Intratubular introducer sheath having polymer layers and supporting elements between them

Abstract

To provide an intraluminal introducer sheath and a method for forming the same. [Solution] The introducer sheath includes a first polymer layer, a second polymer layer, and at least two longitudinal support elements positioned between the first and second polymer layers. The longitudinal support elements are configured to provide columnar strength to facilitate the advance of the intraluminal introducer sheath into the blood vessel without substantial longitudinal compression.

Description

Technical Field

[0005] ,

[0006] ,

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 244,688, filed on September 15, 2021, which is hereby incorporated by reference in its entirety.

[0002] The present disclosure generally relates to medical or surgical sheaths. More specifically, the present disclosure relates to a sheath having a structure provided for support.

Background Art

[0003] Current methods for performing medical procedures on the human body often involve the use of catheters and medical devices that are deliverable intravascularly or intraluminally. Non - limiting examples include, for example, stents and stent grafts (self - expanding or otherwise), branched stents and stent grafts, drug - eluting stents, and vascular filters, as well as intravascular delivery of endoprostheses such as intravascular imaging devices.

[0004] ]> Such catheters and other medical devices may enter the body through an opening or incision. In some cases, a medical conduit is inserted through the opening or incision, and the catheter and other medical devices pass through the medical conduit. Such a medical conduit may be referred to as an introducer sheath. In some cases, the introducer sheath is used to navigate through the lumen within the human body, during which part of the introducer sheath may be crimped or crushed as a result of contact with the lumen wall. In such cases, it is desirable for the introducer sheath to include structural support.

Summary of the Invention

[0005] An intraluminal introducer sheath and a method of manufacturing the same are disclosed. [[ID=,30]]

[0006] According to one example ("Example 1"), the intraluminal introducer sheath includes a first polymer layer, a second polymer layer, and at least two longitudinal support elements positioned between the first and second polymer layers and configured to provide columnar strength to facilitate the advance of the intraluminal introducer sheath into the blood vessel without substantial longitudinal compression. The longitudinal support elements are isolated from each other by the first and second polymer layers.

[0007] In another example ("Example 2"), in addition to Example 1, at least two longitudinal support elements are distinct and isolated from one another.

[0008] In another example ("Example 3"), in addition to Example 1 or Example 2, at least two longitudinal support elements include three longitudinal support elements.

[0009] In another example ("Example 4"), in addition to Example 1 or Example 2, at least two longitudinal support elements include four longitudinal support elements.

[0010] In another example ("Example 5"), in the intraluminal introducer sheath of any of the preceding examples, at least two longitudinal support elements are positioned symmetrically around the circumference of the intraluminal introducer sheath.

[0011] In another example ("Example 6"), in addition to any one of Examples 1-4, at least two longitudinal support elements are positioned asymmetrically around the circumference of the intraluminal introducer sheath.

[0012] In another example ("Example 7"), in addition to any of the preceding examples, at least two longitudinal support elements are roughly aligned with the longitudinal axis of the intraluminal introducer sheath.

[0013] In another example ("Example 8"), in addition to any of the preceding examples, the intraluminal introducer sheath has an average wall thickness of less than approximately 1 mm.

[0014] In another example ("Example 9"), in addition to either of the preceding examples, at least one of the first polymer layer or the second polymer layer includes a plurality of sublayers.

[0015] In another example ("Example 10"), in addition to Example 9, at least one of the at least two longitudinal support elements is positioned between two adjacent layers of a plurality of sublayers.

[0016] In another example ("Example 11"), in addition to any of the preceding examples, the first polymer layer is at least partially bonded to the second polymer layer, and the first and second polymer layers completely encapsulate at least two longitudinal support elements.

[0017] In another example ("Example 12"), in addition to any of the preceding examples, an intermediate layer is further included, positioned between the first polymer layer and the second polymer layer, wherein the first and second polymer layers are at least partially bonded to the intermediate layer.

[0018] In another example ("Example 13"), in addition to any of the preceding examples, at least one of the at least two longitudinal support elements is at least partially radiopaque.

[0019] In another example ("Example 14"), in addition to any of the preceding examples, at least two longitudinal support elements are parts of at least one continuous support member.

[0020] In another example ("Example 15"), in addition to any of the preceding examples, at least two longitudinal support elements further include a plurality of inflection points positioned along the length of at least two longitudinal support elements.

[0021] In another example ("Example 16"), in addition to either of the preceding examples, at least one of the first polymer layer or the second polymer layer includes at least one radiopaque mark on its surface.

[0022] According to another example ("Example 17"), a method for forming an intraluminal introducer sheath includes positioning a first polymer layer around a mandrel, subjecting the first polymer layer to a first heat treatment, and positioning at least two longitudinal support elements on the first polymer layer. The longitudinal support elements are isolated from each other by the first and second polymer layers, and the longitudinal support elements provide columnar strength to facilitate the advance of the intraluminal introducer sheath into the blood vessel without substantial longitudinal compression, positioning the second polymer layer around the first polymer layer and the at least two longitudinal support elements, and subjecting the first polymer layer, the second polymer layer, and the at least two longitudinal support elements positioned between the first and second polymer layers to a second heat treatment.

[0023] In another example ("Example 18"), in addition to Example 17, the method further includes positioning an intermediate polymer layer around the first polymer layer before positioning the second polymer layer around the first polymer layer, wherein the intermediate polymer layer is configured to be positioned between the first polymer layer and the second polymer layer.

[0024] In another example ("Example 19"), in addition to Example 17 or Example 18, the method further includes subjecting the at least two longitudinal support elements to a third heat treatment to impart shape to the at least two longitudinal support elements before positioning the at least two longitudinal support elements on the first polymer layer.

[0025] According to another example ("Example 20"), in addition to any one of Examples 17-19, the method further includes applying at least one radiopaque mark on the surface of at least one of the first polymer layer or the second polymer layer.

[0026] The foregoing examples are exactly examples and should not be read as limiting or otherwise narrowing any scope of the concepts of the invention provided by the present disclosure. Although multiple examples are disclosed, other embodiments will become apparent to those skilled in the art from the following "Modes for Carrying Out the Invention" which illustrate and explain the exemplary examples. Therefore, the drawings and the "Modes for Carrying Out the Invention" should be regarded as being essentially non-limiting and essentially exemplary.

Brief Description of the Drawings

[0027] The accompanying drawings are included to provide a further understanding of the present disclosure, are incorporated herein, form a part of this specification, show embodiments, and serve to explain the principles of the present disclosure together with the description herein.

[0028] [Figure 1] It is a cross-sectional side view of an intraluminal introducer sheath according to an embodiment disclosed herein.

[0029] [Figure 2A] It is a cross-sectional front view of an intraluminal introducer sheath according to an embodiment disclosed herein. [Figure 2B] It is a cross-sectional front view of an intraluminal introducer sheath according to an embodiment disclosed herein. [Figure 2C] It is a cross-sectional front view of an intraluminal introducer sheath according to an embodiment disclosed herein. [Figure 2D] It is a cross-sectional front view of an intraluminal introducer sheath according to an embodiment disclosed herein. [Figure 2E] It is a cross-sectional front view of an intraluminal introducer sheath according to an embodiment disclosed herein.

[0030] [Figure 3A] It is a cross-sectional front view of an intraluminal introducer sheath according to an embodiment disclosed herein. [Figure 3B]This is a cross-sectional front view of an intraluminal introducer sheath according to an embodiment disclosed herein. [Figure 3C] This is a cross-sectional front view of an intraluminal introducer sheath according to an embodiment disclosed herein. [Figure 3D] This is a cross-sectional front view of an intraluminal introducer sheath according to an embodiment disclosed herein.

[0031] [Figure 4A] This is a cross-sectional side view of a portion of an intraluminal introducer sheath according to an embodiment disclosed herein. [Figure 4B] This is a cross-sectional side view of a portion of an intraluminal introducer sheath according to an embodiment disclosed herein.

[0032] [Figure 5] This is a flowchart of a method for manufacturing an intraluminal introducer sheath according to embodiments disclosed herein.

[0033] [Figure 6A] This is an elevation view of an intraluminal introducer sheath with support elements according to an embodiment disclosed herein. [Figure 6B] This is an elevation view of an intraluminal introducer sheath with support elements according to an embodiment disclosed herein. [Figure 6C] This is an elevation view of an intraluminal introducer sheath with support elements according to an embodiment disclosed herein. [Figure 6D] This is an elevation view of an intraluminal introducer sheath with support elements according to an embodiment disclosed herein. [Modes for carrying out the invention]

[0034] Definitions and Terms This disclosure is not intended to be read restrictively. For example, terms used in this application should be interpreted broadly in the context of the meanings to which terms in the art would be attributed.

[0035] With regard to the terminology of inaccuracy, the terms “about” and “approximately” may be used interchangeably to refer to measurements that include the stated measurement and any measurement that is reasonably close to the stated measurement. A measurement that is reasonably close to the stated measurement deviates from the stated measurement by a reasonably small amount that can be understood and readily confirmed by a person skilled in the art. Such deviations may result from, for example, measurement errors, differences in the calibration of measuring instruments and / or manufacturing equipment, human error in the reading and / or setting of measurements, fine-tuning done to optimize performance and / or structural parameters to account for differences in measurements related to other components, specific implementation scenarios, or inaccurate adjustment and / or manipulation of an object by a person or machine. If it is determined that a person skilled in the art cannot readily grasp the value of such a reasonably small difference, the terms “about” and “approximately” may be understood to mean plus or minus 10% of the stated value.

[0036] The term "without substantial longitudinal compression" is used to refer to the physical properties of a material or component that allow it to withstand a certain range of external forces applied to it while substantially maintaining its original longitudinal length. In some examples, substantially maintaining the original longitudinal length may involve maintaining at least about 75%, 80%, 85%, 90%, 95%, or 99% or more of the original longitudinal length, or any other range or value in between.

[0037] The term "approximately aligned" with respect to a line such as an axis is used to refer to the physical positioning of an object with respect to a defined line or axis. For example, an object is aligned with an axis if it is parallel to the axis, and an object is approximately aligned with an axis if a substantial portion of the object, e.g., at least about 80%, 85%, 90%, 95%, or 99% or more of the object is substantially aligned with the axis, where substantially aligned with an axis means that the object is positioned at an angle less than about 10°, less than about 5°, or otherwise within a suitable angle with respect to the axis it is being compared to. Description of various embodiments

[0038] Figure 1 shows a cross-sectional view of a structure 100, which may be in the form of a tube or sheath, particularly an intraluminal introducer sheath, as disclosed herein. The structure 100 includes a first layer or outer layer 102, a plurality of longitudinal support elements or members 104, and a second layer or inner layer 106. The inner layer 106 is also called the base layer. In various examples, as further described herein, each longitudinal support element 104 is isolated from other longitudinal support elements 104 by the first (outer) layer 102 and the second (inner) layer 106, or by (for example, by two of adjacent sublayers) if one or more of the layers 102 and 106 are made of a plurality of smaller or thinner layers (generally referred to herein as “sublayers”). In some examples, the longitudinal support elements 104 are separate and isolated from one another.

[0039] The outer layer 102 is directly or indirectly attached or joined to the inner layer 106, at least partially, such that the support element 104 is completely surrounded or enclosed by the outer layer 102 and the inner layer 106, and therefore the movement of the support element 104 relative to the two layers 102 and 106 is reduced or limited. Attachment or joining can be achieved by a preferred joining method or combination of methods, such as partially melting portions of the first layer 102 and the second layer 106 and thereby joining them together, or by using an adhesive, such as a heat-activated adhesive. In some examples, the support element 104 extends a portion of the length of the structure 100. In some examples, at least one of the support elements 104 may be partially or entirely radiopaque.

[0040] In some examples, the walls of the structure 100 have an average thickness of less than approximately 5 mm, less than 2 mm, less than 1 mm, less than 0.5 mm, less than 0.2 mm, or any other preferred range in between. The wall thickness is defined by the outer layer 102 and the inner layer 106. In some examples, as will be further described herein, the wall thickness may be defined by multiple layers in addition to the aforementioned layers, or the aforementioned layers may be formed from multiple smaller or thinner layers, also called “sublayers”.

[0041] The inner layer 106 defines the shape and size of the lumen or conduit 108 extending through the structure 100. The support elements 104 may be any preferred number, for example, two, three, four, or more. In the example shown, the structure 100 includes two support elements labeled 104A and 104B in the figure. In some examples, the support elements may be made of the same or similar material having the same or similar physical properties. In some examples, the support elements may be made of different material having different physical properties. In some examples, as will be further described below, the support elements may be spaced equally apart circumferentially around the structure, or one or more of the support elements may have different spacings between adjacent support elements.

[0042] The support element 104 is positioned between the outer layer 102 and the inner layer 106 such that the support element 104 provides sufficient columnar strength, allowing the structure 100 to advance into a blood vessel, for example, into a patient's blood vessel, without substantial longitudinal compression. Thus, the support element 104 is made of a material that is less flexible or more easily compressed in the longitudinal direction than the outer layer 102 and the inner layer 106, but which can also alter the configuration of the structure 100 by bending or twisting rather than by compression or crushing, thereby substantially maintaining the structural integrity of the structure 100 and the longitudinal length of the structure 100, which is the length of the structure 100 measured along the longitudinal axis LL of the structure 100.

[0043] In some cases, sufficient columnar strength is determined using stress-strain or compressive force tests to determine the susceptibility of the material to buckling, cracking, or other damage. In some cases, sufficient columnar strength is defined by the ability of the supporting element to maintain at least about 80%, 85%, 90%, 95%, or 99% of the original longitudinal length, or any other range or value in between, in response to an applied force representing the operating conditions, but a variety of values ​​are intended. Regardless of any specific value, columnar strength can be broadly characterized as sufficient to prevent or substantially prevent undesirable creasing or crushing during axial displacement within a blood vessel, while being flexible enough to follow the anatomical structure of a winding blood vessel without significant damage to the blood vessel or device. In some cases, columnar strength may be adjusted or determined based on the polymer layer(s) of the structure and / or the type and / or material of the longitudinal supporting element or member. In some examples, as further disclosed herein, columnar strength can be adjusted by controlling the heat treatment process of the polymer layer so that the layer reaches a desired physical property. In some examples, columnar strength can be determined based on the size, thickness, and / or cross-sectional area / section dimensions of the layers and / or longitudinal support elements or members of the structure.

[0044] In some examples, the support element is a flat wire whose width is greater than the wire's thickness. In some examples, the support element 104 is a round wire, or a wire with other cross-sectional shapes such as square, rectangular, oval, or polygonal. In some examples, the support element is substantially linear and extends along the direction defined by the longitudinal axis of the structure. In some examples, the support element has a curved or bent configuration, but is still roughly aligned with the longitudinal axis of the structure.

[0045] Figure 2A shows an example of the structure 100 as viewed from the direction of the arrow on line AA in Figure 1, where line AA shows a cross-section of the structure 100 cut perpendicular to the longitudinal axis LL. The support elements 104A and 104B may be positioned opposite each other in the structure 100 such that the support elements are located approximately 180 degrees apart from each other.

[0046] Figure 2B shows a structure 100 in another example, which has three support elements 104A, 104B, and 104C. The support elements may be positioned to be equally spaced and distributed along the perimeter of the structure 100, for example, such that the support elements are located approximately 120° apart from each other, but various other angular displacements are intended.

[0047] Figure 2C shows a structure 100 in another example, which has four support elements 104A, 104B, 104C, and 104D. The support elements may be positioned such that one pair of support elements are positioned opposite each other, and another pair of support elements are positioned opposite each other at a different position than the first pair of support elements. Thus, in some examples, the support elements are positioned approximately 90° apart from each other. Additional implementations of the structure 100 with more than four support elements may exist.

[0048] Figures 2A to 2C show examples where the support elements are positioned symmetrically (e.g., mirror symmetry or rotational symmetry) around the outer circumference or circumference of the structure 100. Figure 2D shows an example where the support elements are positioned asymmetrically around the outer circumference or circumference of the structure 100. Specifically, support elements 104A and 104B are positioned such that the distance between the support elements, measured along the circumference of the structure 100, is shorter on one side than on the other, thereby causing asymmetry in such a configuration.

[0049] Figure 2E shows another example in which the support elements are asymmetrical with respect to each other, and one support element 104A has a different shape or size from the other support element 104B. Support element 104A may have a wider or narrower width, a longer or shorter length, or a generally different shape or configuration from the other support element 104B, for example.

[0050] Figure 3A shows an intermediate layer 300 between the outer layer 102 and the inner layer 106, such that the intermediate layer 300 provides the ability to adhesively or tack-bond the outer layer 102 to the inner layer 106. The outer surface of the intermediate layer 300 adheres at least partially to the inner surface of the outer layer 102, and the inner surface of the intermediate layer 300 adheres at least partially to the outer surface of the inner layer 106. In some examples, support elements 104A and 104B may be in contact with the outer layer 102, the intermediate layer 300, and the inner layer 106. In some examples, the intermediate layer 300 is made of any suitable thermoactivating adhesive material, such as any suitable type of thermosetting polyester film, or a thermoplastic film, including but not limited to fluorinated ethylene propylene (FEP).

[0051] Layers 102 and 106 are labeled as the “outer layer” and the “inner layer,” respectively, but in some examples, each of these layers is not made from a single layer or single sheet of material, but rather comprises multiple layers, which may be called sublayers, attached together to form a single layer.

[0052] For example, Figure 3B shows an inner layer 106 having two sublayers 302 and 304. The first sublayer 302 is in contact with the support elements 104A and 104B and the outer layer 102, while the second sublayer 304 is in contact only with the first sublayer 302. The sublayers 302 and 304 are attached together, for example, by adhesive or bonding, to form the inner layer 106. In some examples, the second sublayer 304 may be made of a different material than the first sublayer 302.

[0053] For example, Figure 3C shows an outer layer 102 having two sublayers 306 and 308, where the first sublayer 306 is in contact with the support elements 104A and 104B and the inner layer 106, while the second sublayer 308 is in contact only with the first sublayer 306. The sublayers 306 and 308 are attached together, for example, by adhesive or bonding, to form the outer layer 102. In some examples, the second sublayer 308 may be made of a different material than the first sublayer 306.

[0054] In some examples, the outer layer 102 and the inner layer 106 each have two sublayers, forming a structure with a total of four layers. In some examples, the outer layer 102 and / or the inner layer 106 may each have more than two sublayers, for example, three or more sublayers. The sublayers may be made of the same or different materials, may have similar or different physical and / or chemical properties, and / or may have the same or different thicknesses.

[0055] For example, Figure 3D shows a plurality of support elements 104A to 104F, each positioned between two adjacent sublayers, with the outer layer 102 and inner layer 106 each having two sublayers, forming a total of four sublayers 302, 304, 306, and 308. Both support elements 104A and 104B are positioned between sublayers 302 and 306. Both support elements 104C and 104D are positioned between sublayers 302 and 304. Both support elements 104E and 104F are positioned between sublayers 306 and 308. Other additional or alternative layers or sublayers may also be implemented as suitable.

[0056] Figure 4A shows an additional support element 400 that may be implemented with support elements 104A and 104B. The additional support element 400 may be a helical member wrapped around the inner layer 106 to provide radial support in addition to the longitudinal support provided by support elements 104A and 104B. In some examples, the support element 400 may be attached to support elements 104A and 104B at a position where the support elements are in contact with each other. In some examples, the support element 400 may be a continuous extension of support element 104A or 104B, and may be cut, for example, from a continuous or monolithic tubular piece of material (e.g., by laser cutting).

[0057] Figure 4B shows two additional support elements 400 and 402 that may be implemented together with support elements 104A and 104B. Support elements 400 and 402 may be helical members wound around the inner layer 106, for example, such that the first helical support element 400 is wound at a different angle than the second helical support element 402. Support elements 400 and 402 may be attached to support elements 104A and 104B at positions where the support elements are in contact with each other.

[0058] In some examples, radiopaqueness may be implemented on one or more layers or sublayers of a structure or sheath, as disclosed herein. For example, Figure 4A shows radiopaque marks 404 that may be placed on the inner and / or outer surface of an inner layer 106. Marks 404 allow a user (e.g., a surgeon or physician) to see the location of the structure while it is inside a patient, for example, when X-rays or similar radiation are applied. It should be understood that in any number of the marks 404 may be applied at any location on any layer or sublayer in any one or more of the embodiments disclosed herein. In some examples, marks 404 may be formed on the inner or outer surface of a sublayer such that the marks 404 are located between two adjacent layers or sublayers. In some examples, multiple marks 404 may be placed between multiple different pairs of adjacent layers or sublayers. In some examples, different marks 404 placed at different locations may have different distinctive shapes or configurations so as to be distinguishable from one another. In some examples, marks 404 may be applied to any suitable outer or inner surface using a pad printing method. Mark 404 may take the form of dots, polygons, lines, geometric patterns, or any other suitable configuration that allows for easy recognition by the user during use. Mark 404 may be made of any suitable radiopaque material, including but not limited to tungsten.

[0059] Figure 5 shows a process 500 by which the structure 100 can be fabricated or manufactured according to embodiments disclosed herein. In step 502, a material for the base layer (e.g., a strip of polymer such as a film) is wound around or positioned around a mandrel. The material or film may be wound helically such that a portion of the material in one turn of the helix overlaps with another portion of the material in a subsequent turn of the helix, thereby forming an overlapping helical structure.

[0060] In step 504, the base layer is heat-treated while it is being wrapped around the mandrel. The heat treatment can involve any suitable time and temperature to heat the base layer material without reaching its melting point, and then the base layer is cooled in a controlled manner to select the desired physical properties of the base layer.

[0061] In step 506, a separate heat treatment is applied to the support element. This heat treatment has a different temperature and treatment time than the heat treatment in step 504, and is configured to impart a shape to the support element in order to select the desired physical and mechanical properties of the support element.

[0062] In step 508, the longitudinal support elements are positioned around the base layer along the longitudinal direction of the base layer. The longitudinal support elements may be separate from each other and isolated. The longitudinal direction may be defined by a mandrel. The support elements are positioned to be approximately aligned with or substantially parallel to the longitudinal axis of the base layer or mandrel.

[0063] In step 510, another layer of film, also called the second layer of film, is wrapped around the base layer and support elements, applied, or positioned to form the outer layer. In some examples, the film is wound in an overlapping spiral configuration, similar to step 502. In some examples, the film has a different winding angle or number of turns than the spiral configuration assumed by the first layer of film in step 502. In some examples, the thickness or width of the second layer of film may differ from that of the first layer of film forming the base layer.

[0064] In step 512, a heat treatment is applied to bond the second layer of the film forming the outer layer to the first layer of the film forming the base layer, together with support elements positioned between them. Thus, each longitudinal support element may be isolated from the rest of the longitudinal support elements when bonded together by the first (outer) layer and the second (inner) layer, or may be isolated from each other in other ways. In some examples, the heat treatment temperature is selected to partially melt a portion of the first or second layer of the film to bond to the other layer of the film. In some examples, the surface of the first or second layer of the film is treated with a heat-activated adhesive known in the art and maintained at a certain temperature for a period of time during which the adhesive is activated. Thus, the heat treatment activates the adhesive, bonding the two layers together, and then the adhesive crystallizes as it cools, thereby increasing the strength of the material bond.

[0065] In step 514, which is performed after the cooling of the layer has been observed, the product or structure is removed from the mandrel.

[0066] In some examples, the intermediate layer of the film may be positioned around the base layer either before or after step 508. The intermediate layer may contain a heat-activated adhesive to facilitate bonding the two surrounding layers together, as described in step 512. In some examples, steps 502 and / or 510 include applying multiple film layers, which may be made of the same or different materials as appropriate.

[0067] Figures 6A to 6D show a continuous support member 600 made of multiple longitudinal support elements 104 connected together via multiple connecting vertices 602, according to various examples disclosed herein. Thus, according to some examples, the longitudinal support elements 104 form or are part of the continuous support member 600. In some examples, the continuous support member 600 is made from a continuous and single piece of material. For reference, the outer layer 102 is not shown for simplification. In various examples, each of the vertices 602 connects two adjacent longitudinal support elements 104 to form the continuous support member 600. The support member 600 may optionally include any number of individual longitudinal support elements 104, and the shape and configuration of the vertices 602 may vary, for example, being substantially linear, curved, or bent. In some examples, there may be multiple continuous support members 600, each distinct from one another, positioned around the inner layer 106. In some examples, the longitudinal length of a continuous support member 600, measured along the length of the inner layer 106, may differ from the longitudinal length of other continuous support members 600 positioned around the inner layer 106.

[0068] In Figure 6A, the continuous support member 600 has a configuration similar to an elongated square wave, and as shown in Figure 1, it shows at least seven individual support elements 104A to 104G extending along the longitudinal length of the inner layer 106 in a direction substantially parallel to the longitudinal axis LL. In some examples, each of the individual longitudinal support elements 104A to 104G may be sufficiently or substantially parallel to one another. In some examples, the square wave configuration may resemble a trapezoidal shape so that each of the longitudinal support elements 104A to 104G may be inclined relative to one another.

[0069] In Figure 6B, the continuous support member 600 has a configuration that can be described, for example, as meandering, rounded zigzag, wavy, or elongated sinusoidal, and shows at least nine individual support elements 104A to 104I. As shown, the vertices 602 may be substantially curved or rounded, and each of the individual support elements 104A to 104I is slightly inclined to take an angular position with respect to an axis parallel to the longitudinal axis LL of the structure.

[0070] For example, each support element 104B is positioned to extend at an angle (θ) with respect to a line BB that extends parallel to the longitudinal axis LL of the structure, where the value of θ may be any non-zero value less than approximately 20°, less than approximately 15°, less than approximately 10°, less than approximately 5°, less than approximately 3°, less than approximately 1°, or any other value in between. Various additional angle values ​​are contemplated. Similarly, any one or more of the other individual support elements may also be positioned at an angle that may be the same as or different from the angle (θ) of support element 104B.

[0071] As shown in Figure 6C, the continuous support member 600 further includes at least one inflection point 604 along at least one length of each individual longitudinal support element 104. The inflection point(s) 604 may be sinusoidal, wavy, or zigzag in a direction different from the direction in which the longitudinal support element 104 extends. In some examples, each inflection point 604 may take the shape of an S, inverted S, Z, or inverted Z when viewed along the longitudinal axis of the structure. In some examples, the inflection point 604 may extend laterally or perpendicularly to the longitudinal axis of the structure. In some examples, the inflection point 604 is aligned along a specific point or position along the length of the longitudinal support element 104 such that the inflection point 604 is positioned along a straight line across the surface of the inner layer 106.

[0072] In some examples, there may be multiple sets of inflection points 604 (e.g., a first set 604A and a second set 604B as shown) such that all inflection points belonging to a set are positioned along a straight line drawn across the surface of the inner layer 106. In some examples, the two sets 604A and 604B are substantially parallel to each other and / or extend substantially perpendicular to the longitudinal axis. In some examples, if there are more than two sets of inflection points 604, the multiple sets may be positioned at equal intervals along the longitudinal axis of the structure, or alternatively, such that a first distance between the first set and the second set is different from a second distance between the first set and the third set, with the second and third sets positioned on either side of the first set with no other sets in between.

[0073] As shown in Figure 6D, the inflection points 604 may be positioned in an alternating configuration relative to one another, and the positions of the inflection points 604 are distributed over the entire length of the continuous support member 600. In some examples, when the continuous support member 600 is laid out in a straight line rather than along the longitudinal axis (i.e., when the vertices 602 are not bent), the inflection points 604 are positioned at equal intervals along the length of the continuous support member 600 such that two adjacent inflection points 604 share the same distance along the continuous support member 600.

[0074] As disclosed herein, support elements and / or continuous support members may be made of any suitable material such as nitinol (NiTi) and / or other materials such as stainless steel, L605 steel, polymers, MP35N steel, polymer materials, Phynox, Elgiloy, or any other suitable biocompatible material, and combinations thereof may be used as materials for support elements. The superelastic properties and flexibility of NiTi can enhance the conformability of the support elements. Furthermore, NiTi can be morph-fixed to a desired shape; that is, NiTi can be morph-fixed such that the support elements tend to take on a desired shape when the support elements are not constrained, such as when the support elements are deployed from a delivery system.

[0075] In some examples, the support elements may be made of any suitable radiopaque material, including but not limited to platinum or titanium.

[0076] As disclosed herein, any layer or sublayer may be made of a polymer or a combination of polymers. Examples include, but are not limited to, fluoropolymers such as polytetrafluoroethylene (PTFE) polymer or stretched polytetrafluoroethylene (ePTFE) polymer. In some examples, but are not limited to, polyethylene or foamed polyethylene may be used as the biocompatible material for implants.

[0077] In some examples, materials such as, but not limited to, polyester, silicone, urethane, polyethylene terephthalate, another biocompatible polymer, or a combination thereof may be used to form at least a portion of the layer or sublayer. In some cases, bioabsorbable materials, such as bioabsorbable polymers, may be used. In some examples, the material may include Dacron, polyolefin, carboxymethylcellulose cloth, polyurethane, or other woven, nonwoven, or film elastomers.

[0078] Those skilled in the art will readily understand that various aspects of this disclosure can be realized by any number of methods and apparatus configured to perform the intended functions. It should also be noted that the accompanying drawings referenced herein are not necessarily drawn to scale and may be exaggerated to illustrate various aspects of this disclosure, and in this regard, the drawings should not be construed as limiting.

[0079] The devices, methods, and systems shown in the figures disclosed herein are provided as examples of various features of the devices, methods, and systems, and combinations of those illustrated features are clearly within the scope of the invention; however, the examples and their figures do not imply that the inventive concepts provided herein are limited to fewer features, additional features, or alternative features to one or more of those features shown in the figures.

[0080] The invention of this application has been described above in terms of both general and specific embodiments. It will be apparent to those skilled in the art that various modifications and variations can be made in embodiments without departing from the scope of this disclosure. Therefore, this embodiment is intended to encompass such modifications and variations of the invention, provided that they fall within the scope of the appended claims and their equivalents.

Claims

1. It is an intraluminal introducer sheath, The first polymer layer, A second polymer layer, An intraluminal introducer sheath comprising: at least two longitudinal support elements positioned between the first polymer layer and the second polymer layer and configured to provide columnar strength to facilitate the advance of the intraluminal introducer sheath into a blood vessel without substantial longitudinal compression, wherein the longitudinal support elements are isolated from each other by the first polymer layer and the second polymer layer.

2. The intraluminal introducer sheath according to claim 1, wherein the at least two longitudinal support elements are separate and isolated from one another.

3. The intraluminal introducer sheath according to claim 1 or 2, wherein the at least two longitudinal support elements include three longitudinal support elements.

4. The intraluminal introducer sheath according to claim 1 or 2, wherein the at least two longitudinal support elements include four longitudinal support elements.

5. The intraluminal introducer sheath according to any one of claims 1 to 4, wherein the at least two longitudinal support elements are positioned symmetrically around the circumference of the intraluminal introducer sheath.

6. The intraluminal introducer sheath according to any one of claims 1 to 4, wherein the at least two longitudinal support elements are positioned asymmetrically around the circumference of the intraluminal introducer sheath.

7. The intraluminal introducer sheath according to any one of claims 1 to 6, wherein the at least two longitudinal support elements are substantially aligned with respect to the longitudinal axis of the intraluminal introducer sheath.

8. The intraluminal introducer sheath according to any one of claims 1 to 7, wherein the intraluminal introducer sheath has an average wall thickness of less than approximately 1 mm.

9. The intraluminal introducer sheath according to any one of claims 1 to 8, wherein at least one of the first polymer layer or the second polymer layer comprises a plurality of sublayers.

10. The intraluminal introducer sheath according to claim 9, wherein at least one of the at least two longitudinal support elements is positioned between two adjacent layers of the plurality of sublayers.

11. The intraluminal introducer sheath according to any one of claims 1 to 10, wherein the first polymer layer is at least partially bonded to the second polymer layer, and the first polymer layer and the second polymer layer completely enclose the at least two longitudinal support elements.

12. The intraluminal introducer sheath according to any one of claims 1 to 11, further comprising an intermediate layer positioned between the first polymer layer and the second polymer layer, wherein the first polymer layer and the second polymer layer are at least partially bonded to the intermediate layer.

13. The intraluminal introducer sheath according to any one of claims 1 to 12, wherein at least one of the at least two longitudinal support elements is at least partially radiopaque.

14. The intraluminal introducer sheath according to any one of claims 1 to 13, wherein the at least two longitudinal support elements are portions of at least one continuous support member.

15. The intraluminal introducer sheath according to any one of claims 1 to 14, wherein the at least two longitudinal support elements further comprise a plurality of bending points positioned along the length of the at least two longitudinal support elements.

16. The intraluminal introducer sheath according to any one of claims 1 to 15, wherein at least one of the first polymer layer or the second polymer layer includes at least one radiopaque mark on its surface.

17. A method for forming an intraluminal introducer sheath, wherein the method is Positioning the first polymer layer around the mandrel, The first heat treatment is applied to the first polymer layer, Positioning at least two longitudinal support elements on the first polymer layer, wherein the longitudinal support elements are isolated from each other by the first and second polymer layers, and the longitudinal support elements are configured to provide columnar strength to facilitate the advancement of the intraluminal introducer sheath into the blood vessel without substantial longitudinal compression, Positioning the second polymer layer around the first polymer layer and the at least two longitudinal support elements, A method comprising subjecting the first polymer layer, the second polymer layer, and the at least two longitudinal support elements positioned between the first polymer layer and the second polymer layer to a second heat treatment.

18. The method further includes positioning an intermediate polymer layer around the first polymer layer before positioning the second polymer layer around the first polymer layer, wherein the intermediate polymer layer is positioned between the first polymer layer and the second polymer layer. The method according to claim 17, configured as follows.

19. Before positioning the at least two longitudinal support elements on the first polymer layer, the at least two longitudinal support elements are subjected to a third heat treatment to impart a shape to them. The method according to claim 17 or 18, further comprising:

20. Applying at least one radiopaque mark to at least one surface of the first polymer layer or the second polymer layer, A method according to any one of claims 17 to 19, further comprising:

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