Access Graft Systems and Methods

Abstract

A device for supporting an elongated tubular member, the device including a support member having an inner surface defining a receiving cavity, the support member further defining a peripheral opening, the receiving cavity operable to receive the elongated tubular member therein, and the support member operable to place the elongated tubular member in compression about its periphery.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of Provisional Application No. 63 / 320,386, filed March 16, 2022, which is incorporated by reference in its entirety for all purposes.

[0002] Field The present disclosure relates generally to implantable conduits and, more particularly, to devices, systems and methods for providing self-sealing grafts, including implantable grafts. [Background technology]

[0003] background Vascular access grafts are used in patients with conditions that require periodic intraluminal access. For example, patients undergoing dialysis treatment require periodic cannulation of the graft with a dialysis needle that is inserted through the graft wall into the graft cavity that is connected to a system of blood lines that circulate blood between the patient and the dialysis machine. Although vascular access grafts are operable to self-seal, repeated insertions can cause the graft to break down and allow blood to leak from the graft.

[0004] Another difficulty with repeat access can be the process of accessing the lumen of the graft with a needle. Often, the graft may present a relatively small target or surface area into which a medical professional or a patient trained in self-care must insert a needle to access the graft. Failed access requires the needle to be reinserted, causing further discomfort to the patient.

[0005] If the needle is advanced too far and completely penetrates the access graft, another difficulty arises: it is relatively difficult to determine the depth of the access graft and therefore difficult to discern the appropriate depth at which the needle should be inserted into the lumen of the access graft.

[0006] Home self-managed dialysis is currently being developed and is underway. Home and nocturnal dialysis has the potential to significantly improve the quality of life for people undergoing dialysis, but safe and usable equipment is required to allow patients to safely self-treat.

[0007] What is needed are improvements in providing and / or supporting tubular structures for medical procedures. Summary of the Invention

[0008] Abstract According to one example ("Example 1"), a device for supporting an elongated tubular member includes a support member having an inner surface defining a receiving cavity, the support member further defining a peripheral opening, the receiving cavity operable to receive the elongated tubular member therein, and the support member operable to place the elongated tubular member in compression about its periphery.

[0009] According to another example ("Example 2"), further to Example 1, the receiving cavity is adhesively bonded to the elongated tubular member.

[0010] According to another example ("Example 3"), further to examples 1 or 2, the support member includes a material that is resistant to needle puncture under typical forces manually applied by a user.

[0011] According to another example ("Example 4"), in addition to Example 3, the support member includes a bioabsorbable material.

[0012] According to another example ("Example 5"), in addition to any of Examples 1-4, the peripheral opening of the support member is between about 10% and about 90% of the circumference of the elongated tubular member.

[0013] According to another example ("Example 6"), in addition to any of Examples 1-4, the inner surface of the support member exhibits an elliptical cross-section.

[0014] According to another example ("Example 7"), in addition to any of Examples 1 to 4, the inner surface of the support member exhibits a circular cross-section.

[0015] According to another example ("Example 8"), in addition to any of Examples 6-7, the support member is operable to maintain a cross-sectional area of ​​the elongated tubular member the same inside and outside the receiving cavity.

[0016] According to another example ("Example 9"), in addition to any of Examples 1-8, the support member has two opposing arms defining a peripheral opening, the two opposing arms being interconnected by a body comprising a material having a durometer hardness lower than a durometer hardness of the body.

[0017] According to another example ("Example 10"), in addition to any of Examples 8-9, the two opposing arms apply a compressive force to the elongated tubular member.

[0018] According to another example ("Example 11"), in addition to any of Examples 9-10, the two opposing arms are formed from a shape memory material.

[0019] According to another example ("Example 12"), in addition to Example 11, the shape memory material is Nitinol.

[0020] According to another example ("Example 13"), in addition to any of Examples 9-12, the body is thicker than the two opposing arms.

[0021] According to another example ("Example 14"), further to any of Examples 1-13, the support member includes a plurality of segments along a longitudinal length operable to facilitate bending of the elongated tubular member when positioned with the support member.

[0022] According to another example ("Example 15"), in addition to example 14, the multiple segments are individual elements.

[0023] According to another example ("Example 16"), further to Example 14, the plurality of segments are a unitary member forming the support member, the support member including an extension portion extending between adjacent segments, the extension portion including a low profile operable to facilitate bending.

[0024] According to another example ("Example 17"), in addition to any of Examples 14 to 16, the plurality of segments facilitate bending of the elongated tubular member.

[0025] According to another example ("Example 18"), the support member is puncture resistant.

[0026] According to another example ("Example 19"), in addition to any of Examples 1-17, the support member is operable to place the tubular member in compression.

[0027] According to another example ("Example 20"), in addition to any of Examples 1 to 5, the method further includes a location device operable to magnetically couple to the support member, the location device defining a donut hole through which a needle can be inserted.

[0028] According to another example ("Example 21"), in addition to Example 20, the location device includes indicators around the donut hole, the indicators indicating different positions of needle insertion.

[0029] According to another example ("Example 22"), a method of assembling a support member of any of Examples 1-7 onto an elongated tubular member includes overlapping the support member and the elongated tubular member and applying a compressive force to the tubular member, wherein a diameter of the support member within the overlap is smaller than a diameter of the support member prior to applying the overlap.

[0030] According to another example ("Example 23"), the overlapping occurs after applying an adhesive coupling to the support member and the elongated tubular member and allowing the adhesive to cure.

[0031] According to another example ("Example 24"), a method of assembling a support member of any of Examples 1-7 onto an elongated tubular member includes stretching the tubular member to narrow an outer diameter of the elongated tubular member for receipt within a receiving cavity of the support member, the receiving cavity of the support member having a diameter smaller than an outer diameter of the tubular member when the tubular member is not in a compressed state.

[0032] According to another example ("Example 25"), a method of assembling the support member of Example 24 onto an elastomeric tubular member includes deflecting the arms away from the body to enlarge a peripheral opening operable to receive the tubular member within a receiving cavity.

[0033] According to another example ("Example 26"), an AV access graft includes an elongate tubular member defining a lumen, and an elongate support member defining a receiving cavity and defining a peripheral opening, the receiving cavity operable to receive the elongate tubular member therein, and the elongate support member operable to place the tubular member in a circumferential compressed state.

[0034] According to another example ("Example 27"), further to example 26, the receiving cavity is operable to receive an adhesive for bonding the elongated tubular member within the receiving cavity.

[0035] According to another example ("Example 28"), in addition to any of Examples 25-26, the elongated tubular member is an artery or a vein.

[0036] According to another example ("Example 29"), in addition to any of Examples 25-26, the elongated tubular member is a biological material, a synthetic material, or a combination thereof.

[0037] According to another example ("Example 30"), further to any of Examples 25-28, the elongated tubular member in circumferential compression is operable to recover and seal after being punctured with a 14 gauge, 15 gauge, 16 gauge, or 17 gauge needle.

[0038] According to another example ("Example 31"), in addition to any of Examples 25 to 28, the outer dimension of the elongated tubular member when in a circumferentially compressed state is in the range of about 1% to about 10% of the outer dimension of the elongated tubular member when not in a circumferentially compressed state.

[0039] According to another example ("Example 32"), in addition to any of Examples 25-28, the elongated tubular member includes an elliptical cross-section along at least a portion of the elongated tubular member, and the elongated tubular member is supported by the support member.

[0040] According to another example ("Example 33"), in addition to any of Examples 25-31, the support member is an elongated C-shaped clip.

[0041] According to another example ("Example 34"), an AV access graft includes an elastomeric elongate tubular member including a first longitudinal portion having an elliptical cross-section and resisting deformation along the first longitudinal portion such that the elliptical cross-section of the first longitudinal portion is maintained when exposed to biological forces when implanted within the body.

[0042] According to another example ("Example 35"), in addition to Example 34, the elastomeric elongate tubular member includes a stiffening layer on the first longitudinal portion.

[0043] According to another example ("Example 36"), in addition to Example 34, the elastomeric elongate tubular member includes a shape memory layer on the first longitudinal portion.

[0044] According to another example ("Example 37"), in addition to Example 34, the elastomeric elongate tubular member is treated to include an elliptical cross-section at the first longitudinal portion.

[0045] According to another example ("Example 38"), in addition to Example 37, the elastomeric elongate tubular member is heat set to include an elliptical cross-section at a first longitudinal portion.

[0046] According to another example ("Example 39"), in addition to Example 34, the elastomeric elongate tubular member includes an integral brace member at a first longitudinal portion, the brace member providing an elliptical cross-section.

[0047] According to another example ("Example 40"), further to Examples 34-39, the elastomeric elongate tubular member at the first longitudinal portion includes a first elongate portion and a second elongate portion and defines an elliptical cross-section, and the first elongate portion is operable to self-seal after puncture.

[0048] According to another example ("Example 41"), in addition to Examples 34 to 39, the second elongated portion is reinforced to resist puncture.

[0049] According to another example ("Example 42"), an AV access graft includes an elongate tubular member including a first longitudinal portion having an integral support member about a portion of the circumference of the elastomeric elongate tubular member of the first longitudinal portion.

[0050] According to another example ("Example 43"), further to Example 42, the one-piece support member comprises a higher durometer hardness at the first longitudinal portion than a remainder of a circumference of the elongated tubular member.

[0051] According to another example ("Example 44"), in addition to any of Examples 42-43, the elongated tubular member is a fluoropolymer.

[0052] According to another example ("Example 45"), in addition to any of Examples 42-44, the elongated tubular member comprises a circular profile.

[0053] According to another example ("Example 46"), in addition to any of Examples 42-45, the elongated tubular member comprises an elliptical profile.

[0054] According to another example ("Example 47"), further to Example 46, the integral support member at least partially imparts an elliptical profile to the elongated tubular member.

[0055] According to another example ("Example 48"), in addition to any of Examples 42-47, the elongated tubular member is self-sealing.

[0056] According to another example ("Example 49"), in addition to any of Examples 42-48, the support member is adhered or bonded to the elongated tubular member.

[0057] According to another example ("Example 50"), in addition to any of Examples 42-49, the elongated tubular member is formed from a single layer of material.

[0058] According to another example ("Example 51"), in addition to Example 50, the support member is a densified region of the elongated tubular member.

[0059] According to another example ("Example 52"), in addition to any of Examples 42-50, the support member is disposed about 25% of the circumference of the elongated tubular member at the first longitudinal position.

[0060] According to another example ("Example 53"), in addition to any of Examples 42-51, the elongate tubular member is free of the support members at each end of the elastomeric elongate tubular member.

[0061] According to another example ("Example 54"), in addition to any of Examples 42-53, the integral support member is a stiffening layer.

[0062] According to another example ("Example 55"), in addition to any of Examples 42-54, the one-piece support member is a tubular member and supports a majority of the length of the elongated tubular member.

[0063] According to another example ("Example 56"), a device for supporting a tubular member includes a segmented support member including a plurality of longitudinal segments, the segmented support member having an inner surface defining a receiving cavity operable to be engageable with a tubular member therein, each longitudinal segment of the plurality of longitudinal segments at least partially surrounding a portion of the tubular member.

[0064] According to another example ("Example 57"), in addition to Example 56, each longitudinal segment of the plurality of longitudinal segments is an individual element and is spaced apart from one another.

[0065] According to another example ("Example 58"), in addition to Example 57, the segmented support member is substantially rigid and the tubular member is able to bend due to the longitudinal segments being spaced apart.

[0066] According to another example ("Example 59"), in addition to Example 58, a distance between each longitudinal segment in the plurality of longitudinal segments determines a degree of bending of the tubular member.

[0067] According to another example ("Example 60"), further to Example 58, each longitudinal segment in the plurality of longitudinal segments contacts an adjacent longitudinal segment along an inner bend when the tubular member is bent.

[0068] According to another example ("Example 61"), in addition to any of Examples 56-60, the tubular member is adhered or bonded within the receiving cavity.

[0069] According to another example ("Example 62"), in addition to any of Examples 56-61, the tubular member bends along a length of the tubular member upon engagement with the segmented support member.

[0070] According to another example ("Example 63"), in addition to any of Examples 56-62, the segmented support segment is puncture resistant.

[0071] According to another example ("Example 64"), in addition to any of Examples 56-63, each longitudinal segment in the plurality of longitudinal segments is connected to one another by an extension portion.

[0072] According to another example ("Example 65"), in addition to Example 64, the extension portion is integral with the segmented support member.

[0073] According to another example ("Example 66"), in addition to Example 64, the extension portion is bonded or adhered to the segmented support member.

[0074] According to another example ("Example 67"), in addition to any of Examples 64 to 66, the extension portion positions each longitudinal segment in the plurality of longitudinal segments at a constant distance from an adjacent longitudinal segment when in a neutral orientation.

[0075] According to another example ("Example 68"), in addition to any of Examples 64-67, the extension portion is operable to bend or deflect to facilitate bending of the tubular member.

[0076] According to another example ("Example 69"), in addition to any of Examples 64-68, the extension portion is made from a shape memory material including Nitinol.

[0077] According to another example ("Example 70"), in addition to any of Examples 64-69, the extension portion has a low profile to facilitate bending of the tubular member.

[0078] According to another example ("Example 71"), in addition to any one of Examples 64-70, the segmented support member is operable to place the tubular member in longitudinal compression.

[0079] The foregoing examples are merely examples and should not be construed as limiting or narrowing the scope of any of the inventive concepts provided by this disclosure. While multiple examples have been disclosed, still other embodiments will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative examples. Accordingly, the drawings and detailed description should be regarded as illustrative in nature and not restrictive. [Brief description of the drawings]

[0080] BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings are included to provide a further understanding of the disclosure, and are incorporated in and constitute a part of this specification, illustrate embodiments and, together with the description, serve to explain the principles of the disclosure.

[0081] [Figure 1] FIG. 1 is an illustration of a device including a tubular member supported by a support member, according to an embodiment.

[0082] [Diagram 2] FIG. 2 is an end view of a support member having an elliptical profile, according to an embodiment.

[0083] [Diagram 3] FIG. 3 is a perspective view of a support member having an elliptical profile, according to an embodiment.

[0084] [Figure 4] FIG. 4 is an end view of a support member having a circular profile, according to an embodiment.

[0085] [Diagram 5] FIG. 5 is an end view of a support member having a thick body compared to the arms of the support member, according to an embodiment.

[0086] [Figure 6] FIG. 6 is an end view of needle access to a lumen of a tubular member supported by a support member, according to an embodiment.

[0087] [Figure 7] FIG. 7 is a top view of needle access to a lumen of a tubular member supported by a segmented support member, according to an embodiment.

[0088] [Figure 8] FIG. 8 is a perspective view of a tubular member supported by a segmented support member, according to an embodiment.

[0089] [Figure 9]FIG. 9 is a top view of a support member supported by a segmented support member, where the tubular member includes a bend, according to an embodiment.

[0090] [Figure 10A] FIG. 10A is a side view of a support member including segments joined together by extensions, according to an embodiment.

[0091] [Figure 10B] FIG. 10B is a perspective view of a support member including segments joined together by extensions, according to an embodiment.

[0092] [Figure 10C] FIG. 10C is a bottom view of a support member including segments including chevron shaped configurations, according to an embodiment.

[0093] [Figure 11] FIG. 11 is a perspective view of a tubular member including an integral support member, according to an embodiment.

[0094] [Figure 12] FIG. 12 is a cross-sectional view of a tubular member having an integral support member, according to an embodiment.

[0095] [Figure 13] FIG. 13 is a cross-sectional view of a tubular member having an integral support member disposed on an exterior surface of the tubular member, according to an embodiment.

[0096] [Figure 14] FIG. 14 is a cross-sectional view of a tubular member having an integral support member disposed on an interior surface of the tubular member, according to an embodiment.

[0097] [Figure 15] FIG. 15 is a perspective view of a tubular member having an integral support member disposed at a first longitudinal position, where the tubular member is free of a support member along at least a portion of the tubular member, according to an embodiment.

[0098] [Figure 16] FIG. 16 is a cross-sectional view of a tubular member having an integral support member disposed around less than 50% of the circumference of the tubular member, according to an embodiment.

[0099] [Figure 17] 17A and 17B are cross-sectional views of overlapped devices according to an embodiment.

[0100] [Figure 18] FIG. 18 is an exemplary method of manufacturing a device, according to an embodiment.

[0101] [Figure 19] FIG. 19 is an illustration of a location determining device that assists in determining the location of an implantable device when it is implanted in a patient, according to an embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0102] Detailed Description Definitions and Terminology The present disclosure is not to be construed in a limiting sense, for example, the terms used in this application should be interpreted broadly in the context of the meaning that one of ordinary skill in the art would give such terms.

[0103] With respect to the term imprecision, the terms "about" and "approximately" may be used interchangeably to refer to measurements that include the stated measurement and also measurements that are reasonably close to the stated measurement. Measurements that are reasonably close to the stated measurement deviate from the stated measurement by a reasonably small amount, as understood and readily ascertained by one of ordinary skill in the relevant art. Such deviations may result, for example, from measurement errors, differences in calibration of measuring and / or manufacturing equipment, human error in reading and / or setting measurements, small adjustments made to optimize performance and / or construction parameters to account for differences in measurements associated with other components, specific implementation scenarios, imprecise adjustment and / or manipulation of objects by humans or machines, and / or the like. In cases where it is determined that such reasonably small difference values ​​are not readily identifiable by one of ordinary skill in the relevant art, the terms "about" and "approximately" may be understood to mean plus or minus 10% of the stated value.

[0104] Description of Various Embodiments Those skilled in the art will readily appreciate that the various aspects of the present disclosure may be implemented by any number of methods and devices 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 the present disclosure, and in that regard, the drawings should not be construed as limiting.

[0105] The device shown in FIG. 1 is provided as an example of various features of one embodiment of the device, and while combinations of these illustrated features are clearly within the scope of the invention, the examples and the illustrations are not intended to suggest that the inventive concepts provided herein are limited to one or more of the features illustrated in FIG. 1, from fewer, additional, or alternative features.

[0106] 1, device 10 is provided for repeated and repeatable intraluminal access. For example, intravenous access may be required for procedures such as dialysis that require repeated access at an access site. Device 10 supports the access site to limit leakage after a single puncture or multiple punctures and, in some embodiments, facilitates access by providing an increased surface area that can be implemented to provide intraluminal access.

[0107] In some embodiments, the device 10 includes a support member 12 and a tubular member 14. The support member 12 is operable to support the tubular member 14 in a particular configuration and / or compression state to increase the surface area of ​​the target site and / or limit leakage of the tubular member 14 during and after puncture. The support member 12 may be separate from the tubular member 14 for attachment onto the tubular member 14 (e.g., removable, attached after manufacture, etc.) or may be provided integrally with the tubular member 14 (formed together, inseparably secured, etc.). Each embodiment (i.e., separate and integral support member 12 and tubular member 14) is described in more detail herein.

[0108] With continued reference to FIG. 1 , the illustrated embodiment shows a support member 12 that partially surrounds and provides structural support to a tubular member 14. The tubular member 14 can take a variety of forms, such as a graft, a synthetic vessel, a natural vessel, etc. The support member 12 can be used to support the tubular member 14 for a variety of purposes, including, but not limited to, arterial venous access ("AV access"), e.g., repeated access such as dialysis. Although the device 10 has been described in detail with respect to AV access, the device 10 is also contemplated and discussed with respect to other purposes.

[0109] In some embodiments, including the embodiment shown in FIG. 1, the support member 12 is an elongated C-shaped clip (see also FIG. 3, which illustrates the elongated nature of the support member 12). The support member 12 has an inner surface 22 and an outer surface 26 that define a receiving cavity 24. The inner surface 22 includes a concave profile and the outer surface includes a convex profile. As shown, the inner surface 22 and the outer surface 26 are curved to have concave and convex profiles, however, it is within the scope of the present disclosure that the inner and outer surfaces are not curved or are not generally curved to generally provide concave and convex profiles (e.g., are instead formed from straight line segments). The receiving cavity 24 is operable to receive the tubular member 14 such that the tubular member 14 is disposed and held within the receiving cavity 24 and positioned against the inner surface 22 of the support member 12.

[0110] 3, the support member 12 includes a peripheral opening 28 that provides access to the receiving cavity 24 of the support member 12. In some embodiments, the peripheral opening 28 extends along the entire longitudinal length of the support member 12, and the tubular member 14 can be advanced into the receiving cavity 24 by threading the tubular member 14 through the peripheral opening 28. This allows the tubular member 14 to remain intact while in place with the support member 12. This can be important when the tubular member 14 is a natural vessel or an implanted graft, thus eliminating the need to thread the end of the tubular member 14 through the support member 12. To thread the end of the tubular member 14 through the support member 12, the tubular member 14 must be bisected.

[0111] The width 30 of the peripheral opening 28 of the support member 12 is smaller than the inner dimension 32 of the receiving cavity 24 (e.g., the widest portion of the inner diameter of a non-circular profile, here representing the distance between opposing surfaces of the inner surface, see FIG. 2). This allows the support member 12 to surround the tubular member 14 by more than 180 degrees and less than 360 degrees when the tubular member 14 is disposed within the receiving cavity 24. For example, when the tubular member 14 is mounted within the support member 12, the support member 12 can surround the tubular member 14 by about 190 degrees to about 215 degrees, about 215 degrees to about 240 degrees, about 240 degrees to about 265 degrees, about 265 degrees to about 290 degrees, and about 290 degrees to about 325 degrees. The width 30 of the peripheral opening 28 may be larger in some embodiments and smaller in other embodiments. The gripping force (and compressive force, described below) of the support member 12 may be greater when the width 30 of the peripheral opening 28 is relatively small than in embodiments in which the width 30 of the peripheral opening 28 is larger. For example, the gripping force may be increased by increasing the width of the peripheral opening 28 and decreased by increasing the width of the peripheral opening 28.

[0112] In some embodiments, the support member 12 is sized such that the inner circumference of the support member 12 (including the width 30 of the peripheral opening 28) is smaller than the outer circumference of the tubular member 14. By sizing the inner circumference of the support member 12 smaller than the outer circumference of the tubular member 14, the tubular member is placed in a compressed state (e.g., compressed around the tubular member 14) when the tubular member 14 is engaged with the support member 12. The compression reduces leakage and facilitates resealing of the tubular member 14 during and after a puncture (e.g., a needle puncture for dialysis). The compression causes the faces of the opening created by the puncture to return to contact with each other, which helps prevent or reduce leakage of fluid from the puncture. The amount of compression can be altered by adjusting the relative circumferences of the support member 12 and the tubular member 14. Greater compression can be achieved by narrowing the width 30 of the peripheral opening 28 to bring the tubular member 14 into greater contact with the inner surface 22 of the support member 12 (e.g., compression can be increased by narrowing the width of the peripheral opening 28). A narrower width 30 of the peripheral opening 28 can limit the protrusion of the tubular member 14 from the support member 12 at the peripheral opening 28, reducing compression of the tubular member 14 including the portion that protrudes outwardly from the peripheral opening 28. Thus, a narrower width 30 can be used to increase compression of the tubular member 14 using a tubular member 14 with a larger outer diameter.

[0113] In some embodiments, the circumferential opening 28 of the elongate support member 12 is about 10% to about 90% of the circumference of the support member 12. In some embodiments, the circumferential opening 28 of the elongate support member 12 is about 25% to about 75% of the circumference of the support member 12. In embodiments in which the circumferential opening 28 is greater than 50% of the circumference of the support member 12, the compression of the elongate support member 12 can be a localized compression. For example, the elongate support member 12 can include compressed pores (e.g., microscopic pores), but the elongate tubular member 14 is not compressed around the entire circumference. In embodiments in which the circumferential opening 28 is less than 50% of the circumference of the support member 12, the compression of the elongate support member 12 can be a global compression. For example, the elongate support member 12 can be compressed around the entire circumference. In some embodiments, the width 30 of the circumferential opening 28 defines a cannulation area of ​​the device 12 (e.g., in embodiments used for cannulation, such as for hemodialysis). This may also define the cannulation angle 31 of the device 10, which is the angle at which cannulation access to the tubular member 14 is achieved (see FIG. 1).

[0114] In some embodiments, the support member 12 comprises a material that is substantially resistant to needle puncture under typical manual force applied by a user. This limits the movement of the needle through the device 10. For example, the tubular member 14 may be punctured for intraluminal access at the peripheral opening 28 of the support member 12, but the body of the support member 12 is not penetrated by the needle, thereby limiting movement through the other side of the tubular member. This limits the possibility that the user may extend the needle completely through the tubular member 14, resulting in excessive bleeding, delivery of fluids outside the lumen of the tubular member 14, inefficient absorption of fluids from the lumen of the tubular member 14, etc. One embodiment showing a needle 1000 with limited movement through the support member 12 is shown in FIG. 6. The support member 12 comprises a material (e.g., Nitinol) that is resistant to needle puncture. Note that the needle 1000 can puncture a portion of the back of the tubular member 14, but is constrained from moving beyond it by the support member 12. Thus, the lumen or bore of the needle 1000 is in fluid communication with the lumen of the tubular member 14, and fluid may be delivered to and / or received by the lumen of the tubular member 14. A variety of materials may be implemented to construct the support member 12 to be resistant to needle puncture, including, but not limited to, biocompatible metals, alloys, polymers, and the like.

[0115] In some embodiments, to improve cannulation access, the typically circular cross section of the tubular member 14 can be compressed and constrained to an elliptical or oval shape. Increasing the long axis of the ellipse increases the area that the user (e.g., clinician, phlebotomist, or patient) can target and penetrate. Increasing the long axis reduces the short axis. The smaller short axis decreases the distance that the needle 1000 can be inserted and remain within the lumen of the tubular member 14. Adding a relatively puncture resistant area (e.g., support member 12) opposite the cannulation zone limits the user's ability to pass through the back of the tubular member 14. The combination of ovalization (to increase the cannulation zone) and adding a puncture resistant back wall zone improves graft structure.

[0116] In some embodiments, the support member 12 comprises at least a partially radiopaque material such that the support member 12 may be visualized during delivery, deployment, and use. For example, the support member 12 may be visualized during radiography so that a user attempting to access an artery or vein can visualize the location of the support member 12 and therefore successfully gain access with fewer punctures. Various radiopaque markers may be disposed about the support member 12 and / or tubular member 14 to aid in the delivery and implantation procedure of the device 10.

[0117] 19, in some embodiments, a location device 54 may be implemented in combination with the device 10 to assist in locating, aligning and / or stably holding the device 10. In one embodiment, the device 10 includes a portion 58 (e.g., adjacent the peripheral opening 28 of the support member 12) that has magnetic properties (e.g., is magnetized) or is attracted to a magnet (e.g., is ferromagnetic). The location device 54 may include a donut-shaped magnetic or ferromagnetic material on the outside of the patient (e.g., in the case of dialysis) adjacent the device to magnetically attract (e.g., magnetically couple) the location device 54 and the device 10. When a user (e.g., a professional or a patient in a home dialysis treatment) locates a "target" for inserting the cannulation needle 1000 in the donut hole of the location device 54, the device 10 is located, aligned and / or stably held. In some embodiments, the donut hole of the location device 54 can have indicators 56 (e.g., number / letter markings) around the donut hole of the location device 54 (e.g., similar to an analog clock). The indicators 56 are provided for each day, and the user can find a different indicator for each day (e.g., the Tuesday marking) and insert the needle 1000 next to that indicator 56 to avoid reinserting it in the same place every day.

[0118] In some embodiments, the support member 12 may be formed from a bioabsorbable or bioresorbable material. This allows the support member to be implemented within the user's body for a limited time without a second surgery to remove the support member 12. For example, regular IV access may be required for a limited time. The support member 12 may be implemented for that limited time and slowly resorbed by the patient. The resorption period is timed to ensure that the support member 12 remains structurally sound during the expected period of use.

[0119] 2 and 3, the inner surface 22 of the support member 12 exhibits a substantially elliptical cross-section. In another embodiment, as shown in FIG. 4, the inner surface 22 of the support member 12 exhibits a circular cross-section. It is understood that various other cross-sections can be implemented for various purposes. The inner surface 22 of the support member 12 having the above-mentioned cross-section is operable to keep the cross-sectional area of ​​the tubular member 14 the same inside the receiving cavity 24 and outside the receiving cavity 24. In other words, the inner surface 22 of the support member 12 determines the configuration in which the tubular member 14 is maintained when engaged with the support member 12. The various configurations can provide various functions.

[0120] For example, referring to FIG. 1, the support member 12 includes an inner surface 22 having an elliptical cross section, which places the tubular member 14 in an elliptical shape where the tubular member 14 engages the support member 12. The elliptical shape of the tubular member 14 presents a relatively flat surface (compared to a circular cross section) along the length of the support member at the peripheral opening 28 of the support member 12, since the peripheral opening 28 is defined along the long portion of the ellipse. The relatively flat surface of the tubular member 14 provides an access site for the tubular member 14 that is more easily implemented (e.g., for IV access, including dialysis). The relatively flat profile of the tubular member 14 reduces the likelihood that an access needle will slip off the side of the tubular member 14 (i.e., it is difficult to penetrate the curved surface of the tubular member 14 unless the needle is radially aligned with the circular profile). The flat sidewalls of the tubular member 14 ensure and facilitate access. In other embodiments, a circular profile may be desirable to support the tubular member 14 in a circular profile configuration. For example, natural blood vessels may need to be supported with a circular profile (see FIG. 4). In some embodiments, maintaining the circular profile of the tubular member 14 may provide proper fluid dynamics and resistance to degradation. For example, in some applications, such as dialysis, the tubular member 14 may be placed in a position of high pressure and high velocity relative to the blood flow, and the hemodynamics may be such that the circular profile of the tubular member 14 provides reduced or no disruption to the hemodynamics of the blood vessel. The circular profile of the tubular member 14 may also provide increased longevity of the tubular member 14 during use.

[0121] The support member 12 will be described in more detail with reference to FIGS. 2-5. The support member 12 includes a body portion 40 and an arm portion 42. The arm portion 42 extends from the body portion 40. The arm portions 42 each extend from a portion on either side of the body portion 40 such that each of the arm portions 42 faces each other. The arm portions 42 define a peripheral opening 28 such that access to the receiving cavity 24 is provided between the opposing arm portions 42. The arm portions 42 are curved, whereby the arm portions 42 and the body portion 40 define the receiving cavity 24. In some embodiments, the body portion 40 may also be curved (see FIGS. 2 and 3), and in some embodiments, the body portion 40 is substantially flat (see FIG. 6). In some embodiments, the arm portions 42 include a material having a durometer hardness lower than the durometer hardness of the body portion 40. This allows the arm portions 42 to provide a deflection feature to facilitate insertion of the tubular member 14 into the receiving cavity 24. Once the tubular member 14 is placed in the receiving cavity 24, the arm portions 42 return to an undeflected configuration, even if they deflect during insertion of the tubular member 14. The arm portions 42 can provide a compressive force to the tubular member 14 (e.g., due to compression as described above). In some embodiments, at least the arm portions 42 are formed from a shape memory material, such as Nitinol. By including a shape memory material, the arm portions 42 can provide a greater compressive force. In some embodiments, the entire support member 12 is formed from a shape memory material and provides a compressive force to the tubular member 14 around a majority of the circumference of the tubular member 14.

[0122] 5, in some embodiments, body portion 40 is thicker than arm portion 42. This can allow arm portion 42 to bend more while at the same time allowing body portion 40 to more reliably retain the shape of support member 12. Also, the relatively thicker body portion 40 can provide enhanced durability as a needle backstop. In some embodiments, bending of arm portion 42 can facilitate bending in multiple bending planes.

[0123] It will be appreciated that the support member 12 can provide additional support to the tubular member 14 to reduce kinking of the tubular member 14 during the implant procedure, which can result in undesirable hemodynamics and can also cause the tubular member 14 to kink during the implant procedure. By supporting the tubular member 14 with the support member 12, the tubular member 14 is held in a manner that reduces the risk of kinking of the tubular member 14.

[0124] 7-10, in some embodiments, the support member 12 is segmented to include a plurality of longitudinal segments 50. Each of the longitudinal segments 50 is operable to at least partially surround a portion of the tubular member 14. The longitudinal segments 50 are operable to facilitate bending of the elongated tubular member 14 when positioned with the support member 12. When mounted on the tubular member 14, each of the longitudinal segments 50 are spaced apart from one another. By including a plurality of longitudinal segments 50 and spaced apart from one another, the tubular member 14 is operable to bend at least partially along the length where it engages with the support member 12. This allows the support member 12 to be implanted at a location with a bend or curve in the patient's anatomy. FIG. 8 illustrates a tubular member 14 with a support member 12 coupled thereto, where the support member 12 is segmented and the tubular member 14 is positioned in a bent configuration. Because the various longitudinal segments 50 are spaced apart from one another, the tubular member 14 can be manipulated to bend even though the support member 12 is substantially rigid. In some embodiments, as described above, the support member 12 can include a shape memory material (e.g., Nitinol) that provides flexibility to the support member 12 while also making the support member 12 resistant to puncture (e.g., rigid in at least one plane so as to be resistant to puncture by a needle 1000). The bending of the support member 12 can be in a single bending plane or in multiple bending planes. As seen in FIG. 8, the concave surface of the curved portion of the bent tubular member 14 positions the arm portions 42 on the concave surface closer to the adjacent segments on the concave surface than the arm portions 42 on the convex surface are positioned on the adjacent segments. The spacing of the various longitudinal segments 50 can be slightly less than the outer diameter of a 12, 13, 14, 15, 16, 17, 18, 19, or 20 gauge needle. This limits the ability of the needle to pass through the space between the longitudinal segments.

[0125] 8 and 9, the longitudinal segments 50 can be separate from each other (e.g., the longitudinal segments 50 are individual elements). In this embodiment, each of the longitudinal segments can be attached to the tubular member 14 separately. The longitudinal segments 50 can be spaced apart from each other by any distance determined by the user. The distance between each longitudinal segment 50 can be sufficient to impart a particular curvature to the tubular member 14 when the support member 12 is attached to the tubular member 14. When the tubular member 14 includes or is implanted with a larger curvature, the longitudinal segments 50 can be spaced apart from each other by a greater distance than if a smaller curvature is desired, and the smaller curvature allows the longitudinal segments 50 to be positioned closer together. In some embodiments, when the tubular member 14 includes or is imparted with a curvature, portions of adjacent longitudinal segments 50 contact each other on the inside of the curve, while the longitudinal segments 50 are spaced apart from each other on the outside of the curve.

[0126] In other embodiments, such as those shown in FIGS. 10A and 10B , the longitudinal segments 50 may be coupled to one another by extensions 52 (e.g., a plurality of longitudinal segments 50 are a unitary member forming the support member 12, the support member 12 including extensions extending between adjacent longitudinal segments). The extensions 52 may be integrally formed with each longitudinal segment 50, or the extensions 52 may be coupled to the longitudinal segments 50 (e.g., welded, bonded, operable to receive, etc.). The extensions 52 position the longitudinal segments 50 at a fixed distance from one another when in a neutral orientation. The extensions 52 are operable to bend or flex to facilitate bending of the tubular member 14. In some embodiments, the bending or flexing of the extensions 52 is along a single bending plane (e.g., bending along the extensions 52). The extensions 52 may be formed from a variety of materials, including materials capable of both plastic and elastic deformation. For example, the extension portion 52 may be formed from Nitinol to facilitate bending of the support member 12. The use of Nitinol or other sufficiently elastic and / or rigid material may also make the extension portion 52 resistant to puncture (e.g., puncture by the needle 1000). In some embodiments, the thickness of the material of the extension portion 52 is less than the thickness of the longitudinal segment 50, thus allowing the support member 12 to bend or flex at the extension portion 52 (e.g., the extension portion 52 includes a low-profile profile operable to facilitate bending). As shown in FIGS. 10A and 10B, the extension portion 52 may extend from the body portion 40 of an adjacent longitudinal segment, such that the arm portion 42 remains free from the extension portion 52. In some embodiments, the support member 12 is operable to place the tubular member 14 in longitudinal compression. In some embodiments, the support member 12 may be manufactured by densifying an expanded material such as ePE or ePTFE, by 3D printing (eg, PE), or by machining, casting or molding.

[0127] Various configurations of the longitudinal segments 50 can be provided, including as shown in FIG. 10C. Various configurations can be implemented to accommodate various functions including bending profile (e.g., radius of curve or curvature in a single plane). For example, FIG. 10B shows longitudinal segments 50 including a nesting pattern in which the longitudinal segments 50 are chevron shaped. Extensions may or may not be implemented to connect each of the longitudinal segments 50 having this configuration. In some embodiments, the support member 12 can include different gap widths between the longitudinal segments 50. This can be along the length of the body of the support member 12 or can be on a particular side in particular (e.g., to facilitate bending in one direction).

[0128] The method of assembling the support member 12 onto the tubular member 14 includes elongating the tubular member 14 to narrow an outer diameter of the tubular member 14 to be received within a receiving cavity 24 (e.g., a C-shaped clip) of the support member 12, where the receiving cavity 24 of the support member 12 has a diameter smaller than an outer diameter of the tubular member 14 when the tubular member 14 is in an uncompressed state. In some embodiments, the outer dimension of the tubular member 14 when in a compressed state is in a range of 0.1% to about 10% of an outer dimension of the elongated tubular member when in an uncompressed state. In some embodiments, the method includes deflecting the arm portion 42 away from the body portion 40 and enlarging a peripheral opening 28 operable to allow the tubular member 14 to be received within the receiving cavity 24.

[0129] In some embodiments, the tubular member 14 can be a natural blood vessel (e.g., an artery or vein of a patient) and the support member is disposed around the natural blood vessel to support the natural blood vessel. In some embodiments, the tubular member 14 is formed from a biological material (e.g., autograft, cadaveric graft, etc.). In some embodiments, the tubular member 14 is formed from a synthetic material. Any of the materials used can be materials operable to seal after needle puncture. The recovery and resealability of the tubular member 14 can be enhanced by the support member 12 holding the tubular member 14 in a compressed state to recover from a needle puncture (e.g., a 12 gauge needle).

[0130] 11 , in some embodiments, an AV access graft 100 is provided that includes an elastomeric elongate tubular member 102 that includes a first longitudinal portion 104 having an elliptical cross-section and is resistant to deformation along the first longitudinal portion 104 such that the elliptical cross-section of the first longitudinal portion 104 is maintained when exposed to biological forces when implanted within the body. In some embodiments, the tubular member 102 is treated to include an elliptical cross-section at the first longitudinal portion 104. In some embodiments, the elongate tubular member 102 is heat set to include an elliptical cross-section at the first longitudinal portion 104.

[0131] 12, in some embodiments, the tubular member 102 includes an integral support member 106 at the first longitudinal portion 104. In some embodiments, the tubular member 102 is processed to include an elliptical cross-section. In some embodiments, the elongated tubular member 102 is heat set to include an elliptical cross-section at the first longitudinal portion 104. In some embodiments, the integral support member 106 is a stiffening layer. The stiffening layer is operable to provide support to hold a predetermined shape and can also be operable to provide a stop to resist needle puncture when a needle is placed within the lumen of the elongated tubular member 102 and / or to provide tactile feedback. The stiffening layer includes a durometer hardness sufficient to prevent needle puncture from the back side of the tubular member 102 (e.g., a maximum of about 10 Shore D or Mohs hardness). In some embodiments, the integral support member 106 is a layer that is thermally bonded, chemically bonded, bonded, or otherwise attached to the tubular member 102. The layer can be on the exterior surface (see FIG. 13), the interior surface (see FIG. 14), or can be disposed through the full thickness of the tubular member 102 along a portion of the circumference of the tubular member 102 (see FIG. 12).

[0132] FIG. 15 illustrates a tubular member 102 including an integral support member 106 in a first longitudinal portion 104 (e.g., the tubular member 102 can include a supported portion for needle access and a non-supported portion), with the integral support member 106 absent from at least a second and third longitudinal portions 108, 109 of the tubular member 102. In some embodiments, the first longitudinal portion 104, where the integral support member 106 supports the tubular member 102, can include a majority of the length of the tubular member. For example, the integral support member 106 can include approximately 40 cm of a 45 cm tubular member. However, the integral support member 106 can be provided along any portion or the entire length of the tubular member 102. In some embodiments, the tubular member 102 is absent the support member 106 at both ends of the tubular member 102. This allows the surgeon to cut the tubular member 102 to the desired length and angle without having to cut the support member 12. For scenarios in which the device 10 is implemented for cannulation, the support member 12 may be implemented in the cannulation zone, but can be considered optional in other areas.

[0133] The support member 106 can impart an at least partially elliptical cross-section. In some embodiments, the tubular member 102 includes a first elongate portion 110 and a second elongate portion 112 at the first longitudinal portion 104, defining an elliptical cross-section, the first elongate portion operable to self-seal after puncture. In some embodiments, the second elongate portion 112 is reinforced to be resistant to puncture. It is understood that various other cross-sectional profiles can be implemented. For example, a circular cross-section can be implemented, the circular cross-section being at least partially imparted and maintained by the integral support member 106. As shown in FIG. 15, the support member 106 is disposed about 75% or 270 degrees around the tubular member 102. It is understood that in various embodiments, the support member 106 can be disposed about various portions of the tubular member 102. For example, the support member 102 may be positioned around 180-350 degrees of the tubular member 102 (e.g., from about 180 degrees to about 225 degrees, from about 225 degrees to about 270 degrees, from about 270 degrees to about 315 degrees, and from about 315 degrees to about 350 degrees). Providing more support areas on the tubular member 102 reduces the likelihood that the needle will pass behind the tubular member 102 during puncture. The ovalized configuration allows for easier access to unsupported areas, as discussed above.

[0134] The device 10 can transition from substantially circular to substantially elliptical at multiple longitudinal locations along the length of the device 10. For example, the tubular member 102 can be circular at one end, then gradually transition to a first elliptical shape, then gradually transition to a second elliptical shape, then gradually transition to a circular shape at the other end. The two elliptical regions are cannulation regions (e.g., for AV access). The user can feel these regions (through the skin) to know where the elliptical portions of the device 10 are. In some embodiments, the internal cross-sectional area of ​​the device 10 (e.g., the cross-sectional area of ​​the lumen) remains constant as the device 10 transitions between various cross-sectional shapes. This limits flow interruption and thrombus formation at the transition regions.

[0135] 16, another embodiment of a tubular member 102 is provided in which a support member 106 is disposed around less than about 50% of the circumference of the tubular member 102. Although a peripheral profile of the tubular member 102 is shown, it is understood that any number of configurations for disposing the support member 106 around less than about 50% of the circumference of the tubular member 102 can be implemented. It is also understood that the various configurations described above for disposing the integral support member 106 at a location on a portion of the circumference of the tubular member 102, including on the inner surface, outer surface, or full thickness of the tubular member, can be implemented with respect to disposing the support member 106 around less than about 50% of the circumference of the tubular member 102. For example, the support member 102 can be disposed around 10 to 180 degrees of the tubular member 102 (e.g., about 10 degrees to about 45 degrees, about 45 degrees to about 90 degrees, about 90 degrees to about 135 degrees, and about 135 degrees to about 180 degrees). By providing a support member over less than 50% of the circumference of the tubular member 102, the surface area for accessing the lumen of the tubular member 102 is increased while still providing a backstop to reduce needle punctures from the back side of the tubular member 102.

[0136] 17A and 17B, a device 10 is shown including a tubular member (e.g., tubular member 14 or tubular member 102) according to any of the embodiments discussed herein and a support member (e.g., support member 12 or integral support member 106) according to any of the embodiments discussed herein. The support member 12 and the tubular member 14 are bonded together via an adhesive 200. An overwrap 202 can be applied over the assembly. The overwrap 202 can provide a compressive force (indicated by the arrows in FIG. 17B) to the tubular member (in some embodiments, the compressive force is increased in addition to the compressive force provided by the support member). Before applying the overwrap 202, the device 12 can include a first diameter 204 along the longitudinal axis. After applying the overwrap 202, the device 12 can include a second diameter 206 along the longitudinal axis. In this case, the second diameter 206 is smaller than the first diameter 204. This occurs due to the compressive force provided by the overwrap 202.

[0137] As previously mentioned, the embodiments discussed herein may be implemented in a variety of contexts and are not limited to the specific embodiments described herein. For example, the use of the device 10 for cannulation (e.g., hemodialysis) has been described at length. However, other applications, such as use at anastomotic surfaces, are also applicable and the description herein is not limited to cannulation. For example, increasing the hardness of the device at the anastomotic site may reduce suture hole bleeding, as the increased durometer hardness reduces suture hole bleeding. Another example may involve attachment of the support member 12 to a native blood vessel. For example, the support member 12 may be attached in a location where the blood vessel is compressed by other anatomical structures competing for the same space in the body. This occurs, for example, in May-Thurner syndrome, where the left iliac vein is compressed by the right iliac artery. Compression of the left iliac vein may lead to deep vein thrombosis. The support member 12 may be implanted externally to the blood vessel (e.g., the left iliac vein) to restore blood flow and / or function to the blood vessel.

[0138] 18, a method of manufacturing device 10 is provided that includes manufacturing a luminal graft component (e.g., elongate tubular member 14), manufacturing a support component (e.g., support member 12), assembling the graft and support components with an adhesive (e.g., any suitable elastomeric adhesive), curing the adhesive, overwrapping the subassembly with a film (e.g., a film suitable for extraluminal use), and trimming, sterilizing and packaging the device.

[0139] In any of the embodiments described herein, the tubular member 102 can include a variety of materials and compositions, including biocompatible materials operable to self-seal after puncture. Such materials can be implemented, for example, when intravenous access is required immediately after the tubular member 102 is implanted. Other biocompatible materials operable to promote tissue ingrowth can be implemented so that the tissue can provide a sealing capability after sufficient tissue is incorporated into the material. Materials can be selected for various properties, such as durability, durometer, thickness, etc., to optimize the tubular member for its application (e.g., high flow rates, implant longevity, low implant profile, etc.). In some embodiments, the tubular member 102 is formed from a single layer of material.

[0140] Biocompatible materials for the tubular member components described herein can be used. In certain cases, the graft can include a fluoropolymer, such as polytetrafluoroethylene (PTFE) polymer or expanded polytetrafluoroethylene (ePTFE) polymer. In some examples, the graft can be formed from, but is not limited to, polyester, silicone, urethane, polyethylene terephthalate, fluorinated ethylene propylene, polyethylene (PE), expanded polyethylene (ePE), or other biocompatible polymers, or combinations thereof. In some examples, bioresorbable or bioabsorbable materials can be used, such as bioresorbable or bioabsorbable polymers. In some examples, the graft can include Dacron, polyolefin, carboxymethylcellulose fabric, polyurethane, or other woven, nonwoven, or film elastomers. Biological grafts have also been implemented, including, but not limited to, bovine carotid arteries or lab-grown blood vessels.

[0141] It will be appreciated that in some embodiments, the support member can include a surface texture to either promote tissue ingrowth or to preclude tissue incorporation. This can be accomplished in a variety of ways, including, but not limited to, providing a smooth surface, a textured surface, a porous surface, a treated surface, etc.

[0142] In some embodiments, the tubular members and support members of any of the embodiments described herein can be provided in a straight or curved configuration. The curved configuration can provide a stress-free condition upon implantation when the device is deployed in at least one curve (e.g., as an arteriovenous graft).

[0143] Additionally, Nitinol (NiTi) can be used as the material for the frame or stent (and any of the frames described herein), although other materials can be used as the material for the frame, including but not limited to stainless steel, L605 steel, polymers, MP35N steel, polymeric materials, Pyhnox, Elgiloy, or other suitable biocompatible materials and combinations thereof. The superelastic properties and flexibility of NiTi can enhance the conformability of the stent. Additionally, NiTi can be shape-set into a desired shape, i.e., NiTi can be shape-set such that when the frame is unconstrained, such as when it is deployed from a delivery system, the frame tends to self-expand into a desired shape.

[0144] The invention of this application has been described above generally and with reference to specific embodiments. It is apparent to those skilled in the art that various modifications and variations can be made to the embodiments without departing from the scope of the disclosure. Therefore, the embodiments are intended to cover the modifications and variations of the present invention provided they fall within the scope of the appended claims and their equivalents.

Claims

1. 1. A device for supporting an elongated tubular member, the device including a support member having an inner surface defining a receiving cavity, the support member further defining a peripheral opening, the receiving cavity operable to receive the elongated tubular member therein, and the support member operable to place the elongated tubular member in compression about its periphery.

2. The device of claim 1 , wherein the receiving cavity is adhesively bonded to the elongated tubular member.

3. The device of claim 1 , wherein the support member comprises a material that is resistant to needle puncture under forces typical of those manually applied by a user.

4. The device of claim 3 , wherein the support member comprises a bioabsorbable material.

5. The device of any one of claims 1 to 4, wherein the peripheral opening of the support member is between about 10% and about 90% of the circumference of the elongated tubular member.

6. The device of any one of claims 1 to 4, wherein the inner surface of the support member presents an elliptical cross-section.

7. The device of any one of claims 1 to 4, wherein the inner surface of the support member presents a circular cross-section.

8. The device of any one of claims 6 to 7, wherein the support member is operable to maintain a cross-sectional area of ​​the elongated tubular member the same inside the receiving cavity and outside the receiving cavity.

9. 9. The device of claim 1, wherein the support member has two opposing arms defining a peripheral opening, the two opposing arms being interconnected by a body, the body comprising a material having a durometer hardness lower than a durometer hardness of the body.

10. The device of claim 8 , wherein the two opposing arms apply a compressive force to the elongated tubular member.

11. A device according to any one of claims 9 to 10, wherein the two opposing arm portions are formed from a shape memory material.

12. The device of claim 11 , wherein the shape memory material is Nitinol.

13. The device of any one of claims 9 to 12, wherein the body is thicker than the two opposing arms.

14. The device of any one of claims 1 to 10, wherein the support member includes a plurality of segments along its longitudinal length operable to facilitate bending of the elongated tubular member when positioned with the support member.

15. The device of claim 14 , wherein the plurality of segments are individual elements.

16. 15. The device of claim 14, wherein the plurality of segments are a unitary member forming the support member, the support member including an extension portion extending between adjacent segments, the extension portion including a low profile operable to facilitate bending.

17. The device of any one of claims 14 to 16, wherein the plurality of segments facilitate bending of the elongated tubular member.

18. The device of any one of claims 14 to 17, wherein the support member is puncture resistant.

19. The device of any preceding claim, wherein the support member is operable to place the tubular member in compression.

20. The device of any preceding claim, further comprising a location device operable to magnetically couple to the support member, the location device defining a donut hole through which a needle can be inserted.

21. The device of claim 15 , wherein the location device includes indicators around the donut hole, the indicators indicating different positions of needle insertion.

22. 8. A method of assembling a support member according to any one of claims 1 to 7 onto an elongated tubular member, comprising overlapping the support member and the elongated tubular member and applying a compressive force to the tubular member, wherein a diameter of the support member within the overlap is smaller than a diameter of the support member prior to application of the overlap.

23. 20. The method of assembling a support member of claim 17, wherein overlapping occurs after applying an adhesive coupling to the support member and the elongated tubular member and allowing the adhesive to cure.

24. 8. A method of assembling a support member as claimed in any one of claims 1 to 7 onto an elongated tubular member, comprising stretching the tubular member to narrow an outer diameter of the elongated tubular member for receipt within a receiving cavity of the support member, the receiving cavity of the support member having a diameter smaller than the outer diameter of the tubular member when the tubular member is not in a compressed state.

25. 24. A method of assembling a support member as described in claim 23 onto an elastomeric tubular member, the method including deflecting the arms away from the body to enlarge a peripheral opening operable to receive the tubular member within a receiving cavity.

26. an elongate tubular member defining a lumen; and an elongated support member defining a receiving cavity and defining a peripheral opening; Including, The receiving cavity is operable to receive the elongate tubular member therein, and the elongate support member is operable to place the tubular member in circumferential compression.

27. 26. The AV access graft of claim 25, wherein the receiving cavity is operable to receive an adhesive for bonding the elongated tubular member within the receiving cavity.

28. The AV access graft of any one of claims 25 to 26, wherein the elongated tubular member is an artery or a vein.

29. The AV access graft of any one of claims 25 to 26, wherein the elongate tubular member is made of a biological material, a synthetic material, or a combination thereof.

30. 29. The AV access graft of any one of claims 25 to 28, wherein the elongate tubular member in a circumferentially compressed state is operable to recover and seal after being punctured with a 14 gauge, 15 gauge, 16 gauge, or 17 gauge needle.

31. 29. The AV access graft of any one of claims 25 to 28, wherein the outer dimension of the elongated tubular member when in a circumferentially compressed state is in the range of about 1% to about 10% of the outer dimension of the elongated tubular member when not in a circumferentially compressed state.

32. 29. The AV access graft of any one of claims 25 to 28, wherein the elongated tubular member includes an elliptical cross-section along at least a portion of the elongated tubular member, the elongated tubular member being supported by the support member.

33. The AV access graft of any one of claims 25 to 31, wherein the support member is an elongated C-shaped clip.

34. 1. An AV access graft comprising: an elastomeric elongate tubular member including a first longitudinal portion having an elliptical cross-section, the graft resisting deformation along the first longitudinal portion such that the elliptical cross-section of the first longitudinal portion is maintained when exposed to biological forces when implanted within the body.

35. 35. The AV access graft of claim 34, wherein the elastomeric elongate tubular member includes a stiffening layer in the first longitudinal portion.

36. 35. The AV access graft of claim 34, wherein the elastomeric elongate tubular member includes a shape memory layer in the first longitudinal portion.

37. 35. The AV access graft of claim 34, wherein the elastomeric elongate tubular member is processed to include an elliptical cross-section in the first longitudinal portion.

38. 38. The AV access graft of claim 37, wherein the elastomeric elongate tubular member is heat set to include an elliptical cross-section in the first longitudinal portion.

39. 35. The AV access graft of claim 34, wherein the elastomeric elongate tubular member includes an integral brace member at the first longitudinal portion, the brace member providing an elliptical cross-section.

40. 40. The AV access graft of any one of claims 34 to 39, wherein the elastomeric elongate tubular member in the first longitudinal portion includes a first elongate portion and a second elongate portion, defining an elliptical cross-section, the first elongate portion operable to self-seal after puncture.

41. The AV access graft of any one of claims 34 to 39, wherein the second elongate portion is reinforced to resist puncture.

42. An AV access graft comprising an elongate tubular member including a first longitudinal portion, the first longitudinal portion having an integral support member about a portion of a circumference of the elastomeric elongate tubular member of the first longitudinal portion.

43. 43. The AV access graft of claim 42, wherein the unitary support member comprises a higher durometer hardness in the first longitudinal portion than the remainder of the circumference of the elongated tubular member.

44. The AV access graft of any one of claims 42-43, wherein the elongated tubular member is a fluoropolymer.

45. The AV access graft of any one of claims 42 to 44, wherein the elongate tubular member comprises a circular profile.

46. The AV access graft of any one of claims 42 to 45, wherein the elongate tubular member comprises an elliptical profile.

47. 46. ​​The AV access graft of claim 45, wherein the integral support member at least partially imparts an elliptical profile to the elongate tubular member.

48. The AV access graft of any one of claims 42 to 47, wherein the elongate tubular member is self-sealing.

49. The AV access graft of any one of claims 42 to 48, wherein the support member is adhered or bonded to the elongated tubular member.

50. The AV access graft of any one of claims 42 to 48, wherein the elongate tubular member is formed from a single layer of material.

51. 51. The AV access graft of claim 50, wherein the support member is a densified region of the elongate tubular member.

52. The AV access graft of any one of claims 42 to 50, wherein the support member is disposed about 25% of the circumference of the elongated tubular member at a first longitudinal position.

53. The AV access graft of any one of claims 42 to 51, wherein the elongate tubular member is free of the support members at each end of the elastomeric elongate tubular member.

54. The AV access graft of any one of claims 42 to 53, wherein the integral support member is a stiffening layer.

55. The AV access graft of any one of claims 42 to 54, wherein the unitary support member is a tubular member and supports a majority of the length of the elongated tubular member.

56. 1. A device for supporting a tubular member, the device comprising: A device comprising a segmented support member including a plurality of longitudinal segments, the segmented support member having an inner surface defining a receiving cavity operable to be engageable with a tubular member therein, each longitudinal segment of the plurality of longitudinal segments at least partially surrounding a portion of the tubular member.

57. 57. The device of claim 56, wherein each longitudinal segment of the plurality of longitudinal segments is a separate element and is spaced apart from one another.

58. 58. The device of claim 57, wherein the segmented support member is substantially rigid and the tubular member is capable of bending due to the longitudinal segments being spaced apart.

59. 60. The device of claim 58, wherein the distance between each longitudinal segment in the plurality of longitudinal segments determines a degree of bending of the tubular member.

60. 60. The device of claim 58, wherein each longitudinal segment in the plurality of longitudinal segments contacts an adjacent longitudinal segment along an inner bend when the tubular member is bent.

61. The device of any one of claims 56 to 60, wherein the tubular member is glued or bonded within the receiving cavity.

62. The device of any one of claims 56 to 61, wherein the tubular member bends along its length upon engagement with the segmented support member.

63. The device of any one of claims 56 to 62, wherein the segmented support segment is puncture resistant.

64. The device of any one of claims 56 to 63, wherein each longitudinal segment in the plurality of longitudinal segments is connected to one another by an extension portion.

65. 65. The device of claim 64, wherein the extension portion is integral with the segmented support member.

66. 65. The device of claim 64, wherein the extension portion is bonded or adhered to the segmented support member.

67. The device of any one of claims 64 to 66, wherein the extension portion positions each longitudinal segment in the plurality of longitudinal segments at a constant distance from adjacent longitudinal segments when in a neutral orientation.

68. 68. The device of any one of claims 64 to 67, wherein the extension portion is operable to bend or deflect to facilitate bending of the tubular member.

69. The device of any one of claims 64 to 68, wherein the extension portion is made from a shape memory material including Nitinol.

70. The device of any one of claims 64 to 69, wherein the extension portion has a low profile to facilitate bending of the tubular member.

71. The device of any one of claims 64 to 70, wherein the segmented support member is operable to place the tubular member in longitudinal compression.

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