Patent Application
20230263993
The present application is directed to a sheath for use with catheter-based technologies for repairing and/or replacing heart valves, as well as for delivering an implant, such as a prosthetic valve to a heart via the patient's vasculature.
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. Percutaneous interventional medical procedures utilize the large blood vessels of the body to reach target destinations rather than surgically opening the target site. There are many types of disease states that can be treated via interventional methods, including coronary blockages, valve replacements (TAVR), and brain aneurysms. These techniques involve using wires, catheters, balloons, electrodes, and other thin devices to travel down the length of the blood vessels from the access site to the target site. The devices have a proximal end, which the clinician controls outside of the body, and a distal end inside the body, which is responsible for treating the disease state. Percutaneous interventional procedures offer several advantages over open surgical techniques. First, they require smaller incision sites, which reduces scarring and bleeding as well as an infection risk. Procedures are also less traumatic to the tissue, so recovery times are reduced. Finally, interventional techniques can usually be performed much faster and with fewer clinicians participating in the procedure, so overall costs are lowered. In some cases, the need for anesthesia is also eliminated, further speeding up the recovery process and reducing risk.
A single procedure typically uses several different guidewires, catheters, and balloons to achieve the desired effect. One at a time, each tool is inserted and then removed from the access site sequentially. For example, a guidewire is used to track to the correct location within the body. Next, a balloon may be used to dilate a section of a narrowed blood vessel. Last, an implant may be delivered to the target site. Because catheters are frequently inserted and removed, introducer sheaths are used to protect the local anatomy and simplify the procedure.
An introducer sheath can be used to safely introduce a delivery apparatus into a patient's vasculature (e.g., the femoral artery). Introducer sheaths are conduits that seal onto the access site blood vessel to reduce bleeding and trauma to the vessel caused by catheters with rough edges. 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. Once the introducer sheath is positioned within the vasculature, the shaft of the delivery apparatus is advanced through the sheath and into the vasculature, carrying the prosthetic device. Expandable introducer sheaths, formed of highly elastomeric materials, allow for the dilating of the vessel to be performed by the passing prosthetic device. Expandable introducer sheaths are disclosed in U.S. Pat. No. 8,790,387, entitled “Expandable Sheath for Introducing an Endovascular Delivery Device into a Body,” U.S. Pat. No. 10,639,152, entitled “Expandable Sheath and Methods of Using the Same,” U.S. application Ser. No. 14/880,109, entitled “Expandable Sheath,” U.S. application Ser. No. 16/407,057, entitled “Expandable Sheath with Elastomeric Cross-Sectional Portions,” U.S. Pat. No. 10,327,896, entitled “Expandable Sheath with Elastomeric Cross-Sectional Portions,” U.S. application Ser. No. 15/997,587, entitled “Expandable Sheath for Introducing an Endovascular Delivery Device into a Body,” U.S. application Ser. No. 16/378,417, entitled “Expandable Sheath,” the disclosures of which are herein incorporated by reference.
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. Typically, the introducer is inserted into the sheath during preparation, and both are then inserted into the vessel. Due to the need for a smooth transition from the introducer to the sheath, it is vital that the change in diameter of the introducer occurs distal to the tip of the sheath, such that the tip of the sheath fits snugly around the diameter. During insertion of the sheath and introducer, it is possible that the introducer can move backward within the sheath, eliminating the aforementioned snug fit and creating a lip between the sheath tip and the smaller outer diameter of the introducer. This lip/gap can lead to severe vessel trauma during insertion.
Moreover, some procedures, such as a transseptal approach for mitral valve replacement/repair, require prolonged dilation of incisions in heart tissue and a curving/bending of the sheath to access the treatment site, prolonging procedure time and recovering and increasing the risk of trauma to vessels and heart tissue.
Accordingly, there remains a need for further improvements in expandable introducer sheath for endovascular systems used to implant valves and other prosthetic devices.
Aspects of the current disclosure are directed to the flexible delivery catheter comprising an outer jacket, having a proximal end, a distal end, an inner surface and an outer surface, and defining a central lumen extending longitudinally between the proximal end and the distal end; a coil layer comprising a coil winding and having a proximal end, a distal end, an inner surface, and an outer surface, wherein the coil winding extends helically about a longitudinal axis of the delivery catheter and further defines a central lumen between the proximal end and the distal end; a braided layer having a proximal end and a distal end and comprising a plurality of fibers disposed in a braided pattern and defining a central lumen having an inner surface and an outer surface, wherein the coil layer is disposed within the central lumen of the braided layer, and wherein the braided layer is disposed between the outer jacket and the coil layer, wherein the coil layer is wound to resist axial compression and tension applied to the delivery catheter, the coil layer facilitates bending of the delivery catheter in a direction away from the longitudinal axis of the delivery catheter; wherein the coil layer and the braided layer are provided at a distal tip portion of the delivery catheter, wherein the distal tip portion has a first length extending along a length of the delivery catheter from the distal end of the delivery catheter toward the proximal end of the delivery catheter; and wherein the delivery catheter is omnidirectionally flexible and configured to bend in any direction away from the longitudinal axis of the delivery catheter.
In still further aspects, the flexible delivery catheter as disclosed herein comprises a tie layer provided on the inner surface of the coil layer. In yet further aspects, the disclosed herein delivery catheters can further comprise an outer barrier layer provided between the outer surface of the coil layer and an inner barrier layer provided on the inner surface of the coil layer.
In still further aspects, the flexible delivery catheter as disclosed herein can comprise at least one tensile stiffening fiber for limiting bending of the delivery catheter in a direction opposite a circumferential location of the at least one tensile stiffening fiber.
Also disclosed herein is a flexible delivery catheter comprising: an outer jacket, having a proximal end, a distal end, an inner surface, and an outer surface, and defining a central lumen extending longitudinally between the proximal end and the distal end; a braided layer embedded in the outer jacket comprising a plurality of interwoven fibers disposed in a braided pattern forming an elongated tubular structure defining a central lumen extending therethrough, and wherein a braid density of the braided pattern varies along a length of the braided layer; and wherein the delivery catheter is omnidirectionally flexible and configured to bend in any direction away from the longitudinal axis of the delivery catheter.
Also disclosed is a flexible delivery catheter comprising: an outer jacket, having a proximal end, a distal end, an inner surface and an outer surface, and defining a central lumen extending longitudinally between the proximal end and the distal end; and at least one tensile stiffening fiber extending longitudinally along the delivery catheter from the proximal to the distal end of the delivery catheter, the at least one tensile stiffening fiber liming bending of the delivery catheter in a direction opposite the circumferential location of the at least one tensile stiffening fiber.
In still further aspects, disclosed is a flexible delivery catheter comprising: an outer jacket, having a proximal end, a distal end, an inner surface, and an outer surface, and defining a central lumen extending longitudinally between the proximal end and the distal end; a braided layer comprising a plurality of fibers disposed in a braided pattern, wherein the braided layer is positioned within the central lumen, a hypotube having a proximal end, a distal end, an inner surface, an outer surface, and a plurality of cut-outs which extend between the inner surface and the outer surface of the hypotube such that the hypotube can bend omnidirectionally, and wherein the hypotube is provided at a distal tip portion of the delivery catheter, the distal tip portion extending along a length of the delivery catheter from a distal end of the delivery catheter toward the proximal end of the delivery catheter.
Also disclosed are methods for making a flexible delivery catheter comprising: forming an outer jacket, having a proximal end, a distal end, an inner surface, and an outer surface, and defining a central lumen extending longitudinally between the proximal end and the distal end; forming a coil layer comprising a coil winding and having a proximal end, a distal end, an inner surface, and an outer surface, wherein the coil winding extends helically about a longitudinal axis and defines a central lumen between the proximal end and the distal end; forming a braided layer having a proximal end and a distal end and comprising a plurality of wires disposed in a braided pattern and defining a central lumen having an inner surface and an outer surface, disposing the coil layer within the central lumen of the braided layer, disposing the braided layer between the outer jacket and the coil layer; and coupling the outer jacket, the coil layer and the braided layer together.
Also disclosed are methods for making a flexible delivery catheter comprising forming an outer jacket, having a proximal end, a distal end, an inner surface, and an outer surface, and defining a central lumen extending longitudinally between the proximal end and the distal end; forming a braided layer comprising a plurality of wires disposed in a braided pattern and defining a central lumen; and forming a hypotube having a proximal end, a distal end, an inner surface, an outer surface, and a plurality of cut-outs which extend between the inner surface and the outer surface of the hypotube such that the hypotube can bend omnidirectionally, wherein the hypotube is provided at a distal tip portion of the delivery catheter, the distal tip portion extending along a length of the delivery catheter from a distal end of the delivery catheter toward the proximal end of the delivery catheter.
In still further aspects, also disclosed are methods of making a flexible delivery catheter comprising forming an outer jacket, having a proximal end, a distal end, an inner surface, and an outer surface, and defining a central lumen extending longitudinally between the proximal end and the distal end; braiding a plurality of interwoven fibers in a braided pattern to form a braided layer, embedding the braided layer in the outer jacket forming an elongated tubular structure defining a central lumen extending therethrough, and wherein a braid density of the braided pattern varies along a length of the braided layer.
Still further disclosed are also methods of making a flexible delivery catheter comprising forming an outer jacket, having a proximal end, a distal end, an inner surface, and an outer surface, and defining a central lumen extending longitudinally between the proximal end and the distal end; forming a braided layer embedded in the outer jacket comprising a plurality of interwoven fibers disposed in a braided pattern forming an elongated tubular structure defining a central lumen extending therethrough; coupling at least one tensile stiffening fiber to the outer jacket, and wherein the tensile stiffening fiber extends longitudinally along the delivery catheter from the proximal to the distal end of the delivery catheter, the at least one tensile stiffening fiber limiting bending of the delivery catheter in a direction opposite the circumferential location of the at least one tensile stiffening fiber.
Yet still further, disclosed are methods of deploying a prosthetic into a patient comprising: providing a delivery system comprising a flexible catheter having a proximal end and a distal end, wherein the outer jacket having an elasticity that varies (longitudinally) along a length of the outer jacket; advancing the catheter into a vessel of a patient, and advancing the prosthetic from the proximal end of the catheter to the distal end of the catheter and into the patient.
Also disclosed is a flexible delivery catheter having a proximal end and a distal end and comprising: an outer jacket, having a proximal end, a distal end, an inner surface and an outer surface, and defining a central lumen extending longitudinally between the proximal end and the distal end; a stent layer having a proximal end, a distal end, an inner surface, and an outer surface; an inner barrier layer disposed abut the inner surface of the stent layer; and an outer barrier layer disposed abut the outer surface of the stent layer; wherein the stent layer is disposed within the central lumen; wherein the stent layer is configured to resist axial compression and tension applied to the delivery catheter, the stent layer is configured to facilitate bending of the delivery catheter in a direction away from the longitudinal axis of the delivery catheter, and wherein the stent layer is provided at a distal tip portion of the delivery catheter, the distal tip portion has a length and extends along a length of the delivery catheter from the distal end of the delivery catheter toward the proximal end of the delivery catheter.
In still further aspects, disclosed is a flexible delivery catheter comprising: an outer jacket, having a proximal end, a distal end, an inner surface and an outer surface, and defining a central lumen extending longitudinally between the proximal end and the distal end; a coil layer comprising a coil winding and having a proximal end, a distal end, an inner surface, and an outer surface, wherein the coil winding extends helically about a longitudinal axis of the delivery catheter, a first barrier layer disposed at the inner surface of the coil layer; a second barrier layer disposed at the outer surface of the coil layer; and wherein the coil layer is wound to resist axial compression and tension applied to the delivery catheter, the coil layer facilitates bending of the delivery catheter in a direction away from the longitudinal axis of the delivery catheter, and wherein the coil layer is provided at a distal tip portion of the delivery catheter, wherein the distal tip portion has a first length extending along a length of the delivery catheter from the distal end of the delivery catheter toward the proximal end of the delivery catheter.
While in still further aspects, disclosed is a flexible delivery catheter comprising: an outer jacket, having a proximal end, a distal end, an inner surface and an outer surface, and defining a central lumen extending longitudinally between the proximal end and the distal end; a hypotube having a proximal end, a distal end, an inner surface, an outer surface, and a plurality of cut-outs which extend between the inner surface and the outer surface of the hypotube such that the hypotube can bend omnidirectionally, an inner barrier coating layer disposed at at least a portion of the inner surface of the hypotube; an outer barrier coating layer disposed at at least a portion of on the outer surface of the hypotube, and wherein the hypotube is provided at a distal tip portion of the delivery catheter, the distal tip portion extending along a length of the delivery catheter from a distal end of the delivery catheter toward the proximal end of the delivery catheter.
In still further aspects disclosed is a method of making a flexible delivery catheter comprising: forming an outer jacket, having a proximal end, a distal end, an inner surface, and an outer surface, and defining a central lumen extending longitudinally between the proximal end and the distal end; forming a stent layer having a proximal end, a distal end, an inner surface, and an outer surface defining a central lumen between the proximal end and the distal end; disposing an inner barrier layer at the inner surface of the coil layer; disposing an outer barrier layer at the outer surface of the coil layer; disposing the coil layer and the inner barrier layer and the outer barrier layer within the central lumen of the outer jacket; and wherein the delivery catheter is omnidirectionally flexible and configured to bend in any direction away from the longitudinal axis of the delivery catheter.
The following description of certain examples of the inventive concepts should not be used to limit the scope of the claims. Other examples, features, aspects, embodiments, and advantages will become apparent to those skilled in the art from the following description. As will be realized, the device and/or methods are capable of other different and obvious aspects, all without departing from the spirit of the inventive concepts. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.
For purposes of this description, certain aspects, advantages, and novel features of the aspects of this disclosure are described herein. The described methods, systems, and apparatus should not be construed as limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed aspects, alone and in various combinations and sub-combinations with one another. The disclosed methods, systems, and apparatus are not limited to any specific aspect, feature, or a combination thereof, nor do the disclosed methods, systems, and apparatus require that any one or more specific advantages be present or problems be solved.
Features, integers, characteristics, compounds, chemical moieties, or groups described in conjunction with a particular aspect, embodiment, or example of the invention are to be understood to be applicable to any other aspect, embodiment, 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 invention is not restricted to the details of any foregoing aspects. The invention 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.
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.
As used in the specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, a reference to a “segment” includes aspects having two or more such materials unless the context clearly indicates otherwise.
Ranges may 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. 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.”
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, 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. This applies regardless of the breadth of the range.
“Optional” or “optionally” means that the subsequently described event or circumstance may or may not occur and that the description includes instances where said event or circumstance occurs and instances where it does not.
The terms “proximal” and “distal” as used herein refer to regions of a sheath, catheter, or delivery assembly. “Proximal” means that region closest to handle of the device, while “distal” means the region farthest away from the handle of the device.
“Axially” or “axial” as used herein refers to a direction along the longitudinal axis of the sheath.
Throughout the description and claims of this specification, the word “comprise” and variations of the word, such as “comprising” and “comprises,” means “including but not limited to,” and is not intended to exclude, for example, other additives, components, integers or steps. As used in the specification and in the claims, the term “comprising” can include the aspects “consisting of” and “consisting essentially of.” Additionally, the term “includes” means “comprises.”
“Exemplary” means “an example of” and is not intended to convey an indication of a preferred or ideal aspect. “Such as” is not used in a restrictive sense but for explanatory purposes.
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”).
As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items.
It will be understood that, although 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 a 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 the example aspect.
Spatially relative terms, such as “beneath,” “below,” “lower,” “above,” “upper,” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be oriented “above” the other elements or features. Thus, the term “below” can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations), and the spatially relative descriptors used herein interpreted accordingly.
As used herein, the term “substantially,” in, for example, the context “substantially identical” or “substantially similar” refers to a method or a system, or a component that is 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 similar to the method, system, or the component it is compared to.
The term “tube” or “tubular” as used herein is not meant to limit shapes to circular cross-sections. Instead, tube or tubular can refer to any elongate structure with a closed-cross section and lumen extending axially therethrough. A tube may also have some selectively located slits or openings therein—although it still will provide enough of a closed structure to contain other components within its lumen(s).
An exemplary delivery system is shown in
The delivery system 10 generally includes a guidewire 14 and a balloon catheter 15 configured for advancement over the guidewire 14. The prosthetic valve 11 is provided along the distal end portion of the balloon catheter. The balloon catheter 15 includes a tubular section 16 and a handle/support 17 at a proximal end of the tubular section 16. The tubular section 16 of the balloon catheter 15 is received within a delivery sleeve assembly 18. The delivery sleeve assembly generally comprises an elongated polymeric sleeve 19 as disclosed in detail herein, a steerable section 20, and a shroud section 21. A proximal end of the delivery sleeve assembly 18 is mounted to a handle 22. The delivery system 10 passes through an introducer sheath assembly 400 and a loader assembly 500, both of which will be described in more detail below, to enter the body vessel and deliver the valve 11.
The following figures demonstrate described herein aspects in more detail. Additional exemplary aspects can also be found in U.S. Pat. Nos. 7,780,723, 8,382,826, 9,028,545, 9,907,651, and 10,478,294, contents of which are incorporated herein by reference in their whole entirety.
With reference to
As illustrated in
As illustrated in
In the example shown in
The distal tip portion 305 extends along a length of the delivery catheter 300 from a distal end 306 of the delivery catheter 300 toward the proximal end 304 of the delivery catheter 300. In the example shown in
As described above, the catheter 300 includes a coil layer 318. The coil layer 318 is wound to resist axial compression applied to the delivery catheter 300 while facilitating bending of the delivery catheter 300 in a direction away from the longitudinal axis of the delivery catheter 300. The coil layer 318 includes a coil winding 320, which provides compressive stiffness to the catheter 300 during axial compressive loads. The coil layer 318 has a proximal end 322, a distal end 324, an inner surface, and an outer surface. The coil winding 320 extends helically about a longitudinal axis and defines a central lumen between the proximal end 322 and the distal end 324. In the example shown in
In the example shown in
As described above, the coil windings 320 have a constant pitch along the axial length of the coil layer 318. But in other implementations, the coil windings 320 have a varying pitch along an entire length of the coil winding 320/coil layer 318. For example, a pitch of the coil winding 320 at a proximal end of the distal tip portion 305, e.g., along the tapered portion of the distal tip portion 305, can be less than a pitch of the coil winding 320 at the distal end 306 of the distal tip portion 305. In the example shown in
The coil layer 318 can be composed of at least one a polymer, a metal, or a composite. For example, the coil layer 318 can be composed of a stainless steel wire. The coil winding 320 has a curvilinear shape in the cross section, but the coil winding 320 can have either a rectilinear or curvilinear shape in the cross section.
As described above, the catheter 300 includes a braided layer 326, which provides structural support for catheter 300. The braided layer 326 has a proximal end and a distal end. The braided layer 326 includes a plurality of fibers 334 interwoven into a braided pattern and defines a central lumen, an inner surface, and an outer surface. In the example shown in
As described above, the braided layer 326 is composed of a plurality of interwoven fibers 334. Each of the fibers 334 has a curvilinear cross section, although, in other examples, the fibers 334 have a rectilinear cross section. The fibers 334 are composed of stainless steel, but in other examples, the fibers 334 are composed of at least one of a polyester, a polymer, a metal, a composite, or any other material suitable for composing a stiffening braided layer 326 in a catheter 300. Each of the plurality of interwoven fibers 334 has a diameter of about 0.004 inches. In other examples, each of the plurality of interwoven fibers 334 has a diameter ranging between about 0.002 inches and about 0.006 inches or between about 0.003 inches and about 0.005 inches. The interwoven fibers 334 can be oriented in a single strand braid pattern or in a double strand braid pattern where each interweave includes a plurality of parallel fibers 334 for each weave strand. The plurality of interwoven fibers 334 is composed of 16 individual fibers 334. But in other examples, the plurality of interwoven fibers 334 is composed of about 10 to about 20 individual fibers 334. The braided layer 326 has a braid density, which allows for omnidirectional bending with respect to the central axis of the catheter 300. As the braid density increases, the braided layer 326 becomes more resistant to bending. In the example shown in
As described above, the catheter 300, as shown in
The tensile stiffening fiber 327 extends along at least a portion of the entire length of the elongated body portion 303 of the delivery catheter 300. In the example shown in
The tensile stiffening fiber 327 is coupled to the catheter 300 by weaving/intertwining the tensile stiffening fiber 327 within the fibers/braid pattern of the braided layer 326. The tensile stiffening fiber 327 is further secured to the braided layer 326 when the outer jacket 308 is reflowed into the braided layer 326 during manufacturing. As will be described in more detail below, the distal end of the catheter 300 includes materials of varying durometer along the length of the outer jacket 308. A length/segment of the delivery catheter 300 proximate the distal end 306 of the distal tip portion 305 comprises a material having a higher durometer than the next adjacent segment of the delivery catheter 300. Reflow of the tensile stiffening fiber 327 with the higher durometer material at the distal end 306 of the distal tip portion 305 results in higher friction between the tensile stiffening fiber 327 and the higher durometer material of the outer jacket 308, thereby preventing axial slippage/movement of the tensile stiffening fiber 327 at the distal end of the catheter.
Similarly, the proximal end of the delivery catheter 300 includes a length/segment of a material having a higher durometer than the next adjacent segment of the delivery catheter 300. Accordingly, reflow of the tensile stiffening fiber 327 with the higher durometer material at the proximal end 304 of the delivery catheter 300 prevents slippage/movement of the tensile stiffening fiber 327 with respect to the end of the delivery catheter 300. As such, the tensile stiffening fiber 327 is secured both along the length of the fiber and at its proximal and distal ends, i.e., the tensile stiffening fiber 327 is fixedly coupled to the proximal and distal ends of the outer jacket 308/braided layer 326 and along the along the braided layer 326.
As shown in
The example is shown in
The example, shown in
As described above, the catheter 300 includes an outer jacket 308, having a proximal end 309 and a distal end 311, which forms the outermost layer of catheter 300. The outer jacket 308 is composed of an elastic material. The elasticity of the outer jacket 308 varies (longitudinally) along a length of the outer jacket 308. In the example shown in
For example, the first/distal-most segment is composed of a material having a durometer of 55D and a length of about 0.25 inches. The second segment is composed of a material having a durometer of 25D and a length of about 1 inch. The third segment is composed of a material having a durometer of 35D and a length of about 3 inches. The fourth segment is composed of a material having a durometer of 45D and a length of about 3 inches. The fifth segment is composed of a material having a durometer of 63D and a length of about 1 inch. The sixth/proximal-most segment (along the elongated body portion 303 of the delivery catheter 300) is composed of a material having a durometer of 75D and a length of about 41 inches. It is contemplated that the number, length, and durometer of the various segments may vary from those illustrated and described above. As mentioned above, the distal-most segment (referred to also as a coupling segment) and the proximal-most segment (on the elongated body portion 303) have a lower elasticity and higher durometer than the next adjacent segment of the outer jacket 308 to help secure the tensile stiffening fiber 327 to the outer jacket 308 post-reflow procedure.
In the example shown in
In addition to the components described above, the catheter 300 in the examples shown in
As described above, the catheter 300 includes a liner 333 provided on an inner surface of the tie layer 331. An inner surface of the liner 333 defines an inner lumen of the delivery catheter 300. The liner 333 extends along an entire length of the inner surface of the tie layer 331 and/or the inner lumen of the delivery catheter 300. In some examples, liner 333 has a length that is greater than a length of the distal tip portion 305. In some examples, the liner 333 extends along at a portion of the entire length of the elongated body portion 303 of the delivery catheter 300 or the entire length of the elongated body portion 303 of the delivery catheter 300. The liner 333 in the example shown in
The example shown in
Similarly, the inner and outer barrier layers 336a, 336b are not provided along a length of the coil layer 318 extending distally from the proximal end 322 of the coil layer 318 such that the proximal end 322 of the coil layer 318 is fixedly attached to the outer jacket 308. Like the distal end 324, the proximal end 322 of the coil layer 318 is fixedly coupled to the outer jacket 308 when the outer jacket 308 is bonded (e.g., reflowed) to the tie layer 331. In the example shown in
The delivery catheter 600 includes an elongated body portion 603 and a distal tip portion 605. The elongated body portion 603 extends from the distal tip portion 605 to the proximal end 604 end the delivery catheter 600. The distal tip portion 605 extends along a length of the delivery catheter 600 from the distal end 606 to the elongated body portion 603.
The outer diameter of the catheter 600 is constant along the axial length of the elongated body portion 603 and the distal tip portion 605. In the example shown in
In the example shown in
As described above, the braided layer 626 provides structural support for the catheter 600. The braided layer 626 also provides resistance to compressive deformation due to a varied density in the braid pattern. The braided layer 626 has a proximal end 630 and a distal end 632. The braided layer 626 includes a plurality of fibers 634 interwoven into a braided pattern and defines a central lumen 602, an inner surface 638, and an outer surface 640. In the example shown in
As described above, the braided layer 626 is composed of a plurality of interwoven fibers 634. Each of the fibers 634 has a curvilinear cross section, although, in other examples, the fibers 634 have a rectilinear cross section. The fibers 634 can also be flat wires to promote secure coupling of the fibers 634 in the braided pattern due to increased contact surface. The fibers 634 are composed of stainless steel, but in other examples, the fibers 634 are composed of polyester or at least one of a polymer, a metal, a composite, or any other material suitable for composing a stiffening braided layer 626 in a catheter 600. Each of the plurality of interwoven fibers 634 has a diameter of about 0.004 inches. In some examples, each of the plurality of interwoven fibers 634 has a diameter ranging between about 0.0015 inches and about 0.006 inches, between about 0.003 inches and about 0.004 inches, or between about 0.002 inches and about 0.006 inches, or between about 0.003 inches and about 0.005 inches. The interwoven fibers 634 can be oriented in a single strand braid pattern or in a double strand braid pattern where each interweave includes a plurality of parallel fibers 634 for each weave strand. The plurality of interwoven fibers 634 is composed of 16 individual fibers 634. But in other examples, the plurality of interwoven fibers 634 is composed of about 10 to about 40 individual fibers 634, or about 16 to about 32 individual fibers 634.
As described above, the braided layer 626 has a varied braid density, which allows for omnidirectional bending with respect to the central axis of the catheter 600. As the braid density increases, the braided layer 626 becomes more resistant to bending and axial compression. In the example shown in
In some examples, the braid density along the elongated body portion 603 ranges between about 35 picks per inch and about 10 picks per inch or between about 25 picks per inch and about 20 picks per inch. The plurality of interwoven fibers 634 are woven as individual fibers 634 into the braided pattern. But in other examples, the plurality of interwoven fibers 634 are woven as fibers 634 pairs into the braided pattern, such that two braid strands are used in place of a single braid strand in the example shown in
As described above, the catheter 600, as shown in
The tensile stiffening fiber 627 extends along at least a portion of the entire length of the elongated body portion 603 of the delivery catheter 600. In the example shown in
As described above with respect to catheter 300, the tensile stiffening fiber 627 is similarly coupled to the catheter 600 by the weaving/intertwining of the tensile stiffening fiber 627 into the braid pattern of the braided layer 626. The tensile stiffening fiber 627 is further secured to the braided layer 626 when the outer jacket 608 is reflowed into the braided layer 626. Like catheter 300, the tensile stiffening fiber 627 is fixedly coupled to the proximal and distal ends of the catheter 600. In the example shown in
The example shown in
As described above, the catheter 600 includes an outer jacket 608, which forms the outermost layer of the catheter 600. The outer jacket 608 is composed of an elastic material. Like catheter 300, the elasticity of the outer jacket 608 varies (longitudinally) along a length of the outer jacket 608. In the example shown in
The catheter 600 includes a liner 633 provided on an inner surface of the outer jacket 608, similar to liner 333 described in the aspects described above. The inner surface of the liner 633 defines an inner lumen of the delivery catheter 600. The liner 633 extends along an entire length of the inner lumen of the delivery catheter 600. In some examples, the liner 633 has a length that is greater than a length of the distal tip portion 605. In some examples, the liner 633 extends along at a portion of the entire length of the elongated body portion 603 of the delivery catheter 600 or the entire length of the elongated body portion 603 of the delivery catheter 600. The liner 633, in the example shown in
As shown in
The delivery catheter 800, in particular the distal tip portion 805, is omnidirectionally flexible and configured to bend in any direction away from a longitudinal axis 801 of the delivery catheter 800 while retaining compressive and tensile stiffness. As such, the flexible delivery catheter 800 more easily bends to conform to the patient's vascular structure during an operation while also limiting axial deformation that can damage a patient's vascular structure. The delivery catheter 800 defines a central lumen 802 extending longitudinally between the proximal end 804 and the distal end 806. Like catheters 300, 600, 700, the delivery catheter 800 includes an elongated body portion 803 and a distal tip portion 805. The distal tip portion 805 extends along a length (e.g., approx. 11.25 inches) of the delivery catheter 800 from a distal end 806 of the delivery catheter 800 toward the proximal end 804 of the delivery catheter 800, up to the elongated body portion 803 of the hypotube 818. The elongated body portion 803 extends from the distal tip portion 805 to the proximal end 804 end the delivery catheter 800 (e.g., approx. 41.0 inches). As shown in
The hypotube 818 is disposed of within the distal tip portion 805. As illustrated in
In the example shown in
Like the example catheter, 300 shown in
The hypotube 818, as described above, provides a layer of the catheter 800 that resists axial compression while allowing omnidirectional movement with respect to the central axis of the catheter 800. The cut-outs 823 provide bending flexibility by collapsing and expanding as the hypotube 818 bends. This expansion and contraction of the cut-outs 823 are illustrated as part of the catheter 800, as shown in
In the examples shown in
As illustrated in
In some examples, each row of cutouts includes at least two cut-outs or at least four cut-outs 823. As illustrated in the enlarged portion of
In some examples, such as the examples shown in
The semicircular holes in the examples shown in
The hypotube 818 has an outer diameter of about 0.2030 inches. But in some examples, the hypotube 818 has an outer diameter ranging between about 0.3000 inches and about 0.2000 inches. The hypotube 818 has an inner diameter of about 0.1890 inches. But in some examples, the hypotube 818 has an inner diameter ranging between about 0.1000 and about 0.2000 inches. In some examples, such as the example shown in
As described above, the catheter 800 includes a braided layer 826, which provides structural support for the catheter 800. The braided layer 826 has a proximal end 830 and a distal end 832. The braided layer 826 includes a plurality of wires 834 disposed in a braided pattern and defines a central lumen, an inner surface 838, and an outer surface 840. In the example shown in
Like the catheters 300, 600, 700, the braided layer 826 is composed of a plurality of interwoven fibers 834. Each of the fibers 834 has a curvilinear cross section, although, in other examples, the fibers 834 have a rectilinear cross section. The fibers 834 are composed of stainless steel, but in other examples, the fibers 834 are composed of polyester or at least one of a polymer, a metal, or a composite, or any other material suitable for composing a stiffening braided layer 826 in a catheter 800. Each of the plurality of interwoven fibers 834 has a diameter of about 0.004 inches. In other examples, each of the plurality of interwoven fibers 834 has a diameter ranging between about 0.002 inches and about 0.006 inches or between about 0.003 inches and about 0.005 inches. The interwoven fibers 834 can be oriented in a single strand braid pattern or in a double strand braid pattern where each interweave includes a plurality of parallel fibers 834 for each weave strand. The plurality of interwoven fibers 834 is composed of 16 individual fibers 834. But in other examples, the plurality of interwoven fibers 834 is composed of about 10 to about 20 individual fibers 834. The braided layer 826 has a braid density, which allows for omnidirectional bending with respect to the central axis of the catheter 800. As the braid density increases, the braided layer 826 becomes more resistant to bending. In the example shown in
Similar to the catheter aspects described above, the catheter 800 shown in
The tensile stiffening fiber 827 extends along at least a portion of the entire length of the elongated body portion 803 of the delivery catheter 800. In the example shown in
The examples shown in
As described above, the catheter 800 includes an outer jacket 808, which forms the outermost layer of the catheter 800. The outer jacket 808 is composed of an elastic material. Like catheter 300, the elasticity of the outer jacket 808 varies (longitudinally) along a length of the outer jacket 808. In the examples shown in
Like catheter 300, the catheter 800 in the examples shown in
As illustrated in
As described above, the catheter 800 includes a liner 833 provided on an inner surface of the tie layer 831. An inner surface of the liner 833 defines an inner lumen of the delivery catheter 800. The liner 833 extends along an entire length of the inner surface of the tie layer 831 or the inner lumen of the delivery catheter 800. In some examples, the liner 833 has a length that is greater than a length of the distal tip portion 805. In some examples, the liner 833 extends along at a portion of the entire length of the elongated body portion 803 of the delivery catheter 800 or the entire length of the elongated body portion 803 of the delivery catheter 800. The liner 833, in the example shown in
Also disclosed herein is a method of making a flexible delivery catheter 300. Similar method is contemplated for the construction of flexible delivery catheters 600, 700, 800. The method includes forming an outer jacket 308, a coil layer 318, and a braided layer 326, as described above and shown in
In examples wherein the outer jacket 308 includes a plurality of longitudinal segments as described above, each of the plurality of longitudinal segments are reflowed together with at least one an adjacent longitudinal segment having a differing elastic property. In examples that include tensile stiffening fibers 327, the tensile stiffening fibers 327 are coupled to the braided layer by weaving the tensile stiffening fiber 327 at least partially into the braided layer. The tensile stiffening fiber 327 is inserted into the distal tip of the outer jacket 308 and securing it thereto (e.g., via reflow and/or heat processing).
Also disclosed herein is a method of making a flexible delivery catheter 800, including a hypotube 818. The method includes forming an outer jacket 808, the hypotube 818, and a braided layer 826 as described above and shown in
In examples wherein the outer jacket 808 comprises a plurality of longitudinal segments as described above of varying durometer, each of the plurality of longitudinal segments are reflowed together with at least one an adjacent longitudinal segment having a differing elastic property. In examples that include tensile stiffening fibers 827, the tensile stiffening fibers 827 are coupled to the braided layer 826 by weaving the tensile stiffening fiber 827 at least partially into the braided layer 826. In other examples, the tensile stiffening fibers 827 are coupled to the hypotube 818 by weaving the tensile stiffening fiber 827 at least partially into the cut-outs 823 and/or the anchoring windows 815. In another example, the tensile stiffening fiber 827 is inserted into the distal tip of the outer jacket 808 and secured thereto.
Also disclosed herein is a method of making the flexible delivery catheter 700, including a braided layer 726 with a variable braid pattern. The method includes forming an outer jacket 708 and a braided layer 726 as described above and shown in
In examples wherein the outer jacket 708 comprises a plurality of longitudinal segments as described above, each of the plurality of longitudinal segments are reflowed together with at least one an adjacent longitudinal segment having a differing elastic property. In examples that include tensile stiffening fibers 827, the tensile stiffening fibers 827 are coupled to the braided layer 826 by weaving the tensile stiffening fiber 827 at least partially into the braided pattern of the braided layer 826. The tensile stiffening fiber 827 is inserted into the distal tip of the outer jacket 808 and securing it thereto (e.g., via reflow process).
Also disclosed herein is a method of making a flexible delivery catheter 800. The method includes forming an outer jacket 808 at least one tensile stiffening fiber 827. The at least one tensile stiffening fiber 827 is embedded into the outer layer and coupled thereto.
In examples wherein the outer jacket 808 comprises a plurality of longitudinal segments as described above, each of the plurality of longitudinal segments are reflowed together with at least one an adjacent longitudinal segment having a differing elastic property. The at least one tensile stiffening fiber 827 is inserted into the distal tip of the outer jacket 808 and securing it thereto.
Some additional or alternative aspects are shown in
The delivery catheter 900 defines an elongated tubular structure with a central lumen 902 extending longitudinally between the proximal end 904 and the distal end 906. The central lumen 902 (similar to the aspects disclosed above) is configured for passage of medical devices such as prosthetic heart valves therethrough.
The delivery catheter 900 further comprises an elongated body portion 903 and a distal tip portion 905. In this specific and unlimiting aspect, the distal tip portion 905 extends from the distal end of the catheter towards its proximal end for the first length of about 11.25 inches. The elongated body portion 903 extend from the most proximal portion of the distal tip portion to the proximal end of the catheter and can have a second length of about 41 inches. In this specific and unlimiting aspect, an outer diameter of the distal tip portion is larger than the outer diameter of the elongated body portion. Any ranges disclosed herein and applied to the outer diameter of the respective portion can be utilized without limitations. It is understood, however, that the aspects having a similar construction but no difference in the outer diameter between the distal tip portion and the elongated body portion is also described.
In the aspect shown in
In this particular and unlimiting aspect, the delivery catheter 900 comprises and an outer jacket 908, a braided layer 926, and a coil layer 918. It is understood that in some aspects, the coil layer 918 can comprise any of the disclosed herein coil layers, or, in addition, or in the alternative, it can comprise any of the disclosed herein hypotubes. In the example shown in
Similar to the aspects disclosed above, the coil layer 918 can have a plurality of tightly wound turns of the coil windings. In an example, coil layer 918, a gap/spacing is provided between adjacent turns of the coil winding. In another example, the coil layer 918 is tightly wound such that the adjacent turns of the coil winding contact, i.e., an outer surface of the adjacent turns of the coil winding contact along a circumferential length of the coil winding. This allows for some axial compression in certain applications that require partial axial compression of the catheter. In other aspects, the coil layer has substantially no gap/spacing. In yet other aspects, the coil layer can comprise any known in the art materials and any of the disclosed herein material. In some exemplary and unlimited aspects, the coil layer can comprise stainless steel. The coil layer can also comprise wired having any diameter that can provide for the desired application. In some exemplary and unlimiting aspects, the diameter of the wire used to form the coil layer can be about 0.008″.
Similar to the aspects disclosed above, in this example, the coil layer 918 and the braided layer 926 are only provided at the distal tip portion 905.
The catheter 900 further comprises an inner barrier layer 936a and an outer barrier layer 936b. As it can be seen, the barrier layer 936a is disposed at at least a portion of the inner surface of the coil layer, while barrier layer 936b is disposed at at least a portion of the outer surface of the coil layer. In such aspects, the coil layer can be at least partially encapsulated within the inner and outer barrier layers. The barrier layers used in this aspect can comprise any polymers that improve the frictional properties of the coil layer and the catheter as a whole. In still further aspects, the barrier layers used in this aspect can comprise any polymers that are not melted during the reflow procedures and will stay intact and thus prevent outer materials from reflow through the coil layer. For example, and without limitation, the barrier layers used herein can comprise polyethylene terephthalate (PET) or expanded polytetrafluoroethylene (e-PTFE). The barrier layers disclosed in this aspect can have of the described above thicknesses. For example, and without limitation, it can have a thickness of 0.0005 inch. As can be further seen, the barrier layers are not present through all the lengths of the coil layer. It is understood that at least a portion of the distal tip portion does not comprise the barrier layers disclosed herein. In these exemplary aspects, the portions 940 and 942 that do not comprise the barrier layers are at the most distal end and the most proximal end of the distal tip portion. This is done to ensure that the distal and proximal ends of the coil layer are embedded into the outer layer during the reflow process and fixedly coupled within a body of the catheter.
The braided layer 926 can comprise any of the braided layers described herein. In some aspects, the braided layer 926 can comprise a plurality of fibers interwoven into a braided pattern. In the example shown in
Any disclosed herein fibers can be utilized. The fibers can have any cross-section, for example, and without limitation, they can have a curvilinear cross-section or a rectilinear cross-section. The fibers can be made of any known in the art materials, for example, they can comprise at least one of a polyester, a polymer, a metal, a composite, or any other material suitable for composing a stiffening braided layer 926 in a catheter 900. Each of the plurality of interwoven fibers can have any diameter. In this example, the fibers having a diameter of about 0.004 inches are utilized. The interwoven fibers present in the braided layer 926 can be oriented in a single strand braid pattern or in a double strand braid pattern where each interweave includes a plurality of parallel fibers for each weave strand. The plurality of interwoven fibers present in the braided layer can be, for example, composed of 16 individual fibers. But in other examples, the braided layer can comprise from about 10 to about 20 individual fibers. Any of the disclosed above braid density values can be used. In this specific and unlimiting example, the braid density of 25 picks per inch can be utilized.
Similar to other aspects, the example shown in
As disclosed above, the aspect shown in
Any of the disclosed above outer layers 908 can be utilized for this aspect.
An additional aspect is disclosed in
The catheter 1000 comprises a distal end 1006 and a proximal end (not shown). The distal tip portion 1005 comprises an outer layer 1008, a stent layer 1018, an inner barrier layer 1036a, and an outer barrier layer 1036b. The catheter 1000, as further shown in
In this example, the stent layer can comprise a coil layer or a hypotube. Any of the disclosed above coil layers or hypotubes can be used. In this exemplary aspect, a laser-cut hypotube is utilized. The barrier layers disclosed in this aspect can comprise silicone that is spray-coated on each of the surfaces of the hypotube. It is understood that the most-distal end and the most-proximal ends of the hypotube do not comprise spray silicone coating (portions 1040 and 1042) to ensure the encapsulation of the hypotube stent layer within the tie layer and the outer jacket during the reflow process. The portions can have any length. In the example disclosed herein, the portions that do not comprise barrier layers are about 0.5″ on each side of the stent layer within the distal tip portion of the catheter.
A method of deploying a prosthetic into a patient is also disclosed herein. The method includes. A delivery system is provided that includes a flexible catheter, as described above 300, 600, 700, 800. The catheter is advanced into a patient's vessel to be utilized during a medical procedure such as the insertion of a prosthetic heart valve. The prosthetic is then advanced into the patient through the catheter, and the catheter is removed.
It will be appreciated that aspects of the heart valve delivery system provide improved devices and methods for advancing a prosthetic heart valve through a patient's vasculature. In one exemplary aspect, the cooperation of components described herein allows a prosthetic valve to be advanced through the patient's vasculature and around the aortic arch in a safe manner. Accordingly, the delivery system enables advancement of a prosthetic valve around the aortic arch without requiring the introduction of an outer sheath into the aortic arch. This is an advantageous feature because the use of a sheath would increase the diameter of the delivery system, thereby complicating the delivery of the valve. In addition to providing an improved steering mechanism for navigating the aortic arch without damaging the inner wall of the aorta, it will be appreciated by those skilled in the art that the delivery system provides excellent pushability such that the physician has excellent control over the movement and location of the prosthetic valve during advancement into the native valve. This feature is particularly advantageous when traversing stenotic valve leaflets. Accordingly, aspects of the present invention provide an improved delivery system for advancing a prosthetic valve to the site of a native aortic valve using a steerable assembly that eliminates the need for an outer sheath in the aorta while providing sufficiently pushability to pass through narrow vasculature and/or stenotic valve leaflets. As a result, aspects of the present invention provide improved devices and methods for percutaneously advancing a balloon-expandable prosthetic valve to the site of a stenotic aortic valve using a retrograde approach.
Although several aspects of the invention have been disclosed in the foregoing specification, it is understood by those skilled in the art that many modifications and other aspects of the invention will come to mind to which the invention pertains, having the benefit of the teaching presented in the foregoing description and associated drawings. It is thus understood that the invention is not limited to the specific aspects disclosed hereinabove and that many modifications and other aspects are intended to be included within the scope of the appended claims. Moreover, although specific terms are employed herein, as well as in the claims which follow, they are used only in a generic and descriptive sense and not for the purposes of limiting the described invention nor the claims which follow. We, therefore, claim as our invention all that comes within the scope and spirit of these claims.
EXAMPLE 1: A flexible delivery catheter having a proximal end and a distal end and comprising: an outer jacket, having a proximal end, a distal end, an inner surface and an outer surface, and defining a central lumen extending longitudinally between the proximal end and the distal end; a coil layer comprising a coil winding and having a proximal end, a distal end, an inner surface, and an outer surface, wherein the coil winding extends helically about a longitudinal axis of the delivery catheter and further defines a central lumen between the proximal end and the distal end; a braided layer having a proximal end and a distal end and comprising a plurality of fibers disposed in a braided pattern and defining a central lumen having an inner surface and an outer surface, wherein the coil layer is disposed within the central lumen of the braided layer, and wherein the braided layer is disposed between the outer jacket and the coil layer, wherein the coil layer is wound to resist axial compression and tension applied to the delivery catheter, the coil layer facilitates bending of the delivery catheter in a direction away from the longitudinal axis of the delivery catheter, and wherein the coil layer and the braided layer are provided at a distal tip portion of the delivery catheter, wherein the distal tip portion has a first length extending along a length of the delivery catheter from the distal end of the delivery catheter toward the proximal end of the delivery catheter.
EXAMPLE 2: The delivery catheter of any examples herein, particularly example 1, wherein the delivery catheter is omnidirectionally flexible and configured to bend in any direction away from the longitudinal axis of the delivery catheter.
EXAMPLE 3: The delivery catheter of any examples herein, particularly examples 1-2, wherein the delivery catheter comprises an elongated body portion having a second length and wherein the elongated body portion extends from the distal tip portion to the proximal end of the delivery catheter.
EXAMPLE 4: The delivery catheter any examples herein, particularly example 3, wherein an outer diameter of the delivery catheter at the distal tip portion is greater than an outer diameter of the delivery catheter along an elongated body portion of the delivery catheter.
EXAMPLE 5: The delivery catheter any examples herein, particularly example 4, wherein the outer diameter of the distal tip portion adjacent the elongated body portion comprises a decreasing taper between a larger outer diameter of the distal tip portion and a reduced diameter of the elongated body portion.
EXAMPLE 6: The delivery catheter of any examples herein, particularly examples 4-5, wherein the outer diameter of the distal tip portion ranges between about 4.5 mm and about 6.0 mm.
EXAMPLE 7: The delivery catheter of any examples herein, particularly examples 4-6, wherein the outer diameter of the distal tip portion ranges between about 5.0 mm and about 6.0 mm.
EXAMPLE 8: The delivery catheter of any examples herein, particularly examples 4-7, wherein the outer diameter of the distal tip portion is about 5.6 mm.
EXAMPLE 9: The delivery catheter of any examples herein, particularly examples 4-8, wherein the outer diameter of the elongated body portion ranges between about 4.5 mm and about 6.0 mm.
EXAMPLE 10: The delivery catheter of any examples herein, particularly examples 4-9, wherein the outer diameter of the elongated body portion ranges between about 5 mm and about 6 mm.
EXAMPLE 11: The delivery catheter of any examples herein, particularly examples 4-10, wherein the outer diameter of the elongated body portion is about 5.4 mm (about 0.213 inches).
EXAMPLE 12: The delivery catheter of any examples herein, particularly examples 1-11, wherein an inner diameter of the central lumen of the delivery catheter ranges between 3.5 mm and about 5 mm.
EXAMPLE 13: The delivery catheter of any examples herein, particularly examples 1-12, wherein an inner diameter of the central lumen of the delivery catheter ranges between 4.0 mm and about 4.5 mm.
EXAMPLE 14: The delivery catheter of any examples herein, particularly examples 1-13, wherein an inner diameter of the central lumen of the delivery catheter is about 4.4 mm.
EXAMPLE 15: The delivery catheter of any examples herein, particularly examples 1-14, wherein the first length of the distal tip portion is less than about 520 mm (about 20 inches), wherein the first length of the distal tip portion is measured in a direction along the longitudinal axis of the delivery catheter.
EXAMPLE 16: The delivery catheter of any examples herein, particularly examples 1-15, wherein the first length of the distal tip portion is less than about 385 mm (about 15 inches).
EXAMPLE 17: The delivery catheter of any examples herein, particularly examples 1-16, wherein the first length of the distal tip portion ranges between about 125 mm (about 5 inches) and about 385 mm (about 15 inches).
EXAMPLE 18: The delivery catheter of any examples herein, particularly examples 1-17, wherein the first length of the distal tip portion ranges between about 250 mm (about 10 inches) and about 385 mm (about 15 inches).
EXAMPLE 19: The delivery catheter of any examples herein, particularly examples 1-18, wherein the first length of the distal tip portion is about 285.75 mm (about 11.25 inches).
EXAMPLE 20: The delivery catheter of any examples herein, particularly examples 3-19, wherein the second length of the elongated body portion ranges between 760 mm (about 30 inches) to about 1270 mm (about 50 inches).
EXAMPLE 21: The delivery catheter of any examples herein, particularly examples 3-20, wherein the second length of the elongated body portion ranges between about 885 mm (about 35 inches) to about 1145 mm (about 45 inches).
EXAMPLE 22: The delivery catheter of any examples herein, particularly examples 3-21, wherein the second length of the elongated body portion is about 1045 mm (about 41 inches).
EXAMPLE 23: The flexible delivery catheter of any examples herein, particularly examples 1-22, wherein the outer jacket exhibits an elasticity that varies along a length of the outer jacket.
EXAMPLE 24: The flexible delivery catheter any examples herein, particularly example 23, wherein the elasticity of the outer jacket increases from the proximal end of the outer jacket to the distal end of the outer jacket such that the distal end of the delivery catheter is configured to conform to the aortic geometry of a patient.
EXAMPLE 25: The flexible delivery catheter of any examples herein, particularly examples 23-24, wherein a durometer of the outer jacket decreases between the proximal end and the distal end of the outer jacket.
EXAMPLE 26: The flexible delivery catheter of any examples herein, particularly examples 23-25, wherein the outer jacket comprises a plurality of longitudinal segments, wherein each longitudinal segment extends circumferentially, and wherein the plurality of longitudinal segments comprise materials having a varying durometer.
EXAMPLE 27: The flexible delivery catheter any examples herein, particularly example 26, wherein the materials of the plurality of longitudinal segments are reflowed together.
EXAMPLE 28: The flexible delivery catheter of any examples herein, particularly examples 23-27, wherein the distal end of the outer jacket comprises a coupling segment having a lower elasticity and a higher durometer than an adjacent segment of the outer jacket.
EXAMPLE 29: The flexible delivery catheter any examples herein, particularly example 28, wherein the coupling segment has higher elasticity and a lower durometer than a segment adjacent the proximal end of the outer jacket.
EXAMPLE 30: The flexible delivery catheter any examples herein, particularly example 28 or 29, wherein the coupling segment of the outer jacket has higher elasticity and lower durometer than a segment of the outer jacket adjacent the elongated body portion.
EXAMPLE 31: The flexible delivery catheter of any examples herein, particularly examples 28-30, wherein the coupling segment has a length from about 2.5 mm to about 8.0 mm.
EXAMPLE 32: The flexible delivery catheter of any examples herein, particularly examples 26-31, wherein the plurality of longitudinal segments are present in the outer jacket of the distal tip portion.
EXAMPLE 33: The flexible delivery catheter any examples herein, particularly example 32, wherein each longitudinal segment present in the outer jacket has a length between about 12.5 mm to about 105 mm.
EXAMPLE 34: The flexible delivery catheter of any examples herein, particularly examples 25-33, wherein the durometer varies from about 25D to about 75D.
EXAMPLE 35: The flexible delivery catheter of any examples herein, particularly examples 23-34, wherein at least a portion of the outer jacket comprises an elastomer.
EXAMPLE 36: The flexible delivery catheter of any examples herein, particularly examples 23-35, wherein at least a portion of the outer jacket comprises a polyether block amide.
EXAMPLE 37: The flexible delivery catheter any examples herein, particularly example 36, wherein the polyether block amide comprises PEBAX®.
EXAMPLE 38: The flexible delivery catheter of any examples herein, particularly examples 23-37, wherein at least a portion of the outer jacket comprises a polyamide.
EXAMPLE 39: The flexible delivery catheter any examples herein, particularly example 38, wherein the polyamide comprises Vestamid®, Rilasmid®, Nylon 12, or a combination thereof.
EXAMPLE 40: The delivery catheter of any examples herein, particularly examples 1-39, wherein a length of the coil layer is substantially identical to the first length of the distal tip portion.
EXAMPLE 41: The delivery catheter of any examples herein, particularly examples 1-40, wherein a length of the coil layer is less than the first length of the distal tip portion.
EXAMPLE 42: The delivery catheter of any examples herein, particularly examples 1-40, wherein a length of the coil layer is greater than the first length of the distal tip portion.
EXAMPLE 43: The delivery catheter any examples herein, particularly example 42, wherein the coil layer extends into the elongated body portion of the delivery catheter.
EXAMPLE 44: The delivery catheter of any examples herein, particularly examples 1-43, wherein the coil layer comprises a maximum gap/spacing of about 0.25 mm (about 0.010 inches) between adjacent turns of the coil winding.
EXAMPLE 45: The delivery catheter any examples herein, particularly example 44, wherein outer surfaces of the adjacent turns of the coil winding contact along a circumferential length of the coil winding.
EXAMPLE 46: The delivery catheter of any examples herein, particularly examples 1-45, wherein the coil winding has a diameter ranging between about 0.003 inches and about 0.010 inches.
EXAMPLE 47: The delivery catheter of any examples herein, particularly examples 1-46, wherein the coil winding has a diameter ranging between about 0.004 inches and about 0.008 inches.
EXAMPLE 48: The delivery catheter any examples herein, particularly example 47, wherein the coil winding has a diameter of about 0.004 inches.
EXAMPLE 49: The delivery catheter any examples herein, particularly example 47, wherein the coil winding has a diameter of about 0.008 inches.
EXAMPLE 50: The delivery catheter of any examples herein, particularly examples 1-49, wherein the coil winding has a constant pitch along an entire length of the coil winding.
EXAMPLE 51: The delivery catheter of any examples herein, particularly examples 1-49, wherein the coil winding has a pitch varying along an entire length of the coil winding.
EXAMPLE 52: The delivery catheter any examples herein, particularly example 51, wherein the pitch of the coil winding at a proximal end of the distal tip portion is less than a pitch of the coil winding at a distal end of the distal tip portion.
EXAMPLE 53: The delivery catheter of any examples herein, particularly examples 1-52, wherein the coil winding has between about 55 and 120 turns per inch.
EXAMPLE 54: The delivery catheter of any examples herein, particularly examples 1-53, wherein the coil winding comprises at least one of a polymer, a metal, or a composite material.
EXAMPLE 55: The delivery catheter any examples herein, particularly example 54, wherein the coil winding comprises a stainless-steel wire.
EXAMPLE 56: The delivery catheter of any examples herein, particularly examples 1-55, wherein the coil winding has a rectilinear or curvilinear shape in cross section.
EXAMPLE 57: The delivery catheter of any examples herein, particularly examples 1-56, wherein the coil layer is coupled to the outer jacket along the distal tip portion of the delivery catheter.
EXAMPLE 58: The delivery catheter any examples herein, particularly example 57, wherein the outer jacket is reflowed together with the coil layer.
EXAMPLE 59: The flexible delivery catheter of any examples herein, particularly examples 1-58, further comprising a tie layer provided on the inner surface of the coil layer.
EXAMPLE 60: The flexible delivery catheter any examples herein, particularly example 59, wherein the tie layer extends along a portion of a length of the inner surface of the coil layer.
EXAMPLE 61: The flexible delivery catheter any examples herein, particularly example 59, wherein the tie layer extends along the length of the inner surface of the coil layer.
EXAMPLE 62: The flexible delivery catheter of any examples herein, particularly examples 59-61, wherein the outer jacket is reflowed together with the tie layer.
EXAMPLE 63: The flexible delivery catheter of any examples herein, particularly examples 59-62, wherein the tie layer has a thickness ranging between about 0.002 inches and about 0.005 inches.
EXAMPLE 64: The flexible delivery catheter any examples herein, particularly example 63, wherein the tie layer has a thickness of about 0.003 inches.
EXAMPLE 65: The flexible delivery catheter of any examples herein, particularly examples 59-64, wherein the tie layer comprises a polyether block amide.
EXAMPLE 66: The flexible delivery catheter of any examples herein, particularly examples 59-64, wherein the tie layer comprises one of PEBAX®, Vestamid®, or Rilsamid® PA12.
EXAMPLE 67: The flexible delivery catheter of any examples herein, particularly examples 1-66, further comprising an outer barrier layer provided between the outer surface of the coil layer and an inner barrier layer provided on the inner surface of the coil layer.
EXAMPLE 68: The flexible delivery catheter any examples herein, particularly example 67, wherein the outer barrier layer is provided between the outer surface of the coil layer and the outer jacket and braided layer, wherein the inner barrier layer is provided between the inner surface of the coil layer and the tie layer.
EXAMPLE 69: The flexible delivery catheter of any examples herein, particularly examples 67-68 wherein the inner and outer barrier layers extend along a majority of the length of the coil layer.
EXAMPLE 70: The flexible delivery catheter of any examples herein, particularly examples 67-69, wherein the inner and outer barrier layers are not provided at a length of the coil layer extending proximally from the distal end of the coil layer such that the distal end of the coil layer is fixedly attached to the outer jacket.
EXAMPLE 71: The flexible delivery catheter any examples herein, particularly example 70, wherein the distal end of the coil layer is fixedly coupled at the distal end of the delivery catheter when the outer jacket bonded to the tie layer.
EXAMPLE 72: The flexible delivery catheter of any examples herein, particularly examples 67-69, wherein the inner and outer barrier layers are not provided at a length of the coil layer extending distally from the proximal end of the coil layer such that the proximal end of the coil layer is fixedly attached to the outer jacket.
EXAMPLE 73: The flexible delivery catheter of any examples herein, particularly example 72, wherein the proximal end of the coil layer is fixedly coupled to the outer jacket when the outer jacket is bonded to the tie layer.
EXAMPLE 74: The flexible delivery catheter of any examples herein, particularly examples 67-73, wherein the inner and outer barrier layers comprise a polymer.
EXAMPLE 75: The flexible delivery catheter of any examples herein, particularly example 74, wherein the polymer is polyethylene terephthalate (PET) or expanded polytetrafluoroethylene (e-PTFE).
EXAMPLE 76: The flexible delivery catheter of any examples herein, particularly examples 67-75, wherein the inner and outer barrier layers have a thickness ranging between about 0.0003 inches and about 0.005 inches.
EXAMPLE 77: The flexible delivery catheter of any examples herein, particularly examples 67-76, wherein the inner and outer barrier layers have a thickness ranging between about 0.0004 inches and about 0.001 inches.
EXAMPLE 78: The flexible delivery catheter of any examples herein, particularly examples 67-77, wherein the inner and outer barrier layers have a thickness of about 0.0005 inches.
EXAMPLE 79: The delivery catheter of any examples herein, particularly examples 1-78, wherein the braided layer extends along the first length of the distal tip portion.
EXAMPLE 80: The delivery catheter of any examples herein, particularly examples 1-79, wherein a length of the braided layer is greater than an overall length of the coil layer.
EXAMPLE 81: The delivery catheter of any examples herein, particularly examples 3-80, wherein the braided layer extends along at least a portion of the second length of the elongated body portion of the delivery catheter.
EXAMPLE 82: The delivery catheter of any examples herein, particularly examples 1-81, wherein the braided layer does not extend to the distal tip portion of the delivery catheter.
EXAMPLE 83: The delivery catheter of any examples herein, particularly examples 3-82, wherein the braided layer extends along the second length of the elongated body portion of the delivery catheter.
EXAMPLE 84: The delivery catheter of any examples herein, particularly examples 1-83, wherein the braided layer comprises of a plurality of interwoven fibers.
EXAMPLE 85: The delivery catheter any examples herein, particularly example 84, wherein each of the plurality of interwoven fibers has a diameter ranging between about 0.002 inches and about 0.006 inches.
EXAMPLE 86: The delivery catheter any examples herein, particularly example 85, wherein each of the plurality of interwoven fibers has a diameter ranging between about 0.003 inches and about 0.005 inches.
EXAMPLE 87: The delivery catheter any examples herein, particularly example 85, wherein each of the plurality of interwoven fibers has a diameter of about 0.004″.
EXAMPLE 88: The delivery catheter of any examples herein, particularly examples 84-87, wherein the plurality of interwoven fibers comprises about 10 to about 20 individual fibers.
EXAMPLE 89: The delivery catheter any examples herein, particularly example 88, wherein the plurality of interwoven fibers comprises 16 individual fibers.
EXAMPLE 90: The delivery catheter of any examples herein, particularly examples 1-89, wherein the braided layer has a braid density between about 20 to about 30 picks per inch.
EXAMPLE 91: The delivery catheter of any examples herein, particularly examples 1-90, wherein the braided layer has a braid density varying along an axial length of the delivery catheter.
EXAMPLE 92: The delivery catheter any examples herein, particularly example 91, wherein the braid density of the braided layer is about 25 picks per inch.
EXAMPLE 93: The delivery catheter of any examples herein, particularly examples 1-92, wherein the braided layer comprises of a plurality of interwoven fibers, wherein each of the plurality of interwoven fibers have a rectilinear or curvilinear shape in cross section.
EXAMPLE 94: The delivery catheter of any examples herein, particularly examples 1-93, wherein the braided layer comprises of a plurality of interwoven fibers, and wherein the plurality of interwoven fibers comprises at least one of a polymer, a metal, or a composite material.
EXAMPLE 95: The delivery catheter any examples herein, particularly example 94, wherein the plurality of interwoven fibers comprise stainless steel wire.
EXAMPLE 96: The delivery catheter any examples herein, particularly example 94, wherein the plurality of interwoven fibers comprise a polyester.
EXAMPLE 97: The flexible delivery catheter of any examples herein, particularly examples 1-96, further comprising at least one tensile stiffening fiber for limiting bending of the delivery catheter in a direction opposite a circumferential location of the at least one tensile stiffening fiber.
EXAMPLE 98: The flexible delivery catheter any examples herein, particularly example 97, wherein a length of the at least one tensile stiffening fiber corresponds to the first length of the distal tip portion.
EXAMPLE 99: The flexible delivery catheter of any examples herein, particularly examples 97-98, wherein the length of the at least one tensile stiffening fiber is greater than the first length of the distal tip portion.
EXAMPLE 100: The flexible delivery catheter of any examples herein, particularly examples 97-99, wherein the least one tensile stiffening fiber extends along at least a portion of the second length of the elongated body portion of the delivery catheter.
EXAMPLE 101: The flexible delivery catheter of any examples herein, particularly examples 97-100, wherein the least one tensile stiffening fiber extends along the second length of the elongated body portion of the delivery catheter.
EXAMPLE 102: The flexible delivery catheter of any examples herein, particularly examples 97-101, wherein the at least one tensile stiffening fiber is woven into the braided layer.
EXAMPLE 103: The flexible delivery catheter any examples herein, particularly example 102, wherein the at least one tensile stiffening fiber is woven into a portion of the length of the braided layer.
EXAMPLE 104: The flexible delivery catheter any examples herein, particularly example 103, wherein the at least one tensile stiffening fiber is woven into the braided layer along the length of the braided layer.
EXAMPLE 105: The flexible delivery catheter any examples herein, particularly example 103, wherein the at least one tensile stiffening fiber is not woven into a first portion of the braided layer extending along the distal tip portion of the delivery catheter, and wherein the at least one fiber is woven into a second portion of the braided layer extending along the elongated body portion of the delivery catheter between the distal tip portion and the proximal end the delivery catheter.
EXAMPLE 106: The flexible delivery catheter of any examples herein, particularly examples 97-105, wherein a distal end of the at least one tensile stiffening fiber is fixedly coupled to the distal end of the delivery catheter.
EXAMPLE 107: The flexible delivery catheter of any examples herein, particularly examples 97-106, wherein a distal end of the at least one tensile stiffening fiber is fixedly coupled to the braided layer at the distal end of the braided layer.
EXAMPLE 108: The flexible delivery catheter of any examples herein, particularly examples 97-107, wherein a distal end of the at least one tensile stiffening fiber is fixedly coupled to the outer jacket at the distal end of the outer jacket.
EXAMPLE 109: The flexible delivery catheter of any examples herein, particularly examples 97-108, wherein the at least one tensile stiffening fiber comprises at least one of a polymer, a metal, or a composite material.
EXAMPLE 110: The flexible delivery catheter any examples herein, particularly example 109, wherein the at least one tensile stiffening fiber comprises a polyamide type polymer.
EXAMPLE 111: The flexible delivery catheter any examples herein, particularly example 109 or 110, wherein the at least one tensile stiffening fiber comprises Kevlar.
EXAMPLE 112: The flexible delivery catheter of any examples herein, particularly examples 97-111, wherein the at least one tensile stiffening fiber comprises a plurality of individual tensile stiffening fibers.
EXAMPLE 113: The flexible delivery catheter any examples herein, particularly example 112, wherein the plurality of individual tensile stiffening fibers are equally spaced around a circumference of the delivery catheter.
EXAMPLE 114: The flexible delivery catheter any examples herein, particularly example 113, wherein the plurality of individual tensile stiffening fibers are spaced around the circumference of the delivery catheter every 60 degrees, 90 degrees, 120 degrees, or every 180 degrees.
EXAMPLE 115: The flexible delivery catheter any examples herein, particularly example 112, wherein the plurality of individual tensile stiffening fibers are irregularly spaced around a circumference of the delivery catheter.
EXAMPLE 116: The flexible delivery catheter of any examples herein, particularly examples 97-114, wherein the at least one tensile stiffening fiber comprises six or less individual tensile stiffening fibers.
EXAMPLE 117: The flexible delivery catheter any examples herein, particularly example 116, wherein the at least one tensile stiffening fiber comprises four or less individual tensile stiffening fibers.
EXAMPLE 118: The flexible delivery catheter any examples herein, particularly example 117, wherein the at least one tensile stiffening fiber comprises one individual tensile stiffening fiber.
EXAMPLE 119: The flexible delivery catheter any examples herein, particularly example 118, wherein the one individual tensile stiffening fiber is located at a neutral axis of the delivery catheter.
EXAMPLE 120: The flexible delivery catheter of any examples herein, particularly examples 59-119, further comprising a liner provided on an inner surface of the tie layer.
EXAMPLE 121: The flexible delivery catheter any examples herein, particularly example 120, wherein the liner extends along a length of the inner surface of the tie layer.
EXAMPLE 122: The flexible delivery catheter of any examples herein, particularly examples 120-121, wherein a length of the liner is greater than the length of the distal tip portion.
EXAMPLE 123: The flexible delivery catheter of any examples herein, particularly examples 120-122, wherein the liner extends along at least a portion of the length of the elongated body portion of the delivery catheter.
EXAMPLE 124: The flexible delivery catheter of any examples herein, particularly examples 65-123, wherein the liner extends along the length of the elongated body portion of the delivery catheter.
EXAMPLE 125: The flexible delivery catheter of any examples herein, particularly examples 65-124, wherein the inner surface of the liner defines the central lumen of the delivery catheter.
EXAMPLE 126: The flexible delivery catheter any examples herein, particularly example 125, wherein the liner is provided along a length of the central lumen of the delivery catheter.
EXAMPLE 127: The flexible delivery catheter of any examples herein, particularly examples 120-126, wherein the liner has a thickness ranging between 0.001 inches and about 0.004 inches.
EXAMPLE 128: The flexible delivery catheter of any examples herein, particularly examples 120-127, wherein the liner has a thickness ranging between 0.0015 inches and about 0.003 inches.
EXAMPLE 129: The flexible delivery catheter any examples herein, particularly example 128, wherein the liner has a thickness of about 0.002 inches.
EXAMPLE 130: The flexible delivery catheter of any examples herein, particularly examples 120-129, wherein the liner comprises a polymer.
EXAMPLE 131: The flexible delivery catheter any examples herein, particularly example 130 wherein the polymer comprises one of polytetrafluoroethylene (PTFE), PA12 materials, polyether block amide (PEBA), or fluorinated ethylene propylene (FEP).
EXAMPLE 132: A flexible delivery catheter comprising: an outer jacket, having a proximal end, a distal end, an inner surface, and an outer surface, and defining a central lumen extending longitudinally between the proximal end and the distal end; a braided layer embedded in the outer jacket comprising a plurality of interwoven fibers disposed in a braided pattern forming an elongated tubular structure defining a central lumen extending therethrough, and wherein a braid density of the braided pattern varies along a length of the braided layer.
EXAMPLE 133: The delivery catheter any examples herein, particularly example 132, wherein the delivery catheter is omnidirectionally flexible and configured to bend in any direction away from the longitudinal axis of the delivery catheter.
EXAMPLE 134: The delivery catheter of any examples herein, particularly examples 132-133, wherein an outer diameter of the delivery catheter is constant along an entire length of the delivery catheter.
EXAMPLE 135: The delivery catheter of any examples herein, particularly examples 132-134, wherein the outer diameter of the distal tip portion ranges between about 4.5 mm and about 6.0 mm.
EXAMPLE 136: The delivery catheter of any examples herein, particularly examples 132-135, wherein the outer diameter of the distal tip portion ranges between about 5.0 mm and about 6.0 mm.
EXAMPLE 137: The delivery catheter of any examples herein, particularly examples 132-136, wherein the outer diameter of the distal tip portion is about 5.4 mm.
EXAMPLE 138: The delivery catheter of any examples herein, particularly examples 132-137, wherein the inner diameter of the central lumen of the delivery catheter ranges between 3.5 mm and about 5 mm.
EXAMPLE 139: The delivery catheter of any examples herein, particularly examples 132-138, wherein the inner diameter of the central lumen of the delivery catheter ranges between 4.0 mm and about 4.5 mm.
EXAMPLE 140: The delivery catheter of any examples herein, particularly examples 132-139, wherein the inner diameter of the central lumen of the delivery catheter is about 4.4 mm.
EXAMPLE 141: The delivery catheter of any examples herein, particularly examples 132-140, wherein the distal tip portion has a length less than about 510 mm (about 20 inches), wherein the length of the distal tip portion is measured in a direction along the longitudinal axis of the delivery catheter.
EXAMPLE 142: The delivery catheter of any examples herein, particularly examples 132-141, wherein the distal tip portion has a length less than about 385 mm (about 15 inches).
EXAMPLE 143: The delivery catheter of any examples herein, particularly examples 132-142, wherein the length of the distal tip portion ranges between about 125 mm (about 5 inches) and about 385 mm (about 15 inches).
EXAMPLE 144: The delivery catheter of any examples herein, particularly examples 132-143, wherein the length of the distal tip portion ranges between about 250 mm (about 10 inches) and about 385 mm (about 15 inches).
EXAMPLE 145: The delivery catheter of any examples herein, particularly examples 132-144, wherein the length of the distal tip portion is about 285.75 mm (about 11.25 inches).
EXAMPLE 146: The delivery catheter of any examples herein, particularly examples 132-145, wherein the delivery catheter comprises an elongated body portion that extends from the distal tip portion to the proximal end of the delivery catheter.
EXAMPLE 147: The delivery catheter any examples herein, particularly example 146, wherein the length of the elongated body portion ranges between about 760 mm (about 30 inches) to about 1270 mm (about 50 inches).
EXAMPLE 148: The delivery catheter of any examples herein, particularly examples 132-147, wherein the length of the elongated body portion ranges between about 885 mm (about 35 inches) to about 1145 mm (about 45 inches).
EXAMPLE 149: The delivery catheter of any examples herein, particularly examples 132-148, wherein the length of the elongated body portion is about 1045 mm (about 41 inches).
EXAMPLE 150: The delivery catheter of any examples herein, particularly examples 132-149, wherein the braid density along an entire length of the braided layer varies between about 80 picks per inch and about 10 picks per inch.
EXAMPLE 151: The delivery catheter of any examples herein, particularly examples 132-150, wherein the braid density along the entire length of the braided layer varies between about 65 picks per inch and about 25 picks per inch.
EXAMPLE 152: The delivery catheter of any examples herein, particularly examples 132-151, wherein the delivery catheter comprises a distal tip portion extending along a length of the delivery catheter from a distal end toward the proximal end of the delivery catheter and an elongated body portion extending from the distal tip portion to the proximal end the delivery catheter, and wherein a braid density of the braided layer along the elongated body portion is less than a braid density of the braided layer along the distal tip portion.
EXAMPLE 153: The delivery catheter any examples herein, particularly example 152, wherein the increased braid density along the distal tip portion configured such that the distal tip portion has a greater resistance to axial compression and bending than the elongated body portion.
EXAMPLE 154: The delivery catheter of any examples herein, particularly examples 152-153, wherein the braid density along the distal tip portion ranges between about 80 picks per inch and about 50 picks per inch.
EXAMPLE 155: The delivery catheter of any examples herein, particularly examples 152-154, wherein the braid density along the distal tip portion ranges between about 60 picks per inch and about 65 picks per inch.
EXAMPLE 156: The delivery catheter of any examples herein, particularly examples 152-155, wherein the braid density along the elongated body portion ranges between about 35 picks per inch and about 10 picks per inch.
EXAMPLE 157: The delivery catheter of any examples herein, particularly examples 152-156, wherein the braid density along the elongated body portion ranges between about 25 picks per inch and about 20 picks per inch.
EXAMPLE 158: The delivery catheter of any examples herein, particularly examples 152-157, wherein the braided layer extends along an entire length of the distal tip portion.
EXAMPLE 159: The delivery catheter of any examples herein, particularly examples 152-158, wherein the braided layer extends along at least a portion of the entire length of the elongated body portion of the delivery catheter.
EXAMPLE 160: The delivery catheter of any examples herein, particularly examples 132-159, wherein the braided layer extends along an entire length of the elongated body portion of the delivery catheter.
EXAMPLE 161: The delivery catheter of any examples herein, particularly examples 132-160, wherein each of the plurality of interwoven fibers has a diameter ranging between about 0.0015 inches and about 0.006 inches.
EXAMPLE 162: The delivery catheter of any examples herein, particularly examples 132-161, wherein each of the plurality of interwoven fibers has a diameter ranging between about 0.003 inches and about 0.004 inches.
EXAMPLE 163: The delivery catheter of any examples herein, particularly examples 132-162, wherein the plurality of interwoven fibers comprises about 10 to about 40 individual fibers.
EXAMPLE 164: The delivery catheter of any examples herein, particularly examples 132-163, wherein the plurality of interwoven fibers comprises about 16 to about 32 individual fibers.
EXAMPLE 165: The delivery catheter of any examples herein, particularly examples 132-164, wherein the plurality of interwoven fibers are woven as individual fibers into the braided pattern.
EXAMPLE 166: The delivery catheter of any examples herein, particularly examples 132-165, wherein the plurality of interwoven fibers are woven as fibers pairs into the braided pattern.
EXAMPLE 167: The delivery catheter of any examples herein, particularly examples 132-166, wherein each of the plurality of interwoven fibers have a rectilinear or curvilinear shape in cross section.
EXAMPLE 168: The delivery catheter of any examples herein, particularly examples 132-167, wherein each of the plurality of interwoven fibers is a flat wire.
EXAMPLE 169: The delivery catheter of any examples herein, particularly examples 132-168, wherein the plurality of interwoven fibers extend helically about the circumference of the braided layer, wherein a pitch of the plurality of fibers in the distal tip portion is less than a pitch of the plurality of fibers in the elongated body portion.
EXAMPLE 170: The delivery catheter of any examples herein, particularly examples 132-169, wherein a first portion of the plurality of interwoven fibers extend helically about the circumference of the braided layer in a first circumferential direction, and a second portion of the plurality of interwoven fibers extend helically about the circumference in a second circumferential direction opposite the first circumferential direction.
EXAMPLE 171: The flexible delivery catheter any examples herein, particularly example 170, wherein the first portion of the plurality of interwoven fibers extend helically about the circumference in the first direction at a first pitch and the second portion of the plurality of interwoven fibers extend helically about the circumference in the second direction at a second pitch, where the first pitch is greater than the second pitch.
EXAMPLE 172: The delivery catheter of any examples herein, particularly examples 132-171, wherein the plurality of interwoven fibers are composed of at least one of a polymer, a metal, a composite.
EXAMPLE 173: The delivery catheter any examples herein, particularly example 172, wherein the plurality of interwoven fibers comprise stainless steel wire.
EXAMPLE 174: The delivery catheter any examples herein, particularly example 173, wherein the plurality of interwoven fibers are composed of polyester.
EXAMPLE 175: The flexible delivery catheter of any examples herein, particularly examples 132-174, further comprising at least one tensile stiffening fiber for limiting bending of the delivery catheter in a direction opposite the circumferential location of the at least one tensile stiffening fiber.
EXAMPLE 176: The flexible delivery catheter any examples herein, particularly example 175, wherein a length of the at least one tensile stiffening fiber corresponds to a length of the distal tip portion.
EXAMPLE 177: The flexible delivery catheter of any examples herein, particularly examples 175-176 wherein the length of the at least one tensile stiffening fiber is greater than the length of the distal tip portion.
EXAMPLE 178: The flexible delivery catheter of any examples herein, particularly examples 175-177, wherein the least one tensile stiffening fiber extends along at least a portion of the entire length of the elongated body portion of the delivery catheter.
EXAMPLE 179: The flexible delivery catheter of any examples herein, particularly examples 175-178, wherein the least one tensile stiffening fiber extends along an entire length of the elongated body portion of the delivery catheter.
EXAMPLE 180: The flexible delivery catheter of any examples herein, particularly examples 175-179, wherein the at least one tensile stiffening fiber is woven into the braided layer.
EXAMPLE 181: The flexible delivery catheter any examples herein, particularly example 180, wherein the at least one tensile stiffening fiber is woven into a portion of the length of the braided layer.
EXAMPLE 182: The flexible delivery catheter any examples herein, particularly example 181, wherein the at least one tensile stiffening fiber is woven into the braided layer along an entire length of the braided layer.
EXAMPLE 183: The flexible delivery catheter any examples herein, particularly example 181, wherein the at least one tensile stiffening fiber is not woven into a first portion of the braided layer extending along the distal tip portion of the delivery catheter, and wherein the at least one fiber is woven into a second portion of the braided layer extending along an elongated body portion of the delivery catheter between the distal tip portion and the proximal end of the delivery catheter.
EXAMPLE 184: The flexible delivery catheter of any examples herein, particularly examples 175-181, wherein a distal end of the at least one tensile stiffening fiber is fixedly coupled to the distal end of the delivery catheter.
EXAMPLE 185: The flexible delivery catheter of any examples herein, particularly examples 175-184, wherein a distal end of the at least one tensile stiffening fiber is fixedly coupled to the braided layer at the distal end of the braided layer.
EXAMPLE 186: The flexible delivery catheter of any examples herein, particularly examples 175-185, wherein a distal end of the at least one tensile stiffening fiber is fixedly coupled to the outer jacket at the distal end of the outer jacket.
EXAMPLE 187: The flexible delivery catheter of any examples herein, particularly examples 175-186, wherein the at least one tensile stiffening fiber is composed of at least one of a polymer, a metal, a composite.
EXAMPLE 188: The flexible delivery catheter any examples herein, particularly example 187, wherein the at least one tensile stiffening fiber comprises a polyamide type polymer.
EXAMPLE 189: The flexible delivery catheter any examples herein, particularly example 188, wherein the at least one tensile stiffening fiber comprises Kevlar.
EXAMPLE 190: The flexible delivery catheter of any examples herein, particularly examples 188-189, wherein the at least one tensile stiffening fiber comprises a plurality of individual tensile stiffening fibers.
EXAMPLE 191: The flexible delivery catheter of any examples herein, particularly example 190, wherein the plurality of individual tensile stiffening fibers are equally spaced around the circumference of the delivery catheter.
EXAMPLE 192: The flexible catheter any examples herein, particularly example 191, wherein the plurality of individual tensile stiffening fibers are spaced around the circumference of the delivery catheter every 60 degrees, 90 degrees, 120 degrees, or every 180 degrees.
EXAMPLE 193: The flexible delivery catheter of any examples herein, particularly example 190, wherein the plurality of individual tensile stiffening fibers are irregularly spaced around the circumference of the delivery catheter.
EXAMPLE 194: The flexible delivery catheter of any examples herein, particularly examples 188-193, wherein the at least one tensile stiffening fiber comprises six or less individual tensile stiffening fibers.
EXAMPLE 195: The flexible delivery catheter of any examples herein, particularly examples 188-194, wherein the at least one tensile stiffening fiber comprises four or less individual tensile stiffening fibers.
EXAMPLE 196: The flexible delivery catheter of any examples herein, particularly examples 188-195, wherein the at least one tensile stiffening fiber comprises one individual tensile stiffening fiber.
EXAMPLE 197: The flexible delivery catheter any examples herein, particularly example 196, wherein the one individual tensile stiffening fiber is located at a neutral axis of the delivery catheter.
EXAMPLE 198: The flexible delivery catheter of any examples herein, particularly examples 132-197, wherein the elasticity varies (longitudinally) along a length of the outer jacket.
EXAMPLE 199: The flexible delivery catheter any examples herein, particularly example 198, wherein the elasticity of the outer jacket increases between the proximal and distal end of the outer jacket such that the distal end of the delivery catheter is configured to conform to the aortic geometry of a patient.
EXAMPLE 200: The flexible delivery catheter of any examples herein, particularly examples 198-199, wherein the durometer of the outer jacket decreases between the proximal end and the distal end of the outer jacket.
EXAMPLE 201: The flexible delivery catheter of any examples herein, particularly examples 198-200, wherein various longitudinal segments of the outer jacket are constructed from materials having varying durometer.
EXAMPLE 202: The flexible delivery catheter any examples herein, particularly example 201, wherein the materials of the various longitudinal segments are reflowed together.
EXAMPLE 203: The flexible delivery catheter of any examples herein, particularly examples 198-202, wherein the distal end of the outer jacket comprises a coupling segment having a lower elasticity and higher durometer than an adjacent segment of the outer jacket.
EXAMPLE 204: The flexible delivery catheter of any examples herein, particularly examples 198-203, wherein at least a portion of the outer jacket comprises an elastomer.
EXAMPLE 205: The flexible delivery catheter of any examples herein, particularly examples 198-204, wherein at least a portion of the outer jacket comprises a polyether block amide.
EXAMPLE 206: The flexible delivery catheter any examples herein, particularly example 205, wherein the polyether block amide comprises PEBAX®.
EXAMPLE 207: The flexible delivery catheter of any examples herein, particularly examples 198-206, wherein at least a portion of the outer jacket comprises a polyamide.
EXAMPLE 208: The flexible delivery catheter of any examples herein, particularly example 207, wherein the polyamide comprises Vestamid®, Rilasmid®, Nylon 12, or a combination thereof.
EXAMPLE 209: The flexible delivery catheter of any examples herein, particularly examples 132-208, further comprising a liner provided on an inner surface of the outer jacket.
EXAMPLE 210: The flexible delivery catheter any examples herein, particularly example 209, wherein the liner extends along an entire length of the inner surface of the outer jacket.
EXAMPLE 211: The flexible delivery catheter of any examples herein, particularly examples 209-210, wherein a length of the liner is greater than a length of the distal tip portion.
EXAMPLE 212: The flexible delivery catheter of any examples herein, particularly examples 209-211, wherein the liner extends along at least a portion of the entire length of the elongated body portion of the delivery catheter.
EXAMPLE 213: The flexible delivery catheter of any examples herein, particularly examples 209-212, wherein the liner extends along an entire length the elongated body portion of the delivery catheter.
EXAMPLE 214: The flexible delivery catheter of any examples herein, particularly examples 209-213, wherein the inner surface of the liner defines a central lumen of the delivery catheter.
EXAMPLE 215: The flexible delivery catheter any examples herein, particularly example 214, wherein the liner is provided along an entire length of the central lumen of the delivery catheter.
EXAMPLE 216: The flexible delivery catheter of any examples herein, particularly examples 209-215, wherein the liner has a thickness ranging between 0.001 inches and about 0.004 inches.
EXAMPLE 217: The flexible delivery catheter of any examples herein, particularly examples 209-216, wherein the liner has a thickness ranging between 0.0015 inches and about 0.003 inches.
EXAMPLE 218: The flexible delivery catheter of any examples herein, particularly examples 209-217, wherein the liner has a thickness of about 0.002 inches.
EXAMPLE 219: The flexible delivery catheter of any examples herein, particularly examples 209-218, wherein the liner comprises a polymer.
EXAMPLE 220: The flexible delivery catheter any examples herein, particularly example 219, wherein the polymer comprises polytetrafluoroethylene (PTFE), PA12 materials, polyether block amide (PEBA), fluorinated ethylene propylene (FEP).
EXAMPLE 221: A flexible delivery catheter comprising:
an outer jacket, having a proximal end, a distal end, an inner surface, and an outer surface, and defining a central lumen extending longitudinally between the proximal end and the distal end; and at least one tensile stiffening fiber extending longitudinally along the delivery catheter from the proximal to the distal end of the delivery catheter, the at least one tensile stiffening fiber liming bending of the delivery catheter in a direction opposite the circumferential location of the at least one tensile stiffening fiber.
EXAMPLE 222: The flexible delivery catheter any examples herein, particularly example 221, further comprising a braided layer embedded in the outer jacket comprising a plurality of interwoven fibers disposed in a braided pattern forming an elongated tubular structure defining a central lumen extending therethrough.
EXAMPLE 223: The flexible delivery catheter any examples herein, particularly example 221, wherein the elasticity of the outer jacket varies (longitudinally) along a length of the outer jacket.
EXAMPLE 224: The flexible delivery catheter of any examples herein, particularly examples 221-223, wherein the elasticity of the outer jacket increases between the proximal and distal end of the outer jacket such that the distal end of the delivery catheter is configured to conform to the aortic geometry of a patient.
EXAMPLE 225: The flexible delivery catheter of any examples herein, particularly examples 221-224, wherein the durometer of the outer jacket decreases between the proximal end and the distal end of the outer jacket.
EXAMPLE 226: The flexible delivery catheter of any examples herein, particularly examples 221-225, wherein various longitudinal segments of the outer jacket are constructed from materials having varying durometer.
EXAMPLE 227: The flexible delivery catheter any examples herein, particularly example 226, wherein the materials of the various longitudinal segments are reflowed together.
EXAMPLE 228: The flexible delivery catheter of any examples herein, particularly examples 221-227, wherein the distal end of the outer jacket comprises a coupling segment having a lower elasticity and higher durometer than an adjacent segment of the outer jacket.
EXAMPLE 229: The flexible delivery catheter of any examples herein, particularly examples 221-228, further comprising a liner, is provided along an entire length of the central lumen of the delivery catheter.
EXAMPLE 230: The flexible delivery catheter of any examples herein, particularly examples 221-229, further comprising a liner on an inner surface of the outer jacket.
EXAMPLE 231: The flexible delivery catheter of any examples herein, particularly examples 221-230, further comprising a liner on an inner surface of the braided layer.
EXAMPLE 232: A flexible delivery catheter comprising: an outer jacket, having a proximal end, a distal end, an inner surface, and an outer surface, and defining a central lumen extending longitudinally between the proximal end and the distal end; a braided layer comprising a plurality of fibers disposed in a braided pattern, wherein the braided layer is positioned within the central lumen, a hypotube having a proximal end, a distal end, an inner surface, an outer surface, and a plurality of cut-outs which extend between the inner surface and the outer surface of the hypotube such that the hypotube can bend omnidirectionally, and wherein the hypotube is provided at a distal tip portion of the delivery catheter, the distal tip portion extending along a length of the delivery catheter from a distal end of the delivery catheter toward the proximal end of the delivery catheter.
EXAMPLE 233: The delivery catheter any examples herein, particularly example 232, wherein the delivery catheter is omnidirectionally flexible and configured to bend in any direction away from the longitudinal axis of the delivery catheter.
EXAMPLE 234: The delivery catheter of any examples herein, particularly examples 232-233 wherein the delivery catheter comprises an elongated body portion that extends from the distal tip portion to the proximal end of the delivery catheter.
EXAMPLE 235: The delivery catheter any examples herein, particularly example 234, wherein an outer diameter of the delivery catheter at the distal tip portion is greater than an outer diameter of the delivery catheter along an elongated body portion of the delivery catheter.
EXAMPLE 236: The delivery catheter any examples herein, particularly example 235, wherein the outer diameter of the distal tip portion adjacent the elongated body portion, comprises a decreasing taper between a larger outer diameter tip portion and a reduced diameter body portion.
EXAMPLE 237: The delivery catheter of any examples herein, particularly examples 235-236, wherein the outer diameter of the distal tip portion ranges between about 4.5 mm and about 6.0 mm.
EXAMPLE 238: The delivery catheter of any examples herein, particularly examples 235-237, wherein the outer diameter of the distal tip portion ranges between about 5.0 mm and about 6.0 mm.
EXAMPLE 239: The delivery catheter of any examples herein, particularly examples 235-238, wherein the outer diameter of the distal tip portion is about 5.59 mm.
EXAMPLE 240: The delivery catheter of any examples herein, particularly examples 235-239, wherein the outer diameter of the elongated body portion ranges between about 4.5 mm and about 6.0 mm.
EXAMPLE 241: The delivery catheter of any examples herein, particularly examples 235-240, wherein the outer diameter of the elongated body portion ranges between about 5.0 mm and about 6.0 mm.
EXAMPLE 243: The delivery catheter of any examples herein, particularly examples 235-241, wherein the outer diameter of the elongated body portion is about 5.4 mm.
EXAMPLE 243: The delivery catheter of any examples herein, particularly examples 240-242, wherein the inner diameter of the central lumen of the delivery catheter ranges between 3.5 mm and about 5 mm.
EXAMPLE 244: The delivery catheter of any examples herein, particularly examples 240-243, wherein the inner diameter of the central lumen of the delivery catheter ranges between 4.0 mm and about 4.5 mm.
EXAMPLE 245: The delivery catheter of any examples herein, particularly examples 240-244, wherein the inner diameter of the central lumen of the delivery catheter is about 4.4 mm.
EXAMPLE 246: The delivery catheter of any examples herein, particularly examples 240-245, wherein the distal tip portion has a length less than about 510 mm (about 20 inches), and wherein the length of the distal tip portion is measured in a direction along the longitudinal axis of the delivery catheter.
EXAMPLE 247: The delivery catheter of any examples herein, particularly examples 240-246, wherein the distal tip portion has a length less than about 385 mm (about 15 inches).
EXAMPLE 248: The delivery catheter of any examples herein, particularly examples 240-247, wherein the length of the distal tip portion ranges between about 125 mm (about 5 inches) and about 385 mm (about 15 inches).
EXAMPLE 249: The delivery catheter of any examples herein, particularly examples 240-248, wherein the length of the distal tip portion ranges between about 250 mm (about 10 inches) and about 385 mm (15 inches).
EXAMPLE 250: The delivery catheter of any examples herein, particularly examples 240-249, wherein the length of the distal tip portion is about 285.75 mm (about 11.25 inches).
EXAMPLE 251: The delivery catheter of any examples herein, particularly examples 240-250, wherein the length of the elongated body portion ranges between about 760 mm (about 30 inches) to about 1270 mm (about 50 inches).
EXAMPLE 252: The delivery catheter of any examples herein, particularly examples 240-251, wherein the length of the elongated body portion ranges between about 885 mm (about 35 inches) to about 1145 mm (about 45 inches).
EXAMPLE 253: The delivery catheter of any examples herein, particularly examples 240-252, wherein the length of the elongated body portion is about 1045 mm (about 41 inches).
EXAMPLE 254: The flexible delivery catheter of any examples herein, particularly examples 240-253, wherein the braided layer overlaps at least a portion of the hypotube.
EXAMPLE 255: The flexible delivery catheter of any examples herein, particularly examples 240-254, wherein the braided layer overlaps a length of the hypotube ranging between about 0.050 inches and about 0.100″ inches.
EXAMPLE 256: The flexible delivery catheter of any examples herein, particularly examples 240-255, wherein each of the plurality of cut-outs are disposed in circumferential rows along an axial length of the hypotube.
EXAMPLE 257: The flexible delivery catheter any examples herein, particularly example 256, wherein the hypotube comprises cut-outs along a majority of its axial length.
EXAMPLE 258: The flexible delivery catheter of any examples herein, particularly examples 256-257, wherein a first distal-most row of the rows of cut-outs is offset from the distal end of the hypotube by about 3.8 mm (about 0.150 inches).
EXAMPLE 259: The flexible delivery catheter of any examples herein, particularly examples 256-258, wherein each row comprises at least two cut-outs.
EXAMPLE 260: The flexible delivery catheter of any examples herein, particularly examples 256-259, wherein each row comprises at least four cut-outs.
EXAMPLE 261: The flexible delivery catheter of any examples herein, particularly examples 256-260, each of the plurality of cut-outs in the same row are distributed symmetrically about the circumference of the hypotube.
EXAMPLE 262: The flexible delivery catheter of any examples herein, particularly examples 256-261, wherein each of the plurality of cut-outs in the same row are distributed asymmetrically about the circumference of the hypotube.
EXAMPLE 263: The flexible delivery catheter of any examples herein, particularly examples 256-262, wherein the plurality of cut-outs in a row are circumferentially offset from the plurality of cut-outs in an adjacent row.
EXAMPLE 264: The flexible delivery catheter of any examples herein, particularly examples 232-263, wherein each of the plurality of cut-outs comprises a circumferential slit and a semicircular hole.
EXAMPLE 265: The flexible delivery catheter any examples herein, particularly example 264, wherein each of the plurality of cut-outs is configured to assist in relieving stress during bending of the hypotube.
EXAMPLE 266: The flexible delivery catheter of any examples herein, particularly examples 232-265, wherein each of the plurality of cut-outs comprises a circumferential slit and a semicircular hole provided at a circumferential end of the slit.
EXAMPLE 267: The flexible delivery catheter of any examples herein, particularly examples 232-266, wherein each of the plurality of cut-outs comprises a circumferential slit and semicircular holes provided at each circumferential end of the slit.
EXAMPLE 268: The flexible delivery catheter of any examples herein, particularly examples 264-267, wherein a radius of the semicircular hole ranges between about 0.1000 mm (about 0.004 inches) and about 0.765 mm (about 0.030 inches).
EXAMPLE 269: The flexible delivery catheter of any examples herein, particularly examples 264-268, wherein a radius of the semicircular hole is about 0.1524 mm (about 0.006 inches).
EXAMPLE 270: The flexible delivery catheter of any examples herein, particularly examples 264-269, wherein each of the slits has a circumferential length ranging between about 3.0 mm and about 4.0 mm.
EXAMPLE 271: The flexible delivery catheter of any examples herein, particularly examples 264-270, wherein each of the slits has a circumferential length of about 3.3 mm (about 0.130 inches).
EXAMPLE 272: The flexible delivery catheter of any examples herein, particularly examples 264-271, wherein each of the slits has an axial width ranging between about 0.010 mm (about 0.0004 inches) and about 0.025 mm (about 0.0010 inches).
EXAMPLE 273: The flexible delivery catheter of any examples herein, particularly examples 264-272, wherein each of the slits has an axial width of about 0.018 mm (about 0.0007 inches).
EXAMPLE 274: The flexible delivery catheter of any examples herein, particularly examples 232-273, wherein the hypotube has a thickness ranging between about 0.127 mm (about 0.0050 inches) and about 0.254 mm (about 0.0100 inches).
EXAMPLE 275: The flexible delivery catheter of any examples herein, particularly examples 232-274, wherein the hypotube has a thickness of about 0.0070 inches.
EXAMPLE 276: The flexible delivery catheter of any examples herein, particularly examples 232-275, wherein the hypotube has an outer diameter ranging between about 0.3000 inches and about 0.2000 inches.
EXAMPLE 277: The flexible delivery catheter of any examples herein, particularly examples 232-276, wherein the hypotube has an outer diameter of about 0.2030 inches.
EXAMPLE 278: The flexible delivery catheter of any examples herein, particularly examples 232-277, wherein the hypotube has an inner diameter ranging between about 0.1000 and about 0.2000 inches.
EXAMPLE 279: The flexible delivery catheter of any examples herein, particularly examples 232-278, wherein the hypotube has an inner diameter of about 0.1890 inches.
EXAMPLE 280: The flexible delivery catheter of any examples herein, particularly examples 232-279, wherein an overall length of the hypotube is less than an overall length of the distal tip portion of the delivery catheter.
EXAMPLE 281: The flexible delivery catheter of any examples herein, particularly examples 232-280, wherein an overall length of the hypotube ranges between about 10.5 inches and about 11.5 inches.
EXAMPLE 282: The flexible delivery catheter of any examples herein, particularly examples 232-281, wherein an overall length of the hypotube ranges is about 11.0 inches.
EXAMPLE 283: The flexible delivery catheter of any examples herein, particularly examples 323-282, further including an anchoring window configured to receive reflow material and mechanically interlock with the reflow material post reflow.
EXAMPLE 284: The delivery catheter of any examples herein, particularly examples 232-283, wherein the hypotube is composed of at least one of a polymer, a metal, a composite.
EXAMPLE 285: The delivery catheter any examples herein, particularly example 284, wherein the hypotube is composed of stainless steel.
EXAMPLE 286: The flexible delivery catheter of any examples herein, particularly examples 232-285, wherein the delivery catheter comprises an elongated body portion that extends from the distal tip portion to the proximal end of the delivery catheter, and wherein the braided layer is provided along at least a portion of the elongated body portion.
EXAMPLE 287: The flexible delivery catheter of any examples herein, particularly examples 232-286, wherein the braided layer does not extend to the distal end of the delivery catheter.
EXAMPLE 288: The flexible delivery catheter of any examples herein, particularly examples 232-287, further comprising at least one tensile stiffening fiber for limiting bending of the delivery catheter in a direction opposite the circumferential location of the at least one tensile stiffening fiber.
EXAMPLE 289: The flexible delivery catheter any examples herein, particularly example 288, wherein a length of the at least one tensile stiffening fiber corresponds to a length of the distal tip portion.
EXAMPLE 290: The flexible delivery catheter of any examples herein, particularly examples 288-289, wherein the length of the at least one tensile stiffening fiber is greater than the length of the distal tip portion.
EXAMPLE 291: The flexible delivery catheter of any examples herein, particularly examples 288-290, wherein the least one tensile stiffening fiber extends along at least a portion of the entire length of the elongated body portion of the delivery catheter.
EXAMPLE 292: The flexible delivery catheter of any examples herein, particularly examples 288-291, wherein the least one tensile stiffening fiber extends along an entire length of the elongated body portion of the delivery catheter.
EXAMPLE 293: The flexible delivery catheter of any examples herein, particularly examples 288-292, wherein the at least one tensile stiffening fiber is woven into the braided layer.
EXAMPLE 294: The flexible delivery catheter any examples herein, particularly example 293, wherein the at least one tensile stiffening fiber is woven into a portion of the length of the braided layer.
EXAMPLE 295: The flexible delivery catheter any examples herein, particularly example 294, wherein the at least one tensile stiffening fiber is woven into the braided layer along an entire length of the braided layer.
EXAMPLE 296: The flexible delivery catheter any examples herein, particularly example 294, wherein the at least one tensile stiffening fiber is not woven into a first portion of the braided layer extending along the distal tip portion of the delivery catheter, and wherein the at least one fiber is woven into a second portion of the braided layer extending along an elongated body portion of the delivery catheter between the distal tip portion and the proximal end of the delivery catheter.
EXAMPLE 297: The flexible delivery catheter of any examples herein, particularly examples 288-296, wherein a distal end of the at least one tensile stiffening fiber is fixedly coupled to the distal end of the delivery catheter.
EXAMPLE 298: The flexible delivery catheter of any examples herein, particularly examples 288-297, wherein a distal end of the at least one tensile stiffening fiber is fixedly coupled to the braided layer at the distal end of the braided layer.
EXAMPLE 299: The flexible delivery catheter of any examples herein, particularly examples 288-298, wherein a distal end of the at least one tensile stiffening fiber is fixedly coupled to the outer jacket at the distal end of the outer jacket.
EXAMPLE 300: The flexible delivery catheter of any examples herein, particularly examples 288-299, wherein the at least one tensile stiffening fiber is composed of at least one of a polymer, a metal, a composite.
EXAMPLE 301: The flexible delivery catheter of any examples herein, particularly examples 288-300, wherein the at least one tensile stiffening fiber comprises a polyamide type polymer.
EXAMPLE 302: The flexible delivery catheter of any examples herein, particularly examples 288-301, wherein the at least one tensile stiffening fiber comprises Kevlar.
EXAMPLE 303: The flexible delivery catheter of any examples herein, particularly examples 288-302, wherein the at least one tensile stiffening fiber comprises a plurality of individual tensile stiffening fibers.
EXAMPLE 304: The flexible delivery catheter any examples herein, particularly example 303, wherein the plurality of individual tensile stiffening fibers are equally spaced around the circumference of the delivery catheter.
EXAMPLE 305: The flexible delivery catheter any examples herein, particularly example 304, wherein the plurality of individual tensile stiffening fibers are equally spaced around the circumference of the delivery catheter every 60 degrees, 90 degrees, 120 degrees, or 180 degrees.
EXAMPLE 306: The flexible delivery catheter any examples herein, particularly example 304, wherein the plurality of individual tensile stiffening fibers are irregularly spaced around the circumference of the delivery catheter.
EXAMPLE 307: The flexible delivery catheter of any examples herein, particularly examples 288-306, wherein the at least one tensile stiffening fiber comprises six or less individual tensile stiffening fibers.
EXAMPLE 308: The flexible delivery catheter any examples herein, particularly example 307, wherein the at least one tensile stiffening fiber comprises four or less individual tensile stiffening fibers.
EXAMPLE 309: The flexible delivery catheter any examples herein, particularly example 308, wherein the at least one tensile stiffening fiber comprises one individual tensile stiffening fibers.
EXAMPLE 310: The flexible delivery catheter any examples herein, particularly example 309, wherein the one individual tensile stiffening fiber is located at a neutral axis of the delivery catheter.
EXAMPLE 311: The flexible delivery catheter of any examples herein, particularly examples 232-310, wherein the elasticity varies (longitudinally) along a length of the outer jacket.
EXAMPLE 312: The flexible delivery catheter any examples herein, particularly example 311, wherein the elasticity of the outer jacket increases between the proximal and distal end of the outer jacket such that the distal end of the delivery catheter is configured to conform to the aortic geometry of a patient.
EXAMPLE 313: The flexible delivery catheter of any examples herein, particularly examples 311-312, wherein the durometer of the outer jacket decreases between the proximal end and the distal end of the outer jacket.
EXAMPLE 314: The flexible delivery catheter of any examples herein, particularly examples 311-313, wherein various longitudinal segments of the outer jacket are constructed from materials having varying durometer.
EXAMPLE 315: The flexible delivery catheter any examples herein, particularly example 314, wherein the materials of the various longitudinal segments are reflowed together.
EXAMPLE 316: The flexible delivery catheter of any examples herein, particularly examples 311-315, wherein the distal end of the outer jacket comprises a coupling segment having a lower elasticity and higher durometer than an adjacent segment of the outer jacket.
EXAMPLE 317: The flexible delivery catheter of any examples herein, particularly examples 311-316, wherein at least a portion of the outer jacket comprises an elastomer.
EXAMPLE 318: The flexible delivery catheter of any examples herein, particularly examples 311-317, wherein at least a portion of the outer jacket comprises a polyether block amide.
EXAMPLE 319: The flexible delivery catheter any examples herein, particularly example 318, wherein the polyether block amide comprises PEBAX®.
EXAMPLE 320: The flexible delivery catheter of any examples herein, particularly examples 307-315, wherein at least a portion of the outer jacket comprises a polyamide.
EXAMPLE 321: The flexible delivery catheter any examples herein, particularly example 320, wherein the polyamide comprises Vestamid®, Rilasmid®, Nylon 12, or a combination thereof.
EXAMPLE 322: The flexible delivery catheter of any examples herein, particularly examples 232-321, further comprising a tie layer provided on an inner surface of the hypotube.
EXAMPLE 323: The flexible delivery catheter any examples herein, particularly example 322, wherein the tie layer extends along a length of the inner surface of the coil layer.
EXAMPLE 324: The flexible delivery catheter any examples herein, particularly example 323, wherein the tie layer extends along an entire length of the inner surface of the coil layer.
EXAMPLE 325: The flexible delivery catheter of any examples herein, particularly examples 322-324, wherein the outer jacket is reflowed together with the tie layer.
EXAMPLE 326: The flexible delivery catheter of any examples herein, particularly examples 322-325, wherein the tie layer has a thickness ranging between about 0.002 inches and about 0.005 inches.
EXAMPLE 327: The flexible delivery catheter any examples herein, particularly example 326, wherein the tie layer has a thickness of about 0.003 inches.
EXAMPLE 328: The flexible delivery catheter of any examples herein, particularly examples 322-327, wherein the tie layer comprises a polyether block amide.
EXAMPLE 329: The flexible delivery catheter of any one claims 322-328, wherein the tie layer comprises one of PEBAX®, Vestamid®, or Rilsamid® PA12.
EXAMPLE 330: The flexible delivery catheter of any examples herein, particularly examples 232-329, further comprising a liner provided on an inner surface of the tie layer.
EXAMPLE 331: The flexible delivery catheter any examples herein, particularly example 330, wherein the liner extends along an entire length of the inner surface of the tie layer.
EXAMPLE 332: The flexible delivery catheter of any examples herein, particularly examples 330-331, wherein a length of the liner is greater than a length of the distal tip portion.
EXAMPLE 333: The flexible delivery catheter of any examples herein, particularly examples 330-332, wherein the liner extends along at least a portion of the entire length of the elongated body portion of the delivery catheter.
EXAMPLE 334: The flexible delivery catheter of any examples herein, particularly examples 330-333, wherein the liner extends along an entire length the elongated body portion of the delivery catheter.
EXAMPLE 335: The flexible delivery catheter of any examples herein, particularly examples 330-334, wherein the inner surface of the liner defines a central lumen of the delivery catheter.
EXAMPLE 336: The flexible delivery catheter any examples herein, particularly example 335, wherein the liner is provided along an entire length of the central lumen of the delivery catheter.
EXAMPLE 337: The flexible delivery catheter of any examples herein, particularly examples 330-336, wherein the liner has a thickness ranging between 0.001 inches and about 0.004 inches.
EXAMPLE 338: The flexible delivery catheter of any examples herein, particularly examples 330-337, wherein the liner has a thickness ranging between 0.0015 inches and about 0.003 inches.
EXAMPLE 339: The flexible delivery catheter any examples herein, particularly example 338, wherein the liner has a thickness of about 0.002 inches.
EXAMPLE 340: The flexible delivery catheter of any examples herein, particularly examples 330-339, wherein the liner comprises a polymer.
EXAMPLE 341: The flexible delivery catheter any examples herein, particularly example 340, wherein the polymer comprises one of polytetrafluoroethylene (PTFE), PA12 materials, polyether block amide (PEBA), or fluorinated ethylene propylene (FEP).
EXAMPLE 342: A method of making a flexible delivery catheter comprising: forming an outer jacket, having a proximal end, a distal end, an inner surface, and an outer surface, and defining a central lumen extending longitudinally between the proximal end and the distal end; forming a coil layer comprising a coil winding and having a proximal end, a distal end, an inner surface, and an outer surface, wherein the coil winding extends helically about a longitudinal axis and defines a central lumen between the proximal end and the distal end; forming a braided layer having a proximal end and a distal end and comprising a plurality of wires disposed in a braided pattern and defining a central lumen having an inner surface and an outer surface, disposing the coil layer within the central lumen of the braided layer, disposing the braided layer between the outer jacket and the coil layer; and coupling the outer jacket, the coil layer, and the braided layer together.
EXAMPLE 343: The method of any one any examples herein, particularly example 342, wherein the coil layer comprises a gap/spacing between adjacent turns of the coil winding.
EXAMPLE 344: The method of either of any examples herein, particularly example 342 or 343, wherein an outer surface of adjacent turns of the coiled winding contact along a circumferential length of the coiled winding.
EXAMPLE 345: The method of any examples herein, particularly examples 342-344, wherein the outer jacket comprises a plurality of longitudinal segments.
EXAMPLE 346: The method of any examples herein, particularly examples 342-345, wherein each of the plurality of longitudinal segments are reflowed together with at least one other longitudinal segment.
EXAMPLE 347: The method of any examples herein, particularly examples 342-346, further comprising coupling a tensile stiffening fiber to the braided layer.
EXAMPLE 348: The method of any examples herein, particularly examples 342-347, wherein coupling the tensile stiffening fiber to the braided layer further comprises weaving the tensile stiffening fiber into the braided layer.
EXAMPLE 349: The method of any examples herein, particularly examples 342-348, further comprising coupling the tensile stiffening fiber to the outer jacket.
EXAMPLE 350: The method of any examples herein, particularly examples 342-349, wherein the outer jacket has a distal tip, and wherein coupling the tensile stiffening fiber to the outer jacket comprises threading the tensile stiffening fiber through the distal tip of the outer jacket.
EXAMPLE 351: A method of making a flexible delivery catheter comprising
forming an outer jacket, having a proximal end, a distal end, an inner surface, and an outer surface, and defining a central lumen extending longitudinally between the proximal end and the distal end; forming a braided layer comprising a plurality of wires disposed in a braided pattern and defining a central lumen; and forming a hypotube having a proximal end, a distal end, an inner surface, an outer surface, and a plurality of cut-outs which extend between the inner surface and the outer surface of the hypotube such that the hypotube can bend omnidirectionally, wherein the hypotube is provided at a distal tip portion of the delivery catheter, the distal tip portion extending along a length of the delivery catheter from a distal end of the delivery catheter toward the proximal end of the delivery catheter.
EXAMPLE 352: The method any examples herein, particularly example 351, wherein the delivery catheter is omnidirectionally flexible and configured to bend in any direction away from the longitudinal axis of the delivery catheter.
EXAMPLE 353: The method of 351 or 352, wherein the braided layer overlaps at least a portion of the hypotube.
EXAMPLE 354: The method of any examples herein, particularly examples 351-353, wherein the outer jacket comprises a plurality of longitudinal segments.
EXAMPLE 355: The method of any examples herein, particularly examples 351-354, wherein each of the plurality of longitudinal segments are reflowed together with at least one other longitudinal segment.
EXAMPLE 356: The method of any examples herein, particularly examples 351-355, further comprising coupling a tensile stiffening fiber to the braided layer.
EXAMPLE 357: The method of any examples herein, particularly examples 351-356, wherein coupling the tensile stiffening fiber to the braided layer further comprises weaving the tensile stiffening fiber into the braided layer.
EXAMPLE 358: The method any examples herein, particularly example 357, further comprising coupling the tensile stiffening fiber to the outer jacket.
EXAMPLE 359: The method any examples herein, particularly example 358, wherein the outer jacket has a distal tip, and wherein coupling the tensile stiffening fiber to the outer jacket comprises threading the tensile stiffening fiber through the distal tip of the outer jacket.
EXAMPLE 360: A method of making a flexible delivery catheter comprising forming an outer jacket, having a proximal end, a distal end, an inner surface, and an outer surface, and defining a central lumen extending longitudinally between the proximal end and the distal end; braiding a plurality of interwoven fibers in a braided pattern to form a braided layer, embedding the braided layer in the outer jacket forming an elongated tubular structure defining a central lumen extending therethrough, and wherein a braid density of the braided pattern varies along a length of the braided layer.
EXAMPLE 361: The method any examples herein, particularly example 360, wherein the outer jacket comprises a plurality of longitudinal segments.
EXAMPLE 362: The method any examples herein, particularly example 360 or 361, wherein each of the plurality of longitudinal segments are reflowed together with at least one other longitudinal segment.
EXAMPLE 363: The method of any examples herein, particularly examples 360-362, further comprising coupling a tensile stiffening fiber to the braided layer.
EXAMPLE 364: The method of any examples herein, particularly examples 360-363, wherein coupling the tensile stiffening fiber to the braided layer further comprises weaving the tensile stiffening fiber into the braided layer.
EXAMPLE 365: The method of any examples herein, particularly examples 360-364, further comprising coupling the tensile stiffening fiber to the outer jacket.
EXAMPLE 366: The method any examples herein, particularly example 365, wherein the outer jacket has a distal tip, and wherein coupling the tensile stiffening fiber to the outer jacket comprises threading the tensile stiffening fiber through the distal tip of the outer jacket.
EXAMPLE 367: A method of making a flexible delivery catheter comprising forming an outer jacket, having a proximal end, a distal end, an inner surface and an outer surface, and defining a central lumen extending longitudinally between the proximal end and the distal end; forming a braided layer embedded in the outer jacket comprising a plurality of interwoven fibers disposed in a braided pattern forming an elongated tubular structure defining a central lumen extending therethrough; coupling at least one tensile stiffening fiber to the outer jacket, and wherein the tensile stiffening fiber extends longitudinally along the delivery catheter from the proximal to the distal end of the delivery catheter, the at least one tensile stiffening fiber limiting bending of the delivery catheter in a direction opposite the circumferential location of the at least one tensile stiffening fiber.
EXAMPLE 368: The method any examples herein, particularly example 367, wherein the outer jacket comprises a plurality of longitudinal segments.
EXAMPLE 369: The method any examples herein, particularly example 367 or 368, wherein each of the plurality of longitudinal segments are reflowed together with at least one other longitudinal segment.
EXAMPLE 370: The method of any examples herein, particularly examples 367-369, further comprising coupling a tensile stiffening fiber to the braided layer.
EXAMPLE 371: The method of any examples herein, particularly examples 367-370, wherein coupling the tensile stiffening fiber to the braided layer further comprises weaving the tensile stiffening fiber into the braided layer.
EXAMPLE 372: The method any examples herein, particularly example 371, further comprising coupling the tensile stiffening fiber to the outer jacket.
EXAMPLE 373: The method any examples herein, particularly example 372, wherein the outer jacket has a distal tip, and wherein coupling the tensile stiffening fiber to the outer jacket comprises threading the tensile stiffening fiber through the distal tip of the outer jacket.
EXAMPLE 374: A method of deploying a prosthetic into a patient comprising: providing a delivery system comprising a flexible catheter having a proximal end and a distal end, wherein the outer jacket having an elasticity that varies (longitudinally) along a length of the outer jacket; advancing the catheter into a vessel of a patient, and advancing the prosthetic from the proximal end of the catheter to the distal end of the catheter and into the patient.
EXAMPLE 375: The method any examples herein, particularly example 374, wherein the jacket elastically conforms to the arterial structure of the patient.
EXAMPLE 376: The method any examples herein, particularly example 374 or 375, wherein the flexible catheter further comprises a tensile stiffening fiber configured to allow omnidirectional bending while limiting limit axial tensile deformation within the patient.
EXAMPLE 377: The method of any examples herein, particularly examples 374-376, wherein the flexible catheter further comprises a hypotube configured to allow omnidirectional bending while limiting limit axial compression within the patient.
EXAMPLE 378: The method of any examples herein, particularly examples 374-377, wherein the catheter further comprises a coil configured to allow omnidirectional bending while limiting limit axial compression within the patient.
EXAMPLE 379: The method of any examples herein, particularly examples 374-378, wherein the hypotube further comprises a braided layer that has a longitudinally varying braid pattern configured to allow omnidirectional bending while limiting limit axial compression.
EXAMPLE 380: The method of any examples herein, particularly examples 374-379, wherein the prosthetic is a prosthetic heart valve.
EXAMPLE 381: A flexible delivery catheter having a proximal end and a distal end and comprising: an outer jacket, having a proximal end, a distal end, an inner surface and an outer surface, and defining a central lumen extending longitudinally between the proximal end and the distal end; a stent layer having a proximal end, a distal end, an inner surface, and an outer surface; an inner barrier layer disposed abut the inner surface of the stent layer; and an outer barrier layer disposed abut the outer surface of the stent layer; wherein the stent layer is disposed within the central lumen; wherein the stent layer is configured to resist axial compression and tension applied to the delivery catheter, the stent layer is configured to facilitate bending of the delivery catheter in a direction away from the longitudinal axis of the delivery catheter, and wherein the stent layer is provided at a distal tip portion of the delivery catheter, the distal tip portion has a length and extends along a length of the delivery catheter from the distal end of the delivery catheter toward the proximal end of the delivery catheter.
EXAMPLE 382: The delivery catheter any examples herein, particularly example 381, wherein the delivery catheter is omnidirectionally flexible and configured to bend in any direction away from the longitudinal axis of the delivery catheter.
EXAMPLE 383: The delivery catheter of any examples herein, particularly examples 381-382, wherein the delivery catheter comprises an elongated body portion having a second length and wherein the elongated body portion extends from the distal tip portion to the proximal end of the delivery catheter.
EXAMPLE 384: The delivery catheter any examples herein, particularly example 383, wherein an outer diameter of the delivery catheter at the distal tip portion is greater than an outer diameter of the delivery catheter along an elongated body portion of the delivery catheter.
EXAMPLE 385: The delivery catheter any examples herein, particularly example 384, wherein the outer diameter of the distal tip portion adjacent the elongated body portion comprises a decreasing taper between a larger outer diameter of the distal tip portion and a reduced diameter of the elongated body portion.
EXAMPLE 386: The delivery catheter of any examples herein, particularly examples 384-385, wherein the outer diameter of the distal tip portion ranges between about 4.5 mm and about 6.0 mm.
EXAMPLE 387: The delivery catheter of any examples herein, particularly examples 384-386, wherein the outer diameter of the elongated body portion ranges between about 4.5 mm and about 6.0 mm.
EXAMPLE 388: The delivery catheter of any examples herein, particularly examples 381-387, wherein an inner diameter of the central lumen of the delivery catheter ranges between 3.5 mm and about 5 mm.
EXAMPLE 389: The delivery catheter of any examples herein, particularly examples 381-388, wherein the first length of the distal tip portion is less than about 520 mm (about 20 inches), wherein the first length of the distal tip portion is measured in a direction along the longitudinal axis of the delivery catheter.
EXAMPLE 390: The delivery catheter of any examples herein, particularly examples 381-389, wherein the first length of the distal tip portion ranges between about 125 mm (about 5 inches) and about 385 mm (about 15 inches).
EXAMPLE 391: The delivery catheter of any examples herein, particularly examples 381-390, wherein the first length of the distal tip portion is between about 280 mm to about 290 mm.
EXAMPLE 392: The delivery catheter of any examples herein, particularly examples 383-391, wherein the second length of the elongated body portion ranges between about 760 (about 30 inches) to about 1270 mm (about 50 inches).
EXAMPLE 393: The delivery catheter of any examples herein, particularly examples 383-392, wherein the second length of the elongated body portion is about 1045 mm (about 41 inches).
EXAMPLE 394: The flexible delivery catheter of any examples herein, particularly examples 381-393, wherein the outer jacket exhibits an elasticity that varies along a length of the outer jacket.
EXAMPLE 395: The flexible delivery catheter any examples herein, particularly example 394, wherein the elasticity of the outer jacket increases from the proximal end of the outer jacket to the distal end of the outer jacket such that the distal end of the delivery catheter is configured to conform to the aortic geometry of a patient.
EXAMPLE 396: The flexible delivery catheter of any examples herein, particularly examples 394-395, wherein a durometer of the outer jacket decreases between the proximal end and the distal end of the outer jacket.
EXAMPLE 397: The flexible delivery catheter of any examples herein, particularly examples 394-396, wherein the outer jacket comprises a plurality of longitudinal segments, wherein each longitudinal segment extends circumferentially, and wherein the plurality of longitudinal segments comprise materials having a varying durometer.
EXAMPLE 398: The flexible delivery catheter any examples herein, particularly example 397, wherein the materials of the plurality of longitudinal segments are reflowed together.
EXAMPLE 399: The flexible delivery catheter of any examples herein, particularly examples 394-398, wherein the distal end of the outer jacket comprises a coupling segment having a lower elasticity and a higher durometer than an adjacent segment of the outer jacket.
EXAMPLE 400: The flexible delivery catheter any examples herein, particularly example 399, wherein the coupling segment has higher elasticity and a lower durometer than a segment adjacent the proximal end of the outer jacket.
EXAMPLE 401: The flexible delivery catheter any examples herein, particularly example 398 or 399, wherein the coupling segment of the outer jacket has higher elasticity and a lower durometer than a segment of the outer jacket adjacent the elongated body portion.
EXAMPLE 402: The flexible delivery catheter of any examples herein, particularly examples 398-400, wherein the coupling segment has a length from about 2.5 mm to about 8.0 mm.
EXAMPLE 403: The flexible delivery catheter of any examples herein, particularly examples 397-402, wherein the plurality of longitudinal segments are present in the outer jacket of the distal tip portion.
EXAMPLE 404: The flexible delivery catheter any examples herein, particularly example 403, wherein each longitudinal segment present in the outer jacket has a length between 12.5 mm to about 105 mm.
EXAMPLE 405: The flexible delivery catheter of any examples herein, particularly examples 396-404, wherein the durometer varies from about 25D to about 75D.
EXAMPLE 406: The flexible delivery catheter of any examples herein, particularly examples 394-405, wherein at least a portion of the outer jacket comprises an elastomer.
EXAMPLE 407: The flexible delivery catheter of any examples herein, particularly examples 394-406, wherein at least a portion of the outer jacket comprises a polyether block amide.
EXAMPLE 408: The flexible delivery catheter any examples herein, particularly example 407, wherein the polyether block amide comprises PEBAX®.
EXAMPLE 409: The flexible delivery catheter of any examples herein, particularly examples 394-408, wherein at least a portion of the outer jacket comprises a polyamide.
EXAMPLE 410: The flexible delivery catheter any examples herein, particularly example 409, wherein the polyamide comprises Vestamid®, Rilasmid®, Nylon 12, or a combination thereof.
EXAMPLE 411: The delivery catheter of any examples herein, particularly examples 381-410, wherein the stent layer comprises a coil winding and wherein the coil winding extends helically about a longitudinal axis of the delivery catheter.
EXAMPLE 412: The delivery catheter any examples herein, particularly example 411, wherein a length of the coil layer is substantially identical to the first length of the distal tip portion.
EXAMPLE 413: The delivery catheter of any examples herein, particularly examples 411 or 412, wherein a length of the coil layer is less than the first length of the distal tip portion.
EXAMPLE 414: The delivery catheter of any examples herein, particularly examples 411-413, wherein a length of the coil layer is greater than the first length of the distal tip portion.
EXAMPLE 415: The delivery catheter any examples herein, particularly example 414, wherein the coil layer extends into the elongated body portion of the delivery catheter.
EXAMPLE 416: The delivery catheter of any examples herein, particularly examples 411-415, wherein the coil layer comprises a maximum gap/spacing of about 0.25 mm between adjacent turns of the coil winding.
EXAMPLE 417: The delivery catheter any examples herein, particularly example 416, wherein outer surfaces of the adjacent turns of the coil winding contact along a circumferential length of the coil winding.
EXAMPLE 418: The delivery catheter of any examples herein, particularly examples 411-417, wherein the coil winding has a diameter ranging between about 0.003 inches and about 0.010 inches.
EXAMPLE 419: The delivery catheter any examples herein, particularly example 418, wherein the coil winding has a diameter of about 0.004 inches.
EXAMPLE 420: The delivery catheter any examples herein, particularly example 418, wherein the coil winding has a diameter of about 0.008 inches.
EXAMPLE 421: The delivery catheter of any examples herein, particularly examples 411-419, wherein the coil winding has a constant pitch along an entire length of the coil winding.
EXAMPLE 422: The delivery catheter of any examples herein, particularly examples 411-419, wherein the coil winding has a pitch varying along an entire length of the coil winding.
EXAMPLE 423: The delivery catheter any examples herein, particularly example 422, wherein the pitch of the coil winding at a proximal end of the distal tip portion is less than a pitch of the coil winding at a distal end of the distal tip portion.
EXAMPLE 424: The delivery catheter of any examples herein, particularly examples 411-423, wherein the coil winding has between about 55 and 120 turns per inch.
EXAMPLE 425: The delivery catheter of any examples herein, particularly examples 411-424 wherein the coil winding comprises at least one of a polymer, a metal, or a composite material.
EXAMPLE 426: The delivery catheter any examples herein, particularly example 425, wherein the coil winding comprises a stainless-steel wire.
EXAMPLE 427: The delivery catheter of any examples herein, particularly examples 411-426, wherein the coil winding has a rectilinear or curvilinear shape in cross section.
EXAMPLE 428: The delivery catheter of any examples herein, particularly examples 411-427, wherein the coil layer is coupled to the outer jacket along the distal tip portion of the delivery catheter.
EXAMPLE 429: The delivery catheter any examples herein, particularly example 428, wherein the outer jacket is reflowed together with the coil layer.
EXAMPLE 430: The delivery catheter of any examples herein, particularly examples 381-410, wherein the stent layer comprises a hypotube having a proximal end, a distal end, an inner surface, an outer surface, and a plurality of cut-outs that extend between the inner surface and the outer surface of the hypotube such that the hypotube can bend omnidirectionally.
EXAMPLE 431: The flexible delivery catheter any examples herein, particularly example 430, wherein each of the plurality of cut-outs are disposed in circumferential rows along an axial length of the hypotube.
EXAMPLE 432: The flexible delivery catheter any examples herein, particularly example 431, wherein the hypotube comprises cut-outs along a majority of its axial length.
EXAMPLE 433: The flexible delivery catheter of any examples herein, particularly examples 431-432, wherein a first distal-most row of the rows of cut-outs is offset from the distal end of the hypotube by about 3.8 mm (about 0.150 inches).
EXAMPLE 434: The flexible delivery catheter of any examples herein, particularly examples 431-433, wherein each row comprises at least two cut-outs.
EXAMPLE 435: The flexible delivery catheter of any examples herein, particularly examples 431-434, wherein each row comprises at least four cut-outs.
EXAMPLE 436: The flexible delivery catheter of any examples herein, particularly examples 431-435, each of the plurality of cut-outs in the same row are distributed symmetrically about the circumference of the hypotube.
EXAMPLE 437: The flexible delivery catheter of any examples herein, particularly examples 431-436, wherein each of the plurality of cut-outs in the same row are distributed asymmetrically about the circumference of the hypotube.
EXAMPLE 438: The flexible delivery catheter of any examples herein, particularly examples 431-437, wherein the plurality of cut-outs in a row are circumferentially offset from the plurality of cut-outs in an adjacent row.
EXAMPLE 439: The flexible delivery catheter of any examples herein, particularly examples 430-438, wherein each of the plurality of cut-outs comprises a circumferential slit and a semicircular hole.
EXAMPLE 440: The flexible delivery catheter any examples herein, particularly example 439, wherein each of the plurality of cut-outs is configured to assist in relieving stress during bending of the hypotube.
EXAMPLE 441: The flexible delivery catheter of any examples herein, particularly examples 430-440, wherein each of the plurality of cut-outs comprises a circumferential slit and a semicircular hole provided at a circumferential end of the slit.
EXAMPLE 442: The flexible delivery catheter of any examples herein, particularly examples 430-441 wherein each of the plurality of cut-outs comprises a circumferential slit and semicircular holes provided at each circumferential end of the slit.
EXAMPLE 443: The flexible delivery catheter of any examples herein, particularly examples 439-442, wherein a radius of the semicircular hole ranges between about 0.1000 mm (about 0.004 inches) and about 0.765 mm (about 0.030 inches).
EXAMPLE 444: The flexible delivery catheter of any examples herein, particularly examples 439-443, wherein a radius of the semicircular hole is about 0.1524 mm (about 0.006 inches).
EXAMPLE 445: The flexible delivery catheter of any examples herein, particularly examples 439-444, wherein each of the slits has a circumferential length ranging between about 3.0 mm and about 4.0 mm.
EXAMPLE 446: The flexible delivery catheter of any examples herein, particularly examples 439-445, wherein each of the slits has a circumferential length of about 3.3 mm (about 0.130 inches).
EXAMPLE 447: The flexible delivery catheter of any examples herein, particularly examples 439-446, wherein each of the slits has an axial width ranging between about 0.010 mm (about 0.0004 inches) and about 0.025 mm (about 0.0010 inches).
EXAMPLE 448: The flexible delivery catheter of any examples herein, particularly examples 439-447, wherein each of the slits has an axial width of about 0.018 mm (about 0.0007 inches).
EXAMPLE 449: The flexible delivery catheter of any examples herein, particularly examples 439-448, wherein the hypotube has a thickness ranging between about 0.127 mm (about 0.0050 inches) and about 0.254 mm (about 0.0100 inches).
EXAMPLE 450: The flexible delivery catheter of any examples herein, particularly examples 439-449, wherein the hypotube has a thickness of about 0.0070 inches.
EXAMPLE 451: The flexible delivery catheter of any examples herein, particularly examples 439-450, wherein the hypotube has an outer diameter ranging between about 0.3000 inches and about 0.2000 inches.
EXAMPLE 452: The flexible delivery catheter of any examples herein, particularly examples 439-451, wherein the hypotube has an outer diameter of about 0.2030 inches.
EXAMPLE 453: The flexible delivery catheter of any examples herein, particularly examples 439-452, wherein the hypotube has an inner diameter ranging between about 0.1000 and about 0.2000 inches.
EXAMPLE 454: The flexible delivery catheter of any examples herein, particularly examples 439-453, wherein the hypotube has an inner diameter of about 0.1890 inches.
EXAMPLE 455: The flexible delivery catheter of any examples herein, particularly examples 439-454, wherein an overall length of the hypotube is less than an overall length of the distal tip portion of the delivery catheter.
EXAMPLE 456: The flexible delivery catheter of any examples herein, particularly examples 439-455, wherein an overall length of the hypotube ranges between about 10.5 inches and about 11.5 inches.
EXAMPLE 457: The flexible delivery catheter of any examples herein, particularly examples 439-456, wherein an overall length of the hypotube ranges is about 11.0 inches.
EXAMPLE 458: The flexible delivery catheter of any examples herein, particularly examples 381-457 wherein the inner and outer barrier layers extend along a majority of the length of the stent layer.
EXAMPLE 459: The flexible delivery catheter of any examples herein, particularly examples 381-458, wherein the inner and outer barrier layers are not provided at a length of the stent layer extending proximally from the distal end of the stent layer such that the distal end of the stent layer is fixedly attached to the outer jacket.
EXAMPLE 460: The flexible delivery catheter of any examples herein, particularly example 459, wherein the distal end of the stent layer is fixedly coupled at the distal end of the delivery catheter within the outer jacket.
EXAMPLE 461: The flexible delivery catheter any examples herein, particularly example 459 or 460, wherein the length of the stent layer extending proximally from the distal end of the stent layer that does not comprise the inner and/or the outer barrier layers is from about 0.25 inch to about 0.5 inches.
EXAMPLE 462: The flexible delivery catheter of any examples herein, particularly examples 381-461, wherein the inner and outer barrier layers are not provided at a length of the stent layer extending distally from the proximal end of the stent layer such that the proximal end of the stent layer is fixedly attached to the outer jacket.
EXAMPLE 463: The flexible delivery catheter any examples herein, particularly example 462, a length of the stent layer extending distally from the proximal end of the stent layer that does not comprise the inner and/or the outer barrier layer, is from about 0.25 inches to about 0.4 inches.
EXAMPLE 464: The flexible delivery catheter of any examples herein, particularly examples 381-463, wherein the inner and outer barrier layers comprise a polymer.
EXAMPLE 465: The flexible delivery catheter any examples herein, particularly example 464, wherein the polymer is polyethylene terephthalate (PET) or expanded polytetrafluoroethylene (e-PTFE).
EXAMPLE 466: The flexible delivery catheter of any examples herein, particularly examples 430-462, wherein the inner and outer barrier layers comprise silicone.
EXAMPLE 467: The flexible delivery catheter any examples herein, particularly example 466, wherein the inner and outer barrier layers are spray coated.
EXAMPLE 468: The flexible delivery catheter of any examples herein, particularly examples 381-465, wherein the inner and outer barrier layers have a thickness ranging between about 0.0001 inches and about 0.005 inches.
EXAMPLE 469: The flexible delivery catheter of any examples herein, particularly examples 381-466, wherein the inner and outer barrier layers have a thickness of about 0.0005 inches.
EXAMPLE 470: The flexible delivery catheter of any examples herein, particularly examples 431-469, further comprising a tie layer, provided abut the inner surface of the stent layer.
EXAMPLE 471: The flexible delivery catheter any examples herein, particularly example 470, wherein the tie layer extends along a portion of a length of the inner surface of the stent layer.
EXAMPLE 472: The flexible delivery catheter any examples herein, particularly example 470, wherein the tie layer extends along the length of the inner surface of the stent layer.
EXAMPLE 473: The flexible delivery catheter of any examples herein, particularly examples 470-472, wherein the outer jacket is reflowed together with the tie layer.
EXAMPLE 474: The flexible delivery catheter of any examples herein, particularly examples 470-473, wherein the tie layer has a thickness ranging between about 0.002 inches and about 0.005 inches.
EXAMPLE 475: The flexible delivery catheter of any examples herein, particularly examples 470-474, wherein the tie layer comprises a polyether block amide.
EXAMPLE 476: The flexible delivery catheter of any examples herein, particularly examples 470-475, wherein the tie layer comprises one of PEBAX®, Vestamid®, or Rilsamid® PA12.
EXAMPLE 477: The flexible delivery catheter of any examples herein, particularly examples 381-476, further comprising a braided layer having a proximal end and a distal end and comprising a plurality of fibers disposed in a braided pattern.
EXAMPLE 478: The flexible delivery catheter any examples herein, particularly example 477, wherein the braided layer is disposed between the outer jacket and the stent layer.
EXAMPLE 479: The flexible delivery catheter any examples herein, particularly example 477 or 478, wherein the braided layer is disposed between the outer jacket and the outer barrier layer.
EXAMPLE 480: The delivery catheter of any examples herein, particularly examples 477-479, wherein the braided layer extends along the length of the distal tip portion.
EXAMPLE 481: The delivery catheter of any examples herein, particularly examples 477-480, wherein a length of the braided layer is greater than a length of the stent layer.
EXAMPLE 482: The delivery catheter of any examples herein, particularly examples 477-481, wherein the braided layer extends along at least a portion of the length of the elongated body portion of the delivery catheter.
EXAMPLE 483: The delivery catheter of any examples herein, particularly examples 477-482, wherein the braided layer does not extend to the distal tip portion of the delivery catheter.
EXAMPLE 484: The delivery catheter of any examples herein, particularly examples 481-483, wherein the braided layer extends along the length of the elongated body portion of the delivery catheter.
EXAMPLE 485: The delivery catheter of any examples herein, particularly example 477-484, wherein the braided layer comprises of a plurality of interwoven fibers.
EXAMPLE 486: The delivery catheter any examples herein, particularly example 485, wherein each of the plurality of interwoven fibers has a diameter ranging between about 0.002 inches and about 0.006 inches.
EXAMPLE 487: The delivery catheter any examples herein, particularly example 486, wherein each of the plurality of interwoven fibers has a diameter of about 0.004″.
EXAMPLE 488: The delivery catheter of any examples herein, particularly examples 485-487, wherein the plurality of interwoven fibers comprises about 10 to about 20 individual fibers.
EXAMPLE 489: The delivery catheter any examples herein, particularly example 488, wherein the plurality of interwoven fibers comprises 16 individual fibers.
EXAMPLE 490: The delivery catheter of any examples herein, particularly examples 477-489, wherein the braided layer has a braid density between about 20 to about 30 picks per inch.
EXAMPLE 491: The delivery catheter of any examples herein, particularly examples 477-490, wherein the braided layer has a braid density varying along the axial length of the catheter.
EXAMPLE 492: The delivery catheter any examples herein, particularly example 491, wherein the braid density of the braided layer is about 25 picks per inch.
EXAMPLE 493: The delivery catheter of any examples herein, particularly examples 477-491, wherein the braided layer comprises of a plurality of interwoven fibers, wherein each of the plurality of interwoven fibers have a rectilinear or curvilinear shape in cross section.
EXAMPLE 494: The delivery catheter of any examples herein, particularly examples 477-492, wherein the braided layer comprises of a plurality of interwoven fibers, and wherein the plurality of interwoven fibers comprises at least one of a polymer, a metal, or a composite material.
EXAMPLE 495: The delivery catheter any examples herein, particularly example 493, wherein the plurality of interwoven fibers comprise stainless steel wire.
EXAMPLE 496: The delivery catheter any examples herein, particularly example 493, wherein the plurality of interwoven fibers comprise a polyester.
EXAMPLE 497: The flexible delivery catheter of any examples herein, particularly examples 477-496, further comprising at least one tensile stiffening fiber for limiting bending of the delivery catheter in a direction opposite a circumferential location of the at least one tensile stiffening fiber.
EXAMPLE 498: The flexible delivery catheter any examples herein, particularly example 497, wherein a length of the at least one tensile stiffening fiber corresponds to the first length of the distal tip portion.
EXAMPLE 499: The flexible delivery catheter of any examples herein, particularly examples 497-498, wherein the length of the at least one tensile stiffening fiber is greater than the first length of the distal tip portion.
EXAMPLE 500: The flexible delivery catheter of any examples herein, particularly examples 497-499, wherein the least one tensile stiffening fiber extends along at least a portion of the second length of the elongated body portion of the delivery catheter.
EXAMPLE 501: The flexible delivery catheter of any examples herein, particularly examples 497-500, wherein the least one tensile stiffening fiber extends along the second length of the elongated body portion of the delivery catheter.
EXAMPLE 502: The flexible delivery catheter of any examples herein, particularly examples 497-501, wherein the at least one tensile stiffening fiber is woven into the braided layer.
EXAMPLE 503: The flexible delivery catheter any examples herein, particularly example 502, wherein the at least one tensile stiffening fiber is woven into a portion of the length of the braided layer.
EXAMPLE 504: The flexible delivery catheter any examples herein, particularly example 503, wherein the at least one tensile stiffening fiber is woven into the braided layer along the length of the braided layer.
EXAMPLE 505: The flexible delivery catheter any examples herein, particularly example 504, wherein the at least one tensile stiffening fiber is not woven into a first portion of the braided layer extending along the distal tip portion of the delivery catheter, and wherein the at least one fiber is woven into a second portion of the braided layer extending along the elongated body portion of the delivery catheter between the distal tip portion and the proximal end the delivery catheter.
EXAMPLE 506: The flexible delivery catheter of any examples herein, particularly examples 497-505, wherein a distal end of the at least one tensile stiffening fiber is fixedly coupled to the distal end of the delivery catheter.
EXAMPLE 507: The flexible delivery catheter of any examples herein, particularly examples 497-506, wherein a distal end of the at least one tensile stiffening fiber is fixedly coupled to the braided layer at the distal end of the braided layer.
EXAMPLE 508: The flexible delivery catheter of any examples herein, particularly examples 497-507, wherein a distal end of the at least one tensile stiffening fiber is fixedly coupled to the outer jacket at the distal end of the outer jacket.
EXAMPLE 509: The flexible delivery catheter of any examples herein, particularly examples 497-508, wherein the at least one tensile stiffening fiber comprises at least one of a polymer, a metal, or a composite material.
EXAMPLE 510: The flexible delivery catheter any examples herein, particularly example 509, wherein the at least one tensile stiffening fiber comprises a polyamide type polymer.
EXAMPLE 511: The flexible delivery catheter any examples herein, particularly example 509 or 510, wherein the at least one tensile stiffening fiber comprises Kevlar.
EXAMPLE 512: The flexible delivery catheter of any examples herein, particularly examples 497-511, wherein the at least one tensile stiffening fiber comprises a plurality of individual tensile stiffening fibers.
EXAMPLE 513: The flexible delivery catheter any examples herein, particularly example 512, wherein the plurality of individual tensile stiffening fibers are equally spaced around a circumference of the delivery catheter.
EXAMPLE 514: The flexible delivery catheter any examples herein, particularly example 513, wherein the plurality of individual tensile stiffening fibers are spaced around the circumference of the delivery catheter every 60 degrees, 90 degrees, 120 degrees, or every 180 degrees.
EXAMPLE 515: The flexible delivery catheter any examples herein, particularly example 512, wherein the plurality of individual tensile stiffening fibers are irregularly spaced around a circumference of the delivery catheter.
EXAMPLE 516: The flexible delivery catheter of any examples herein, particularly examples 497-515, wherein the at least one tensile stiffening fiber comprises six or less individual tensile stiffening fibers.
EXAMPLE 517: The flexible delivery catheter any examples herein, particularly example 516, wherein the at least one tensile stiffening fiber comprises four or less individual tensile stiffening fibers.
EXAMPLE 518: The flexible delivery catheter any examples herein, particularly example 517, wherein the at least one tensile stiffening fiber comprises one individual tensile stiffening fibers.
EXAMPLE 519: The flexible delivery catheter any examples herein, particularly example 518, wherein the one individual tensile stiffening fiber is located at a neutral axis of the delivery catheter.
EXAMPLE 520: The flexible delivery catheter of any examples herein, particularly examples 470-519, further comprising a liner provided on an inner surface of the tie layer.
EXAMPLE 521: The flexible delivery catheter any examples herein, particularly example 520, wherein the liner extends along a length of the inner surface of the tie layer.
EXAMPLE 522: The flexible delivery catheter of any examples herein, particularly examples 520-521, wherein a length of the liner is greater than the length of the distal tip portion.
EXAMPLE 523: The flexible delivery catheter of any examples herein, particularly examples 520-522, wherein the liner extends along at least a portion of the length of the elongated body portion of the delivery catheter.
EXAMPLE 524: The flexible delivery catheter of any examples herein, particularly examples 381-523, wherein the liner extends along the length of the elongated body portion of the delivery catheter.
EXAMPLE 525: The flexible delivery catheter of any examples herein, particularly examples 381-524, wherein the inner surface of the liner defines a central lumen of the delivery catheter.
EXAMPLE 526: The flexible delivery catheter any examples herein, particularly example 525, wherein the liner is provided along a length of the central lumen of the delivery catheter.
EXAMPLE 527: The flexible delivery catheter of any examples herein, particularly examples 520-526, wherein the liner has a thickness ranging between 0.001 inches and about 0.004 inches.
EXAMPLE 528: The flexible delivery catheter any examples herein, particularly example 527, wherein the liner has a thickness of about 0.002 inches.
EXAMPLE 29: The flexible delivery catheter of any examples herein, particularly examples 520-528, wherein the liner comprises a polymer.
EXAMPLE 530: The flexible delivery catheter any examples herein, particularly example 529 wherein the polymer comprises one of polytetrafluoroethylene (PTFE), PA12 materials, polyether block amide (PEBA), or fluorinated ethylene propylene (FEP).
EXAMPLE 531: A flexible delivery catheter comprising: an outer jacket, having a proximal end, a distal end, an inner surface and an outer surface, and defining a central lumen extending longitudinally between the proximal end and the distal end; a coil layer comprising a coil winding and having a proximal end, a distal end, an inner surface, and an outer surface, wherein the coil winding extends helically about a longitudinal axis of the delivery catheter, a first barrier layer disposed at the inner surface of the coil layer; a second barrier layer disposed at the outer surface of the coil layer; and wherein the coil layer is wound to resist axial compression and tension applied to the delivery catheter, the coil layer facilitates bending of the delivery catheter in a direction away from the longitudinal axis of the delivery catheter, and wherein the coil layer is provided at a distal tip portion of the delivery catheter, wherein the distal tip portion has a first length extending along a length of the delivery catheter from the distal end of the delivery catheter toward the proximal end of the delivery catheter.
EXAMPLE 532: The flexible catheter any examples herein, particularly example 531, further comprising a braided layer having a proximal end and a distal end and comprising a plurality of fibers disposed in a braided pattern, wherein the braided layer is disposed between the outer jacket and the outer barrier layer.
EXAMPLE 533: A flexible delivery catheter comprising: an outer jacket, having a proximal end, a distal end, an inner surface, and an outer surface, and defining a central lumen extending longitudinally between the proximal end and the distal end; a hypotube having a proximal end, a distal end, an inner surface, an outer surface, and a plurality of cut-outs which extend between the inner surface and the outer surface of the hypotube such that the hypotube can bend omnidirectionally, an inner barrier coating layer disposed at at least a portion of the inner surface of the hypotube; an outer barrier coating layer disposed at at least a portion of on the outer surface of the hypotube, and wherein the hypotube is provided at a distal tip portion of the delivery catheter, the distal tip portion extending along a length of the delivery catheter from a distal end of the delivery catheter toward the proximal end of the delivery catheter.
EXAMPLE 534: The delivery catheter any examples herein, particularly example 533, further comprising a braided layer having a proximal end and a distal end and comprising a plurality of fibers disposed in a braided pattern, wherein the braided layer is disposed between the outer jacket and the outer barrier coating layer.
EXAMPLE 535: A method of making a flexible delivery catheter comprising: forming an outer jacket, having a proximal end, a distal end, an inner surface, and an outer surface, and defining a central lumen extending longitudinally between the proximal end and the distal end; forming a stent layer having a proximal end, a distal end, an inner surface, and an outer surface defining a central lumen between the proximal end and the distal end; disposing an inner barrier layer at the inner surface of the coil layer; disposing an outer barrier layer at the outer surface of the coil layer; disposing the coil layer and the inner barrier layer and the outer barrier layer within the central lumen of the outer jacket; and wherein the delivery catheter is omnidirectionally flexible and configured to bend in any direction away from the longitudinal axis of the delivery catheter.
EXAMPLE 536: The method any examples herein, particularly example 535, wherein the stent layer is a coil winding, wherein the coil winding extends helically about a longitudinal axis.
EXAMPLE 537: The method of any one any examples herein, particularly example 536, wherein the coil layer comprises a gap/spacing between adjacent turns of the coil winding.
EXAMPLE 538: The method of either of any examples herein, particularly example 536 or 537, wherein an outer surface of adjacent turns of the coiled winding contact along a circumferential length of the coiled winding.
EXAMPLE 539: The method any examples herein, particularly example 535, wherein the stent layer is a hypotube having a proximal end, a distal end, an inner surface, an outer surface, and a plurality of cut-outs that extend between the inner surface and the outer surface of the hypotube such that the hypotube can bend omnidirectionally.
EXAMPLE 540: The method any examples herein, particularly example 539, wherein the hypotube is provided at a distal tip portion of the delivery catheter, the distal tip portion extending along a length of the delivery catheter from a distal end of the delivery catheter toward the proximal end of the delivery catheter.
EXAMPLE 541: The method of any examples herein, particularly examples 535-540, further comprising forming a braided layer comprising a plurality of wires disposed in a braided pattern and defining a central lumen and disposing such that the stent layer is positioned within the central lumen of the braided layer.
EXAMPLE 542: The method any examples herein, particularly example 541, wherein the braided layer is disposed between the outer jacket and the outer barrier layer.
EXAMPLE 543: The method any examples herein, particularly example 541 or 542, further comprising coupling the outer jacket, the coil layer, and the braided layer together.
EXAMPLE 544: The method of any examples herein, particularly examples 535-543, wherein the outer jacket comprises a plurality of longitudinal segments.
EXAMPLE 545: The method any examples herein, particularly example 544, wherein each of the plurality of longitudinal segments are reflowed together with at least one other longitudinal segment.
EXAMPLE 546: The method of any examples herein, particularly examples 541-545, further comprising coupling a tensile stiffening fiber to the braided layer.
EXAMPLE 547: The method any examples herein, particularly example 546, wherein coupling the tensile stiffening fiber to the braided layer further comprises weaving the tensile stiffening fiber into the braided layer.
EXAMPLE 548: The method of any examples herein, particularly examples 546 or 547, further comprising coupling the tensile stiffening fiber to the outer jacket.
EXAMPLE 549: The method of any examples herein, particularly examples 546-548, wherein the outer jacket has a distal tip, and wherein coupling the tensile stiffening fiber to the outer jacket comprises threading the tensile stiffening fiber through the distal tip of the outer jacket.
This application of a continuation of International Application No. PCT/US2021/058245, filed Nov. 5, 2021, which claims benefit of U.S. Provisional Application No. 63/110,162, filed Nov. 5, 2020, and U.S. Provisional Application Nos. 63/143,507, filed Jan. 29, 2021, the contents of which are incorporated herein by reference in their entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63143507 | Jan 2021 | US | |
| 63110162 | Nov 2020 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2021/058245 | Nov 2021 | US |
| Child | 18142484 | US |
