connected" or "directly coupled" to another element, there are no intervening elements present. Other words used to describe the relationship between elements or layers should be interpreted in a like fashion (e.g., "between" versus "directly between," "adjacent" versus "directly adjacent," "on" versus "directly on").
[0046] As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.
[0047] It will be understood that the terms "first," "second," etc., may be used herein to describe various elements, components, regions, layers, and/or sections. These elements, components, regions, layers, and/or sections should not be limited by these terms. These terms are only used to distinguish one element, component, region, layer, or section from another element, component, region, layer, or section. Thus, a first element, component, region, layer, or section discussed below could be termed a second element, component, region, layer, or section without departing from the teachings of example embodiments.
[0048] The terms “proximal” and “distal,” as used herein, refer to regions of a sheath, catheter, or delivery assembly. “Proximal” means the region closest to the handle of the device, while “distal” means the region farthest away from the handle of the device.
[0049] “Axially” or “axial,” as used herein, refers to a direction along the longitudinal axis of the sheath, catheter, or valve.
[0050] Features, integers, characteristics, compounds, chemical moieties, or groups described in conjunction with a particular aspect or example of the present disclosure are to be understood to be applicable to any other aspect or example described herein unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract, and drawings) and/or all of the steps of any method or process so disclosed may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive. The present disclosure is not restricted to the details of any foregoing aspects. The present disclosure extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract, and drawings) or to any novel one, or any novel combination, of the steps of any method or process so disclosed.
[0051] It should be appreciated that any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.
[0052] Although the operations of exemplary aspects of the disclosed method may be described in a particular sequential order for convenient presentation, it should be understood that disclosed aspects can encompass an order of operations other than the particular sequential order disclosed. For example, operations described sequentially may, in some cases, be rearranged or performed concurrently. Further, descriptions and disclosures provided in association with one particular aspect are not limited to that aspect and may be applied to any aspect disclosed. [0053] Moreover, for the sake of simplicity, the attached figures may not show the various ways (readily discernable, based on this disclosure, by one of ordinary skill in the art) in which the disclosed system, method, and apparatus can be used in combination with other systems, methods, and apparatuses. Additionally, the description sometimes uses terms such as “produce” and “provide” to describe the disclosed method. These terms are high-level abstractions of the actual operations that can be performed. The actual operations that correspond to these terms can vary depending on the particular implementation and are, based on this disclosure, readily discernible by one of the ordinary skills in the art.
[0054] Disclosed herein is a valve delivery apparatus configured to deliver a heart valve into a natural anatomy of a subject. The disclosed delivery apparatus comprises an introducer sheath, balloon catheter, and a valve that comprise a water-soluble lubricant that allows for minimized push forces and thus minimizes damages to the natural anatomy of the subject.
[0055] In certain aspects, prior to delivery of the valve, the sheath and/or subjects’ blood vessels can be pre-dilated using dilator systems.
[0056] FIG. 1 illustrates a sheath 8 according to the present disclosure, in use with a representative delivery apparatus 10, for delivering a prosthetic device 12, such as a tissue heart valve, to a patient. The apparatus 10 can include a steerable guide catheter 14 (also referred to as a flex catheter), a balloon catheter 16 extending through the guide catheter 14, and a nose catheter 18 extending through the balloon catheter 16. The guide catheter 14, the balloon catheter 16, and the nose catheter 18 in the illustrated aspect are adapted to slide longitudinally relative to each other to facilitate delivery and positioning of the prosthetic device 12/valve at an implantation site in a patient’s body, as described in detail below. Generally, sheath 8 is inserted into a vessel, such as the transfemoral vessel, passing through the skin of the patient, such that the distal end of the sheath 8 is inserted into the vessel. Sheath 8 can include a hemostasis valve at the opposite, proximal end of the sheath. The delivery apparatus 10 can be inserted into the sheath 8, and the prosthetic device 12 can then be delivered and implanted within the patient.
[0057] FIG. 3 shows a more detailed schematic of an exemplary delivery system 10. The delivery system comprises a flex catheter 302 with flex indicator 307 that aids in valve alignment to the ballon, tracking, and positioning of the valve. The delivery system includes a tapered tip 304 to facilitate the crossing of the native valve. The delivery system 10 includes a handle portion 303 that can include a side arm 305 having an internal passage that fluidly communicates with a lumen defined by the handle portion 20. The handle portion 303 can further comprise a flex wheel 306 to control flexing of the flex catheter 302, and a balloon lock 308 and fine adjustment wheel 310 to facilitate valve alignment and position of the valve with the native annulus. A stylet is included within the guidewire lumen of the delivery system. The balloon catheter 312 comprises balloon 314, which has radiopaque valve alignment markers 316, defining the working length of the balloon 314. A radiopaque center marker 318 in balloon 314 is provided to help with valve positioning. A radiopaque triple marker 320 proximal to the balloon 314 indicates the flex catheter 302 position during deployment. The balloon is inflated through inflation port 322 using volume indicator 324. The flex catheter 302 and the balloon catheter 312 in the illustrated embodiment are adapted to slide longitudinally relative to each other to facilitate delivery and positioning of the prosthetic valve not shown here at an implantation site in a patient's body, as described in detail below.
[0058] FIG. 4 depicts a partial schematic of an additional example of a delivery system 10 having a delivery sheath 52, which forms an internal lumen 54 through which other devices (e.g., balloon catheters, etc.) may be introduced into the patient's heart. The delivery sheath 52 is coupled to an introducer housing 56 containing a series of valves that provide a seal to prevent fluid (e.g., blood) leakage through the internal lumen 54. The valves will prevent leakage when the sheath is free of instruments and will also provide a tight seal around instruments of various sizes (e.g., diameters) as they are introduced through the introducer. For example, the valves seal around both a guidewire and a balloon catheter, whether introduced together or separately.
The delivery sheath 52 can extend into the patient's body and into the heart, with the introducer housing 56 located outside the patient's body. The surgeon or other user can thus remotely introduce instruments into the patient's heart by passing the instruments through the proximal opening 58, into the internal lumen 54, and out of the distal opening 60 of the delivery sheath 52 of the internal lumen. A side port tube 84 extends away from the introducer and terminates in a three-way stopcock 66. Ths side port tube 64 enters the lumen 54 at a position distal of the sealing valves in the introducer housing 56. This permits the user to infuse medicaments or other fluids through the lumen 54 of the introducer 50 even if devices such as the balloon catheter are advanced through the proximal opening 58.
[0059] More detailed descriptions of the delivery apparatus and balloon catheters can be found in U.S. Patent No. 7,780,723, U.S. Patent No. 8,382,826, U.S. Patent No. 9,061 ,1 19, U.S. Patent No. 10,456,253, U.S. Patent No. 10,478,296, U.S. Patent No. 10,507,103, U.S. Patent Application No. 17/11 1 ,148, the content of which incorporated herein by reference in a full entirety.
[0060] FIGs. 2A-2H show exemplary steps of introducing the valve into the subject’s natural anatomy. FIG. 2A shows a portion of the heart 200, and more specifically, the left ventricle 207. The procedure is to introduce a prosthetic valve (not shown) to replay a diseased mitral valve 204. It is understood that while these figures depict steps for replacing a mitral valve, similar steps can be utilized to replace an aortic valve, tricuspid, and/or pulmonary prosthetic valves. First, a docking system 203 is employed in the vascular system of the subject, such that the docking system is configured to lock the valve into the desired position. Various docking systems can be utilized. For example, and without limitations such an exemplary docking system is described in U.S. Patent Application Publication No. 2020/0383777, the content of which is incorporated herein in its whole entirety. The introducer sheath 202 is introduced into the vascular system first. In certain aspects, a guidewire 205 is also introduced. It is understood, however, that the use of a guidewire can be optional. It is understood that the positioning of the introducer sheath and all elements of the delivery system can be monitored using radiopaque markers and fluoroscopy and/or using other imaging systems such as transesophageal echo, transthoracic echo, intravascular ultrasound imaging (IVUS), and/or an injectable dye that is radiopaque. The guidewire may be advanced into the heart prior to the introduction of the introducer sheath, with the sheath being advanced over the guidewire. The order may also be reversed, with the introducer sheath advanced first and the guidewire introduced through the introducer sheath. Methods according to the invention may include using an introducer sheath but without the use of a guidewire, using a guidewire without the use of an introducer sheath, and using both a guidewire and an introducer sheath.
[0061] FIG. 2B shows delivery of a prosthetic valve 210 using the introducer sheath 202 and a flex catheter 208 with a tapered tip 214. The prosthetic valve 210 is crimped up on a balloon 212. As shown in FIGs. 2C-2D, the balloon 212 is inflated to the desired volume such that the valve 210 is expanded to the desired size. Then, as shown in FIGs. 2E and 2F, balloon 212 is deflated and removed, leaving valve 210 locked in with the dock. The valve is comprised of an outer sealing member 210a of the valve adjacent to the natural anatomy walls and a plurality of leaflets 210b positioned in the inner portion of the valve. FIG. 2G and 2H show the prosthetic valve positioned within the dock, such that the leaflets 210b are open (FIG. 2G) and closed (FIG. 2H) during valve operation, mimicking the natural valve.
[0062] As discussed above, the valve can be mitral, tricuspid, and/or pulmonary prosthetic valves. Some exemplary valves are described in U.S. Patent No. 5,411 ,522, U.S. Patent No. 6,214,054, U.S. Patent No. 6,547,827, U.S. Patent No. 6,561 ,970, U.S. Patent No. 6,730,118, U.S. Patent No. 6,908,481 , U.S. Patent No. 7,214,344, U.S. U.S. Patent No. 7,510,575, Patent No. 7,530,253, Patent No. 7,585,321 , Patent No.
7,784,203, Patent No. 7,993,394, Patent No. 8,057,540, Patent No. 8,454,685, Patent No. 8,591 ,575, U.S. Patent No. 9,168,133, U.S. Patent No. 9,339,383, U.S. Patent No. 1 1 ,008,676, U.S. Application No. 18/198,643, the foreign counter applications of the disclosed patents, the content of each is incorporated by reference herein in its entirety.
[0063] Some exemplary sheaths are described, for example, in U.S. Patent No. 8,690,936, U.S. Patent No. 8,790,387, U.S. Patent No. 10,639,152, U.S. Patent No. 10,792,471 , U.S. Patent No. Application No. 16/407,057, U.S. Patent No. 10,327,896, U.S. Patent No. 1 1 ,273,062, Application No. PCT/US2021/019514, Application No. PCT/US2021/031227, Application No. PCT/US2021/031275, U.S. Application No. 17/113,268, Application No. PCT/US2021/058247, Application No.
PCT/US2022/012785, U.S. Patent No. 11 ,051 ,939, Application No.
PCT/US2022/012684, U.S. Application No. 17/078,556, Application No. PCT/US2021/025038, Application No. PCT/US2021/050006, Application No. PCT/US2022/049968, U.S. Application No. 18/531 ,355, U.S. Application No. 18/531 ,307, U.S. Application No. 17/822,689, U.S. Application No. 17/063,375, U.S. Application No. 14/880,1 1 1 , U.S. Application No. 18/831 ,261 , U.S. Application No. 18/531 ,355, U.S. Application No. 18/531 ,202, U.S. Application No. 18/482,636, U.S. Application No. 18/352,120, Application No. PCT/US2022/032906, Application No. PCT/US2022/032903, Application No. PCT/US2022/032902, Application No.
PCT/US2022/032905, Application No. PCT/US2021/031275, Application No. PCT/US2021/019514, the disclosures of which are herein incorporated by reference.
[0064] A more detailed description of the exemplary lubricant, introducer sheath, and delivery system is disclosed below.
LUBRICANT
[0065] The hydrophilic lubricants are often used to improve the performance of the valve delivery devices. Commonly used lubricants are silicon-based. However, such silicon-based lubricants can produce particulate matter that can cause embolism, and other complications during the prosthetic valve implantation and valve’s performance. [0066] The lubricants of the current disclosure are biocompatible, water-soluble liquid lubricants that can be applied to the various elements of the valve delivery system. Such water-soluble liquid lubricants are biocompatible, do not produce particular matter, and can be fully dissolved in blood within the natural anatomy of the subject and then excreted from the patient's body without any damage.
[0067] In still further aspects, the water-soluble lubricants disclosed herein are substantially fully dissolved in water. In yet other aspects, the lubricants disclosed herein are fully dissolved in water. In still further aspects, the lubricants disclosed herein are viscous liquids at room temperature or dry films until hydration (with saline or sterile water).
[0068] In still further aspects, the disclosed herein lubricants comprise at least one liquid polyethylene glycol polymer (PEG). In such aspects, the at least one liquid PEG polymer has a molecular weight of less than about 1000 g/mol. In still further aspects, the at least one liquid PEG has a molecular weight of about 200 to equal to or less than about 1000 g/mol, including exemplary values of about 250 g/mol, about 300 g/mol, about 400 g/mol, about 500 g/mol, about 600 g/mol, about 700 g/mol, about 800 g/mol, about 900 g/mol, and about 950 g/mol. It is also understood that the at least one liquid PEG can have any molecular weight value that falls in any range between (and including to) any two of the disclosed above values or any two values that fall between (and including to) any two of the mentioned above values. For example, and without limitations, the at least one liquid PEG can have any molecular weight of about 200 g/mol to about 1000 g/mol, about 200 g/mol to about 900 g/mol, or about 200 g/mol to about 800 g/mol, or about 200 g/mol to about 700 g/mol and so on.
[0069] In still further aspects, the water-soluble lubricant can further comprise additional polymers. For example, and without limitations, the water-soluble lubricants disclosed herein can comprise polyvinylpyrrolidone, polyvinylpyrrolidone vinyl acetate copolymer glycerol, glycerol, polyethylene oxide, or any combination thereof. In yet still further aspects, the polyvinylpyrrolidone vinyl acetate copolymer glycerol has less than about 60 mol% vinyl acetate, less than about 55 mol% vinyl acetate, less than about 50 mol% vinyl acetate, less than about 45 mol% vinyl acetate, less than about 40 mol% vinyl acetate, less than about 35 mol% vinyl acetate, less than about 30 mol% vinyl acetate, or less than about 25 mol% vinyl acetate.
[0070] In still further aspects, these additional polymers can have a molecular weight of about 90 g/mol to about 450,000 g/mol, including exemplary values of about 150 g/mol, about 300 g/mol, about 600 g/mol, about 1 ,000 g/mol, about 5,000 g/mol, about 1 ,0000 g/mol, about 50,000 g/mol, about 100,000 g/mol, about 150,000 g/mol, about 200,000 g/mol, about 250,000 g/mol, about 300,000 g/mol, about 350,000 g/mol, and about 400,000 g/mol. It is also understood that the polymers can have any molecular weight value that falls in any range between (and including to) any two of the disclosed above values or any two values that fall between (and including to) any two of the mentioned above values. For example, and without limitations, the polymers can have any molecular weight of about 90 g/mol to about 360,000 g/mol, about 150 g/mol to about 200,000 g/mol, or about 200 g/mol to about 100,000 g/mol, and so on.
[0071] In still further aspects, the water-soluble lubricants of the current disclosure exhibit a room temperature kinematic viscosity of about 400 to 1400 cSt, including exemplary values of about 500 cSt, about 600 cSt, about 700 cSt, about 800 cSt, about 900 cSt, about 1000 cSt, about 1100 cSt, about 1200 cSt, and about 1300 cSt. It is also understood that the water-soluble lubricants of the current disclosure can exhibit any kinematic viscosity (measured at room temperature) that falls in any range between (and including to) any two of the disclosed above values or any two values that fall between (and including to) any two of the mentioned above values. For example, and without limitations, the water-soluble lubricants of the current disclosure can exhibit a kinematic viscosity (measured at room temperature) of about 400 cSt to about 1300 cSt, about 400 cSt to about 1200 cSt, or about 400 cSt to about 1000 cSt, or about 400 cSt to about 800 cSt and so on. [0072] In still further aspects, the polymers in the mixture can be present in any ratio that would result in a water-soluble lubricant. In certain aspects, the polymers in the mixture can be present in any ratio that would result in the desired viscosity.
[0073] In still further aspects, if mixture of the polymers is present in the water- soluble lubricant, this mixture can comprise any of the disclosed above polymers in an amount of greater than 0 wt% to 100 wt%, including exemplary values of about 1 wt%, about 2 wt%, about 5 wt%, about 10 wt%, about 15 wt%, about 20 wt%, about 25 wt%, about 30 wt%, about 35 wt%, about 40 wt%, about 45 wt%, about 50 wt%, about 55 wt%, about 60 wt%, about 65 wt%, about 70 wt%, about 75 wt%, about 80 wt%, about 85 wt%, about 90 wt%, about 95 wt%, and about 99 wt%. It is also understood that the polymers can be present in any amounts that fall in any range between (and including to) any two of the disclosed above values or any two values that fall between (and including to) any two of the mentioned above values. For example, and without limitations, the polymers can be present in of about 2 wt% to about 95 wt%, about 5 wt% to about 90 wt%, or about 10 wt% to about 99 wt%, or about 2 wt% to about 60 wt% and so on. It is also understood that the amount of the polymer in the mixture will be dependent on the molecular weight of the polymer and the final viscosity of the mixture.
[0074] In certain exemplary and unlimiting aspects, the lubricant can comprise a mixture of glycerol and PEG. In such exemplary aspects, the glycerol can be present in an amount of less than about 90 wt%, less than about 80 wt%, less than about 70 wt%, or less than about 60 wt%. Yet in other aspects, in such a mixture, the glycerol can be present in an amount greater than about 50 wt%, greater than about 60 wt%, greater than about 70 wt%, or greater than about 80 wt%.
[0075] In still further aspects, the mixture, for example, and without limitations, can comprise a polyvinylpyrrolidone and PEG. In such exemplary aspects, the polyvinylpyrrolidone (with a molecular weight of 360,000 g/mol) can be present in an amount of less than about 5 wt%, less than about 4 wt%, less than about 3 wt%, less than about 2 wt%, or less than about 1 wt%. Yet in other aspects, the polyvinylpyrrolidone (with a molecular weight of 360,000 g/mol) can be present in an amount greater than about 1 wt%, greater than about 2 wt%, greater than about 3 wt%, greater than about 4 wt%, or about 5 wt%.
[0076] In still further aspects, the water-soluble lubricant can comprise a water- soluble solvent. For example, and without limitations, the solvents can comprise ethanol, isopropanol, deionized water, or any combination thereof.
[0077] Also disclosed are aspects where the water-soluble lubricant does not have to comprise PEG. In such exemplary and unlimiting aspects, each of the disclosed polymers can be used in any combination or in any ratio.
[0078] In still further aspects, the disclosed herein water-soluble lubricants produce substantially no particulate matter. While in still further aspects, the water-soluble lubricants are configured to be dissolved in a natural anatomy of a subject at a predetermined time.
SHEATH
[0079] During transcatheter aortic valve replacement (TAVR) procedures, a sheath as disclosed herein is used to provide access to the vasculature with no trauma to the patient, acting to maintain hemostasis and facilitate the delivery of interventional devices, as well as wire and catheter exchanges. In order for the sheath to be as minimally invasive as possible, it must have a low profile or low outer diameter (OD) upon entry. However, the sheath must expand to a larger diameter once inside the body in order to allow passage of catheters larger than the initial diameter of the sheath. The force to advance these devices through the sheath is commonly referred to as push force. With larger devices, such as a crimped valve on a delivery system (DS), as well as challenging vessel anatomies, such as small, tortuous, or constricted vessels, the push force during the procedure is of great importance. High push force can cause procedural delays, physician dissatisfaction, and even inability to complete the procedure.
[0080] An important function of the sheath is to have clinically acceptable push force to advance the delivery system and valve throughout the sheath for all patient anatomies. In some aspects, lubrication is used to aid in this reduction of push force. Lubrication is placed in between layers that slide over one another, reducing the frictional forces that are needed to be overcome to expand the sheath, thus making the DS easier to pass through the sheath. Recent studies have shown that lubrication is needed in order to bring push forces down to acceptable levels.
[0081] Disclosed herein one aspect of an introducer sheath comprising: a variable diameter inner liner comprising a sheet having a first edge and a second edge and is defined by an inner surface and an outer surface, wherein the sheet is wound in a scroll configuration such that at least a portion of the inner surface of the sheet overlays at least a portion of the outer surface of the sheet and wherein the first edge of the sheet is slidable along at least a portion of the inner surface of the sheet and the second edge is slidable along at least a portion of the outer surface of the sheet, wherein the inner surface of the sheet defines a lumen of the sheath; an outer layer having an inner surface and an outer surface and circumferentially disposed on at least a portion of the variable diameter inner liner, such that at least a portion of the inner surface of the outer layer is disposed on at least a portion of the outer surface of the inner liner; and wherein the introducer sheath comprises a first water-soluble lubricant disposed on the outer surface of the sheet such that at least a portion of the first water-soluble lubricant is between at least a portion of an overlying portion of the sheet and at least a portion of sliding portions of the sheet. In a still further aspect, an amount of the first water-soluble lubricant is disposed between at least a portion of the inner liner and at least a portion of the outer layer.
[0082] Any of the disclosed above water-soluble lubricants can be used in the sheath. [0083] In one disclosed aspect, the sheet of the sheath comprises a high-density polyethylene, polypropylene, polyamide, fluoropolymer, copolymers thereof, or blends thereof. In a still further aspect, the sheet can have a multilayer structure. In still further aspects, the inner surface of the sheet is at least partially ribbed. In one exemplary aspect, the sheet is lubricious and has a coefficient of friction less than about 0.5.
[0084] In still further aspects, the outer layer can comprise a braid (or a coil) and a layer of an elastomeric polymer having a predetermined thickness and having an inner surface and outer surface. In yet other disclosed aspects, the outer surface of the layer of the elastomeric polymer can define at least a portion of the outer surface of the outer layer. In some of the disclosed aspects, at least a portion of the inner surface of the layer of the elastomeric polymer is at least partially bonded to at least a portion of the outer surface of the sheet of the inner liner. In still further aspects, at least a portion of the inner surface of the layer of the elastomeric polymer can define at least a portion of the inner surface of the outer layer. While in other aspects, at least a portion of the braid or coil can define at least a portion of the inner surface of the outer layer.
[0085] In still further aspects, the braid or coil is an expandable braid or coil. In still further aspects, the braid or coil can comprise at least one filament comprising stainless steel, nitinol, a polymer material, or a composite material. In certain aspects, the at least one filament can be a round filament or a flat filament. In aspects where the at least one filament comprises a polymer material, the polymer material can be polyester or nylon. In aspects where the at least one filament is round, the round filament can have a diameter of less than about 0.015”. While in aspects where the at least one filament is flat, the flat filament can have a height of less than about 0.006” and a width from greater than about 0.003” to about 0.015”. In yet further aspects, the braid can have a per-inch crosses (PIC) count of less than 50. In yet still further aspects, the braid’s PIC can vary along the longitudinal axis of the lumen. [0086] In still further aspects, where the at least one filament is nitinol, the nitinol is heat set. In yet other aspects, where the at least one filament comprises stainless steel or nitinol, the filament can be configured to be atraumatic at least at the distal end of the sheath.
[0087] In yet other aspects, the elastomeric polymer present in the outer layer comprises a styrene-based elastomer, polyurethane, latex, copolymers thereof, blends thereof, or co-extrudates thereof. In one aspect, the elastomeric polymer exhibits a Shore A durometer of less than 90. In certain aspects, the braid or coil can be at least partially embedded within at least a portion of the layer of the elastomeric polymer. And yet, in other aspects, any of the disclosed above water-soluble lubricants can be disposed on the outer surface of the outer layer.
[0088] Also disclosed herein is an aspect comprising methods of making a sheath having a proximal and a distal end. In certain aspects, the method of making such a sheath comprises forming a variable diameter inner liner by rolling a sheet having a first edge and a second edge wherein the sheet is defined by an inner surface and an outer surface in a spiral configuration such that at least a portion of the inner surface of the sheet overlays at least a portion of the outer surface of the sheet thereby forming an overlying portion and wherein the first edge of the sheet is slidable along at least a portion the inner surface of the sheet and the second edge is slidable along at least a portion of the outer surface of the sheet, wherein the inner surface of the sheet defines a lumen of the sheath having a longitudinal axis. In yet still further aspects, any of the disclosed herein water-soluble lubricants are applied to the outer surface of the sheet such that at least a portion of this water-soluble lubricant is between at least a portion of an overlying portion of the sheet and at least a portion of sliding portions of the sheet. In still further aspects, the methods comprise forming an outer layer having an inner surface and an outer surface and extending about at least a portion of the variable diameter inner liner such that the inner surface of the outer layer is positioned adjacent to the outer surface of the inner liner. In certain aspects, the outer layer can comprise: a braid or coil and a layer of an elastomeric polymer having a predetermined thickness and having an inner surface and outer surface. Yet, in other aspects, the outer layer is free of a braid or a coil. In yet still further aspects, the method can comprise disposing of any of the disclosed herein water-soluble lubricants on the outer surface of the outer layer. Yet, in certain aspects, the sheath also comprises any of the disclosed above water lubricants between the outer surface of the inner liner and the inner surface of the outer layer.
[0089] In certain aspects, the lubricant is disposed within the sheath during the sheath formation. For example, and without limitations, a mandrel can be inserted into the inner diameter of the sheath. The mandrel can have a tip of sufficient diameter that blocks a tip of the sheath. Still further, the mandrel can have ports along the length of the mandrel for lubricant to flow out into the sheath's inner diameter. Then, an amount of the water-soluble lubricant is injected under low pressure into the inner diameter of the sheath such that the lubricant coats the inner sheath surface and flows between the sheath inner member and outer layer through the scrolled section of the inner member. It was discovered that controlling lubricant viscosity is critical to ensure lubricant coats between the sheath inner member and outer layer through the scrolled section of the inner member.
[0090] In certain aspects, the sheath is formed from an elongated tube. In such exemplary and unlimiting aspects, an amount of the water-soluble lubricant can be disposed on the inner diameter or/and outer diameter of the sheath before or after the slit is made to make into scrolled form. In yet other aspects, the sheath can be formed from a sheet that is then arranged into a scroll configuration. In such aspects, the lubricant can be disposed on a sheet surface both on the inner and outer surface before and/or after the sheet is arranged into the scroll. In still further aspects, the lubricant is dried at a temperature between an ambient to about 65 °C to evaporate a solvent.
Then, in some exemplary and unlimiting aspects, an outer layer is disposed over the scrolled inner liner. [0091] Yet in still further exemplary aspects, prior to the step of disposing the outer layer on the inner liner, an amount of the water-soluble lubricant is disposed between at least a portion of the inner liner and at least a portion of the outer layer in the sheath. As disclosed above, during the steps of forming the sheath, an amount of the water-soluble lubricant can be applied to at least a portion of the inner liner prior to the step of forming the outer layer such that the amount of the water-soluble lubricant is disposed between at least a portion of the inner liner and at least a portion of the outer liner in the sheath. While in other aspects, an amount of any of the disclosed above water-soluble lubricants is applied to at least a portion of the overlying and sliding portions of the sheet prior to the step of forming the outer layer. In still further aspects, the lubricant can be applied homogenously across all the surfaces of the sheath. In still further aspects, the water-soluble lubricant is disposed along a whole circumference of the inner liner, or it can be disposed between at least a portion of the overlying portion of the sheet and at least a portion of the sliding portions of the sheet.
[0092] In certain aspects, the water-soluble lubricant can be dried. In still further aspects, the dried water-soluble lubricant can be sufficiently hydrated with saline or sterile water before inserting the sheath into the natural anatomy of the patient. In yet other aspects, the water-soluble lubricant can also form a film. When a film of the water- soluble lubricant is formed, such a film can have a thickness of equal to or less than about 20 pm, about 15 pm, about 10 pm, about 5 pm, about 1 pm, or even equal to or less than about 0.5 pm.
[0093] Still, further, the water-soluble lubricant can be disposed along at least a portion of the inner surface of the sheet or at least a portion of the outer surface of the sheet, or a combination thereof.
[0094] In other aspects, in the methods described herein, the sheet can comprise a high-density polyethylene, polypropylene, polyamide, fluoropolymer, copolymers thereof, or blends thereof. In yet other aspects, the sheet can have a multilayer structure. In still further aspects, the inner surface of the sheet can be at least partially ribbed. In yet other aspects, the sheet can be lubricious and have a coefficient of friction less than about 0.5, less than about 0.4, less than about 0.3, less than about 0.2, or less than about 0.1 .
[0095] In yet further aspects, the methods disclosed herein can comprise the braid or coil, wherein the braid or coil is an expandable braid or coil. In still further aspects, the braid or coil of the disclosed methods can comprise at least one filament comprising a stainless steel, nitinol, a polymer material, or a composite material. In certain aspects, the at least one of the filaments can be a round filament or a flat filament. In certain aspects, the polymeric material present in the braid can be a polyester or nylon. In the aspects where the at least one filament is the round filament, such a filament can have a diameter of less than about 0.015”. In yet other aspects, where the at least one filament is the flat filament, such a filament can have a height of less than about 0.006” and a width greater than about 0.003” to about 0.015”, including exemplary values of about 0.004”, about 0.005”, about 0.006”, about 0.007”, about 0.008”, about 0.009”, about 0.010”, about 0.01 1 ”, about 0.012”, about 0.013”, and about 0.014”. It is also understood that the filament can have any width values that fall in any range between (and including to) any two of the disclosed above values or any two values that fall between (and including to) any two of the mentioned above values. For example, about 0.003” to about 0.014”, about 0.003” to about 0.012”, or about 0.003” to about 0.010”, and so on.
[0096] In the aspects of the methods disclosed herein, the braid can have a perinch cross (PIC) count of less than about 50, less than about 45, less than about 40, or even less than about 35. In yet further exemplary aspects, the PIC can vary along the longitudinal axis of the lumen.
[0097] In the aspects where the at least one filament comprises nitinol, the nitinol is heat set at. In the aspects where the at least one filament comprises stainless steel or nitinol, the filament is configured to be atraumatic, at least at the distal end of the sheath.
[0098] In yet further aspects, the methods disclosed herein comprise the elastomeric polymer comprising a styrene-based elastomer, polyurethane, latex, copolymers thereof, blends thereof, or co-extrudates thereof. In yet further aspects, the elastomeric polymer can exhibit a Shore A durometer of less than 90. In still further aspects, the methods can further comprise disposing a hydrophilic coating layer on the outer surface of the layer of the elastomeric polymer.
[0099] In some methods, a soft tip portion can be coupled to a distal end of the expandable sheath to facilitate passing the expandable sheath through a patient’s vasculature.
[0100] Disclosed aspects of an expandable sheath can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery system, followed by a return to the original diameter once the device passes through. Some aspects can comprise a sheath with a smaller profile (e.g., a smaller diameter in the rest configuration) than that of prior art introducer sheaths. Furthermore, present aspects can reduce the length of time a procedure takes, as well as reduce the risk of a longitudinal or radial vessel tear or plaque dislodgement because only one sheath is required, rather than several different sizes of sheaths. Aspects of the present expandable sheath can avoid the need for multiple insertions for the dilation of the vessel. Such expandable sheaths can be useful for many types of minimally invasive surgery, such as any surgery requiring introduction of an apparatus into a subject’s vessel. For example, the sheath can be used to introduce other types of delivery apparatus for placing various types of intraluminal devices (e.g., stents, prosthetic heart valves, stented grafts, etc.) into many types of vascular and non- vascular body lumens (e.g. veins, arteries, esophagus, ducts of the biliary tree, intestine, urethra, fallopian tube, other endocrine or exocrine ducts, etc.). [0101] In still further aspects, the sheet can comprise one or more layers. In some aspects, if one or more layers are present, each layer can comprise the same or different polymer. In still further aspects, the sheet can have a predetermined thickness, wherein the predetermined thickness can be defined by one of the ordinary skills in the art depending on the specific application. In certain aspects, the predetermined thickness of the inner liner can be from about 0.002 inches to about 0.025 inches, including exemplary values of about 0.003, about 0.004, about 0.005, about 0.006, about 0.007, about 0.008, about 0.009, about 0.01 , about 0.015, and about 0.02 inches. It is also understood that the inner liner can have any thickness values that fall in any range between (and including to) any two of the disclosed above values or any two values that fall between (and including to) any two of the mentioned above values. For example, the thickness can be about 0.002 inches to about 0.025 inches, about 0.002 inches to about 0.02 inches, or about 0.002 inches to about 0.01 inches, and so on.
[0102] It is further understood that the predetermined thickness of the sheet forming the inner liner can be varied depending on the desired amount of radial expansion, as well as the strength required.
[0103] In still further aspects, the inner surface of the sheet can be at least partially ribbed. In yet further aspects, the sheet can also be lubricious. In some exemplary aspects, the sheet that forms the inner liner can have a coefficient of friction less than about 0.5, less than about 0.4, less than about 0.3, less than about 0.2, less than about 0.1 , or less than about 0.05, or even less than about 0.01 . It is further understood that the sheet can have a coefficient of friction having any value between any two foregoing values. Such a liner can facilitate passage of a delivery apparatus through the lumen of the disclosed sheath. In some further exemplary aspects, materials that can be used to form suitable lubricious inner liners include materials that can reduce the coefficient of friction of the inner liner, such as PTFE, polyethylene, polyvinylidene fluoride, and combinations thereof. Suitable materials for a lubricious liner also include other materials desirably having a coefficient of friction of about 0.1 or less, of about 0.09 or less, about 0.08 or less, about 0.07 or less, about 0.05 or less, about 0.04 or less, about 0.03 or less, about 0.02 or less, or about 0.01 or less.
[0104] In yet further aspects, the outer layer comprising the braid or coil and the layer of the elastomeric polymer can have any predetermined thickness. It is understood that the predetermined thickness of the outer layer can be dependent on the specific application of the sheath. For example, and without limitation, the thicknesses of the inner liner and the outer layer comprising the braid (or coil) and the layer of the elastomeric material can also be varied depending on the particular application of the disclosed sheath. In some aspects, the thickness of the inner liner ranges from about 0.0005 inches to about 0.010 inches, including exemplary values of about 0.0006, about 0.0007, about 0.0008, about 0.0009, about 0.001 , about 0.002, about 0.003, about 0.004, about 0.005, about 0.006, about 0.007, about 0.008, about 0.009 inches, and in one particular aspect, the thickness can be about 0.002 inches. It is also understood that the inner liner can have any thickness values that fall in any range between (and including to) any two of the disclosed above values or any two values that fall between (and including to) any two of the mentioned above values. For example, the thickness can be about 0.0002 inches to about 0.010 inches, about 0.0002 inches to about 0.008 inches, or about 0.0002 inches to about 0.005 inches, and so on.
[0105] The outer layer comprising the braid (or coil) and the layer of the elastomeric material can have a thickness of from about 0.002 inches to about 0.015 inches, including exemplary values of about 0.003, about 0.004, about 0.005, about 0.006, about 0.007, about 0.008, about 0.009, and about 0.01 inches. It is also understood that the braid and the layer of the elastomeric material can have any thickness values that fall in any range between (and including to) any two of the disclosed above values or any two values that fall between (and including to) any two of the mentioned above values. For example, they can be about 0.002 inches to about 0.015 inches, about 0.002 inches to about 0.01 inches, or about 0.002 inches to about 0.008 inches, and so on. [0106] As disclosed herein, the outer layer of the sheath has an inner surface and an outer surface. The outer layer of the disclosed sheath extends about at least a portion of the variable diameter inner liner such that the inner surface of the outer layer is positioned adjacent to the outer surface of the inner liner. As disclosed herein, the outer layer can comprise a braid (or coil) and a layer of an elastomeric polymer having a predetermined thickness and having an inner surface and outer surface. In certain aspects, the braid or coil can be an expandable braid or coil. In yet further aspects, the braid or coil can comprise at least one filament comprising stainless steel, nitinol, a polymer material, or a composite material. In certain unlimiting aspects, the braid or coil comprises filaments comprising Nitinol and/or other shape memory alloys. In yet other unlimiting aspects, the braid can have filaments comprising polyester or nylon. In yet some other exemplary aspects, the braid can comprise filaments comprising spectra fiber, polyethylene fiber, aramid fiber, or combinations thereof. In yet other aspects, the outer layer does not comprise a braid or coil.
[0107] If braid and/or coil are present, they can have any configurations known in the art. In certain aspects, the braid (or coil) is generally a thin, hollow, substantially cylindrical tube comprising an arrangement, pattern, structure, or configuration of filaments or struts, however other geometries can also be used. Suitable filaments can be round, having a diameter less than about 0.015”, less than about 0.01 ”, less than about 0.008”, less than about 0.005”, less than about 0.002”, less than about 0.001 ”, less than about 0.0008”, or less than about 0.0005”. In yet other aspects, suitable filaments can be round and have a diameter ranging from about 0.0005” inches thick to about 0.015” thick, including exemplary values of about 0.0006”, about 0.0007”, about 0.0008”, about 0.0009”, about 0.001 ”, about 0.002”, about 0.003”, about 0.004”, about 0.005”, about 0.006”, about 0.007”, about 0.008”, about 0.009”, about 0.01 ”, about 0.012”, about 0.013”, and about 0.014”. It is also understood that the diameter can have any values that fall in any range between (and including to) any two of the disclosed above values or any two values that fall between (and including to) any two of the mentioned above values. For example, the diameter can be about 0.0005 inches to about 0.015 inches, about 0.0005 inches to about 0.01 inches, or about 0.0005 inches to about 0.008 inches, and so on.
[0108] In yet other aspects, the suitable filaments can be flat filaments having a height of less than about 0.006”, less than about 0.005”, less than about 0.004”, less than about 0.003”, less than about 0.001 ”, less than about 0.0009”, less than about 0.0008”, less than about 0.0007”, less than about 0.0006”, and about 0.0005”. In yet other aspects, the flat filaments can have a width from greater than about 0.003” to about 0.015”, including exemplary values of about 0.004”, about 0.005”, about 0.006”, about 0.007”, about 0.008”, about 0.009”, about 0.01 ”, about 0.012”, about 0.013”, and about 0.014”. It is also understood that the width can have any values that fall in any range between (and including to) any two of the disclosed above values or any two values that fall between (and including to) any two of the mentioned above values. For example, the diameter can be about 0.003 inches to about 0.015 inches, about 0.003 inches to about 0.01 inches, or about 0.003 inches to about 0.008 inches, and so on. However, other geometries and sizes are also suitable for certain aspects.
[0109] In yet further aspects, the braid can have a per-inch crosses (PIC) count of less than about 50, less than about 40, less than about 30, less than about 20, or less than about 10. In yet other aspects, the braid can have the PIC count from about 10 to about 2, including exemplary values of about 9, about 8, about 7, about 6, about 5, about 4, and about 3. Or it can be about 10 to about 2, about 10 to about 5, or about 10 to about 8. In still further aspects, the PIC can vary along the longitudinal axis of the lumen.
[0110] In still further aspects, the outer layer comprises the layer of the elastomeric polymer. In certain aspects, the elastomeric polymer can comprise a styrene-based elastomer, polyurethane, latex, copolymers thereof, blends thereof, or co-extrudates thereof. In certain and unlimiting aspects, the elastomeric polymer can comprise polyether block ester copolymer, polyesters, polyvinyl chloride, thermoset silicone, polyisoprene rubbers, polyolefin, other medical grade polymers, or combinations thereof. In yet further aspects, the elastomeric polymer described herein can have any useful additives. In certain aspects, the elastomeric polymers can comprise at least one friction reduction additive. In some exemplary aspects, the friction reduction additives can comprise, for example, BaSC , ProPell™, PTFE, any combination thereof, and the like. It is understood that this list of the friction reduction additives is not limiting, and any known in the art friction reduction additives can be utilized.
[0111] It is understood that the hardness of each layer of the disclosed sheath can also be varied depending on the particular application and desired properties of the sheath. In some aspects, the layer of the elastomeric polymer has a Shore hardness of less than about 90 Durometer, less than about 80 Durometer, less than about 70 Durometer, less than about 60 Durometer, less than about 50 Durometer, less than about 40 Durometer, less than about 30 Durometer, or less than about 20 Durometer. In yet further exemplary aspects, the layer of the elastomeric polymer has a Shore hardness from about 25 Durometer to about 75 Durometer, including exemplary values of about 30 Durometer, about 35 Durometer, about 40 Durometer, about 45 Durometer, about 50 Durometer, about 55 Durometer, about 60 Durometer, about 65 Durometer, and about 70 Durometer. It is also understood that the Shore hardness can be any value that falls in any range between (and including to) any two of the disclosed above values or any two values that fall between (and including to) any two of the mentioned above values. For example, the diameter can be about 25 Durometers to about 60 Durometers, about 25 Durometers to about 50 Durometers, or about 25 Durometers inches to about 45 Durometers, and so on.
[0112] In still further aspects, the outer surface of the layer of the elastomeric polymer defines at least a portion of the outer surface of the outer layer. In yet other aspects, at least a portion of the inner surface of the layer of the elastomeric polymer is at least partially bonded to at least a portion of the outer surface of the sheet of the inner liner. In one aspect, wherein at least a portion of the inner surface of the layer of the elastomeric polymer defines at least a portion of the inner surface of the outer layer. While in the other aspect, at least a portion of the braid defines at least a portion of the inner surface of the outer layer. It is understood that the outer layer of the disclosed sheath is configured to provide hemostasis and prevent bleeding of the patient during the procedure.
[0113] FIGS. 5A-5D show exemplary aspects of a sheath for introducing a prosthetic device as disclosed herein. FIG. 5A shows the sheath 600A comprising the inner liner 602 having the first edge 602a and the second edge 602b, and the overlaying portion 602c, where the inner and outer surfaces of the inner liner overlay each other. The sheath 600A further comprises an amount of any of the disclosed herein water-soluble lubricants 608 that is disposed between the sliding and overlaying portions of the inner sheath. The sheath further comprises the braid 604 and the layer of the elastomeric polymer 606. It is understood that aspects of the sheath where the outer layer does not comprise a braid or coil are also disclosed (not shown). In the aspect described in FIG. 5A, braid 604 is present but is not embedded in the layer of the elastomeric polymer 606. FIG. 5B depicts an alternative aspect of the sheath 600B where an additional amount of any of the disclosed above water-soluble lubricants 610 is applied between the inner liner and the outer layer comprising the braid 604 and the layer of the elastomeric polymer 606. The water-soluble lubricant 608 is still disposed between the sliding and overlaying portions of the inner sheath. Again, it is understood that the braid is optional, and aspects where the outer layer is free of the braid are also disclosed.
[0114] An additional aspect of the sheath 600C is shown in FIG. 5C. In this aspect, the sheath 600C comprises the inner liner 602, having the first edge 602a and the second edge 602b, and the overlaying portion 602c, where the inner and outer surfaces of the inner liner overlay each other. The sheath further comprises the braid 604 and the layer of the elastomeric polymer 606 that together form the outer layer of the sheath. The sheath 600C further comprises an amount of water-soluble lubricant 610, as disclosed herein, that is disposed between the outer layer and the inner liner of the inner sheath. In this exemplary aspect, the braid 604 is not embedded in the layer of the elastomeric polymer 606. In the exemplary aspect shown in FIG. 5D, the exemplary sheath 600D comprises the braid 604 embedded within the layer of the elastomeric polymer 606.
[0115] It is understood that in aspects where the outer layer does not comprise braid or coil similar configurations of the sheath can be constructed with the only difference of absence of the coil or braid. Such an exemplary sheath 600E is shown in FIG. 5E. The sheath 600E. In this aspect, the sheath 600E comprises the inner liner 602, having the first edge 602a and the second edge 602b, and the overlaying portion 602c, where the inner and outer surfaces of the inner liner overlay each other. The outer layer 607 of the sheath does not comprise a braid. The outer layer 607 of the sheath comprises any of the disclosed above elastomeric layers. The sheath 600E further comprises an amount of water-soluble lubricants 608 and 610, as disclosed above.
[0116] In still further aspects, the sheath of the instant disclosure can comprise a hemostasis valve inside the lumen of the sheath, at or near the proximal end of the sheath. Additionally, the exemplary sheaths disclosed herein can comprise a soft tip at the distal end of the sheath. Such a soft tip can be provided with a lower hardness than the other portions of the sheath. In some aspects, the soft tip can have a Shore hardness from about 25 D to about 40 D, including exemplary values of about 26 D, about 27 D, about 28 D, about 29 D, about 30 D, about 31 D, about 32 D, about 33 D, about 34 D, about 35 D, about 36 D, about 37 D, about 38 D, and about 39 D. Yet in other aspects, the soft tip can have a Shore hardness from about 25 D to about 40 D, about 25 D to about 38 D, or about 25 D to about 30 D, and so on. In yet other aspects, the soft tip can have a Shore hardness from about 25 A to about 40 A, including exemplary values of about 26 A, about 27 A, about 28 A, about 29 A, about 30 A, about 31 A, about 32 A, about 33 A, about 34 A, about 35 A, about 36 A, about 37 A, about 38 A, and about 39 A. Yet in other aspects, the soft tip can have a Shore hardness from about 25 A to about 40 A, about 25 A to about 38 A, or about 25 A to about 30 a, and so on.
[0117] In certain aspects, the outer layer and the inner liner can be bonded together or otherwise physically associated with one another. It is understood that the amount of adhesion between the inner liner 602 and the outer polymer layer that comprises braid 604 and the layer of the elastomeric polymer 606 can be variable over the surfaces of the layers. The bonding between the layers can be created by, for example, thermal bonding. In certain aspects, the bonding can be facilitated by the presence of an additional portion of the elastomeric polymer.
[0118] Applications can utilize a sheath of the present disclosure with the rest diameter of the lumen formed by the inner liner 602 that is expandable to an expanded diameter de from about 3 Fr to about 26 Fr, including exemplary values of about 5 Fr, about 8 Fr, about 10 Fr, about 12 Fr, about 15 Fr, about 18 Fr, about 20 Fr, about 22 Fr, about 25 Fr. The expanded diameter can vary along the length of the disclosed sheath. For example, the expanded outer diameter at the proximal end of the sheath can range from about 3 Fr to about 28 Fr, including exemplary values of about 5 Fr, about 8 Fr, about 10 Fr, about 12 Fr, about 15 Fr, about 18 Fr, about 20 Fr, about 22 Fr, about 25 Fr, while the expanded outer diameter at the distal end of the sheath can range from about 3 Fr to about 25 Fr, including exemplary values of about 8 Fr, about 10 Fr, about 12 Fr, about 15 Fr, about 18 Fr, about 20 Fr, and about 22 Fr. The expanded diameter can also be from about 3 Fr to about 26 Fr, or about 3 Fr to about 24 Fr, or about 3 Fr to about 20 Fr, and so on. Aspects of the disclosed sheath can expand to an expanded outer diameter that is from about 10% greater than the original unexpanded outer diameter to about 100% greater than the original unexpanded outer diameter, including exemplary values of about 15 % greater, about 20 % greater, about 25 % greater, about 30 % greater, about 35 % greater, about 40 % greater, about 45 % greater, about 50 % greater, about 55 % greater, about 60 % greater, about 65 % greater, about 70 % greater, about 75 % greater, about 80 % greater, about 85 % greater, about 90 % greater, and about 95 % greater than the original unexpanded outer diameter.
[0119] It is understood, and as described above, that the disclosed sheath can expand from its rest position. The expansion of the disclosed sheath can result in an expansion of the rest diameter from about 10% or less to about 430% or more. In certain aspects, expansion of the sheath can result in expansion of the rest diameter to about 10 % or less, to about 9 % or less, to about 8 % or less, to about 7 % or less, to about 6 % or less, to about 5 % or less, to about 4 % or less, to about 3 % or less, to about 2 % or less, to about 1 % or less. In yet other aspects, expansion of the disclosed sheath can result in expansion of the rest diameter to about 10 % or more, about 20 % or more, about 30 % or more, about 40 % or more, about 50 % or more, about 60 % or more, about 70 % or more, about 80 % or more, about 90 % or more, about 100 % or more, about 125 % or more, about 150 % or more, about 175 % or more, about 200 % or more, about 225 % or more, or about 250 % or more.
[0120] As with previously disclosed aspects, the aspects illustrated in FIGS. 5A-5E can be applied to sheaths having a wide variety of rest diameters and outer diameters. In some aspects, the outer diameter of the sheath gradually decreases from the proximal end of the sheath to the distal end of the sheath. For example, in one aspect, the outer diameter can gradually decrease from about 26 Fr at the proximal end to about 18 Fr at the distal end. The diameter of the sheath can transition gradually across substantially the entire length of the sheath. In other aspects, the transition or reduction of the diameter of the sheath can occur only along a portion of the length of the sheath. For example, the transition can occur along a length from the proximal end to the distal end, where the length can range from about 0.5 inches to about the entire length of the sheath, including any values between any two foregoing values. In yet further aspects, the d0 is minimal and constant along the section of the sheath that passes through the vasculature. In such aspects, the tapered section is about 4” or less at the proximal side of the sheath. [0121] For example, the disclosed sheath can also be used to introduce other types of delivery apparatus for placing various types of intraluminal devices e.g., stents, stented grafts, etc.) into many types of vascular and non-vascular body lumens {e.g., veins, arteries, esophagus, ducts of the biliary tree, intestine, urethra, fallopian tube, other endocrine or exocrine ducts, etc.).
[0122] Typically, the medical device has a greater outer diameter than the diameter of the sheath in its original configuration. The medical device can be advanced through the expandable sheath towards the implantation site, and the expandable sheath can locally expand to accommodate the medical device as the device passes through. The radial force exerted by the medical device can be sufficient to locally expand the sheath to an expanded diameter e.g., the expanded configuration) just in the area where the medical device is currently located. Once the medical device passes a particular location of the sheath, the sheath can at least partially contract to the smaller diameter of its original configuration. The expandable sheath can thus be expanded without the use of inflatable balloons or other dilators. Once the medical device is implanted, the sheath and any sutures holding it in place can be removed. In some exemplary aspects, the sheath is removed without rotating it.
DEVICE
[0123] An exemplary and unlimiting article represented by a prosthetic heart valve 100 is shown in FIG. 6.
[0124] The prosthetic valve 100 can have four main components: a stent or frame 120, a valvular structure 140, an inner skirt 160, and a perivalvular outer sealing member or outer skirt 180. The prosthetic valve 100 can have an inflow end portion 150, an intermediate portion 170 (the area that forms a waist portion of the valve when it is positioned within the native anatomy), and an outflow end portion 190. The inner skirt 160 can be arranged on and/or coupled to an inner surface of frame 120, while the outer skirt (often referred to as a sealing member) 180 can be arranged on and/or coupled to an outer surface of frame 120.
[0125] The valvular structure 140 can comprise three leaflets (not shown), collectively forming a leaflet structure, which can be arranged to collapse in a tricuspid arrangement, although, in other aspects, there can be greater or fewer number of leaflets (e.g., one or more leaflets). The leaflets can be secured to one another at their adjacent sides to form commissures 240 (at connections 220) of the leaflet structure 140. The lower edge of valvular structure 140 can have an undulating, curved, scalloped shape and can be secured to the inner skirt 160. By forming the leaflets with this scalloped geometry, stresses on the leaflets are reduced, which in turn improves the durability of the prosthetic valve. Moreover, by virtue of the scalloped shape, folds, and ripples at the belly of each leaflet (the central region of each leaflet), which can cause early calcification in those areas, can be eliminated or at least minimized. The scalloped geometry also reduces the amount of tissue material used to form leaflet structure, thereby allowing a smaller, more even crimped profile at the inflow end of the prosthetic valve. The leaflet structure 140 can be formed of pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in U.S. Patent No. 6,730,1 18, which is incorporated by reference herein.
[0126] As noted above, the leaflet structure 140 in the illustrated aspect includes three flexible leaflets (although a greater or a smaller number of leaflets can be used). Additional information regarding the leaflets, as well as additional information regarding inner skirt material, can be found, for example, in U.S. Patent Application Publication No. 2015/0320556 or U.S. Patent Application Publication No. 2018/036530, the contents of which are incorporated by reference in its entirety.
[0127] Suitable plastically expandable materials that can be used to form the frame 120 include, without limitation, stainless steel, biocompatible, high-strength alloys (e.g., a cobalt-chromium or a nickel-cobalt-chromium alloys), polymers, or combinations thereof. In particular aspects, frame 120 is made of a nickel-cobalt-chromium- molybdenum alloy, such as MP35N® alloy (SPS Technologies, Jenkintown, Pa.), which is equivalent to UNS R30035 alloy (covered by ASTM F562-02). MP35N® alloy/UNS R30035 alloy comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight. It has been found that the use of MP35N® alloy to form frame 120 provides superior structural results over stainless steel. In particular, when MP35N® alloy is used as the frame material, less material is needed to achieve the same or better performance in radial and crush force resistance, fatigue resistance, and corrosion resistance. Moreover, since less material is required, the crimped profile of the frame can be reduced, thereby providing a lower-profile prosthetic valve assembly for percutaneous delivery to the treatment location in the body.
[0128] Frame 120 is configured to reduce, prevent, or minimize possible overexpansion of the prosthetic valve at a predetermined balloon pressure, especially at the outflow end portion of the frame, which supports the leaflet structure 140. In addition, the inflow end portion 150 and outflow end portion 190 of a frame generally tend to over-expand more so than the middle portion of the frame due to the “dog-boning” effect of the balloon used to expand the prosthetic valve.
[0129] The middle portion of the valve, upon delivery forms a waist portion. It is understood that the exact position of the waist portion will be dependent on the deployment of the valve and locking it within the dock. It is understood that the “middle portion” does not have to be exactly in the middle of the valve and can be anywhere between the outflow and inflow portions of the valve. In such aspects, the waist portion makes a direct contact with the mitral annulus and ensures a tight seal against the mitral annulus. In certain aspects, the waist portion can be too narrow, and therefore, an additional step of post-dilation is required. In such aspects, the balloon catheter is inserted into the delivered valve and inflated to increase the diameter of the valve around the waist portion. These additional post-dilating steps can complicate the medical procedures, damage prosthetic leaflets, and increase the risk of structural valve deterioration. Therefore, there is a need to deliver the valve into the natural anatomy without a need for the post-dilation. An X-ray of an exemplary valve 800 that would require this post-dilation procedure is shown in FIG. 7. The diameter of the outflow portion of the valve is defined as 410, the diameter of the inflow portion of the valve is defined as 450, the middle portion 430 (or the waist portion) of the valve is defined by the diameter 470, where the valve is locked in a dock 460. Due to the relatively narrow waist portion of this valve, the valve would require an additional volume post-dilation to ensure proper contact with the mitral annulus.
[0130] Thus, disclosed herein are systems that can deliver valves having desired dimensions in the waist portion without a need for a post-dilation. In certain aspects, disclosed herein is a system comprising: a heart valve delivery system comprising: a balloon catheter having a distal end with a balloon thereon, the balloon having a prosthetic-valve receiving portion, wherein the prosthetic-valve receiving portion is configured to have a radially expandable prosthetic heart valve crimped thereon; and a radially-expandable prosthetic heart valve configured to be crimped over the balloon, wherein the radially-expandable prosthetic valve comprises an inflow portion, an outflow portion and a middle portion; wherein at least one of the balloon or radially-expandable prosthetic heart valve comprise a second water-soluble lubricant. Any of the disclosed above water-soluble lubricants can be used.
[0131] In still further aspects, the balloon can be disposed in the balloon catheter in a crimped form comprising a plurality of pleats, wherein the plurality of pleats are coated with the second water-soluble lubricant. It is understood that the delivery system and balloon catheter can be any of the known in the art balloon catheters and delivery systems. Some of these systems are disclosed in detail in U.S. Patent No. 7,780,723, U.S. Patent No. 8,382,826, U.S. Patent No. 9,061 ,119, U.S. Patent No. 10,456,253, U.S. Patent No. 10,478,296, U.S. Patent No. 10,507,103, U.S. Patent Application No. 17/111 ,148, the content of which incorporated herein by reference in a full entirety. In such aspects, any of the disclosed above water-soluble lubricants can be disposed on all portions of the balloon catheter, including balloon pleats, flex catheters, and the like.
[0132] In still further aspects, the valves disclosed herein can comprise any of the disclosed water-soluble lubricants. For example, and without limitations, in certain aspects, at least one of the annular frame, the outer sealing member, or the plurality of leaflets is coated with the second water-soluble lubricant.
[0133] In still further aspects, all portions of the delivery system, balloon catheter, and valve are coated with the second water-soluble lubricant. In certain aspects, some of the portions of the delivery system, balloon catheter, and valve are coated with the second water-soluble lubricant. Yet, in certain aspects, only the valve is coated with the second water-soluble lubricant. Yet, in certain aspects, only the portions of the delivery system are coated with the second water-soluble lubricant. Yet in still further aspects, only the balloon itself is coated with the second water-soluble lubricant.
[0134] In still further aspects, the heart valve is deployed in a natural anatomy of a subject without a post-dilation inflation procedure such that a waist portion formed in the middle portion of the heart valve has a diameter that is substantially identical to a diameter of a waist portion formed in an inflow and an outer blood flow portion of a substantially identical reference heart valve that is free of the second water-soluble lubricant delivered with a substantially identical reference heart valve delivery system that is free of the second water-soluble lubricant, and wherein the substantially identical reference heart valve is deployed in the natural anatomy of the subject with a postdilation inflation procedure.
[0135] In still further aspects, an outer diameter of the waist portion of the heart valve after the deployment in the natural anatomy of the subject without the post-dilation inflation procedure is about 90% to 100%, including exemplary values of about 91%, about 92%, about 93%, about 94%, about 98%, about 99%, and about 99.99% of an outer diameter of a waist portion of the radially expandable prosthetic heart valve before it is crimped on the balloon. In still further aspects, the outer diameter of the waist after deployment can be about 90% to about 99%, or about 90% to about 98%, or about 90% to about 97%, or about 90% to about 96%, or about 90% to about 95%, or about 91 % to 100%, or about 92% to 100% or about 93% to 100%, or about 94% to 100%, or about 95% to 100%, and so one of the outer diameter of a waist portion of the radially expandable prosthetic heart valve before it is crimped on the balloon.
[0136] In still further aspects, an outer diameter of the waist portion of the heart valve after the deployment in the natural anatomy of the subject without the post-dilation inflation procedure is about 90% to 100%, including exemplary values of about 91%, about 92%, about 93%, about 94%, about 98%, about 99%, and about 99.99% of an outer diameter the inflow and outflow portions of the radially expandable prosthetic heart valve after deployment. In still further aspects, the outer diameter of the waist after deployment can be about 90% to about 99%, or about 90% to about 98%, or about 90% to about 97%, or about 90% to about 96%, or about 90% to about 95%, or about 91 % to 100%, or about 92% to 100% or about 93% to 100%, or about 94% to 100%, or about 95% to 100% of the outer diameter the inflow and outflow portions of the radially expandable prosthetic heart valve after deployment.
[0137] In still further aspects, the systems disclosed herein comprise a docking system that is configured to retain the heart valve in a natural anatomy of the subject. For example, and without limitations such an exemplary docking system is described in U.S. Patent Application Publication No. 2020/0383777, the content of which is incorporated herein in its whole entirety. In certain aspects, the docking system comprises a third water-soluble lubricant. In yet still further aspects, the third water- soluble lubricant is the same or different from the first water-soluble lubricant and/or the second water-soluble lubricant if present.
[0138] Again, it is understood that the first, second, and/or third water-soluble lubricant can comprise any of the disclosed above water-soluble lubricants. [0139] As represented in FIGS. 8A-8C, also disclosed herein are methods comprising: disposing a water-soluble lubricant on a balloon positioned in a distal end of a balloon catheter; positioning a radially expandable prosthetic heart valve in a prosthetic-valve receiving portion of the balloon and crimping the radially expandable prosthetic heart valve over the balloon; wherein the balloon is configured to be inflated during a deployment of the radially expandable prosthetic heart valve into a natural anatomy of a subject.
[0140] In still further aspects, disclosed are methods where the balloon catheter comprises an introducer sheath comprising: a variable diameter inner liner comprising a sheet having a first edge and a second edge and is defined by an inner surface and an outer surface, wherein the sheet is wound in a scroll configuration such that at least a portion of the inner surface of the sheet overlays at least a portion of the outer surface of the sheet and wherein the first edge of the sheet is slidable along at least a portion the inner surface of the sheet and the second edge is slidable along at least a portion of the outer surface of the sheet, wherein the inner surface of the sheet defines a lumen of the sheath; an outer layer having an inner surface and an outer surface and circumferentially disposed on at least a portion of the variable diameter inner liner, such that at least a portion of the inner surface of the outer layer is disposed on at least a portion of the outer surface of the inner liner; and wherein the introducer sheath comprises a further water-soluble lubricant disposed on the outer surface of the sheet such that at least a portion of the second water-soluble lubricant is between at least a portion of an overlying portion of the sheet and at least a portion of sliding portions of the sheet. In such aspects, the further water-soluble lubricant is disposed between the outer surface of the inner liner and the inner surface of the outer layer. Any of the disclosed above water-soluble lubricants can be employed.
[0141] Still further, the methods disclosed herein comprise steps of deploying the heart valve in a natural anatomy of a subject. In such aspects, the step of deploying comprises a single inflation of the balloon. When methods of the current disclosure are employed and the heart valve is deployed in a natural anatomy of a subject, a waist portion formed in a middle portion of the heart valve has a diameter that is substantially identical to a diameter of a waist portion formed in a middle portion of a substantially identical reference heart valve that is free of the water-soluble lubricant delivered with a substantially identical reference heart valve delivery system that is free of the water- soluble lubricant, and wherein the substantially identical reference heart valve is deployed in the natural anatomy of the subject with a post-dilation inflation procedure.
[0142] In still further aspects, the heart valve is positioned in a docking system deployed into the natural anatomy of the subject. In such aspects, the docking system comprises an additional water-soluble lubricant. These additional water-soluble lubricants can be any of the disclosed above water-soluble lubricants.
[0143] Also disclosed is a method comprising: positioning a docking system in a natural anatomy of a subject; deploying a radially-expandable prosthetic heart valve crimped over a balloon, wherein the balloon is positioned in a balloon catheter; wherein the deploying comprises: delivering the balloon catheter to the natural anatomy of the subject; inflating the balloon to radially expand the prosthetic heart valve such that it is immobilized by the docking system; wherein at least one of the balloon or radially- expandable prosthetic heart valve comprise a water-soluble lubricant. In yet other aspects, the step of deploying comprises delivering the balloon and the radially expandable prosthetic heart valve with an introducer sheath. In such aspects, any of the disclosed above valves, balloon catheters, and introducers sheaths can be used. In still further aspects, each of the valves, balloon catheters, introducers sheaths, and docks can comprise any of the disclosed above water-soluble lubricants.
[0144] In view of the described processes and compositions, hereinbelow are described certain more particularly described aspects of the disclosures. These particularly recited aspects should not, however, be interpreted to have any limiting effect on any different claims containing different or more general teachings described herein, or that the “particular” aspects are somehow limited in some way other than the inherent meanings of the language and formulas literally used therein.
EXEMPLARY ASPECTS:
[0145] Exemplary Aspect 1 . An introducer sheath comprising: a variable diameter inner liner comprising a sheet having a first edge and a second edge and is defined by an inner surface and an outer surface, wherein the sheet is wound in a scroll configuration such that at least a portion of the inner surface of the sheet overlays at least a portion of the outer surface of the sheet and wherein the first edge of the sheet is slidable along at least a portion the inner surface of the sheet and the second edge is slidable along at least a portion of the outer surface of the sheet, wherein the inner surface of the sheet defines a lumen of the sheath; an outer layer having an inner surface and an outer surface and circumferentially disposed on at least a portion of the variable diameter inner liner, such that at least a portion of the inner surface of the outer layer is disposed on at least a portion of the outer surface of the inner liner; and wherein the introducer sheath comprises a first water-soluble lubricant disposed between the inner liner and the outer layer.
[0146] Exemplary Aspect 2. The introducer of any one of examples herein, particularly Exemplary Aspect 1 , wherein the first water-soluble lubricant is disposed on the outer surface of the sheet such that at least a portion of the first water-soluble lubricant is positioned between at least a portion of an overlying portion of the sheet and at last a portion of a sliding portion of the sheet.
[0147] Exemplary Aspect 3. A system comprising: a heart valve delivery system comprising: a balloon catheter having a distal end with a balloon thereon, the balloon having a prosthetic-valve receiving portion, wherein the prosthetic-valve receiving portion is configured to have a radially expandable prosthetic heart valve crimped thereon; and a radially expandable prosthetic heart valve configured to be crimped over the balloon, wherein the radially expandable prosthetic valve comprises an inflow portion, an outflow portion, and a middle portion; wherein at least one of the balloon or radially expandable prosthetic heart valve comprise a second water-soluble lubricant.
[0148] Exemplary Aspect 4. The introducer of any one of examples herein, particularly Exemplary Aspects 1 -2, or system of any one of examples herein, particularly Exemplary Aspect 3, wherein the first and the second water-soluble lubricants are substantially fully soluble in water.
[0149] Exemplary Aspect 5. The introducer sheath of any one of examples herein, particularly Exemplary Aspects 1 -2, or the system of any one of examples herein, particularly Exemplary Aspect 3-4, wherein the first water-soluble and/or the second water-soluble lubricant is a viscous liquid at room temperature or a dry film until hydration (with saline or sterile water).
[0150] Exemplary Aspect 6. The system of any one of examples herein, particularly Exemplary Aspects 3-5, wherein the balloon is disposed in the balloon catheter in a crimped form comprising a plurality of pleats, wherein the plurality of pleats are coated with the second water-soluble lubricant.
[0151] Exemplary Aspect 7. The system of any one of examples herein, particularly Exemplary Aspects 3-6, wherein the prosthetic heart valve comprises an annular frame, an outer sealing member, a plurality of leaflets, or a combination thereof.
[0152] Exemplary Aspect 8. The system of any one of examples herein, particularly Exemplary Aspect 7, wherein at least one of the annular frame, the outer sealing member, or the plurality of leaflets is coated with the second water-soluble lubricant.
[0153] Exemplary Aspect 9. The system of any one of examples herein, particularly Exemplary Aspects 3-8, wherein both the balloon and the heart valve are coated with the second water-soluble lubricant. [0154] Exemplary Aspect 10. The system of any one of examples herein, particularly Exemplary Aspects 3-9, wherein when the heart valve is deployed in a natural anatomy of a subject without a post-dilation inflation procedure such that a waist portion formed in the middle portion of the heart valve has a diameter that is substantially identical to a diameter of a waist portion formal in a middle portion of a substantially identical reference heart valve that is free of the second water-soluble lubricant delivered with a substantially identical reference heart valve delivery system that is free of the second water-soluble lubricant, and wherein the substantially identical reference heart valve is deployed in the natural anatomy of the subject with a postdilation inflation procedure.
[0155] Exemplary Aspect 1 1 . The introducer sheath of any one of examples herein, particularly Exemplary Aspects 1 -2, or the system of any one of examples herein, particularly Exemplary Aspects 3-10, wherein the first water-soluble lubricant and the second water-soluble lubricant comprise at least one liquid polyethylene glycol having a molecular weight of less than about 1000 g/mol.
[0156] Exemplary Aspect 12. The introducer sheath or the system of any one of examples herein, particularly Exemplary Aspect 1 1 , wherein the first water-soluble lubricant and the second water-soluble lubricant comprise polyethylene glycol having a molecular weight of about 200 to about 800 g/mol.
[0157] Exemplary Aspect 13. The introducer sheath or the system of any one of examples herein, particularly Exemplary Aspect 1 1 or 12, wherein the first water-soluble lubricant and the second water-soluble lubricant comprise polyvinylpyrrolidone, polyvinylpyrrolidone vinyl acetate copolymer, glycerol, polyethylene oxide, or any combination thereof.
[0158] Exemplary Aspect 14. The introducer sheath of any one of examples herein, particularly Exemplary Aspect any one of examples herein, particularly Exemplary Aspects 1 -2 or 1 1 -13, or the system of any one of examples herein, particularly Exemplary Aspects 3-13, wherein the first water-soluble lubricant and the second water- soluble lubricant exhibit a room temperature kinematic viscosity of about 400 to 1400 cSt.
[0159] Exemplary Aspect 15. The introducer sheath of any one of examples herein, particularly Exemplary Aspects 1 -2 or 1 1 -14, or the system of any one of examples herein, particularly Exemplary Aspects 3-14, wherein the first water-soluble lubricant and the second water-soluble lubricant produce substantially no particulate matter.
[0160] Exemplary Aspect 16. The introducer sheath of any one of examples herein, particularly Exemplary Aspects 1 -2 or 1 1 -15, or the system of any one of examples herein, particularly Exemplary Aspects 3-15, wherein the first water-soluble lubricant and the second water-soluble lubricant are configured to be dissolved in a natural anatomy of a subject at a predetermined time.
[0161] Exemplary Aspect 17. The system of any one of examples herein, particularly Exemplary Aspects 3-16, further comprising the introducer sheath of any one of examples herein, particularly Exemplary Aspects 1 -2 or 1 1 -16.
[0162] Exemplary Aspect 18. The system of any one of examples herein, particularly Exemplary Aspects 10-17, wherein an outer diameter of the waist portion of the heart valve after the deployment in the natural anatomy of the subject without the post-dilation inflation procedure is about 90% to 100% of an outer diameter of a waist portion of the radially expandable prosthetic heart valve before it is crimped on the balloon.
[0163] Exemplary Aspect 19. The system of any one of examples herein, particularly Exemplary Aspects 10-18, wherein an outer diameter of the waist portion of the heart valve after the deployment in the natural anatomy of the subject without the post-dilation inflation procedure is about 90% to 100% of an outer diameter the inflow and outflow portions of the radially expandable prosthetic heart valve after deployment. [0164] Exemplary Aspect 20. The system of any one of examples herein, particularly Exemplary Aspects 3-19, further comprising a docking system configured to retain the heart valve in a natural anatomy of the subject.
[0165] Exemplary Aspect 21 . The system of any one of examples herein, particularly Exemplary Aspect 20, wherein the docking system comprises a third water- soluble lubricant.
[0166] Exemplary Aspect 22. The system of any one of examples herein, particularly Exemplary Aspect 21 , wherein the third water-soluble lubricant is the same or different from the first water-soluble lubricant and/or the second water-soluble lubricant if present.
[0167] Exemplary Aspect 23. A method comprising: disposing a water-soluble lubricant on a balloon positioned in a distal end of a balloon catheter; positioning a radially expandable prosthetic heart valve in a prosthetic-valve receiving portion of the balloon, and crimping the radially expandable prosthetic heart valve over the balloon; wherein the balloon is configured to be inflated during a deployment of the radially expandable prosthetic heart valve into a natural anatomy of a subject.
[0168] Exemplary Aspect 24. The method of any one of examples herein, particularly Exemplary Aspect 23, wherein the prosthetic heart valve comprises an annular frame, an outer sealing member, a plurality of leaflets, or a combination thereof.
[0169] Exemplary Aspect 25. The method of any one of examples herein, particularly Exemplary Aspect 23 or 24, further comprises disposing the water-soluble lubricant on the radially expandable prosthetic heart valve prior to positioning it in the prosthetic-valve receiving portion of the balloon.
[0170] Exemplary Aspect 26. The method of any one of examples herein, particularly Exemplary Aspects 23-25, wherein the balloon catheter comprises an introducer sheath comprising: a variable diameter inner liner comprising a sheet having a first edge and a second edge and is defined by an inner surface and an outer surface, wherein the sheet is wound in a scroll configuration such that at least a portion of the inner surface of the sheet overlays at least a portion of the outer surface of the sheet and wherein the first edge of the sheet is slidable along at least a portion the inner surface of the sheet and the second edge is slidable along at least a portion of the outer surface of the sheet, wherein the inner surface of the sheet defines a lumen of the sheath; an outer layer having an inner surface and an outer surface and circumferentially disposed on at least a portion of the variable diameter inner liner, such that at least a portion of the inner surface of the outer layer is disposed on at least a portion of the outer surface of the inner liner; and wherein the introducer sheath comprises a further water-soluble lubricant disposed between the inner liner and the outer layer.
[0171] Exemplary Aspect 27. The method of any one of examples herein, particularly Exemplary Aspect 26, the further water-soluble lubricant disposed on the outer surface of the sheet such that at least a portion of the further water-soluble lubricant is between at least a portion of an overlying portion of the sheet and at least a portion of a sliding portion of the sheet.
[0172] Exemplary Aspect 28. The method of any one of examples herein, particularly Exemplary Aspect 23-27, wherein the further water-soluble lubricant present in the introducer sheath is the same or different from the water-soluble lubricant present at the at least one of the balloon or radially expandable prosthetic heart valve.
[0173] Exemplary Aspect 29. The method of any one of examples herein, particularly Exemplary Aspects 23-28, wherein the water-soluble lubricant and/or the further water-soluble lubricant, if present, are substantially fully water-soluble lubricants.
[0174] Exemplary Aspect 30. The method of any one of examples herein, particularly Exemplary Aspects 23-29, wherein the water-soluble lubricant and/or the further water-soluble lubricant, if present, comprise at least one liquid polyethylene glycol having a molecular weight of less than about 1000 g/mol.
[0175] Exemplary Aspect 31 . The method of any one of examples herein, particularly Exemplary Aspect 30, wherein the water-soluble lubricant and/or the further water-soluble lubricant, if present, comprise polyethylene glycol having a molecular weight of about 200 to about 800 g/mol.
[0176] Exemplary Aspect 32. The method of any one of examples herein, particularly Exemplary Aspect 30 or 31 , wherein the water-soluble lubricant and/or the further water-soluble lubricant, if present, further comprise polyvinylpyrrolidone, polyvinylpyrrolidone vinyl acetate copolymer, glycerol, polyethylene oxide, or any combination thereof.
[0177] Exemplary Aspect 33. The method of any one of examples herein, particularly Exemplary Aspects 23-32, wherein the water-soluble lubricant and/or the further water-soluble lubricant, if present, exhibit kinematic viscosity of about 400 to about 1400 cSt.
[0178] Exemplary Aspect 34. The method of any one of examples herein, particularly Exemplary Aspects 23-33, wherein the water-soluble lubricant and/or the further water-soluble lubricant, if present, produce substantially no particulate matter.
[0179] Exemplary Aspect 35. The method of any one of examples herein, particularly Exemplary Aspects 23-34, wherein the water-soluble lubricant and/or the further water-soluble lubricant, if present, are configured to be dissolved in a natural anatomy of a subject at a predetermined time.
[0180] Exemplary Aspect 36. The method of any one of examples herein, particularly Exemplary Aspects 23-35, further comprises deploying the heart valve in a natural anatomy of a subject. [0181] Exemplary Aspect 37. The method of any one of examples herein, particularly Exemplary Aspect 36, wherein the step of deploying comprises a single inflation of the balloon.
[0182] Exemplary Aspect 38. The method of any one of examples herein, particularly Exemplary Aspect 36 or 37, wherein when the heart valve is deployed in a natural anatomy of a subject, a waist portion formed in a middle portion of the heart valve has a diameter that is substantially identical to a diameter of a waist portion formed in a middle portion of a substantially identical reference heart valve that is free of the water-soluble lubricant delivered with a substantially identical reference heart valve delivery system that is free of the water-soluble lubricant, and wherein the substantially identical reference heart valve is deployed in the natural anatomy of the subject with a post-dilation inflation procedure.
[0183] Exemplary Aspect 39. The method of any one of examples herein, particularly Exemplary Aspect 38, wherein an outer diameter of the waist portion of the heart valve after the deployment in the natural anatomy of the subject without the postdilation inflation procedure is about 90% to 100% of an outer diameter of a waist portion of the radially expandable prosthetic heart valve before it is crimped on the balloon.
[0184] Exemplary Aspect 40. The method of any one of examples herein, particularly Exemplary Aspects 38-39, wherein an outer diameter of the waist portion of the heart valve after the deployment in the natural anatomy of the subject without the post-dilation inflation procedure is about 90% to 100% of an outer diameter the inflow and outflow portions of the radially expandable prosthetic heart valve after deployment.
[0185] Exemplary Aspect 41 . The method of any one of examples herein, particularly Exemplary Aspects 38-40, wherein the heart valve is positioned in a docking system deployed into the natural anatomy of the subject. [0186] Exemplary Aspect 42. The method of any one of examples herein, particularly Exemplary Aspect 41 , wherein the docking system comprises an additional water-soluble lubricant.
[0187] Exemplary Aspect 43. The method of any one of examples herein, particularly Exemplary Aspect 42, wherein the additional water-soluble lubricant is the same or different from the water-soluble lubricant and/or the further water-soluble lubricant if present.
[0188] Exemplary Aspect 44. A method comprising: positioning a docking system in a natural anatomy of a subject; deploying a radially expandable prosthetic heart valve crimped over a balloon, wherein the balloon is positioned in a balloon catheter; wherein the deploying comprises: delivering the balloon catheter to the natural anatomy of the subject; inflating the balloon to radially expand the prosthetic heart valve such that it is immobilized by the docking system; wherein at least one of the balloon or radially expandable prosthetic heart valve comprise a water-soluble lubricant.
[0189] Exemplary Aspect 45. The method of any one of examples herein, particularly Exemplary Aspect 44, wherein the step of deploying comprises delivering the balloon and the radially expandable prosthetic heart valve with an introducer sheath.
[0190] Exemplary Aspect 46. The method of any one of examples herein, particularly Exemplary Aspect 45, wherein the introducer sheath comprises a further water-soluble lubricant.
[0191] Exemplary Aspect 47. The method of any one of examples herein, particularly Exemplary Aspects 44-46, wherein the docking system comprises an additional water-soluble lubricant. [0192] Exemplary Aspect 48. The method of any one of examples herein, particularly Exemplary Aspects 44-47, wherein the method is substantially free of postdilation proceedings.