Passage graft systems and methods

Abstract

A device for supporting an elongate tubular member, the device comprising a support member having an interior surface defining a receiving cavity, the support member further defining a peripheral opening wherein the receiving cavity is operable to receive the elongate tubular member therein, the support member being operable to place the elongate tubular member in a compressed state around the periphery.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of Provisional Patent Application No. 63 / 320,386, filed on March 16, 2022, which is incorporated herein by reference in its entirety for all purposes. Technical Field

[0002] The present disclosure relates generally to implantable catheters. More particularly, the present disclosure relates to devices, systems, and methods for providing self-sealing grafts including implantable grafts. Background Art

[0003] Vascular access grafts are used in patients who require periodic intraluminal access (entry into the lumen). For example, patients receiving dialysis treatments require periodic cannulation of the graft with a dialysis needle, which is inserted through the graft wall into the graft lumen, which is connected to the vascular system to enable blood to circulate between the patient and the dialysis machine. Although vascular access grafts can be operated to be self-sealing, repeated entry can damage the graft, causing blood to leak out of the graft.

[0004] Another difficulty with repeated access can be the process of gaining access for the needle into the lumen of the graft. Often, the graft may present a relatively small target or surface area through which a medical professional or a trained patient from a self-administered (self-medicated) treatment must insert the needle to gain access to the graft. Failure to gain access results in the need to reinsert the needle, which can cause further discomfort to the patient.

[0005] Another difficulty arises when the needle is advanced too far and passes completely through the access graft. Determining the depth of an access graft is relatively difficult, so it is difficult to discern the proper depth to which the needle should be inserted into the lumen of the access graft.

[0006] There are current and ongoing developments in home self-administered dialysis. Home and overnight dialysis has the potential to provide significant quality of life improvements for patients undergoing dialysis, however, safe and accessible facilities are necessary to provide patients with the ability to safely self-administer treatment.

[0007] What is needed are improved methods of providing and / or supporting tubular structures for use in medical procedures. Summary of the invention

[0008] According to one example ("Example 1"), a device for supporting a slender tubular member includes a support member having an interior surface defining a receiving cavity, the support member also defining a peripheral opening, wherein the receiving cavity is operable to receive the slender tubular member therein, and the support member is operable to place the slender tubular member in a compressed state around the periphery.

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

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

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

[0012] According to another example (“Example 5”) that is further relative to any one of Examples 1 to 4, the peripheral opening of the support member is about 10% to about 90% of the circumference of the slender tubular member.

[0013] According to another example (“Example 6”) further than any one of Examples 1 to 4, the inner surface of the support member presents an oval cross-section.

[0014] According to another example (“Example 7”) further relative to any one of Examples 1 to 4, an inner surface of the support member presents a circular cross-section.

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

[0016] According to another example ("Example 9") further relative to any one of Examples 1 to 8, the support member has two opposing arms defining a peripheral opening, the two opposing arms are interconnected by a body, and include a material having a lower hardness than the body.

[0017] According to another example (“Example 10”) that is further relative to any one of Examples 8 to 9, two opposing arms apply a compressive force to the elongated tubular member.

[0018] According to another example (“Example 11”) further relative to any one of Examples 9 to 10, the two opposing arm portions are formed of a shape memory material.

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

[0020] According to another example (“Example 13”) further than any one of Examples 9 to 12, the body is thicker than the two opposing arms.

[0021] According to another example ("Example 14") further relative to any one of Examples 1 to 13, the support member includes a plurality of segments along the longitudinal length, which are operable to promote flexure of the slender tubular member when positioned by means of the support member.

[0022] According to another example (“Example 15”) further than Example 14, the plurality of segments are discrete elements.

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

[0024] According to another example ("Example 17") further than any of Examples 14 to 16, the plurality of segments facilitate flexing 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") further than any of Examples 1 to 17, the support member is operable to place the tubular member in a compressed state.

[0027] According to another example ("Example 20") that is further than any one of Examples 1 to 5, it also includes a positioning device that is operable to magnetically connect to a supporting member, the positioning device forming a donut-shaped (ring-shaped) hole through which a needle can be inserted.

[0028] According to another example ("Example 21") further relative to Example 20, the positioning device includes indicators around the perimeter of the donut-shaped hole, indicating different positions for needle insertion.

[0029] According to another example ("Example 22"), a method of assembling a support member according to any one of Examples 1 to 7 to a slender tubular member includes overlapping the support member and the slender tubular member to apply a compressive force to the tubular member, wherein a diameter of the support member in the outer wrapping is smaller than a diameter of the support member before the outer wrapping is applied.

[0030] According to another example ("Example 23"), overwrapping is performed after applying the adhesive, coupling the support member and the elongated tubular member, and curing the adhesive.

[0031] According to another example ("Example 24"), a method of assembling a support member according to any one of Examples 1 to 7 to a slender tubular member includes extending the tubular member to neck the outer diameter of the slender tubular member so as to be received in a receiving cavity of the support member, wherein, when the tubular member is not in a compressed state, the diameter of the receiving cavity of the support member is smaller than the outer diameter of the tubular member.

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

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

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

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

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

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

[0038] According to another example ("Example 31") further than any one of Examples 25 to 28, the outer dimensions of the slender tubular member when in a circumferentially compressed state are in a range of about 1% to about 10% relative to the outer dimensions of the slender tubular member when not in a circumferentially compressed state.

[0039] According to another example ("Example 32") further than any one of Examples 25 to 28, the elongated tubular member includes an oval cross-section along at least a portion of the elongated tubular element, wherein the elongated tubular member is supported by a support member.

[0040] According to another example (“Example 33”) further than any one of Examples 25 to 31, the support member is an elongated C-shaped clamp.

[0041] According to another example ("Example 34"), an AV access graft includes an elastomeric elongated tubular member including a first longitudinal portion having an oval cross-section, and the AV access graft resists deformation along the first longitudinal portion such that the oval cross-section at the first longitudinal portion is retained when exposed to biological forces when implanted in vivo.

[0042] According to another example ("Example 35") further than Example 34, the elastomeric elongated tubular member includes a rigidification layer in the first longitudinal portion.

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

[0044] According to another example ("Example 37") further than Example 34, the elastomeric elongated tubular member is processed to include an oval cross-section at a first longitudinal portion.

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

[0046] According to another example ("Example 39") further relative to Example 34, the elastomeric slender tubular member includes an integral (integrated) support member at the first longitudinal portion, which imparts an oval cross-section.

[0047] According to another example ("Example 39") that is further than any one of Examples 34 to 39, the elastomeric elongated tubular member at the first longitudinal portion includes a first elongated portion and a second elongated portion defining an oval cross-section, wherein the first elongated portion is operable to self-seal after puncture.

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

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

[0050] According to another example ("Example 43") further relative to Example 42, the integrated support member includes a higher hardness than the remaining portion of the periphery of the slender tubular member at the first longitudinal portion.

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

[0052] According to another example (“Example 45”) that is further relative to any one of Examples 42 to 44, the slender tubular member includes a circular profile.

[0053] According to another example (“Example 46”) that is further relative to any one of Examples 42 to 45, the slender tubular member includes an oval profile.

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

[0055] According to another example ("Example 48") that is further relative to any one of Examples 42 to 47, the slender tubular member is self-sealing.

[0056] According to another example ("Example 49") further than any one of Examples 42 to 48, the support member is bonded or coupled to the elongated tubular member.

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

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

[0059] According to another example ("Example 52") further than any one of Examples 42 to 50, the support member is positioned at the first longitudinal position to be approximately 25% of the circumference (periphery) of the slender tubular member.

[0060] According to another example ("Example 53") that is further relative to any one of Examples 42 to 51, the slender tubular member has no support members at each end of the elastic slender tubular member.

[0061] According to another example ("Example 54") further than any one of Examples 42 to 53, the integrated support member is a rigidization layer.

[0062] According to another example ("Example 55") that is further relative to any one of Examples 42 to 54, the integral support member is a tubular member and supports most of the length of the slender tubular member.

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

[0064] According to another example ("Example 57") further relative to Example 56, each of the plurality of longitudinal segments is a discrete element and is spaced apart from each other.

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

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

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

[0068] According to another example ("Example 61") further than any one of Examples 56 to 60, the tubular member is bonded or incorporated into the receiving cavity.

[0069] According to another example ("Example 62") that is further relative to any one of Examples 56 to 61, the tubular member flexes along the length of the tubular member when engaged with the segmented support member.

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

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

[0072] According to another example ("Example 65") further relative to Example 64, the extension portion is integrated with the segmented support member.

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

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

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

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

[0077] According to another example ("Example 70") further relative to any one of Examples 64 to 69, the extension portion has a thinned profile to facilitate flexing of the tubular member.

[0078] According to another example ("Example 71") further than any of Examples 64 to 70, the segmented support member is operable to place the tubular member in a longitudinally compressed state.

[0079] The foregoing examples are merely examples and should not be construed as limiting or otherwise narrowing the scope of any inventive concept otherwise provided in this disclosure. Although a number of examples are disclosed, other embodiments will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative examples. Therefore, the drawings and detailed description should be considered illustrative in nature and not restrictive in nature. BRIEF DESCRIPTION OF THE DRAWINGS

[0080] 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 is an illustration of an apparatus including a tubular member supported by a support member according to an embodiment;

[0082] Figure 2 is an end view of a support member having an oval profile according to an embodiment;

[0083] Figure 3 is a perspective view of a support member having an oval profile according to an embodiment;

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

[0085] Figure 5 is an end view of a support member according to an embodiment, the support member having a body that is thicker relative to an arm of the support member;

[0086] Figure 6 is an end view of a needle entering an interior lumen of a tubular member supported by a support member according to an embodiment;

[0087] Figure 7 is a top view of a needle entering an interior lumen of a tubular member supported by a segmented support member according to an embodiment;

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

[0089] Fig. 9 is a top view of a support member supported by a segmented support member according to an embodiment, the tubular member including a bent portion;

[0090] Fig. 10A is a side view of a support member according to an embodiment, the support member comprising segments coupled together by extensions;

[0091] Fig. 10B is a perspective view of a support member according to an embodiment, the support member comprising segments coupled together by extensions;

[0092] Fig. 10C is a bottom view of a support member according to an embodiment, the support member including a segment having a chevron-shaped configuration;

[0093] Fig.11 is a perspective view of a tubular member including an integral support member according to an embodiment;

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

[0095] Fig.13 is a cross-sectional view of a tubular member having an integral support member positioned on an exterior surface of the tubular member according to an embodiment;

[0096] Fig.14 is a cross-sectional view of a tubular member having an integral support member positioned on an interior surface of the tubular member according to an embodiment;

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

[0098] Fig.16 is a cross-sectional view of a tubular member having an integral support member positioned less than 50% of the circumference of the tubular member according to an embodiment;

[0099] Fig.17A and Fig. 17B is a cross-sectional view of an overwrapped device according to an embodiment;

[0100] Fig.18 is an exemplary method of manufacturing a device according to an embodiment; and

[0101] Fig.19 is a diagram of a positioning device for assisting in positioning an implantable device when the implantable device is implanted in a patient according to an embodiment. DETAILED DESCRIPTION Definitions and terminology

[0102] This disclosure is not intended to be read in a limiting manner.For example, the terms used in this application should be read broadly in the context of the meaning that one skilled in the art would attribute to such terms.

[0103] Regarding imprecise terms, the terms "about" and "approximately" are used interchangeably to refer to measurements including the measured value and also any measurements that are reasonably (fairly) close to the measured value. As understood and easily determined by a person of ordinary skill in the relevant art, a measurement that is reasonably (fairly) close to the measured value deviates from the measured value by a reasonably small amount. Such deviations may be attributed to, for example, measurement errors, differences in calibration of the measured values ​​and / or manufacturing equipment, human errors in reading and / or setting the measured values, fine-tuning to optimize performance and / or structural parameters in view of differences in the measured values ​​associated with other components, specific implementation scenarios, imprecise adjustments and / or manipulations of objects by humans or machines, and / or the like. In the case where it is determined that a person of ordinary skill in the relevant art will not easily determine a value for such a reasonably small difference, the terms "about" and "approximately" may be understood as the value plus or minus 10%. Description of various embodiments

[0104] Those skilled in the art will readily appreciate that 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 drawings referenced herein are not necessarily drawn to scale, but may be exaggerated to illustrate various aspects of the present disclosure, and in this regard, the drawings should not be construed as limiting.

[0105] Figure 1 The device shown in the figure is provided as an example of various features of one embodiment of the device, and although the combination of those shown features is clearly within the scope of the present invention, the example and its illustration are not meant to imply that the inventive concept provided herein is limited to from fewer features, additional features or alternative features. Figure 1 One or more of those features shown.

[0106] refer to Figure 1 , a device 10 for repeated and repeatable intraluminal access is provided. For example, intravenous access may be necessary for procedures such as dialysis that require repeated access (access) at an access (access) site. The device 10 facilitates access by providing support to the access site to limit leakage after single or multiple punctures, and in some embodiments, provides increased surface area, which can be implemented for providing 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 compressed 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 can be separate from the tubular member 14 so that it is mounted on the tubular member 14 (e.g., removable, attached after manufacturing, etc.), or can be integrally provided with the tubular element 14 (formed together, inseparably fixed thereto, etc.). Each embodiment (i.e., separate and integral support members 12 and tubular members 14) will be discussed in more detail herein.

[0108] Still reference Figure 1 , the illustrated embodiment shows a support member 12 that partially circumferentially surrounds a tubular member 14 and provides structural support for the tubular member 14. The tubular member 14 can take a variety of forms, including grafts, synthetic blood vessels, natural blood vessels, etc. The support member 12 can be used to support the tubular member 14 for a variety of purposes, including but not limited to arteriovenous access ("AV access"), for example, for repeated (access) access such as dialysis. Although the device 10 is discussed in detail with respect to AV access, the device 10 is contemplated and discussed for other purposes.

[0109] Including Figure 1In some embodiments of the illustrated embodiments, the support member 12 is an elongated C-shaped clamp (see also Figure 3 , illustrating the elongated nature of the support member 12). The support member 12 has an interior surface 22 defining a receiving cavity 24 and has an exterior surface 26. The interior surface 22 includes a concave profile, while the exterior surface includes a convex profile. As shown, the interior surface 22 and the exterior surface are curved to have concave and convex profiles; however, within the scope of the present disclosure, the interior and exterior surfaces that are generally provided with concave and convex profiles are not curved, or are not completely curved (for example, but are instead formed by straight sections). The receiving cavity 24 is operable to receive the tubular member 14 so that the tubular member 14 is positioned and retained within the receiving cavity 24 and positioned against the interior surface 22 of the support member 12.

[0110] refer to Figure 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, so that the tubular member 14 can be advanced into the receiving cavity 24 by passing the tubular member 14 through the peripheral opening 28. This allows the tubular member 14 to remain intact during installation with the support member 12. This may be important when the tubular member 14 is a native blood vessel or an implanted graft, thereby eliminating the need to pass one end of the tubular member 14 through the support member 12, which would require bisecting (halving) the tubular member 14 in order to pass one end of the tubular member through the support member 12.

[0111] The width 30 of the peripheral opening 28 of the support member 12 is less than the inner dimension 32 of the receiving cavity 24 (e.g., the widest portion of the inner diameter of the non-circular profile, the inner diameter representing the distance between opposite sides of the inner surface, see Figure 2 ). This achieves that when the tubular member 14 is positioned in the receiving cavity 24, the support member 12 surrounds the tubular member 14 greater than 180 degrees and less than 360 degrees. For example, when the tubular member 14 is installed in the support member 12, the support member 12 can surround the tubular member 14 from about 190 degrees to about 215 degrees, from about 215 degrees to about 240 degrees, from about 240 degrees to about 265 degrees, from about 265 degrees to about 290 degrees, and from about 290 degrees to about 325 degrees. The width 30 of the peripheral opening 28 can be larger in some embodiments and smaller in other embodiments. When the width 30 of the peripheral opening 28 is relatively smaller than the embodiment in which the width 30 of the peripheral opening 28 is larger, the clamping force (and the compression force described below) of the support member 12 can be increased. For example, the clamping force can be increased by increasing the width of the peripheral opening 28, and the clamping force can be reduced by increasing the width of the peripheral opening 28.

[0112] In some embodiments, support member 12 is sized such that the inner perimeter of support member 12 (including width 30 of perimeter opening 28) is smaller than the outer perimeter of tubular member 14. By sizing the inner perimeter of support member 12 smaller than the outer perimeter of tubular member 14, when tubular member 14 is engaged with support member 12, the tubular member is placed in a compressed state (e.g., compression around the perimeter of tubular member 14). The compression reduces leakage and helps reseal the tubular member 14 during and after a puncture (e.g., a needle puncture for dialysis). The compression pushes the sides of the opening formed by the puncture back into contact with each other to help prevent or reduce fluid leakage through the puncture. The amount of compression can be varied by adjusting the relative circumferences of the support member 12 and the tubular member 14. Greater compression can be achieved by providing a narrower width 30 of the peripheral opening 28, thereby placing the tubular member 14 in increased contact with the interior surface 22 of the support member 12 (e.g., compression can be increased by reducing the width of the peripheral opening 28). The narrower width 30 of the peripheral opening 28 can also limit the protrusion of the tubular member 14 from the support member 12 at the peripheral opening 28, which can reduce compression of the tubular member 14, including at the portion that protrudes outward from the peripheral opening 28. Thus, the narrower width 30 can facilitate the use of a tubular member 14 with an increased outer diameter to promote increased compression of the tubular member 14.

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

[0114] In some embodiments, the support member 12 includes a material that is substantially resistant to (resistance to) needle penetration under typical forces manually applied by a user. This limits the travel of the needle through the device 10. For example, the tubular member 14 can be punctured at the peripheral opening 28 of the support member 12 for intraluminal access, but because the body of the support member 12 is not penetrated by the needle, the travel through the opposite side of the tubular member is limited. This limits the user's ability to potentially fully extend the needle through the tubular member 14, which may result in excessive bleeding, delivery of fluid outside the lumen of the tubular member 14, ineffective absorption of fluid from the lumen of the tubular member 14, etc. Figure 6 , which illustrates a needle 1000 that is restricted from traveling through a support member 12. The support member 12 includes a material that is resistant to needle penetration (e.g., Nitinol). It should be noted that the needle 1000 can penetrate a portion of the back side of the tubular member 14, but is restricted from moving beyond by the support member 12. Therefore, the lumen or bore (pore) of the needle 1000 is in fluid communication with the lumen of the tubular member 14, and the fluid can be delivered to the lumen of the tubular member 14 and / or received by the lumen of the tubular member 14. Various materials can be used in constructing the support member 12 to resist needle penetration, including but not limited to biocompatible metals, alloys, polymers, etc.

[0115] In some embodiments, in order to improve the cannulation path, the typical circular cross-section of the tubular member 14 can be compressed and constrained to an oval or elliptical shape. By increasing the major axis of the oval, the user (e.g., a clinician, a phlebotomist, or a patient) can aim at and penetrate a larger area. By increasing the major axis, the minor axis is reduced. Due to the reduction in the minor axis, the distance that the needle 1000 can be inserted and still remain in the lumen of the tubular member 14 is reduced. The addition of a relatively puncture-resistant area (e.g., a support member 12) relative to the cannulation area (one or more) limits the occurrence of a user passing through the back side of the tubular member 14. The combination of an ovalization (to increase the cannulation area) and a puncture-resistant back wall (dorsal wall) area provides an improved graft structure.

[0116] In some embodiments, the support member 12 includes at least a partially radiopaque material so that the support member 12 can be seen during delivery, deployment, and use. For example, the support member 12 can be viewed during radiography so that a user attempting to gain arterial or venous access can observe the position of the support member 12 to successfully gain access with fewer punctures. Various radiopaque markers can be positioned around the support member 12 and / or tubular member 14 to aid in the delivery and implantation of the device 10.

[0117] refer to Fig.19In some embodiments, a positioning device 54 can be used in conjunction with the device 10 to help position, align and / or keep the device 10 stable. In one embodiment, the device 10 includes a portion 58 (e.g., adjacent to the peripheral opening 28 of the support member 12) that has magnetic properties (e.g., magnetized) or is attracted by a magnet (e.g., ferromagnetic). The positioning device 54 can include a donut-shaped magnetic or ferromagnetic piece located outside the patient (e.g., an arm for dialysis) that is adjacent to the device to magnetically attract (e.g., magnetically couple) the positioning device 54 and the device 10 together. When a user (e.g., a professional or a patient receiving dialysis treatment at home) positions the "target" to insert the cannula needle 1000 through the donut-shaped hole of the positioning device 54, the device 10 is positioned, aligned and / or kept stable. In some embodiments, the donut-shaped hole of the positioning device 54 can have an indicator 56 (e.g., a numbered / lettered mark) around the donut-shaped hole (e.g., similar to an analog clock). The indicator 56 may be provided daily so that the user can find a different indicator each day (e.g., a Tuesday marker) and insert the needle 1000 next to the indicator 56 rather than reinserting it at the same location day after day.

[0118] In some embodiments, the support member 12 can be formed of a bioabsorbable or bioresorbable material. This allows the support member to be implemented in the user's body for a limited time without having to perform a second operation to remove the support member 12. For example, regular IV access may be required for a limited time. The support member 12 can be implemented for a limited time and can be slowly reabsorbed by the patient, with the reabsorption period being adjusted to ensure that the support member 12 remains structurally intact during the expected use period.

[0119] refer to Figure 2 and Figure 3 , the inner surface 22 of the support member 12 has a generally oval cross-section. Figure 4 As shown, the interior surface 22 of the support member 12 presents a circular cross-section. It should be understood that various other cross-sections may be implemented for various purposes. The interior surface 22 of the support member 12 having the cross-section in question is operable to maintain the same cross-sectional area of ​​the tubular member 14 inside the receiving cavity 24 and outside the receiving cavity 24. In other words, the interior surface 22 of the support member 12 determines the configuration in which the tubular member 14 will be maintained when engaged with the support member 12. Various configurations may provide various functions.

[0120] For example, refer to Figure 1, the support member 12 includes an interior surface 22 having an oval cross-section, thereby placing the tubular member 14 in an ovalized shape where the tubular member 14 is engaged with the support member 12. The ovalized 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 because the peripheral opening 28 is defined along the elongated portion of the oval. The relatively flat surface of the tubular member 14 provides the tubular member 14 with an easier access (entry) site to implement (e.g., for IV access including dialysis). The relatively flat profile of the tubular member 14 reduces the occurrence of an access needle grazing (deflecting after impacting the surface) from one side of the tubular member 14 (i.e., the curved surface of the tubular member 14 is more difficult to penetrate unless the needle is radially aligned with the circular profile). The flattened sidewalls of the tubular member 14 make access reliable and easily accessible. In other embodiments, a circular profile may be required so that the support tubular member 14 is constructed with a circular profile. For example, a natural blood vessel may need to be supported with a circular profile (see Figure 4 ). In some embodiments, by maintaining a circular profile of the tubular member 14, appropriate fluid dynamics and resistance to degradation may be provided. For example, in some applications such as dialysis, the tubular member 14 is positioned at a high pressure, high velocity location for blood flow, and the hemodynamics may be such that the circular profile of the tubular member 14 interferes less or not with the hemodynamics of the blood vessel. The circular profile of the tubular member 14 may also provide a longer life for the tubular member 14 during use.

[0121] refer to Figures 2 to 5 , describes the support member 12 in more detail. The support member 12 includes a main body portion 40 and an arm portion 42. The arm portion 42 extends from the main body portion 40. The arm portions 42 each extend from an opposing portion of the main body portion 40, such that each arm portion 42 is opposed to each other. The arm portions 42 define a peripheral opening 28, such that a passage to the receiving cavity 24 is provided between the arm portions 42 that are opposed to each other. The arm portions 42 are curved, such that the arm portions 42 and the main body portion 40 define the receiving cavity 24. In some embodiments, the main body portion 40 may also be curved (see Figure 2 and Figure 3 ), while in some embodiments, the main body portion 40 is substantially flat (see Figure 6). In some embodiments, the arm portion 42 includes a material having a lower hardness than the hardness of the main body portion 40. This allows the arm portion 42 to include a deflection function to facilitate the insertion of the tubular member 14 into the receiving cavity 24. Once the tubular member 14 is positioned in the receiving cavity 24, if deflection occurs during the insertion of the tubular member 14, the arm portion 42 will return to an undeflected configuration. The arm portion 42 can apply a compressive force to the tubular member 14 (e.g., for the compression discussed previously). In some embodiments, at least the arm portion 42 is formed of a shape memory material such as nitinol. By including a shape memory material, the arm portion 42 may be able to apply an increased compressive force. In some embodiments, the entire support member 12 is formed of a shape memory material and applies a compressive force to the tubular member 14 across most of the circumference of the tubular member 14.

[0122] refer to Figure 5 In some embodiments, the body portion 40 is thicker than the arm portion 42. This can allow the arm portion 42 to flex more while allowing the body portion 40 to more firmly retain the shape of the support member 12. The relatively thick body portion 40 also allows the body portion 40 to have enhanced durability as a needle backstop. In some embodiments, the flexure of the arm portion 42 can promote bending (flexion) in multiple bending (flexion) planes.

[0123] It should be understood that the support member 12 can also support the tubular member 14 to reduce twisting of the tubular member 14 during implantation. Twisting of the tubular member 14 during implantation can lead to undesirable hemodynamics and can also cause kinking of the tubular member 14. By supporting the tubular member 14 with the support member 12, the tubular member 14 is held to reduce the risk of twisting of the tubular member 14.

[0124] refer to Figure 7 to Figure 1 0, in some embodiments, the support member 12 is segmented to include a plurality of longitudinal segments 50. Each longitudinal segment 50 is operable to at least partially surround a portion of the tubular member 14. The longitudinal segments 50 are operable to facilitate flexing of the elongated tubular member 14 when positioned with the support member 12. When mounted on the tubular member 14, each longitudinal segment 50 is spaced apart from one another. By including a plurality of longitudinal segments 50 and spacing the longitudinal segments 50 apart from one another, the tubular member 14 is operable to flex at least partially along the length at which it engages the support member 12. This allows the support member 12 to be implanted in the patient's anatomy at a location where a bend or curve is located. Figure 8A tubular member 14 is depicted having a support member 12 coupled thereto, the support member 12 being segmented, with the tubular member 14 positioned in a bent configuration. Because the individual longitudinal segments 50 are spaced apart from one another, the tubular member 14 can be manipulated to bend even when 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 imparts flexibility (flexibility) to the support member 12 while also allowing the support member 12 to resist puncture (e.g., being rigid in at least one plane to resist puncture by a needle 1000). The flexing of the support member 12 can be within a single bending plane or within multiple bending planes. As described above, the support member 12 can be configured to have a plurality of longitudinal segments 50 spaced apart from one another. Figure 8 As shown, the concave side of the bend of the bent tubular member 14 positions the arm portion 42 on the concave side closer to the adjacent segment on the concave side than the arm portion 42 on the convex side. The spacing of the various longitudinal segments 50 can be such that the space is slightly smaller 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 travel through the space between the longitudinal segments.

[0125] refer to Figure 8 and Fig. 9 , the longitudinal segments 50 can be separated from each other (e.g., each longitudinal segment 50 is a discrete element). In this embodiment, each longitudinal segment can be mounted separately to the tubular member 14. The longitudinal segments 50 can be spaced apart from each other by any distance determined by the user. The distance of each longitudinal segment 50 can be sufficient to allow the tubular member 14 to have a specific curvature imparted by the support member 12 mounted on the tubular member 14. When the tubular member 14 includes a larger curvature or is to be implanted with a larger curvature, the longitudinal segments 50 can be spaced apart from each other by a larger distance than when a smaller curvature is required, and the smaller curvature allows the longitudinal segments 50 to be positioned more closely together. In some embodiments, when a curvature is included or applied to the tubular member 14, portions of adjacent longitudinal segments 50 can 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 such Fig. 10A and Fig. 10BIn other embodiments shown, the longitudinal segments 50 can be coupled to each other via extensions 52 (e.g., multiple longitudinal segments 50 are integral members forming the support member 12, and the support member 12 includes extensions extending between adjacent longitudinal segments). The extensions 52 can be integrally formed with each longitudinal segment 50, or the extensions 52 can be coupled to the longitudinal segments 50 (e.g., welded to, bonded to, operable to receive them, etc.). When in a neutral orientation, the extensions 52 position the longitudinal segments 50 at a fixed distance from each other. The extensions 52 are operable to bend or deflect, thereby facilitating the bending (curvature) of the tubular member 14. In some embodiments, the bending or deflection of the extensions 52 is along a single bending plane (e.g., bending along the extensions 52). The extensions 52 can be formed from a variety of materials, including materials capable of plastic deformation and elastic deformation. For example, the extensions 52 can be formed from Nitinol to facilitate bending of the support member 12. The use of nitinol or other sufficiently resilient and / or rigid material can also make the extension portion 52 resistant to puncture (e.g., puncture by needle 1000). In some embodiments, the material thickness of the extension portion 52 is less than the thickness of the longitudinal segment 50, thereby allowing the support member 12 to bend or deflect at the extension portion 52 (e.g., the extension portion 52 includes a thinned profile operable to facilitate flexure). Fig. 10A and Fig. 10B As shown, the extension portion 52 can extend from the main body portion 40 of the adjacent longitudinal segment, thereby leaving the arm portion 42 free of (without) the extension portion 52. In some embodiments, the support member 12 is operable to place the tubular member 14 in a longitudinally compressed state. In some embodiments, the support member 12 can be manufactured by densifying an expandable material such as ePE or ePTFE, 3D printing (e.g., PE) or machining, casting, or molding.

[0127] Various configurations of the longitudinal section 50 may be provided, including Fig. 10C The various configurations may be implemented to accommodate a variety of functions, including bending profiles, such as curve radii or bends in a single plane. For example, Fig. 10B A longitudinal segment 50 is shown including a nested pattern, wherein the longitudinal segment 50 is V-shaped. An extension may or may not be implemented to connect each longitudinal segment 50 having such a configuration. In some embodiments, the support member 12 may include different gap widths between the longitudinal segments 50. This may be along the length of the body of the support member 12, or may be on one lateral side (lateral side) compared to another lateral side (lateral side) (e.g., to facilitate unidirectional bending).

[0128] A method of assembling a support member 12 to a tubular member 14 includes elongating the tubular member to neck down (narrow) the outer diameter of the tubular member 14 to be received in a receiving cavity 24 of the support member 12 (e.g., a C-clamp), wherein the diameter of the receiving cavity 24 of the support member 12 is smaller than the outer diameter of the tubular member 14 when the tubular member 14 is not in a compressed state. In some embodiments, the outer dimension of the tubular member 14 when in a compressed state is in a range from 0.1% to about 10% relative to the outer dimension of the elongated tubular member when not in a compressed state. In some embodiments, the method includes deflecting the arm portion 42 away from the body portion 40, thereby enlarging the peripheral opening 28, which is operable to receive the tubular member 14 in 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 placed around the natural blood vessel to support the natural blood vessel. In some embodiments, the tubular member 14 is formed of a biological material (e.g., an autologous graft, a cadaver graft, etc.). In some embodiments, the tubular member 14 is formed of a synthetic material. Any material used can be a material that can be operated to seal after needle puncture. The recovery and resealing of the tubular member 14 can be enhanced by the support member 12 to maintain the tubular member 14 in a compressed state to recover from a needle puncture (e.g., a 12-gauge needle).

[0130] refer to Fig.11 In some embodiments, an AV access graft 100 is provided, wherein the AV access graft 100 includes an elastomeric elongated tubular member 102 including a first longitudinal portion 104 having an oval cross-section and resisting deformation along the first longitudinal portion 104 such that when implanted in a human body and exposed to biological forces, the oval cross-section at the first longitudinal portion 204 is retained. In some embodiments, the tubular member 102 is processed to include the oval cross-section at the first longitudinal portion 104. In some embodiments, the elongated tubular member 102 is heat set to include the oval cross-section at the first longitudinal portion 104.

[0131] refer to Fig.12In 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 oval cross-section. In some embodiments, the elongated tubular member 102 is heat set to include an oval cross-section at the first longitudinal portion 104. In some embodiments, the integral support member 106 is a rigidizing layer. The rigidizing layer can be used to provide support to retain a predetermined shape, and it can be operable to provide a stop (piece) to resist needle penetration and / or provide tactile feedback when the needle is located within the lumen of the elongated tubular member 102. The rigidizing layer includes sufficient hardness to prevent needle penetration through the back side of the tubular member 102 (e.g., Shore D or a higher hardness with a maximum value of about Mohs 10). 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 located on the outer surface (see Fig.13 ), internal surface (see Fig.14 ) or along a portion of the periphery of the tubular member 102 (see Fig.12 ) are positioned throughout the thickness of the tubular member 102.

[0132] Fig.15 A tubular member 102 is shown that includes an integral support member 106 located at a first longitudinal portion 104 (e.g., the tubular member 102 may include a supported portion and an unsupported portion for needle entry), and the integral support member 106 is absent from at least the second longitudinal portion 108 and the third longitudinal portion 109 of the tubular member 102. In some embodiments, the integral support member 106 supports the tubular member 102 at the first longitudinal portion 104, which may include most of the length of the tubular member. For example, the integral support member 106 may include approximately 40 cm or 45 cm of the tubular member. However, the integral support member 106 may be provided along any portion or all of the length of the tubular member 102. In some embodiments, the tubular member 102 does not have a support member 106 at each end of the tubular member 102. This allows the surgeon to cut the tubular member 102 to a desired length and angle without having to cut through the support member 12. For scenarios where the device 10 is implemented for intubation, the support member 12 may be implemented in the intubation area, but may be considered optional in other areas.

[0133] The support member 106 can at least partially impart an oval cross-section. In some embodiments, the tubular member 102 at the first longitudinal portion 104 includes a first elongated portion 110 and a second elongated portion 112 defining an oval cross-section, wherein the first elongated portion is operable to self-seal after puncture. In some embodiments, the second elongated portion 112 is reinforced to resist puncture. It should be understood that various other cross-sectional profiles can be implemented. For example, a circular cross-section can be implemented, which is at least partially imparted and maintained by the integral support member 106. Fig.15 As shown, the support member 106 is positioned around approximately 75% or 270 degrees of the tubular member 102. It should be understood that in various embodiments, the support member 106 can be positioned around various portions of the tubular member 102. For example, the support member 106 can be positioned around the support member over 180 to 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). By providing a larger support area on the tubular member 102, it is less likely that the needle will pass through the back side of the tubular member 102 during puncture. With the oval configuration, as previously described, unsupported areas can be more easily accessed.

[0134] The device 10 can transition from a substantially circular shape to a substantially oval shape 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 oval shape, then transition back to a circular shape, then gradually transition to a second oval shape, and then transition back to a circular shape at the other end. The two oval regions are cannulation regions (e.g., in the case of an AV access). The user can feel these regions (through the skin) to know where the oval portion of the device 10 is. 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 disruption and thrombosis at the transition region.

[0135] refer to Fig.16, another embodiment of a tubular member 102 is provided in which a support member 106 is positioned around less than about 50% of the circumference of the tubular member 102. A circular profile of the tubular member 102 is shown, but it should be understood that any number of configurations may implement the positioning of the support member 106 around less than about 50% of the circumference of the tubular member 102. It should also be understood that the various configurations discussed above with respect to positioning of an integral support member 106 on an interior surface, an exterior surface, or throughout the thickness of the tubular member including a portion of the circumference of the tubular member 102 may be implemented with respect to the support member 106 being positioned around less than about 50% of the circumference of the tubular member 102. For example, the support member 102 may be positioned around the support member over (a range of) 10 to 180 degrees of the tubular member 102 (e.g., from about 10 degrees to about 45 degrees, from about 45 degrees to about 90 degrees, from about 90 degrees to about 135 degrees, and from about 135 degrees to about 180 degrees). By providing a support member on less than 50% of the circumference of tubular member 102, the surface area for access to the lumen of tubular member 102 is increased while still providing a backstop (thrust member) to reduce needle penetration through the back side of tubular member 102.

[0136] refer to Fig.17A and Fig. 17B , shows a device 10 that includes a tubular member according to any embodiment described herein (e.g., tubular member 14 or tubular member 102) and a support member according to any embodiment discussed herein (e.g., support member 12 or integrated support member 106). Support member 12 and tubular member 14 are coupled to each other via adhesive 200. An overwrap 202 can be applied over the assembly. Overwrap 202 can apply a compressive force (e.g., Fig. 17B 206) (in some embodiments, the compressive force can be added in addition to the compressive force applied by the support member). Before the overwrap 202 is applied, the device 12 can include a first diameter 204 along the long axis. After the overwrap 202 has been applied, the device 12 can include a second diameter 206 along the long axis, wherein the second diameter 206 is smaller than the first diameter 204. This occurs due to the compressive force applied by the overwrap 202.

[0137] As previously mentioned, the embodiments discussed herein can be implemented in a variety of contexts and are not limited to any specific embodiments discussed herein. For example, the use of the device 10 for cannulation (e.g., in hemodialysis) is discussed in detail. However, other applications are also applicable, such as use on the anastomotic side, so the description provided herein is not limited to cannulation. For example, the increased hardness of the device can be implemented at the anastomotic site, wherein the increased hardness reduces bleeding from the suture hole. Another example can include when the support member 12 is implemented on a natural blood vessel. For example, the support member 12 can be implemented at the following position, where the blood vessel is compressed by other anatomical structures competing for the same space in the body. For example, this occurs 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 can be implanted outside a blood vessel (e.g., the left iliac vein) to restore blood flow and / or capacity of the blood vessel.

[0138] refer to Fig.18 , a method of making a device 10 is provided. The method includes making an intraluminal graft component (e.g., elongated tubular member 14), making a support component (e.g., support member 12), assembling the graft and support component 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 wrapping the device.

[0139] In any embodiment discussed herein, tubular member 102 may include various materials and compositions, including biocompatible materials that can be operated to self-seal after puncture. For example, when intravenous access is needed soon after tubular member 102 is implanted, such material may be implemented. Other biocompatible materials may be implemented, which are operable to promote tissue ingrowth, thereby allowing tissue to provide sealing capabilities after sufficient tissue has been included in the material. Materials may be selected for various properties of the material (such as durability, hardness, thickness, etc.) to optimize the tubular member (e.g., for high-speed flow, life of the implant, low profile of the implant, etc.) for its application. In some embodiments, tubular member 102 is formed by a single layer of material.

[0140] The biocompatible materials for tubular member components discussed herein can be used. In some cases, the graft can include fluoropolymers, such as polytetrafluoroethylene (PTFE) polymers or expanded polytetrafluoroethylene (ePTFE) polymers. In some cases, the graft can be formed by, for example, but not limited to polyester, silicone, polyurethane, polyethylene terephthalate, fluorinated ethylene propylene, polyethylene (PE), expanded polyethylene (ePE) or another biocompatible polymer or a combination thereof. In some cases, bioresorbable materials or bioabsorbable materials can be used, for example, bioresorbable polymers or bioabsorbable polymers. In some cases, the graft can include dacron, polyolefin, carboxymethyl cellulose fabric, polyurethane or other woven fabrics, nonwovens or (thin) film elastomers. Biological grafts can also be implemented, including but not limited to bovine carotid artery or laboratory cultured blood vessels.

[0141] In some embodiments, it should be understood that the support member can include surface textures to promote tissue ingrowth or exclude tissue incorporation (incorporation). This can be achieved in various 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 embodiment discussed herein can be provided with a straight configuration or a curved configuration. When the device is positioned with at least one bend (e.g., as an arteriovenous graft), the curved configuration can provide a stress-free state when implanted.

[0143] In addition, NiTi (NiTi) can be used as the material of framework or support (and any framework discussed herein), but other materials, such as but not limited to stainless steel, L605 steel, polymer, MP35N steel, polymeric material, Phynox, Elgiloy (Elgiloy non-magnetic alloy) or any other suitable biocompatible material and their combination can be used as the material of framework. The superelasticity and softness of NiTi can enhance the conformability of support. In addition, NiTi shape can be set to a desired shape. That is, NiTi can be set to a shape so that when the framework is unconstrained, for example, when the framework is deployed from a delivery system, the framework tends to self-expand into a desired shape.

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

Claims

1. A device for supporting an elongated tubular member, the device include: A support member having an interior surface defining a receiving cavity, the support member further defining a peripheral opening, wherein the receiving cavity is operable to receive an elongated tubular member therein, the support member being operable to place the elongated tubular member in a compressed state about the periphery.

2. The device according to claim 1, It is characterized in that The receiving cavity is adhesively coupled to the elongated tubular member.

3. The device according to claim 1, It is characterized in that The support member comprises a material that resists needle penetration under typical forces applied manually by a user.

4. The device according to claim 3, It is characterized in that The support member comprises a bioabsorbable material.

5. The device according to any one of claims 1 to 4, It is characterized in that The peripheral opening of the support member is about 10% to about 90% of the circumference of the elongated tubular member.

6. The device according to any one of claims 1 to 4, It is characterized in that The interior surface of the support member presents an oval cross-section.

7. The device according to any one of claims 1 to 4, It is characterized in that The inner surface of the support member presents a circular cross-section.

8. The device according to any one of claims 6 to 7, It is characterized in that The support member is operable to maintain the same cross-sectional area of ​​the elongated tubular member within and outside of the receiving cavity.

9. The device according to any one of claims 1 to 8, It is characterized in that The support member has two opposing arms defining the peripheral opening, the two opposing arms being interconnected by a body and comprising a material having a lower hardness than the body.

10. The device according to claim 8, It is characterized in that The two opposing arms apply a compressive force to the elongated tubular member.

11. The device according to any one of claims 9 to 10, It is characterized in that The two opposing arm portions are formed from a shape memory material.

12. The device according to claim 11, It is characterized in that The shape memory material is Nitinol.

13. The device according to any one of claims 9 to 12, It is characterized in that The body is thicker than the two opposing arms.

14. The device according to any one of claims 1 to 10, It is characterized in that The support member includes a plurality of sections along a longitudinal length operable to facilitate flexing of the elongated tubular member when positioned by the support member.

15. The device according to claim 14, It is characterized in that The plurality of segments are discrete elements.

16. The device according to claim 14, It is characterized in that 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 thinned profile operable to facilitate flexing.

17. The device according to any one of claims 14 to 16, It is characterized in that The plurality of segments facilitate flexing of the elongated tubular member.

18. The device according to any one of claims 14 to 17, It is characterized in that The support member is puncture-resistant.

19. The device according to any one of claims 1 to 17, It is characterized in that The support member is operable to place the tubular member in a compressed state.

20. The device according to any one of claims 1 to 5, Features Also included is a positioning device operable to magnetically couple to the support member, the positioning device forming a donut-shaped hole through which a needle can be inserted.

21. The device according to claim 15, It is characterized in that The positioning means comprises indicators around the perimeter of the donut-shaped hole, the indicators indicating different positions for needle insertion.

22. A method of assembling a support member according to any one of claims 1 to 7 to an elongate tubular member, the method comprising overlapping the support member and the elongate tubular member to apply a compressive force to the tubular member, in, The diameter of the support member in the overwrap is smaller than the diameter of the support member prior to application of the overwrap.

23. The method of assembling a support member according to claim 17, It is characterized in that Overwrapping is performed after applying an adhesive coupling the support member and the elongated tubular member and curing the adhesive.

24. A method of assembling a support member according to any one of claims 1 to 7 to an elongated tubular member, the method comprising extending the tubular member to neck down the outer diameter of the elongated tubular member to be received in the receiving cavity of the support member, in, When the tubular member is not in a compressed state, the receiving cavity of the support member has a diameter that is smaller than an outer diameter of the tubular member.

25. A method of assembling a support member according to claim 23 to an elastomeric tubular member, the method comprising deflecting the arm away from the body, enlarging the peripheral opening, the peripheral opening being operable for receiving the tubular member in the receiving cavity.

26. An AV access graft, include: an elongated tubular member defining an inner lumen; as well as An elongated support member defining a receiving cavity and defining a peripheral opening, wherein the receiving cavity is operable to receive the elongated tubular member therein, the elongated support member being operable to place the tubular member in a circumferentially compressed state.

27. The AV access graft according to claim 25, It is characterized in that The receiving cavity is operable to receive an adhesive to couple the elongated tubular member within the receiving cavity.

28. The AV access graft according to any one of claims 25 to 26, It is characterized in that The elongated tubular member is an artery or a vein.

29. The AV access graft according to any one of claims 25 to 26, It is characterized in that The elongated tubular member is a biological material, a synthetic material, or a combination thereof.

30. The AV access graft according to any one of claims 25 to 28, It is characterized in that The elongated tubular member is operable in a circumferentially compressed state to recover and seal after being punctured by a 14, 15, 16, or 17 gauge needle.

31. The AV access graft according to any one of claims 25 to 28, It is characterized in that An outer dimension of the elongated tubular member when in the circumferentially compressed state is in a range of about 1% to about 10% relative to an outer dimension of the elongated tubular member when not in the circumferentially compressed state.

32. The AV access graft according to any one of claims 25 to 28, It is characterized in that The elongated tubular member includes an oval cross-section along at least a portion of the elongated tubular element, wherein the elongated tubular member is supported by the support member.

33. The AV access graft according to any one of claims 25 to 31, It is characterized in that The support member is an elongated C-shaped clamp.

34. An AV access graft, include: An elastomeric elongated tubular member includes a first longitudinal portion having an oval cross-section and resists deformation along the first longitudinal portion such that when implanted in the body, the oval cross-section at the first longitudinal portion is retained when exposed to biological forces.

35. The AV access graft according to claim 34, It is characterized in that The elastomeric elongated tubular member includes a rigidifying layer at the first longitudinal portion.

36. The AV access graft according to claim 34, It is characterized in that The elastomeric elongated tubular member includes a shape memory layer at the first longitudinal portion.

37. The AV access graft according to claim 34, It is characterized in that The elastomeric elongated tubular member is processed to include an oval cross-section at the first longitudinal portion.

38. The AV access graft according to claim 37, It is characterized in that The elastomeric elongated tubular member is heat set to include the oval cross-section at the first longitudinal portion.

39. The AV access graft according to claim 34, It is characterized in that The elastomeric elongated tubular member includes an integral support member at the first longitudinal portion, the integral support member imparting the oval cross-section.

40. The AV access graft according to any one of claims 34 to 39, It is characterized in that The elastomeric elongated tubular member at the first longitudinal portion includes a first elongated portion and a second elongated portion defining the oval cross-section, wherein the first elongated portion is operable to self-seal after puncturing.

41. The AV access graft according to any one of claims 34 to 39, It is characterized in that The second elongated portion is reinforced to resist puncture. 42.An AV access graft, include: An elongated tubular member includes a first longitudinal portion having an integral support member over a portion of a periphery of the elastomeric elongated tubular member at the first longitudinal portion.

43. The AV access graft according to claim 42, It is characterized in that The integral support member includes a higher stiffness than a remainder of the periphery of the elongated tubular member at the first longitudinal portion.

44. The AV access graft according to any one of claims 42 to 43, It is characterized in that The elongated tubular member is a fluoropolymer.

45. The AV access graft according to any one of claims 42 to 44, It is characterized in that The elongated tubular member includes a circular profile.

46. ​​The AV access graft according to any one of claims 42 to 45, It is characterized in that The elongated tubular member includes an oval profile.

47. The AV access graft according to claim 45, It is characterized in that The integral support member at least partially imparts the oval profile to the elongated tubular member.

48. The AV access graft according to any one of claims 42 to 47, It is characterized in that The elongated tubular member is self-sealing.

49. The AV access graft according to any one of claims 42 to 48, It is characterized in that The support member is bonded or otherwise joined to the elongated tubular member.

50. The AV access graft according to any one of claims 42 to 48, It is characterized in that The elongated tubular member is formed from a single layer of material.

51. The AV access graft according to claim 50, It is characterized in that The support member is a densified region of the elongated tubular member.

52. The AV access graft according to any one of claims 42 to 50, It is characterized in that The support member is positioned at a first longitudinal position at approximately 25% of the circumference of the elongated tubular member.

53. The AV access graft according to any one of claims 42 to 51, It is characterized in that The elongated tubular member is devoid of the support member at each end of the resilient elongated tubular member.

54. The AV access graft according to any one of claims 42 to 53, It is characterized in that The integral support member is a rigidifying layer.

55. The AV access graft according to claims 42 to 54, It is characterized in that The integral support member is a tubular member and supports a majority of the length of the elongated tubular member.

56. A device for supporting a tubular member, the device include: A segmented support member comprising a plurality of longitudinal segments having an interior surface defining a receiving cavity, wherein the receiving cavity is operable to engage the tubular member therein, each of the plurality of longitudinal segments at least partially surrounding a portion of the tubular member.

57. The device according to claim 56, It is characterized in that Each of the plurality of longitudinal segments is a discrete element and is spaced apart from one another.

58. The device according to claim 57, It is characterized in that The segmented support member is substantially rigid and the tubular member is able to bend due to the spacing of the longitudinal segments.

59. The device according to claim 58, It is characterized in that The distance between each of the plurality of longitudinal sections determines the degree of bending of the tubular member.

60. The device according to claim 58, It is characterized in that When the tubular member is bent, each longitudinal segment of the plurality of longitudinal segments contacts an adjacent longitudinal segment along the inner curvature.

61. The device according to any one of claims 56 to 60, It is characterized in that The tubular member is bonded or incorporated into the receiving cavity.

62. The device according to any one of claims 56 to 61, It is characterized in that The tubular member flexes along the length of the tubular member when engaged with the segmented support member.

63. The device according to any one of claims 56 to 62, It is characterized in that The segmented support section is puncture resistant.

64. The device according to claims 56 to 63, It is characterized in that Each of the plurality of longitudinal segments is connected together by an extension portion.

65. The device according to claim 64, It is characterized in that The extension portion is integral with the segmented support member.

66. The device according to claim 64, It is characterized in that The extension portion is coupled or bonded to the segmented support member.

67. The device according to any one of claims 64 to 66, It is characterized in that When in a neutral orientation, the extension portion positions each longitudinal segment of the plurality of longitudinal segments at a fixed distance from an adjacent longitudinal segment.

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

69. The device according to claims 64 to 68, It is characterized in that The extension portion is made of a shape memory material including Nitinol.

70. The device according to any one of claims 64 to 69, It is characterized in that The extension portion has a thinned profile to facilitate flexing of the tubular member.

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

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